A Quien Le Amarga Un Dulce La Regla (Ii), Amchafibrin

La HIPERMENORREA es un sangrado uterino anormal: la cantidad del sangrado durante la menstruacion es mayor de lo normal. No se trata del tiempo que dure sino de cuanta sangre se pierde, aunque una regla de mas de 7 dias no es lo normal. Se entiende como cantidad excesiva los 80ml por ciclo (lo normal son 30-40ml). Dado que estimar esa cantidad no es facil, suele hacerse mediante la cantidad de compresas empapadas completamente con sangre. Mas de 6 al dia se considera hipermenorrea. Segun la Universidad de Pittsburg un 30% de las mujeres tienen una menstruacion abundante, pero solo un 10% sufre menorragia o hipermenorrea. En las sociedad occidentales es la causa mas frecuente de anemia.

El termino menorragia tambien es utilizado por los medicos como sinonimo de hipermenorrea. Algunos las diferencian, senalando que la segunda es un sangrado uterino regular pero de cantidad excesiva; y la menorrgia, una perdida ginecologica excesiva con caracteristicas de hemorragia, de duracion prolongada y que aparece a intervalos regulares.

Otras mujeres sufren un sangrado intermenstural (a mediados del ciclo), es lo que se llama metrorragia (de cantidad variable) o spotting (sangrado escaso que se produce entre dos periodos normales y que ocurre cuando se produce una caida de estrogenos despues de la ovulacion o por la toma de anticonceptivos orales); por lo general no requiere tratamiento.

La principal causa encontrada para la hipermenorrea o menorragia es un trastorno en la contraccion del musculo uterino (miometrio), que es insuficiente para comprimir los vasos sangrantes y finalizar la hemorragia. Otras posibles causas son la menstruacion sin ovulacion o sangrado ovulatorio, la presencia de miomas o fibromas, la endometriosis, las alteraciones endocrinologicas (hipo - o hipertiroidismo fundamentalmente), el embarazo ectopico o la anemia ferropenica (esta puede ser causa de o estar causada por la menorragia). Para descartarlas se realizan analisis de sangre (para conocer los niveles de ferritina, hemoglobina, plaquetas y los niveles tiroideos), una exploracion general y/o ginecologica, test de embarazo y ecografias. Tambien el uso del DIU (dispositivo intrauterino) puede provocar en algunas mujeres un sangrado mas abundante de lo normal (menorragia), en cuyo caso, la extraccion del mismo hara disminuir la perdida de sangre.

Hay que tener en cuenta que algunos medicamentos como la aspirina, los dicumarinicos o la heparina pueden provocar o aumentar el sangrado. Se distinguen tres tipos de tratamiento de la hipermenorrea o menorragia, segun su causa: 1. Tratamiento no hormonal. En aquellas pacientes sin patologia organica, con ciclos ovulatorios y sin sangrados intermenstruales. Los medicamentos mas utilizados, en especial los dos primeros, son:

Antiinflamatorios No Esteroideos (AINEs). tambien denominados "antiprostaglandinicos" ya que inhiben la enzima ciclooxigenasa (COX), evitando asi que el acido arquidonico se transforme en prostaglandina. Las prostaglandinas son acidos grasos naturales que segrega nuestro cuerpo y provocan la contraccion de los musculos del utero. Se distinguen dos tipos: las vasodilatadoras y las vasoconstrictoras. En el caso de las menorragias lo ideal seria que estos medicamentos inhibieran solo las prostaglandinas vasodilatadoras, para reducir los sangrados, pero a dia de hoy las que se recetan inhiben las dos, razon por la cual los AINEs sirven tambien para la dismenorrea (regla dolorosa) que a menudo acompana a la hipermenorrea o menorragia. Estos medicamentos surgen efecto en la gran mayoria de las pacientes y se ha observado que producen una reduccion del sangrado de entre 20 y 35%. En algunas mujeres pueden provocar un mayor sangrado o no surtir efecto alguno, aunque por lo general son muy utiles. Entre los AINEs mas conocidos estan el Ibuprofeno, el naproxeno (Naprosyn, Tacron, Aleve, Antalgin) y el acido mefenanico (Coslan), para cuyo uso conviene consultar al medico.

Antifibrinoliticos. no son tan recetados como los anteriores, dado que existen menos investigaciones, en especial investigaciones sobre los posibles efectos secundarios a largo plazo (trombos) y que estas estan menos difundidas entre los medicos (segun he leido); sin embargo, parece ser que la reduccion de la perdida de sangre puede llegar al 50%. Son farmacos que inhiben la activacion del plasminogeno en plasmina, produciendo asi hemostasia (detencion de la hemorragia). El medicamento mas utilizado es el acido tranexamico (AMCHA; amchafibrin).

protectores de la pared vascular. el etamsylato es el mas conocido. Refuerza la pared de los capilares, reduciendo la perdida y el tiempo de sangrado. No se conoce muy bien como funciona, quiza mediante una accion antihialuronidasa y antiprostaglandinica, corrigiendo una funcion plaquetaria anormal (aumenta la adhesion de plaquetas).

Otros: existen otros farmacos utiles para la menorragia pero cuya eficacia no esta demostrada por completo.

2.Tratamiento hormonal. la menorragia puede ser contralada de manera eficaz con un tratamiento hormonal que, ademas, ayuda a reducir la dismenorrea y es un metodo anticonceptivo eficaz. Los Anticonceptivos orales combinados (AOC) reducen el sangrado y alivian los dolores menstruales (dismenorrea) ; como consecuencia, aumentan los niveles de hemoglobina y la anemia ferropenica disminuye. Existen otros anticonceptivos como los gestagenos, cuya eficacia parece estar limitada a las menorragias anovulatorias. En cualquier caso, hay que consultar al medico. 3. Tratamiento quirurgico. aquellas menorragias debidas a patologias organicas (polipos endometriales, miomas uterinos y adenomiosis) y la menorragias funcionales (que no tienen patologia organica pero para las que han fallado los tratamientos medicos anteriores) pueden ser tratadas mediante operacion, entre ellas estan la dilatacion y el legrado, la ablacion-reseccion endometrial, la histeroscopia operativa y la histerectomia.

12 comentarios:

tenia un leve retraso y tuve una infeccion vaginal, fui al medico estuve en tratamiento y cuando lo termine me bajo, no tuve colicos y siempre tengo fuertes dolores, pasaron 15 dias y me volvio a bajar y ya tengo una semana sangrando pero no me duele ni nada y tengo muchos coagulos y he subido unos kilos de mas. que me puede estar pasando?

Hola, anonimo, bienvenida.

Me gustaria saber mas sobre el tema y poder darte un diagnostico certero, pero mis conocimientos de medicina son bastante escuetos. Creo que lo mejor seria consultarle al especialista (ginecolog@).

Con mucho miedo a equivocarme, te dire que parece cuestion de hormonas, que por algun motivo estan "revueltas"; pero tampoco conozco tu historia, tal vez sea por una situacion tensa que te provoque nervios, porque el medicamento haya tenido algun efecto secundario, por un embarazo, por menopausia. hay muchas razones posibles que yo, al no ser medico, no conozco, por eso te aconsejo ir al ginecologo/a, que, como especialista, podra ayudarte.

Espero que se solucione. Si puedo ayudarte en algo mas, no dudes en escribirme.

hola tengo un problema con respecto a mi periodo. yo soy regular con mi menstruacion pero desd hace 1mes se me habia adelantado, me parecio normal pero en el mes abril me vino mi periodo normal 5 dias como siempre, pero el 8 d mayo m volvio a bajar el periodo y dsd ese dia no ha dejado de bajar. no es mucha la cantidad q me baja y aveces es menos como aveces es mas y me preocupa muchisimo por favor q me recomiendan y muchas gracias de antemano. bye. >s

hola, desde q empece a menstruar por primera vez q fue a los 11 anos me han durado de 7 a 8 dias, los primeros dias abundantes. El medico me ha recetado anticonseptivos (cerazet)pero en vez de regularme me han aumentado el sangrado y cada 6 u 8 dias me viene la menstruacion de hasta 10 dias de sangrado. he dejado de tomar las pastillas pero sigo igual desde hace dos meses. Estoy muy preocupada y no se como detener el sangrado, tambien tengo anemia ¿no se si puede ser esa la causa de los sangrados abundantes? por favor si puede ayudeme. Reciba un cordial saludo y mis sinceros agradecimientos.

hace 6 anos que me operaron de salpingo y desde entonces tengo sangrados abundantes, siempre me duraba mi periodo 7 a 9 dias, pero desde la operacion me dura de 9 a 13 dias x que sera asi

Hola, tengo 28 anos y desde q empece a menstruar por primera vez q fue a los 12 anos mi periodo me ha durado de 8 hasta 15 dias; posteriormente conforme han pasado los anos se ha ido agudizando, en varias ocasiones he durado hasta uno o dos meses mestruando y siempre es abundante, con coagulos y seguido de un cuadro severo de anemia. He consultado a varios ginecolog@s y todos me han recetado anticonseptivos, sin embargo soy alergica a ellos, he probado de casi todos, hasta los parches que son de dosis minima y siempre me causan reaccion, haciendome sentir peor de lo que ya estoy, lo mismo pasa con los estrogenos y la progesterona. En aproximadamente dos anos (Mayo 2008 y Agosto 2009), me han realizado dos aspiraciones endouterinas (legrados) porque no pueden controlarme el sangrado, pero no quiero estar asi toda la vida y quisiera saber si existe algun medicamento o solucion alternativa que me pueda ayudar. De antemano muchas gracias.

hola hoy me detectaron un mioma de 2x2 que me intervendran por laser fui a revision normal. pero la ultima vez que fui al medico fue porque me sentia cansada y me detectaron el hierro bajo. estoy tomando hierro pero la ginecologa hoy me dijo que el bajo hierro se debia a mi hipermenorrea que no es mas que la alteracion del ciclo menstrual soy irregular de toda la vida. tambien me ha dicho que es por eso que quizas no me quedo embarazada asi que luego de la intervencion veremos..

hola tuve una amenorrea secundaria estuve en control, y se me controlo peroooooooooooooooo este mes pasado estuve manchando casi por todo el mes ¿sera que ahora? bb

Tengo la regla muy segida heso es malo

Yo he empezado a tener una regla muy abundante despues de comenzar a tomar los AO Diane 35 ¿Es normal?

Hola, te cuento: me vino dos veces en el mismo mes y las dos con mucha hemorragia y coagulos (los tampones tamano super me duran de dos a tres horas) y estoy preocupada, tambien antes de que se me valla pasa un dia que no me baja nada y al dia siguiente baja poco y luego se va. queria saber si me podrias informar sobre que me anda pasando, desde ya gracias! Antonella

hola tengo 20 dias con la menstruacion abundante q debo hacer y q pudo causar eso..

Sinalgico Ketorolac Para Que Sirve, Sinalgico

SINALGICO KETOROLAC

Acceso rapido al contenido

Tenga especial cuidado durante el embarazo .

No usar SINALGICO KETOROLAC con lactantes.

Revise siempre que no sea alergico a ninguno de los componentes de SINALGICO KETOROLAC . podria poner en peligro su salud

Recuerda antes de tomar este medicamento consultar siempre con su medico, la informacion que ofrecemos es orientativa y no sustituye en ningun caso la de su medico u otro profesional de la salud.

Prospecto e indicaciones

Laboratorio

Microsules y Bernabo

Composición

Comprimidos Ketorolac Trometamina 10 y 20 mg Inyectable i. m. cada ampolla contiene 15, 30 y 60 mg. Comprimidos sublinguales: Cada comprimido contiene 10 mg de ketorolac trometamina.

Para Que Sirve

Analgésico del grupo de los antiinflamatorios no esteroides (AINE). Por vía oral, tratamiento a corto plazo del dolor agudo de moderado a severo. Por vía parenteral, tratamiento a corto plazo del dolor post-operatorio agudo de moderado a severo.

Presentación

10 y 20 mg x 10 y 20 comprimidos. Inyectable 15, 30 y 60 mg: 3 ampollas de 1 ml. Comprimidos sublinguales: envases con 10 y 20 comprimidos sublinguales.

Como tomar

La dosis diaria se adecuará a la intensidad del dolor aceptándose como dosis diaria máxima 90 mg. Comprimidos: dosis inicial 10 mg. Dosis de mantenimiento 10 a 20 mg, cada 6 horas no más de 5 días. Inyectable:Uso por vía i. m. o e. v. Se aconseja una dosis inicial de 10 mg con dosis subsiguientes de 10 a 30 mg cada 8 horas, no más de dos días. Comprimidos sublinguales: La dosis diaria se adecuará a la intensidad del dolor y la función renal del paciente. La dosis inicial es de 10 mg.

Contraindicaciones

No administrar en pacientes con insuficiencia hepática o renal severas. Ulceras pépticas en período agudo o sangrante. Embarazo o lactancia. Hipersensibillidad a la droga.

Precauciones

Puede ocasionar trastornos digestivos, de la hemostasia, renales y reacciones alérgicas.

TroquelNombre. ComercialVar. Pres. FormaPrecio publicoCob. IomaCob. Pami

Dolcispray, Dolcispray

Common use Indomethacin belongs to a class of non-steroidal anti-inflammatory drugs (NSAIDs). This medication helps to reduce fever, stiffness, pain, and swelling. It can also be used in other cases.

Dosage and direction Take Indocin by mouth with a glass of water, with or without food. Avoid cutting, crushing or chewing this medicine. Do not take the medicine more often than it is prescribed. Do not give up taking it except following the advice of your doctor. It may need time for the medicine to help. Consult your doctor concerning proper dose for you.

Precautions Before taking Indocin tell your doctor or chemist if you are allergic to it; or if you have other allergies. Indocin, like other NSAIDs, can inhibit the excretion of sodium and lithium. Be cautious when using this drug along with lithium supplements. Avoid drinking alcohol and smoking while being treated with this medication. Aged people can be more sensitive to side effects of the medicine. Inform your doctor if you have Parkinson's disease, kidney or liver disease, high blood pressure; if you are pregnant or breast-feed.

Contraindications Indocin should not be used by patients with sodium-sensitive hypertension as well as by patients having demonstrated a reaction of hypersensitivity to it.

Possible side effect The most common side effects are dry mouth, dizziness, irritability, sedation, insomnia, urinary retention, etc. A very serious allergic reaction rarely occurs. Many people using this medicine do not have serious side effects. Turn to your doctor or pharmacist for more details. In case you notice the effects not listed here, contact your doctor or pharmacist.

Drug interaction Tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use before using this medication. Indocin can interact with: * NSAIDs of the salicylate family (Aspirin) * medicines for pain and inflammation (ibuprofen or naproxen) * medicines that treat or prevent blood clots (warfarin) * anticoagulants. Turn to your doctor or pharmacist for more details.

If you have missed your dose, take it as soon as you remember. If you see that it is prectically the time for the next dose, skip the missed dose and resume your usual dosing schedule. Do not take your dose twice.

If you think you have used too much of this medicine seek emergency medical attention right away. The symptoms of overdose usually include chest pain, nausea, irregular heartbeat, and feeling light-headed or fainting.

Storage Store your medicines at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store your drugs in the bathroom. Keep all drugs away from children and pets.

Disclaimer We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information on the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

Metoprolol Uses, Dosage, Side Effects, Metoprolin

Metoprolol

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Metoprolol dosing information

Usual Adult Dose of Metoprolol for Angina Pectoris Prophylaxis:

Initial dose: 100 mg orally in 1 or 2 divided doses. Maintenance dose: 100 to 450 mg/day. Extended release may be used at the same total daily dose given once a day.

Usual Adult Dose for Hypertension:

Initial dose: 100 mg orally in 1 or 2 divided doses. Maintenance dose: 100 to 450 mg/day. Extended release may be used at the same total daily dose given once a day.

Usual Adult Dose for Supraventricular Tachycardia:

Initial dose: 100 mg orally in 1 or 2 divided doses. Maintenance dose: 100 to 450 mg/day. Extended release may be used at the same total daily dose given once a day.

Usual Adult Dose of Metoprolol for Angina Pectoris:

Initial dose: 100 mg orally in 1 or 2 divided doses. Maintenance dose: 100 to 400 mg/day. Extended release may be used at the same total daily dose given once a day.

Usual Adult Dose for Myocardial Infarction:

Early treatment: IV: 3 bolus injections of 5 mg given at 2 minute intervals. Oral: In patients who tolerate the full IV dose (15 mg), metoprolol tablets, 50 mg every 6 hours, should be initiated 15 minutes after the last IV dose and continued for 48 hours. Maintenance dose: 100 mg orally twice a day. Patients who appear not to tolerate the full IV dose should be started on metoprolol tablets at 25 mg or 50 mg every 6 hours 15 minutes after the last intravenous dose or as soon as their clinical condition allows.

Late treatment: Oral: 100 mg orally twice a day. Patients with contraindications to treatment during the early phase of suspected or definite myocardial infarction, patients who appear not to tolerate the full early treatment, and patients in whom the physician wishes to delay therapy for any other reason should be started on metoprolol tablets as soon as their clinical condition allows.

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 25 mg once daily (of the XL formulation) for two weeks in patients with NYHA class II heart failure and 12.5 mg once daily (of the XL formulation) in patients with more severe heart failure. Maintenance dose: This dosage should then be doubled every two weeks to the highest dosage level tolerated or up to 200 mg.

If transient worsening of heart failure occurs, it may be treated with increased doses of diuretics, and it may also be necessary to lower the dose or temporarily discontinue treatment. The dose should not be increased until symptoms of worsening heart failure stabilize.

Initial difficulty with titration should not preclude later attempts to institute therapy. If heart failure patients experience symptomatic bradycardia, the dose should be reduced.

Usual Pediatric Dose of Metoprolol for Hypertension:

Immediate release: 1 to 17 years: Initial dose: 1 to 2 mg/kg/day, administered in 2 divided doses. Dosage should be adjusted based on patient response. Maximum dose: 6 mg/kg/day (less than or equal to 200 mg/day)

Extended release: 6 to 16 years: Initial dose: 1 mg/kg orally once daily (not to exceed 50 mg once daily). The minimum available dose is one half of the 25 mg tablet. Maintenance dose: Dosage should be adjusted according to blood pressure response. Doses above 2 mg/kg (or in excess of 200 mg) once daily have not been studied.

What other drugs will affect metoprolol?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with metoprolol, especially:

an antidepressant - bupropion, clomipramine, desipramine, duloxetine, fluoxetine, fluvoxamine, paroxetine, sertraline;

an ergot medicine - dihydroergotamine, ergonovine, ergotamine, methylergonovine;

heart or blood pressure medications - amlodipine, clonidine, digoxin, diltiazem, dipyridamole, hydralazine, methyldopa, nifedipine, quinidine, reserpine, verapamil, and others;

a MAO inhibitor - isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine; or

medicine to treat mental illness - chlorpromazine, fluphenazine haloperidol, thioridazine.

This list is not complete. Other drugs may interact with metoprolol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

More about metoprolol

Consumer resources

Professional resources

Related treatment guides

Where can I get more information?

Your pharmacist can provide more information about metoprolol.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use metoprolol only for the indication prescribed.

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2016 Cerner Multum, Inc. Version: 16.04. Revision Date: 2016-03-25, 7:51:38 AM.

Drug Status

Availability Rx Prescription only

Pregnancy Category C Risk cannot be ruled out

CSA Schedule N Not a controlled drug

Approval History Calendar Drug history at FDA

Zovirax (Acyclovir) Uses, Dosage, Side Effects, Vilerm

Zovirax

What is Zovirax?

Zovirax (acyclovir) is an antiviral drug. It slows the growth and spread of the herpes virus in the body. Acyclovir will not cure herpes, but it can lessen the symptoms of the infection.

Zovirax is used to treat infections caused by herpes viruses, such as genital herpes. cold sores, shingles. and chicken pox .

Zovirax may also be used for purposes not listed in this medication guide.

Important information

Take Zovirax for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

Treatment with Zovirax should be started as soon as possible after the first appearance of symptoms (such as tingling, burning, blisters).

Herpes infections are contagious and you can infect other people, even while you are being treated with Zovirax. Avoid letting infected areas come into contact with other people. Avoid touching an infected area and then touching your eyes. Wash your hands frequently to prevent passing the infection to others.

Before taking this medicine

You should not take Zovirax if you are allergic to acyclovir or valacyclovir (Valtrex).

To make sure Zovirax is safe for you, tell your doctor if you have:

kidney disease; or

a weak immune system (caused by disease or by using certain medicine).

FDA pregnancy category B. Zovirax is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Herpes can be passed to your baby during childbirth if you have a genital lesion when your baby is born. If you have genital herpes, it is very important to prevent herpes lesions during pregnancy. Take your medicine as directed to best control your infection.

Acyclovir passes into breast milk and may harm a nursing infant. Do not take this medication without telling your doctor if you are breast-feeding a baby.

How should I take Zovirax?

Take Zovirax exactly as it was prescribed for you. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Treatment with Zovirax should be started as soon as possible after the first appearance of symptoms (such as tingling, burning, blisters).

Shake the oral suspension ( liquid ) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Tell your doctor if you have any changes in weight. Zovirax doses are based on weight (especially in children and teenagers), and any changes may affect the dose.

Drink plenty of water while you are taking Zovirax to keep your kidneys working properly.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely treated. Zovirax will not treat a viral infection such as the flu or a common cold.

Lesions caused by herpes viruses should be kept as clean and dry as possible. Wearing loose clothing may help to prevent irritation of the lesions.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include agitation, seizure (convulsions), or loss of consciousness.

What should I avoid while taking Zovirax?

Herpes infections are contagious and you can infect other people, even while you are being treated with Zovirax. Avoid letting infected areas come into contact with other people. Avoid touching an infected area and then touching your eyes. Wash your hands frequently to prevent passing the infection to others.

Taking this medicine will not prevent you from passing genital herpes to your sexual partner. Avoid sexual intercourse while you have active lesions or the first symptoms of an outbreak. Genital herpes may still be contagious through "viral shedding" from your skin, even if you have no symptoms.

Zovirax side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Zovirax: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

easy bruising or bleeding, purple or red pinpoint spots under your skin; or

signs of a kidney problem--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.

Common Zovirax side effects may include:

general ill feeling;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Zovirax?

Zovirax can harm your kidneys. This effect is increased when you also use certain other medicines, including: probenecid, antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Other drugs may interact with acyclovir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

More about Zovirax (acyclovir)

Consumer resources

Professional resources

Other formulations

Related treatment guides

Where can I get more information?

Your pharmacist can provide more information about Zovirax.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2016 Cerner Multum, Inc. Version: 5.07. Revision Date: 2014-07-14, 10:52:21 PM.

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Selectine, Selectine

Male students who fail to register with Selective Service before turning age 26 are ineligible for Federal student loan and grant programs, including Pell Grants, Federal Work Study, and Stafford Loans. (Parents who want to borrow a PLUS loan do not have to satisfy the registration requirement.) Several states have also made Selective Service registration a prerequisite for state financial aid and for matriculation at public colleges and universities.

Even if you disagree with the requirement, you should register. Failure to register can have a serious negative impact on your ability to obtain a driver's license, qualify for financial aid, pursue an education, or obtain employment.

If you are at least 18 years old and have not yet reached your 26th birthday, you can register by checking the appropriate box on the Free Application for Federal Student Aid (FAFSA). (Note: If you are not yet 18, your data will not be transmitted to Selective Service and you will not be registered.) You can also register online at the Selective Service web site.

Additional information on this topic may be found on the Selective Service web site in the registration information section. (See also 34 CFR 668.37.) The Selective Service site includes a form that may be used to check a man's Selective Service registration. Registration may also be verified by calling 1-888-655-1825. The results will include the selective service number and the date registered.

Who Must Register?

Male US citizens (regardless of where they live) and male permanent resident aliens living in the US who were born after December 31, 1959 are required to register with Selective Service within 30 days of their 18th birthday (30 days before and after). If you fail to register during this time period, you may submit a late registration up until your 26th birthday.

Male non-citizens (including illegal aliens, legal permanent residents, seasonal agricultural workers, and refugees) who take up residency in the US before their 26th birthday are required to register. All relevant INS forms (e. g. the application for Resident Alien status, I-485, and so on) include a clear statement regarding the requirement to register.

Dual nationals of the US and another country are required to register regardless of where they live.

Conscientious objectors are required to register. If a draft is instituted, they will have an opportunity to file a claim for exemption based on their religious or moral objections. But they must nevertheless register with Selective Service.

Disabled men who can move about independently in public with or without assistance must register with Selective Service, even if their disability would disqualify them from military service.

Members of the Reserve and National Guard who are not on full-time active duty must register. Men attending the Merchant Marine Academy must register. Men who attempt to enlist and are rejected before reaching age 26 must register.

Who Is Not Required to Register?

Men born from March 29, 1957 to December 31, 1959 were never required to register because the Selective Service program was not in operation at the time they turned 18. The requirement to register was reinstated in 1980 and applies to all men born on or after January 1, 1960 (50 USC 453). Although men born before March 29, 1957 were required to register, failure to register makes one ineligible for student aid only if one was born on or after January 1, 1960.

Other reasons why a student might not have been required to register include:

Men who are hospitalized, institutionalized, or incarcerated are not required to register during their confinement.

Men who are serving in the military on full-time active duty are not required to register. Men attending the service academies are also not required to register.

Disabled men who were continually confined to a residence, hospital or institution are not required to register.

However, if they are released before their 26th birthday they must register within 30 days of their release.

Other exceptions include:

Non-immigrants visiting the US on student or visitor visas and men who are part of a diplomatic or trade mission and their families.

Citizens of the Federated States of Micronesia, the Republic of the Marshall Islands, or the Republic of Palau.

Noncitizens who first entered the US after turning age 26.

Noncitizens who entered the US as lawful non-immigrants on a valid visa and remained in the US on the terms of that visa until after they turned 26. (The date of entry on Form I-94 will be relevant.)

Student is not yet 18. (For federal aid purposes, if a student is not yet 18 years old as of the date the FAFSA form is submitted, he is eligible for federal student aid this award year even if he turned 18 shortly afterward and has not yet registered. Such a student would need to register to be eligible for federal student aid in subsequent years.)

Individuals who are born female and have a gender change are not required to register. U. S. citizens or immigrants who are born male and have a gender change are still required to register.

NOTE: Transgender students are welcome to contact Selective Service regarding their registration requirements if they are unclear about how they should answer Question 21 or Question 22 on the Free Application for Federal Student Aid (FAFSA), or need a status information letter from Selective Service that clarifies whether or not they are exempt from the registration requirement. This can be done by calling our Registration Information Office on 1-888-655-1825. Individuals who have changed their gender to male will be asked to complete a request form for a status information letter and provide a copy of their birth certificate. One exemption letter may be used in multiple school financial aid processes.

What If You Didn't Register and It's Now Too Late?

Male students who did not register with the Selective Service and are now age 26 or older are ineligible for Federal student aid and other Federal and state benefits. There are only a few options for regaining eligibility, and they depend on showing that either the student was not required to register . or that the failure to register was not knowing and willful .

If the student was not required to register, he will need to obtain a status information letter from Selective Service. This letter will indicate whether the student was or was not required to register. To obtain such a letter, call 1-847-688-6888 or 1-888-655-1825 (stay on the line until the operator answers) or write to Selective Service System, PO Box 94638, Palatine, IL 60094-4638 and ask for a status information letter.

The student will need to describe, in detail, the circumstances that prevented him from registering (e. g. hospitalization, institutionalization, incarceration, military service) and provide documentation of those circumstances. The documentation should be specific as to the dates of the circumstances. (For example, if the student served in the military and was released before age 26, he would still have been required to register within 30 days of his release.) If the student was not a US citizen, he will need to provide documentation of when he entered the United States. The student should also provide his name, Social Security Number, date of birth, and mailing address.

A status information letter is not required if the student can document his status as a veteran (copy of DD-214, active duty orders, military ID card) or that he was born before 1960. Also, non-US men under certain circumstances will not be required to obtain a status information letter.

If the student did not satisfy any of the criteria for a waiver of the registration requirement, the student will need to show by a preponderance of evidence that his failure to register was not knowing and willful . The term "preponderance of evidence" refers to the standard of proof used in civil litigation, where the evidence for a fact is of greater weight or more convincing than conflicting evidence. In other words, the probability that the assertion is true must be greater than 50%.

The best evidence is original documentation, especially when it is first hand documentation produced at the time of the event. In other words, direct evidence is better than indirect or circumstantial evidence. Examples of direct evidence include a birth certificate, a date of entry stamp in a passport, and a certificate of mailing. It is best if the source of the evidence is an independent disinterested third-party. For example, a signed statement by the student is a fairly weak form of evidence, although it can shed light on the student's situation and his sincerity. Positive evidence is better than negative evidence, since it is very hard to prove a negative. Original documentation is better than a copy.

Accordingly, it is in the student's best interest to provide as much evidence as possible and in as much detail as possible.

The final decision regarding eligibility is made by the financial aid administrator, not the Selective Service. The Selective Service only makes a determination as to whether the student was required to register, not whether the failure to register was knowing and willful. The financial aid administrator's decision is final and cannot be appealed to the US Department of Education. The US Department of Education will only hear appeals from students who have provided their schools with a status information letter demonstrating compliance (i. e. that they registered or that they are exempt from registration) but are still being denied aid based on the registration requirement.

For students who were required to register, the financial aid administrator will base his or her decision on whether the failure to register was:

Knowing . Was the student aware of the requirement to register or not? If the student knew about the requirement to register, was he misinformed about the applicability of the requirement to him (e. g. veterans who were discharged before their 26th birthday were occasionally told that they did not need to register)? On which date did the student first learn that he was required to register? Where did the student live when he was between the ages of 18 and 26? Does the status information letter indicate that Selective Service sent letters to the student and did not receive a response?

Willful . Was the failure to register done deliberately and intentionally? In other words, did the student have the mental capacity to choose whether or not to register and decided not to register?

In addition to the status information letter, the financial aid administrator may also require a signed statement from the student explaining why he did not register and independent third party documentation of any unusual circumstances or facts pertaining to the student's failure to register. It is very important to provide sufficient documentation, since many financial aid administrators will deny the request for an override without documentation. A signed statement on its own is often not sufficient to justify awarding of federal student aid. (Frankly, many financial aid administrators find it hard to believe that a student was not aware of the requirement, given the extensive publicity by Selective Service.)

Ultimately, the decision will depend on whether the financial aid administrator believes the student and the student has credibly argued that his failure to register was either not knowing or not willful.

The most common examples where financial aid administrators have granted an override include the following. Please note that each situation is reviewed individually.

Student served in the Armed Forces on full-time active duty, was released under a condition other than dishonorable before his 26th birthday, and either assumed or was misinformed about not being required to register.

Student tried to enlist in the military, but was turned down, and didn't realize that enlisting and registering for Selective Service are different requirements.

Student was kidnapped by a parent in a custody battle, and that parent prevented the student from registering.

Parents were illegal aliens and kept the student unaware of the requirement to register.

Student claims he was not aware of the requirement and lived abroad for the entire period from age 18 through age 26.

Student was aware of the requirement, but incorrectly believed that the requirement did not apply to him because he is his parent's only child or because all of his parent's other children are already serving in the armed forces.

Student documents that he did submit a registration. (During the mid to late 1990s, data for some students who tried to register for Selective Service using the FAFSA form was never transmitted to Selective Service. In particular, data for students who had not yet reached their 18th birthday was never transmitted to Selective Service. A documented attempt to register demonstrates that the failure to register was not willful.)

Schools are much less likely to grant an override when the excuse is ignorance of the requirement without extenuating circumstances. Likewise if the student failed to register because of an error made by the student, such as thinking that registering to vote automatically registered one for selective service. But on the whole, schools tend to be lenient when the excuse is reasonable and they believe the student is being honest.

If the student insists that he registered but the Selective Service web site disagrees, the student will need to provide documentation of the attempt to register, such as a photocopy of the registration form. Occasionally the Selective Service database will have the student's information recorded under a different date of birth or social security number. This can happen when there are digit transpositions in the social security number or the month and day are swapped. The financial aid administrator should ask the student for a copy of their social security card and birth certificate, and then call Selective Service to ask for a name search.

Mediderm Laboratories Latest Skincare Products, Menaderm

Update Your Beauty Routine For Spring

Spring is here! Find out what type of products you should be introducing into your spring time skincare regimen by reading this article on our blog.

3 Essential Skin Care Tips for the Busy Modern Woman

Think you're too busy for a beauty routine? Think again. We've put together three essential skincare tips for the woman on the go.

10 Delicious Foods for Beautiful Healthy Skin

You are what you eat. Here are 10 delicious foods to add to your #beautifulskindiet right now.

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Proactiv Plus Acne Treatment, Acneplus

Proactiv ®

The Proactiv+ Solution:

Proactiv+ is a dermatologist-developed system that targets acne. It starts removing acne-causing bacteria on contact and reduces irritation while providing the skin with premium skin care ingredients.

Step 1. Skin smoothing exfoliator Cleanse and exfoliate Fights acne & leaves skin hydrated

Step 2. Targeting treatment Target and treat Smart target technology gets more in the pore

Step 3. Complexion perfecting hydrator Hydrate and refine Soothe skin and reduce redness

Prevention Means Routine:

We treat acne and the bacteria that causes it to help prevent future breakouts. Acne isn’t curable, but prevention is possible with a skincare routine. Our system is designed to be your complete skincare regimen to help maintain the clear, healthy-looking skin you deserve.

Acne is a Challenge:

We understand your skin challenges at every age, and created a system that targets every step of the acne cycle.

Blackheads & whiteheads

Dry skin

Post-acne dark marks & pigmentation

Large pores

Excessive oil production

Red, swollen pimples

Body acne

Karen L, Katen

Karen L. Katen

Background

Ms. Karen L. Katen serves as a Senior Advisor at Essex Woodlands Health Ventures. She joined Essex Woodlands in October 2007. Ms. Katen joined the Essex Woodlands Health Ventures on October 1, 2007. She served as the President at Pfizer Human Health since March 2005 and Head of Pharmaceutical Division at Pfizer Inc. and Pfizer Limited. She served as Pfizer Inc.'s Executive Vice President from April 1, 2001 to March 2005 and as the President at Pfizer Pharmaceuticals. Group from April 1, 2001 to March 2005. She was the President of Pfizer Global Pharmaceuticals and Executive Vice President of Pfizer from 2001 to 2005 and President of Pfizer Human Health from 2005 to 2007. She served as the President at Pfizer Inc.'s United States Pharmaceuticals Group from 1995 to July 2002, a Senior Vice President at Pfizer Inc. from May 1999 to 2001, and an Executive Vice President at Global Pfizer Pharmaceuticals Group from 1997 to 2001. She joined Pfizer in 1974. She served as the Treasurer of Pharmaceutical Research and Manufacturers of America. She is a Director of Home Depot U. S.A. Inc. since November 15, 2007. Ms. Katen has been a Director of Harris Information Technology Services Inc. since December 1994; The Home Depot, Inc. since November 2007 and Harris Corporation since December 1994. She serves as a Member of Takeda Global Advisory Board at Takeda Pharmaceutical Company Limited. She has been an Independent Director of L'Air Liquide SA since May 2008. She also serves as the Chairman at RAND Corporation’s Health Board of Advisors. Ms. Katen is also on the National Board of Trustees for the American Cancer Society Research Foundation. She serves on the Economic Club of New York Board of Trustees. She is a Trustee at the University of Booth Graduate cago. She serves as Director of ARMGO Pharma, Inc. She has been a Director of IMS Health Holdings, Inc. since March 2015. She serves as an Honorary Director of Catalyst Inc. and served as its Director. Ms. Katen is a trustee for the University of Chicago and is a council member of Booth Graduate School of Business at the University of Chicago. She served as Vice Chairman at Pfizer, Inc. since March 2005 till March 2007. She served as Vice Chairman at Pfizer Limited. She served as a Director of Motors Liquidation Company from 1997 to July 2009; Pharmaceutical Research and Manufacturers of America. She served as a Director of Catamaran Corporation since December 10, 2012 till July 2015 and General Motors Company since December 1997 till 2009. Ms. Katen has served on the National Alliance for Hispanic Health. She was also active on a variety of international policy bodies, including as the Chairman of United States-Japan Business Council. She served as the Chairman of the Pfizer Foundation. Ms. Katen received her Bachelor of Arts degree and Master of Business Administration degree from the University of Chicago.

Corporate Headquarters

335 Bryant Street Palo Alto, California 94301

Phone. 650-543-1555 Fax. 650-327-9755

Board Members Memberships

Director and Member of Governance & Corporate Responsibility Committee

Independent Director, Member of Nominating & Corporate Governance Committee and Member of Finance Committee

Baclofen Oral Uses, Side Effects, Interactions, Pictures, Warnings - Dosing, Baclofenum

baclofen

Uses

Baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis. spinal cord injury/disease). It works by helping to relax the muscles.

How to use baclofen

Take this medication by mouth with or without food as directed by your doctor, usually 3 times a day. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or take it more often than prescribed.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience withdrawal symptoms such as hallucinations and seizures. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

Drowsiness, dizziness. weakness. tiredness, headache. trouble sleeping. nausea. increased urination, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as confusion, depression. hallucinations).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction. including: rash. itching /swelling (especially of the face/tongue /throat), severe dizziness, trouble breathing .

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www. fda. gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking baclofen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease. mental/mood disorders (such as schizophrenia ), brain disorders (such as seizures, stroke ).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially drowsiness and mental/mood changes (such as confusion).

During pregnancy. this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast - feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine. diphenhydramine ), drugs for sleep or anxiety (such as alprazolam. diazepam. zolpidem), other muscle relaxants, and narcotic pain relievers (such as codeine).

Check the labels on all your medicines (such as allergy or cough - and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Overdose

If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: vomiting. severe drowsiness, slow/shallow breathing, seizures.

Notes

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor directs you to do so. A different medication may be necessary in that case.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised March 2016. Copyright(c) 2016 First Databank, Inc.

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Incepta Pharmaceuticals, Presonil

Metoprolol tartrate BP, is a selective ?1- adrenoreceptor blocking agent. Metoprolol tartrate is (?)-1- (isopropylamino)-3-[p-(2-methoxyethyl)phenoxy]-2-propanol L-(+)-tartrate (2:1) salt. It is a white, practically odorless, crystalline powder with a molecular weight of 684.82. It is very soluble in water;freely soluble in methylene chloride, in chloroform, and in alcohol, slightly soluble in acetone; and insoluble in ether.

Hypertension: initially 100mg daily, maintenance 100-200mg daily in 1-2 divided doses Angina Pectoris: 50-100mg 2-3 times daily. Myocardial Infarction: After early intravenous treatment for 48 hours, patients should receive a maintenance dose of 100mg twice daily. Arrhythmias: usually 50mg 2-3 times daily; up to 300mg daily in divided doses if necessary. Hyperthyroidism: (adjunct), 50mg 4 times daily Migraine Prophylaxis: 100-200mg daily in divided doses.

Bradycardia, Heart failure, hypotension, Conduction disorder, Bronchospasm, Peripheral vasoconstriction, Gastrointestinal disturbances, Fatigue, Sleep disturbance, Rare reports of rashes and dry eyes, Sexual dysfunction, and Exacerbation of psoriasis.

Gereral: Metoprolol should be used with caution in patients with impaired hepatic function. Information for Patients: Patients should be advised to take Metoprolol regularly and continuously, as directed, with or immediately following meals. If a dose missed, the patient should take only the next scheduled dose (without doubling it). Patient should not discontinue Metoprolol without consulting the physician. Patients should be advised to avoid operating automobiles and machinery or engaging in other tasks requiring alertness until the patient's response to therapy with Metoprolol has been determined. contact the physician if any difficulty in breathing occurs. inform the physician or dentist before any type of surgery that he or she is taking Metoprolol.

Hypertension and Angina: Metoprolol is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure.

Myocardial Infarction: Metoprolol is contraindicated in patients with a heart rate

Cyclofemina, Cyclofemina

Center for Young Women's Health

Estrogen/Progestin Hormonal Injections

Mesigyna® (Norigynon, Mesigyna Instayect, Mesygest, and No 3 injectable Norigynon) and Cyclofem® (Lunelle, Cyclofemina, Feminena, Novafem, Lunella, and Cyclo-Provera) are two brand names of combination hormone injections. Both products are available in Latin America and Asia. Cyclofem is also available in Africa. However they are not approved by the United States Food and Drug Administration and therefore are not obtainable in the United States. Estrogen-Progestin hormonal injections are very effective in preventing pregnancy.

Out of 100 women using estrogen/progestin injections

Typical use: 6 women become pregnant

Perfect use: 1 or fewer women become pregnant

What are Cyclofem® and Mesigyna® injections?

Cyclofem® and Mesigyna® injections contain synthetic (man-made) forms of the hormones estrogen and progestin (which your body makes). The hormones suppress your pituitary gland which stops your ovaries from releasing eggs. Without these eggs, pregnancy can’t happen. The injections also change the lining of your uterus and the mucus in your cervix. By changing your cervical mucus, the hormones make it more difficult for sperm to reach the egg.

How often and when should I get Cyclofem® injections?

The Cyclofem® and Mesigyna® injections give one month protection against pregnancy. Therefore, you should get one injection every month to get the best protection. The injection should be given every 28-30 days. If there is more than 33 days between injections, the injections aren’t as effective. The first injection is given within 5 days of a normal menstrual period, within 7 days of stopping oral contraceptives, or 11-13 weeks after the last dose of Depo-Provera®.

How effective are Cyclofem® and Mesigyna® injections?

If women get Cyclofem® and Mesigyna® injections at the right time every month, they are more than 99% effective. This means that if 100 women get Cyclofem® or Mesigyna® injections at the right time, less than 1 woman will become pregnant in a year. However, if the injection is given too late, it becomes 94% effective.

Cyclofem® and Mesigyna® injections do not protect against sexually transmitted infections, so you need to use a condom to protect against STIs.

Are there any side effects of Cyclofem® or Mesigyna® injections?

There are possible side effects from Cyclofem® or Mesigyna® injections. They can be different for each woman.

Irregular menstrual periods - longer or shorter menstrual periods, heavier or lighter periods

Loss of menstrual periods

Headaches

Weight gain (Most women do not gain weight, but those that do gain an average of 4 pounds over a year. You can help maintain your weight by eating a healthy diet and getting regular exercise.)

Breast pain

“Nervousness”

Blood clots (Very rare, but serious)

If you get any of these side effects, you should speak with your health care provider.

Will I get my period while I’m getting Cyclofem® or Mesigyna® injections?

Some women have regular periods, others have irregular cycles (especially in the beginning), and some stop getting their menstrual periods altogether while getting Cyclofem® or Mesigyna® injections. It’s not a medical problem if you aren’t getting your period, it just means that your ovaries are resting and the lining in your uterus does not grow, so there is no menstrual bleeding. You will get your menstrual period back after you stop getting Cyclofem® or Mesigyna® injections.

Can any woman get Cyclofem® or Mesigyna® injections?

No. Cyclofem® cannot be used by women who:

Are pregnant

Have a liver problem or disease

Have blood clots or a history of blood clots

Have very high blood pressure

Have serious migraines headaches

Have certain kinds of heart disease

If you are interested in trying Cyclofem® or Mesigyna® and live in an area that has it, your health care provider will want to do a physical exam and ask you about your medical history and your family’s medical history. This way, he or she can find out if these injections are a good type of contraception for you.

Wh at are the differences between Depo-Provera® and Cyclofem® or Mesigyna® injections?

The biggest difference is that Cyclofem ® and Mesigyna ® contains estrogen and progestin and Depo-Provera ® only has progestin. You have to get a shot once every month with Cyclofem® and Mesigyna®, whereas only once every three months with Depo-Provera®. However, Cyclofem® and Mesigyna® cause less menstrual irregularities than Depo-Provera®. There are fewer reports of amenorrhea (not getting your menstrual period), infrequent bleeding, irregular bleeding, and extra-long menstrual bleeding in Cyclofem® and Mesigyna® users than in Depo-Provera® users. Also, fertility (being able to get pregnant) comes back quicker with Cyclofem® and Mesigyna® than with Depo-Provera®. Depo-Provera® may possibly cause a decrease in bone density, but it’s not a problem with Cyclofem® and Mesigyna®. Talk with your health care provider about which choice is best for you.

Related Content

Litij Klorid, Litij Klorid

Depression - Litij klorid (Brand name: lithium)

Lithium Carbonate is used to treat the manic episodes of manic-depressive illness, the condition when a person's mood swings from depression to excessive excitement. A manic episode may involve some or all of the following symptoms:

Aggressiveness; Elation; Fast, urgent talking; Frenetic physical activity; Grandiose, unrealistic ideas; Hostility; Little need for sleep; Poor judgment. Some doctors also prescribe Litij klorid for premenstrual tension, eating disorders such as bulimia, certain movement disorders, and sexual addictions.

Use Lithium Carbonate as directed by your doctor.

To avoid stomach upset, take Lithium Carbonate immediately after meals or with food or milk. While taking Lithium Carbonate, you should drink 10 to 12 glasses of water or fluid a day. To minimize the risk of harmful side effects, eat a balanced diet that includes some salt and lots of liquids. If you have been sweating a great deal or have had diarrhea, make sure you get extra liquids and salt. Ask your health care provider any questions you may have about the usage of Lithium Carbonate.

Drug Class and Mechanism

Lithium Carbonate is an antimanic agent. The way Lithium works is not known exactly, but it may work by altering the balance of certain chemicals in the brain.

If you miss a dose of Lithium Carbonate and are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Store Lithium Carbonate at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep in a tight, light-resistant container. Keep Lithium Carbonate out of the reach of children and away from pets.

Do not use Lithium Carbonate if:

you are allergic to any ingredient in Lithium Carbonate; you have moderate to severe kidney, heart, or blood vessel problems; you have low blood sodium levels; you are severely dehydrated, ill, or weakened; you are taking an angiotensin-converting enzyme (ACE) inhibitor (e. g. enalapril) or a diuretic (e. g. furosemide, hydrochlorothiazide). Contact your doctor or health care provider right away if any of these apply to you.

Important: Lithium Carbonate may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Lithium Carbonate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do not take more than the recommended dose without checking with your doctor. It may take 1 to 3 weeks for Lithium Carbonate to work. Do not stop using Lithium Carbonate without checking with your doctor. Tell your doctor or dentist that you take Lithium Carbonate before you receive any medical or dental care, emergency care, or surgery. Fever, infection, vomiting, diarrhea, or excessive sweating may affect the levels of Lithium Carbonate in your blood. If you experience any of these conditions, contact your doctor. Consult your doctor about the problem of salt loosing. Do not change the amount of salt in your diet unless instructed by your doctor. Check with your doctor before restricting your salt intake. Tell your doctor if you are on a low-salt diet. While you are taking Lithium Carbonate, lab tests - including blood Litij klorid levels and kidney function tests - may be performed. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Lithium Carbonate with caution in the elderly; they may be more sensitive to its effects. Lithium Carbonate should not be used in children younger than 12 years old; safety and effectiveness in these children have not been confirmed. Pregnancy and breast-feeding: Lithium Carbonate may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lithium Carbonate while you are pregnant. Lithium Carbonate is found in breast milk. Do not breast-feed while taking Lithium Carbonate since it may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lithium Carbonate while you are pregnant. Lithium Carbonate is found in breast milk. Do not breast-feed while taking Lithium Carbonate.

Possible Side Effects

Check with your doctor if some of these most common side effects persist or become bothersome:

mild hand tremor; mild thirst; temporary, mild nausea and general discomfort at the beginning of treatment. Seek medical attention right away if any of these severe side effects occur: severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; confusion; diarrhea; drowsiness; excessive weight gain; fainting; giddiness; inability to control the bladder or bowels; increased thirst; increased or decreased urination; involuntary twitching or muscle movements; loss of consciousness; loss of coordination; muscle weakness; persistent headache; persistent or severe nausea; ringing in the ears; seizures; slow or irregular heartbeat; slurred speech; swelling of the ankles or wrists; unsteadiness; vision changes; vomiting.

Lithium Carbonate is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Medikamente Packungsbeilage Enabeta Comp 10 Mg, Enabeta

Enabeta comp 10 mg/25 mg Tabletten

Wie wirkt der Inhaltsstoff? Das Medikament ist eine Kombination aus den Wirkstoffen Enalapril und Hydrochlorothiazid. Es wird bei erhohtem Blutdruck eingesetzt.

Herzleistung und Blutdruck werden laufend durch ein kompliziertes System aus verschiedenen Botenstoffen und Nervensignalen den Bedurfnissen des Korpers angepasst. Einer der Botenstoffe, die an der normalen Blutdruckeinstellung im Korper beteiligt sind, ist das Hormon Angiotensin-II. Es erhoht den Blutdruck durch eine Verengung der Blutgefa?e. Gleichzeitig regt es in der Nebenniere die Bildung des Hormons Aldosteron an. Aldosteron vermindert die Salz - und Wasserausscheidung uber die Niere: Die Flussigkeitsmenge im Korper nimmt zu, und das Blutvolumen steigt. Damit steigt ebenfalls der Blutdruck.

Enalapril ist ein ACE-Hemmer. Er blockiert einen wichtigen Eiwei?stoff, der an der Herstellung von Angiotensin beteiligt ist: das Angiotensin-Converting-Enzym, kurz ACE genannt. Durch diese Blockade wird weniger Angiotensin gebildet. Die Gefa?e erweitern sich, und das Herz muss nicht mehr gegen den hohen Widerstand anpumpen. So wird das Herz entlastet, und der Blutdruck sinkt. Der Korper bildet nun ebenfalls weniger Aldosteron - die Ausscheidungsleistung der Niere steigt dadurch wieder an.

Hydrochlorothiazid ist ein Entwasserungsmittel (Diuretikum). Es fordert ebenfalls die Salz - und Wasserausscheidung uber die Niere. Durch Abnahme des Wasseranteils im Blut verringert sich die Blutmenge, die vom Herzen durch den Korper gepumpt wird. Dadurch wird das Herz entlastet und der Blutdruck gesenkt. Wasser, dass aus den Blutgefa?en in das Gewebe ubergetreten ist (Odeme), wird ausgeschwemmt.

Anwendungsgebiete •Bluthochdruck (Hypertonie) Packungsgro?en •30 Tbl. (N1) •50 Tbl. (N2) •100 Tbl. (N3) Warnhinweise! •Die Behandlung des Bluthochdrucks mit diesem Arzneimittel bedarf der regelma?igen arztlichen Kontrolle. Durch individuell auftretende, unterschiedliche Reaktionen kann die Fahigkeit zur aktiven Teilnahme am Stra?enverkehr oder zum Bedienen von Maschinen beeintrachtigt werden. Dies gilt in verstarktem Ma?e bei Behandlungsbeginn und Praparatewechsel sowie im Zusammenwirken mit Alkohol. Wann ist das Medikament nicht fur Sie geeignet (Gegenanzeigen)? •Beidseitige Verengung der Nierenarterien •Besteht eine Uberempfindlichkeit gegen Antibiotika aus der Gruppe der Sulfonamide, kann auch bei Anwendung des o. g. Praparats eine Uberempfindlichkeit bestehen (Kreuzreaktion). •Erkrankungen des Herzmuskels •Schwere Leber - und Nierenfunktionsstorungen •Storungen des Mineralstoff - und Wasserhaushalts •Verengung der Aortenklappe (Herzklappe) •Verengung der Mitralklappe (Herzklappe) •Vorsicht bei Personen mit Zuckerkrankheit (Diabetes mellitus) •Vorsicht bei Personen, die zu erhohten Harnsaurewerten neigen (Gicht). Schwangerschaft und Stillzeit •Wahrend der Schwangerschaft und der Stillzeit darf das Medikament nicht angewendet werden. Nebenwirkungen Aufgelistet sind die wichtigsten, bekannten Nebenwirkungen. Sie konnen auftreten, mussen aber nicht, da jeder Mensch unterschiedlich auf Medikamente anspricht.

Manchmal reagieren Menschen allergisch auf Medikamente. Sollten Sie Anzeichen einer allergischen Reaktion verspuren, informieren Sie sofort Ihren Arzt oder Apotheker.

•Trockener Reizhusten (Gelegentlich) •Magen-Darm-Beschwerden (Gelegentlich) •Uberempfindlichkeitsreaktionen mit Hautreaktionen, z. B. Rotung, Juckreiz, Ausschlag, Quaddelbildung (Gelegentlich) •Flussigkeitsverlust fuhrt zu Mundtrockenheit, Mudigkeit und Kopfschmerzen. Bei starken Flussigkeitsmangel sind Verwirrtheit und Blutdruckabfall mit Kollapsneigung moglich. (Gelegentlich) •Verminderung des Kaliumspiegels im Blut (Hypokaliamie) mit Symptomen wie Benommenheit, Muskelschwache, Magen-Darm-Beschwerden, Verstopfung, Herzrhythmusstorungen (Gelegentlich) •Nierenfunktionsstorung (Gelegentlich) Wechselwirkungen Andere blutdrucksenkende Arzneimittel wie Kalzium-Antagonisten oder gefa?erweiternde Medikamente werden in ihrer blutdrucksenkenden Wirkung verstarkt.

Eine kochsalzarme Ernahrung erhoht die blutdrucksenkende und herzschutzende Wirkung von Enalapril.

Die Wirkung von Alkohol wird durch Enalapril verstarkt.

Entzundungshemmende Medikamente aus der Arzneistoffgruppe der Nichtsteroidalen Antiphlogistika wie Diclofenac oder Ibuprofen vermindern die harntreibende und blutdrucksenkende Wirkung.

Digitalisglykoside zur Behandlung der Herzschwache werden in ihrer Wirkung verstarkt.

Bei zusatzlicher Gabe von Kaliumsalzen oder kaliumsparenden Arzneimitteln erhoht sich die Gefahr eines zu hohen Kaliumspiegels. Die gleichzeitige Einnahme von Kortison oder von Abfuhrmittel fuhrt moglicherweise zu Kaliumverlusten.

Bei Allergikern erhoht sich das Risiko einer allergischen Schockreaktion. Enalapril darf nicht wahrend einer Desensibilisierungstherapie mit Insektengiften angewendet werden.

Das Praparat kann die Wirkung weiterer Medikamente verstarken oder abschwachen oder selbst verstarkt oder abgeschwacht werden. Halten Sie in jedem Fall Rucksprache mit ihrem Arzt oder Apotheker, wenn Sie noch andere Medikamente einnehmen.

Medikamente mit demselben Wirkstoff Enahexal® comp 10/25 Tabletten Enalapril HCT AZU 10/25 mg Tabletten Enalapril plus 10/25 - 1A-Pharma® Tabletten Pres® plus Tabletten RENACOR® Tabletten

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Movelat Cream, Movesan

MOVELAT CREAM

Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

MOVELAT RELIEF CREAM

mucopolysaccharide polysulfate (MPS) 0.2% w/w and salicylic acid 2.0% w/w Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side-effects, talk to your doctor or pharmacist. This includes any possible side-effects not listed in this leaflet. See section 4. - You must talk to a doctor if your signs of illness or injury do not improve. What is in this leaflet 1. What Movelat Relief Cream is and what it is used for 2. What you need to know before you use Movelat Relief Cream 3. How to use Movelat Relief Cream 4. Possible side-effects 5. How to store Movelat Relief Cream 6. Contents of the pack and other information 1. WHAT MOVELAT RELIEF CREAM IS AND WHAT IT IS USED FOR Movelat Relief Cream contains the active substances mucopolysaccharide polysulfate (MPS) and salicylic acid. Movelat Relief Cream is a mild to moderate anti-inflammatory and analgesic (pain-relieving) preparation which, when applied to the skin, provides relief from muscular pain and stiffness, sprains and strains, and pain due to rheumatic and non-serious arthritic conditions. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MOVELAT RELIEF CREAM Do not use Movelat Relief Cream: • if you are allergic (hypersensitive) to mucopolysaccharide polysulfate, salicylic acid (or any other aspirin-like medicine) or other related painkillers known as non-steroidal anti-inflammatory drugs (NSAIDS). This is particularly important if you suffer from asthma • if you are allergic to any of the other ingredients of Movelat Relief Cream (listed in section 6) • if you have broken skin, infected skin or eczema • on large areas of skin • on or near sensitive areas such as the mouth, eyes or ano-genital regions. Movelat Relief Cream should NOT be used on children under the age of 12 years old. Warnings and precautions - Movelat Relief Cream is for external use only. Do NOT swallow. - Do not exceed the dose stated in section 3. - Talk to your doctor or pharmacist before using Movelat Relief Cream: ? if your signs of injury or illness do not improve or get worse. ? if you are pregnant or breast-feeding. ? if you suffer from asthma. ? if you have pre-existing renal/kidney damage. ? if you are using any prescribed medicines. - You may experience discomfort if you have sensitive skin, use the cream in hot weather or after a bath. - Wash your hands immediately after use. - Stop using this cream if you experience irritation or other unwanted effects. See section 4 for information about possible side-effects. Other medicines and Movelat Relief Cream Tell your doctor or pharmacist if you are using coumarin anti-coagulants (medicines for thinning the blood, such as Warfarin), as Movelat Relief Cream may affect the way that such anti-coagulants work. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Movelat Relief Cream should not be used during the first three or last three months of pregnancy or on the breast area during breast-feeding/lactation. Movelat Relief Cream contains cetostearyl alcohol This may cause local skin reactions (for example contact dermatitis). 3. HOW TO USE MOVELAT RELIEF CREAM External use only. Do not swallow. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. • Before use, pierce the tube seal with the spiked top of the cap. • Push and turn the spiked end of the cap firmly into the nozzle until you hear a click. • The amount of cream you use will depend on the size of the area being treated. • Between 2 and 6 inches (5-15 cm) of cream should be gently massaged into the affected area at any one time. • You can apply Movelat Relief Cream up to four times a day. • Do not exceed this dose. • Some people experience discomfort, particularly those with sensitive skin or if used in hot weather or after a bath. • Remember to wash your hands after applying Movelat Relief Cream, unless this is the area being treated. • If you accidentally swallow some of this cream you should contact your doctor or a hospital casualty department. You may experience rapid breathing, a ringing sound in the ears, deafness, light-headedness or sweating. 4. POSSIBLE SIDE-EFFECTS Like all medicines, Movelat Relief Cream can cause side-effects, although not everybody gets them. Rarely, Movelat Relief Cream can cause the following in sensitive individuals: • redness • burning sensation • a rash. If any of these occur, STOP using the cream and tell your doctor or pharmacist. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme at: www. mhra. gov. uk/yellowcard Malta www. medicinesauthority. gov. mt/adrportal Please read the back of this leaflet. 25254702 *Trademark

9254745 1602 GB/MT

5. HOW TO STORE MOVELAT RELIEF CREAM Keep this medicine out of the sight and reach of children. Do not use Movelat Relief Cream after the expiry date which is stated on the tube and carton after EXP. The expiry date refers to the last day of that month. Store below 25°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION What Movelat Relief Cream contains The active substances are: - mucopolysaccharide polysulfate 0.2% w/w - salicylic acid 2.0% w/w. The other ingredients are: - glycerol 85% - stearic acid - anhydrous eucerine - myristyl alcohol - emulsifying cetostearyl alcohol - ethanolamine - thymol - isopropyl alcohol - purified water. What Movelat Relief Cream looks like and the contents of the pack Movelat Relief Cream is a white cream available in aluminium lacquered tubes of 14, 40, 50, 80, 100 and 125 grams. Not all pack sizes may be marketed. P PL 06831/0176 Movelat Relief Cream MA 085/00202 Marketing Authorisation Holder: Genus Pharmaceuticals Linthwaite, Huddersfield, HD7 5QH, UK. Manufacturers: Mobilat Produktions GmbH Luitpoldstrasse 1, 85276 Pfaffenhofen, Germany. STADA Arzneimittel AG Stadastrasse 2-18, 61118 Bad Vilbel, Germany. This leaflet was last revised in February 2016.

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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Disclaimer: The indications, uses and warnings for individual medications outside the USA are determined by local regulatory bodies in each country or region. The Drugs. com website is intended primarily for audiences in the United States and its territories. Indications, uses and warnings on Drugs. com patient information leaflets are derived from FDA product labels and may differ in countries outside the USA. Every effort has been made to ensure that the information provided on this page is accurate, up-to-date and complete, but no guarantee is made to that effect. Drugs. com does not endorse drugs, diagnose patients or recommend specific therapies. The information on this page is not a substitute for the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that a drug or drug combination is safe, effective or appropriate for any given patient. Drugs. com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided here. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. Always consult your doctor or healthcare specialist for medical advice.

Chemical formula: C19H20FNO3 Drugbank ID: DB00715 ATC code(s): N06AB05

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Drugs. com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include Micromedex® (updated Sep 2nd, 2016), Cerner Multum™ (updated Sep 5th, 2016), Wolters Kluwer™ (updated Aug 8th, 2016) and others. To view content sources and attributions, please refer to our editorial policy .

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Buy Sali-Aldopur - Spironolactone - Online Without Prescriptions, Sali-Aldopur

Aldactone (Sali-aldopur)

Aldactone is used for treating swelling and fluid retention in patients with congestive heart failure, liver cirrhosis, or kidney problems (nephrotic syndrome). It is also used for treatment of high blood pressure. It may also be used to treat or prevent low blood potassium. It may also be used to treat excess secretion of the hormone aldosterone by the adrenal gland. Aldactone is a potassium-sparing diuretic. It works by blocking the hormone aldosterone, causing the kidney to eliminate excess water, save potassium, and lower blood pressure.

Use Aldactone as directed by your doctor.

Take Aldactone by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

Aldactone may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.

If you miss a dose of Aldactone, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If more than one dose is missed, restart the medication and advise your doctor or pharmacist at your next appointment.

Ask your health care provider any questions you may have about how to use Aldactone.

Store Aldactone at room temperature, between 59 and 77 degrees F (15 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aldactone out of the reach of children and away from pets.

Active Ingredient: Spironolactone.

Do NOT use Aldactone if:

you are allergic to any ingredient in Aldactone

you are unable to urinate, have severe kidney problems, or have high blood potassium levels

you are taking a potassium supplement, another potassium-sparing diuretic (eg, amiloride, triamterene), or another aldosterone-blocker (eg, eplerenone).

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Aldactone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have high acidity in your body fluids; low blood sodium levels; high blood potassium levels; kidney, liver, or heart disease; diabetes; or high urea or nitrogen in your blood

if you have menstrual disease.

Some medicines may interact with Aldactone. Tell your health care provider if you are taking any other medicines, especially any of the following:

Adrenocorticotropic hormone (corticotropin) (ACTH) or corticosteroids (eg, prednisone) or because low blood electrolyte levels may occur

Barbiturates (eg, phenobarbital) or narcotics (eg, morphine) because dizziness upon standing may occur

Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), angiotensin II receptor antagonists (eg, valsartan), cyclosporine, macrolide immunosuppressives (eg, tacrolimus), other aldosterone-blockers (eg, eplerenone), other potassium sparing diuretics (eg, amiloride, triamterene), or potassium supplements because high blood potassium levels may occur (eg, listlessness, confusion, abnormal skin sensations of the arms and legs, heaviness of limbs, slowed heart rate, irregular heart rhythm, potentially life-threatening slow or irregular heartbeat)

Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, indomethacin) because they may decrease Aldactone's effectiveness and increase the risk of kidney problems and high blood potassium

Digoxin, digitoxin, lithium, nondepolarizing muscle relaxants (eg, tubocurarine), or quinidine because the risk of their side effects and toxicity may be increased by Aldactone

Pressor amines (eg, norepinephrine) because their effectiveness may be decreased by Aldactone.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Aldactone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

Aldactone may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Aldactone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Aldactone can raise your body's potassium levels. This is more likely to occur in people with kidney problems or diabetes, in the elderly, or if the patient is severely ill. Potassium levels must be closely monitored in people with any of these problems or illnesses. If not treated, high potassium levels can be fatal.

Check with your doctor before you use a salt substitute or a product that has potassium in it.

Lab tests, including kidney function, blood pressure, blood potassium, and chemistries, may be performed while you use Aldactone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Aldactone with caution in the elderly; they may be more sensitive to its effects.

Aldactone should be used with extreme caution in children; safety and effectiveness in children have not been confirmed.

Pregnancy and breast-feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aldactone while you are pregnant. Aldactone is found in breast milk. Do not breast-feed while taking Aldactone.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Diarrhea; drowsiness; headache; nausea; stomach cramping; vomiting.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; change in the amount of urine produced; confusion; dark urine; decreased sexual ability; enlarged breasts in men; irregular or missed menstrual periods; pale stools; severe or persistent stomach pain; symptoms of abnormal fluid or electrolyte levels (eg, fast, slow, or irregular heartbeat; increased thirst; muscle weakness; severe or persistent dry mouth, nausea, or vomiting; severe or persistent dizziness or drowsiness; unusual fatigue or sluggishness; tingling sensation); yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

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Check with your physician if you have any of the following:

Conditions:

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Apo-Hydroxyzine - Uses, Side Effects, Interactions, Apo-Hydroxyzine

Apo-Hydroxyzine

How does this medication work? What will it do for me?

Hydroxyzine belongs to the class of medications called antihistamines . It is used to relieve itching and other symptoms caused by allergic conditions. It can help to alleviate itching due to an adverse reaction to opiod medications. It works by blocking the actions of one of the body's natural chemicals known as histamine . Histamine is responsible for many of the symptoms seen when an allergic reaction occurs. The calming effects of hydroxyzine result from its sedating side effect.

It is also used to manage anxiety and tension caused by situations such as dental procedures or acute emotional problems. Hydroxyzine is sometimes used as part of the treatment of alcoholism. Hydroxyzine is also used to control nausea and vomiting (except in pregnancy).

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

This medication is available as 10 mg, 25 mg, and 50 mg capsules.

How should I use this medication?

For adults, the recommended dose of hydroxyzine when taken by mouth ranges from 25 mg to 100 mg, 3 or 4 times a day.

For children under 6 years of age, the daily dose when taken by mouth is 30 mg to 50 mg in divided doses.

For children over 6 years of age, the daily dose is 50 mg to 100 mg in divided doses.

Hydroxyzine may be taken with or without food.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

This medication is available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms listed here. The forms available for the specific brand you have searched are listed under "What form(s) does this medication come in?"

Do not dispose of medications in wastewater (e. g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Hydroxyzine should not be taken by anyone who:

is allergic to hydroxyzine or to any of the ingredients of the medication

is in early pregnancy

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

constipation

decreased appetite

diarrhea

drowsiness

dry mouth, nose, or throat

stomach upset, stomach pain, or nausea

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

blurred vision or any change in vision

confusion

difficult or painful urination

fast heartbeat

skin rash

sore throat

tremor

unusual bleeding or bruising

unusual excitement, restlessness, nervousness, or irritability

unusual tiredness or weakness

Stop taking the medication and seek immediate medical attention if any of the following occur:

hallucinations

signs of an allergic reaction (e. g. rash, itching, or hives)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

June 6, 2016

Health Canada has issued new restrictions concerning the use of Atarax (hydroxyzine). To read the full Health Canada Advisory, visit Health Canada's web site at www. hc-sc. gc. ca .

Drowsiness/reduced alertness: Since hydroxyzine causes drowsiness, you should not drive a car or perform hazardous tasks until you determine that this medication does not impair your ability to perform these tasks safely.

Enlarged prostate and urinary difficulties: Hydroxyzine may worsen urinary difficulties.

Epilepsy: Hydroxyzine should be used with caution by people with epilepsy as it may increase the risk for seizures.

Glaucoma: This medication may cause a slight increase in pressure in the eye and therefore should be used with caution by anyone with glaucoma.

Sedation: The sedating effect of hydroxyzine must be considered when the medication is used at the same time as other sedating medications such as narcotics, non-narcotic pain relievers, sleeping pills, sedatives, barbiturates, or alcohol.

Pregnancy: Hydroxyzine should not be used during early pregnancy. It should be used during later pregnancy only if the potential benefits outweigh the risks.

Breast-feeding: It is not known if hydroxyzine passes into breast milk. Hydroxyzine should not be used by breast-feeding mothers.

Seniors: Seniors may be at increased risk for the sedating and impaired coordination effects of this medication. Seniors should use extra caution, for example, when getting up during the night.

What other drugs could interact with this medication?

There may be an interaction between hydroxyzine and any of the following:

alcohol

anticholinergics

barbiturates

narcotics

psychiatric medications

sedatives

St. John's wort

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

stop taking one of the medications,

change one of the medications to another,

change how you are taking one or both of the medications, or

leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Apo-Hydroxyzine

How does this medication work? What will it do for me?

Hydroxyzine belongs to the class of medications called antihistamines . It is used to relieve itching and other symptoms caused by allergic conditions. It can help to alleviate itching due to an adverse reaction to opiod medications. It works by blocking the actions of one of the body's natural chemicals known as histamine . Histamine is responsible for many of the symptoms seen when an allergic reaction occurs. The calming effects of hydroxyzine result from its sedating side effect.

It is also used to manage anxiety and tension caused by situations such as dental procedures or acute emotional problems. Hydroxyzine is sometimes used as part of the treatment of alcoholism. Hydroxyzine is also used to control nausea and vomiting (except in pregnancy).

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

This medication is available as 10 mg, 25 mg, and 50 mg capsules.

How should I use this medication?

For adults, the recommended dose of hydroxyzine when taken by mouth ranges from 25 mg to 100 mg, 3 or 4 times a day.

For children under 6 years of age, the daily dose when taken by mouth is 30 mg to 50 mg in divided doses.

For children over 6 years of age, the daily dose is 50 mg to 100 mg in divided doses.

Hydroxyzine may be taken with or without food.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

This medication is available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms listed here. The forms available for the specific brand you have searched are listed under "What form(s) does this medication come in?"

Do not dispose of medications in wastewater (e. g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Hydroxyzine should not be taken by anyone who:

is allergic to hydroxyzine or to any of the ingredients of the medication

is in early pregnancy

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

constipation

decreased appetite

diarrhea

drowsiness

dry mouth, nose, or throat

stomach upset, stomach pain, or nausea

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

blurred vision or any change in vision

confusion

difficult or painful urination

fast heartbeat

skin rash

sore throat

tremor

unusual bleeding or bruising

unusual excitement, restlessness, nervousness, or irritability

unusual tiredness or weakness

Stop taking the medication and seek immediate medical attention if any of the following occur:

hallucinations

signs of an allergic reaction (e. g. rash, itching, or hives)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

June 6, 2016

Health Canada has issued new restrictions concerning the use of Atarax (hydroxyzine). To read the full Health Canada Advisory, visit Health Canada's web site at www. hc-sc. gc. ca .

Drowsiness/reduced alertness: Since hydroxyzine causes drowsiness, you should not drive a car or perform hazardous tasks until you determine that this medication does not impair your ability to perform these tasks safely.

Enlarged prostate and urinary difficulties: Hydroxyzine may worsen urinary difficulties.

Epilepsy: Hydroxyzine should be used with caution by people with epilepsy as it may increase the risk for seizures.

Glaucoma: This medication may cause a slight increase in pressure in the eye and therefore should be used with caution by anyone with glaucoma.

Sedation: The sedating effect of hydroxyzine must be considered when the medication is used at the same time as other sedating medications such as narcotics, non-narcotic pain relievers, sleeping pills, sedatives, barbiturates, or alcohol.

Pregnancy: Hydroxyzine should not be used during early pregnancy. It should be used during later pregnancy only if the potential benefits outweigh the risks.

Breast-feeding: It is not known if hydroxyzine passes into breast milk. Hydroxyzine should not be used by breast-feeding mothers.

Seniors: Seniors may be at increased risk for the sedating and impaired coordination effects of this medication. Seniors should use extra caution, for example, when getting up during the night.

What other drugs could interact with this medication?

There may be an interaction between hydroxyzine and any of the following:

alcohol

anticholinergics

barbiturates

narcotics

psychiatric medications

sedatives

St. John's wort

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

stop taking one of the medications,

change one of the medications to another,

change how you are taking one or both of the medications, or

leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

More on CHealth

Condition and disease information is written and reviewed by the MediResource Clinical Team. The contents of this site are for informational purposes only and are meant to be discussed with your physician or other qualified health care professional before being acted on. Never disregard any advice given to you by your doctor or other qualified health care professional. Always seek the advice of a physician or other licensed health care professional regarding any questions you have about your medical condition(s) and treatment(s).

This site is not a substitute for medical advice. © 1996 - 2016

MediResource Inc. - MediResource reaches millions of Canadians each year.

Condition and disease information is written and reviewed by the MediResource Clinical Team. The contents of this site are for informational purposes only and are meant to be discussed with your physician or other qualified health care professional before being acted on. Never disregard any advice given to you by your doctor or other qualified health care professional. Always seek the advice of a physician or other licensed health care professional regarding any questions you have about your medical condition(s) and treatment(s).

This site is not a substitute for medical advice. © 1996 - 2016

MediResource Inc. - MediResource reaches millions of Canadians each year.

Becloforte Drug Information, Professional, Becloforte

Becloforte

Generic Name: Corticosteroids This monograph includes information on the following:

1) Beclomethasone 2) Budesonide 3) Flunisolide 4) Triamcinolone

Note: See also individual monograph, Fluticasone (Inhalation-Local)—Introductory Version .

JAN: Beclomethasone—Beclometasone dipropionate VA CLASSIFICATION Primary: RE110 Secondary: RE190

Commonly used brand name(s): AeroBid 3 ; AeroBid-M 3 ; Azmacort 4 ; Beclodisk 1 ; Becloforte 1 ; Beclovent 1 ; Beclovent Rotacaps 1 ; Bronalide 3 ; Pulmicort Nebuamp 2 ; Pulmicort Respules 2 ; Pulmicort Turbuhaler 2 ; QVAR 1 ; Vanceril 1 ; Vanceril 84 mcg Double Strength 1 .

Other commonly used names for beclomethasone are beclomethasone dipropionate, beclometasone, and beclometasone dipropionate. Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

Note: Bracketed information in the Indications section refers to uses that are not included in U. S. product labeling.

Asthma, bronchial, chronic (treatment)—Beclomethasone, budesonide, flunisolide, and triamcinolone are indicated as primary maintenance treatment in patients with persistent symptoms of chronic bronchial asthma. Treatment with inhaled corticosteroids is indicated in asthmatic patients whose conditions require anti-inflammatory treatment and in patients dependent on oral corticosteroids who may benefit from a gradual withdrawal from oral corticosteroids to decrease the likelihood of side effects . Regular, continuous use of inhaled corticosteroids controls chronic airway inflammation, decreases airway hyperresponsiveness, prevents asthma symptoms, reduces the frequency of asthma exacerbations, and reduces hospital admissions for asthma . Clinical studies have also reported that regular use with inhaled corticosteroids is associated with decreased mortality. Inhaled corticosteroids are effective in all types of asthma and in patients of all ages. —Initiation of therapy with daily doses of inhaled corticosteroids shortly after a diagnosis of chronic asthma (even if mild) may prevent irreversible structural changes in the airways resulting from uncontrolled inflammation, may decrease progression of severe disease, and may reduce the need for administration of systemic corticosteroids . —Information comparing dose-related systemic effects or the ratios of local to systemic activity of beclomethasone, budesonide, flunisolide, and triamcinolone is limited. However, since conclusive evidence is lacking and further studies are needed, the concept of individualized dose titration in each patient to identify the lowest effective dose of an inhaled corticosteroid to achieve and maintain the desired clinical control of asthma seems prudent . —Because of the potent anti-inflammatory effects of inhaled corticosteroids and the potential morbidity and mortality associated with theophylline treatment . inhaled corticosteroids in conventional low doses are preferred to theophylline as first-line therapy for chronic asthma. —Guidelines for the treatment of asthma: —Children aged 5 years and younger—Preferred treatment for mild asthma (more than 2 symptoms per week but less than 1 symptom per day) is a low-dose inhaled corticosteroid. Alternative treatment may consist of cromolyn or a leukotriene receptor antagonist. Preferred treatment with moderate asthma (greater than 1 symptom per night) is a low-dose inhaled corticosteroid and long-acting inhaled beta-adrenergic bronchodilator. Alternative treatment may consist of a low-dose inhaled corticosteroid and either a leukotriene receptor antagonist or theophylline. Preferred treatment with severe asthma (continual symptoms throughout the day) is a high-dose inhaled corticosteroid and a long-acting inhaled beta-adrenergic bronchodilator. —Children older than 5 years of age—Preferred treatment for mild asthma (more than 2 symptoms per week but less than 1 symptom per day) is a low-dose inhaled corticosteroid. Alternative treatment may consist of cromolyn, a leukotriene receptor antagonist, nedocromil, or theophylline. Preferred treatment with moderate asthma (greater than 1 symptom per night) is a low-to-medium dose inhaled corticosteroid and a long-acting inhaled beta-adrenergic bronchodilator. Alternative treatment may consist of a low-dose inhaled corticosteroid and either a leukotriene receptor antagonist or theophylline. Preferred treatment with severe asthma (continual symptoms throughout the day) is a high-dose inhaled corticosteroid and a long-acting inhaled beta-adrenergic bronchodilator. —Budesonide dry-powder inhalers are indicated for use in [ children 3 months to 6 years of age] 1 and older. Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Acceptance not established Use in children younger than 3 months of age for the treatment of asthma has not been established . Unaccepted Corticosteroid inhalation therapy does not relieve acute bronchospasm and is not indicated for the primary treatment of status asthmaticus or other acute asthmatic episodes requiring more intensive or rapid treatment measures. Oral corticosteroids are more effective than inhaled corticosteroids for the treatment of acute asthmatic episodes.

Dexamethasone inhalation is not recommended for use in asthma because it has demonstrated a significantly higher incidence of systemic effects with no additional benefit over other inhaled corticosteroids. The high ratio of systemic glucocorticoid activity to local anti-inflammatory activity of inhaled dexamethasone may be due to its greater water solubility and longer metabolic half-life after absorption relative to the other inhaled corticosteroids.

1 Not included in Canadian product labeling.

Physicochemical characteristics: Molecular weight— Beclomethasone dipropionate: 521.05 Budesonide: 430.54 Flunisolide: 443.52 Triamcinolone acetonide: 434.5 Mechanism of action/Effect:

In the treatment of chronic bronchial asthma, orally inhaled corticosteroids have many probable sites of action. The net effect is to reduce the chronic inflammation in asthmatic airways.

The potent anti-inflammatory action may be due to an inhibition of the secretion of growth factors, endothelial activating and other cytokines from lymphocytes, eosinophils, macrophages, fibroblasts, and mast cells. The results are decreased influx of inflammatory cells into the bronchial walls, due in part to inhibition of expression of adhesion molecules on the endothelium and in the tissue. Decreased activation and survival of eosinophils in the lung tissue and a reduction in numbers of mast cells are further effects.

Corticosteroids may inhibit release of mediators from basophils and enzymes from macrophages. There is decreased permeability through vasoconstriction and direct inhibition of endothelial cell contraction.

Beta-adrenergic-receptor numbers may be increased, which results in an enhanced response to beta-adrenergic bronchodilators and reduced down-regulation of beta-receptors after prolonged beta-agonist exposure.

Inhaled corticosteroids also inhibit mucus secretion in airways, possibly by a direct action on submucosal gland cells and an indirect inhibitory effect caused by the reduction in inflammatory mediators that stimulate mucus secretion. The amount and viscosity of sputum are reduced.

The effect of inhaled corticosteroids on bronchial asthma is to block the late inflammatory response to inhaled allergens and reduce over time the response to nonspecific triggers such as exercise. Bronchial wall inflammation and edema are reduced, sputum production is diminished, and the airways become less hyperresponsive to direct and indirect challenges. Absorption:

Beclomethasone, budesonide, and flunisolide are rapidly absorbed from the lungs and gastrointestinal tract. Triamcinolone is absorbed more slowly.

Without the use of a spacer, approximately 10 to 25% of an inhaled corticosteroid dose is deposited in the airways ; the remainder is deposited in the mouth and throat, and swallowed. A greater percentage of the inhaled dose may reach the respiratory tract with the use of a spacer device. The Budesonide powder for inhalation does not require the use of a spacer device. The budesonide inhalation suspension requires the use of a jet nebulizer device. In asthmatic children 4 to 6 years of age, the total absolute bioavailability (i. e. lung and oral) is approximately 6% of the labeled dose, delivered via jet nebulizer.

Volume of distribution (Vol D )

—Budesonide inhalation suspension: 3 liters per kilogram of body weight (L/kg) in children 4 to 6 years of age; approximately the same as in healthy adults. Biotransformation:

For beclomethasone dipropionate:

Rapidly transformed in the lungs to beclomethasone monopropionate, an active metabolite, which is significantly more potent topically than beclomethasone dipropionate.

For budesonide, flunisolide, and triamcinolone acetonide:

Absorbed unchanged. Those portions of each drug absorbed through the lungs or absorbed after being swallowed are rapidly and extensively transformed to inactive metabolites in the liver.

For budesonide—120 to 180 minutes (plasma).

For triamcinolone—88 minutes (plasma).

Note: The plasma half-life of the inhaled corticosteroids does not correspond well with the biologic half-life.

Improvement in the control of asthma symptoms following inhalation of budesonide suspension can occur within 2 to 8 days of beginning treatment.

Maximum improvement in pulmonary function and symptoms may take up to 4 to 6 weeks, while reduction in airway hyperresponsiveness occurs gradually over a period of weeks to months. Response depends on disease severity and the daily dose of the inhaled corticosteroid. Some patients fail to normalize their airway hyperresponsiveness despite years of treatment.

Time to peak concentration:

The peak plasma concentration of inhaled budesonide suspension occurred 10 to 30 minutes after start of nebulization. Elimination: Fecal and renal.

Precautions to Consider Carcinogenicity

Studies in animals showed no evidence of carcinogenicity for beclomethasone or triamcinolone. Studies in mice and rats on oral flunisolide showed an increase in pulmonary adenomas in mice but not in rats. Female rats showed an increased incidence of mammary adenocarcinoma. Studies of budesonide in mice showed no evidence of carcinogenesis. However, studies in rats showed an increase in gliomas in male rats at higher doses. No changes were found in female rats at higher doses or in male and female rats at lower doses. Two additional studies on male rats with budesonide at higher doses did not show an increase in glioma incidence but an increased incidence in hepatocellular tumors occurred. Mutagenicity

Studies with budesonide have been performed using six different test systems: Ames Salmonella/microsome plate test, mouse micronucleus test, mouse lymphoma test, chromosome aberration test in human lymphocytes, sex-linked recessive lethal test in Drosophila melanogaster, and DNA repair analysis in rat hepatocyte culture. Budesonide was not found to be mutagenic. There have been no mutagenesis studies carried out with triamcinolone. Pregnancy/Reproduction Fertility— In animal studies performed in rats and dogs, some impairment of fertility was seen for beclomethasone, budesonide, and flunisolide at high doses. When lower doses were evaluated, no impairment of fertility was noted. Triamcinolone showed no evidence of impaired fertility in animal studies.

Pregnancy— Chronic administration of systemic corticosteroids to pregnant women has shown decreased birth weights and a slight increase in the incidence of premature deliveries.

The use of conventional doses of inhaled corticosteroids by pregnant asthmatic women has not been reported to be associated with an increased incidence of congenital abnormalities in the newborn. Inhaled corticosteroids may be used during pregnancy when clinically necessary, since poorly controlled asthma and loss of pulmonary function and hypoxia present a greater risk to the mother and may cause fetal hypoxia. If inhaled corticosteroids are effective before pregnancy, it is advisable to continue regular maintenance dosing during pregnancy.

In animal studies, decreases in fetal survival and weight have been demonstrated with systemic corticosteroids. All of the inhaled corticosteroids have been shown to be teratogenic in animal studies. Rodents appear to be more susceptible to the teratogenic effects of glucocorticoids than humans.

Beclomethasone is the preferred inhaled corticosteroid during pregnancy in the U. S. because of more extensive clinical experience with its use than with flunisolide or triamcinolone.

Budesonide inhalation powder —FDA Pregnancy Category B

Postpartum — Infants whose mothers were treated with substantial doses of inhaled corticosteroids during pregnancy should be monitored for signs of hypoadrenalism. Breast-feeding

It is not known whether inhaled corticosteroids are distributed into breast milk. However, problems in humans have not been documented. Although systemic corticosteroids are distributed into breast milk, it is unlikely that inhaled corticosteroids would reach significant quantities in maternal serum, and the concentration in breast milk would probably be of minor clinical significance. Pediatrics

Orally inhaled corticosteroids are valuable and highly effective therapies in the management of asthma in pediatric patients. The Food and Drug Administration (FDA) and its advisory committees consider these products to be safe and effective in children when used according to their labeling guidelines. Clinical studies have shown that inhaled corticosteroids may cause a reduction in growth velocity in pediatric patients. In these studies (over a period of about 1 year), the mean reduction in growth velocity was approximately one centimeter (cm) per year (range 0.3 to 1.8 cm). This reduction appears to be related to the dose and the duration of exposure to the inhaled corticosteroid. This effect was observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, which suggests that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than are some commonly used tests of HPA axis function.

However, recent clinical trials have reported that while there is a slowing of growth velocity during the first 12 months of therapy, children treated with inhaled corticosteroids attain their predicted adult height at maturity. Studies comparing inhaled corticosteroid use in asthma to placebo have found no significant difference in adult height. Conflicting data comparing the adult height in children who were asthmatic and nonasthmatics exists. Some data indicates that asthmatic children, regardless of treatment, attained a lower adult height than nonasthmatic children. Other data indicates that attained adult height of patients with asthma is not different from adult height in nonasthmatics patients, regardless of treatment with inhaled corticosteroids.

In general, it is recommended that the growth of pediatric patients receiving orally inhaled corticosteroids should be monitored routinely, for example, via stadiometry. The potential effects on growth velocity of prolonged treatment with inhaled corticosteroids should be weighed against the clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives. To minimize the systemic effects of orally inhaled corticosteroids, the dose should be titrated to the lowest effective dose for the patient.

Use of prolonged, high daily doses of inhaled corticosteroids may cause a reduction in secretion of endogenous cortisol, although there have been no reports of clinically significant adrenal insufficiency in children treated with inhaled corticosteroids only. However, monitoring for the possibility of some suppression of the hypothalamic-pituitary-adrenal axis may be advisable in children receiving prolonged treatment.

Using a spacer device with beclomethasone, flunisolide, and triamcinolone (budesonide can not be used with a spacer device) . rinsing the mouth after inhalations, using the lowest possible doses, and reducing doses after favorable responses have been obtained appear to minimize the risk of adverse systemic and local side effects. A spacer device may enhance inhalation techniques and thus improve intrapulmonary delivery of inhaled corticosteroids and increase compliance in pediatric patients.

Children who are taking systemic corticosteroids in immunosuppressant doses may be more susceptible to infectious diseases, especially chickenpox and measles. Chickenpox and measles may be more serious or possibly fatal in children on immunosuppressant doses of corticosteroids. Although it is highly unlikely that inhaled corticosteroids in usual doses would be associated with an increased risk of serious infection . some precautions are advisable for children who are taking larger than usual doses of inhaled corticosteroids and who have not had these diseases. Particular care should be taken to avoid exposure to chickenpox and measles and to immunize at an early age against infectious diseases for which there are vaccines, such as measles. If the child is exposed to chickenpox, preventative treatment with varicella zoster immune globulin (VZIG) may be appropriate. If the child is exposed to measles, pooled intramuscular immunoglobulin (IG) for prophylaxis may be indicated. Treatment with antiviral medications may be used if chickenpox should develop.

Appropriate studies on the relationship of age to the effects of inhaled corticosteroids have not been performed in the geriatric population. However, in studies that have included patients over 65 years of age, geriatrics-specific problems that would limit the usefulness of this medication in the elderly have not been documented. Drug interactions and/or related problems Significant drug interactions are unlikely to occur with usual doses of inhaled corticosteroids. Although there are no defined drug interactions with inhaled corticosteroids . if these medications are used in high doses for a long time and systemic absorption occurs, some of the interactions seen with systemic corticosteroids have a potential to occur. (See Corticosteroids—Glucocorticoid Effects [Systemic] .)

Laboratory value alterations The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive ( » = major clinical significance):

With physiology/laboratory test values

Note: The following values may be affected with chronic use of larger-than-recommended doses of inhalation corticosteroids.

Adrenal function and Hypothalamic-pituitary-adrenal (HPA) axis function as assessed by 24-hour urinary free cortisol, morning serum cortisol concentration, or short tetracosactrin cortisol test (may be decreased if significant absorption of inhaled corticosteroid occurs, especially in children )

Glucose, blood or urine (high-dose therapy may be associated with an increase in fasting insulin, peak glucose, and insulin to glucose ratios after glucose tolerance tests )

Hematologic status (neutrophils and total white blood cell count may be increased; eosinophils and lymphocytes may be decreased; clinical relevance of these systemic effects may be insignificant )

Osteocalcin, serum (may be decreased in children and adults taking inhaled corticosteroids; however, decrease may also be seen in asthma patients not taking corticosteroids )

Medical considerations/Contraindications The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive ( » = major clinical significance).

Risk-benefit should be considered when the following medical problems exist Cirrhosis (may cause the effects of the corticosteroids to be enhanced )

Glaucoma (may increase intraocular pressure )

Hypothyroidism (may cause the effects of the corticosteroids to be enhanced )

Infections, untreated systemic, including bacterial, fungal, parasitic, or viral (use with caution, if at all; however, if the infection is an upper respiratory viral infection, the patient should continue therapy with the inhaled corticosteroid. In patients who have a history of asthma control deteriorating quickly during viral respiratory infection, prompt treatment with a short course of systemic corticosteroids should be considered )

Osteoporosis (may be exacerbated in postmenopausal women taking high doses over a prolonged time and not receiving an estrogen supplement. The daily dose of corticosteroid should be adjusted to the minimum required to maintain good control of asthma symptoms and estrogen replacement therapy may be considered )

(clinical studies have shown that cumulative inhaled corticosteroid doses have an inverse relationship with bone-mineral density at the lumbar spine and proximal femur )

Tuberculosis (may be reactivated during prolonged inhaled corticosteroid therapy unless chemoprophylaxis is administered concurrently; asthmatic patients with a positive Mantoux test who are using inhaled corticosteroids should be carefully monitored for manifestation or reactivation, especially in countries with a high incidence of tuberculosis ; inhaled corticosteroids should be avoided or used with great caution in patients with drug-resistant pulmonary tuberculosis or atypical tuberculosis )

Patient monitoring The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

(may be advisable every year during treatment in both children and adults if dosing guidelines are exceeded, especially if systemic corticosteroids are used concurrently or prior to inhaled corticosteroids )

Growth and development in children (careful monitoring of growth, for example via stadiometry, is recommended periodically during therapy with inhaled corticosteroids )

Inhalation technique (frequent assessment of inhalation technique and patient education on the importance of continuous prophylactic treatment with inhaled corticosteroids is recommended to ensure compliance, enhance delivery of medication to lungs, and reduce local and systemic side effects)

Intraocular pressure (periodic assessment is advisable in patients, such as the elderly, who may be at risk for glaucoma; patients who have glaucoma should be monitored prior to initiating treatment with inhaled corticosteroids and at appropriate intervals )

Pulmonary function assessment (periodic assessment is advisable during, and for several months following, transfer of a patient from systemic to inhalation corticosteroid therapy ; frequent pulmonary function monitoring may be necessary in some patients for as long as 4 to 8 months after discontinuation of oral corticosteroids ; daily outpatient peak expiratory flow rate [PEFR] measurements are useful in following the course of asthma and the patient's response to therapy )

Signs of systemic absorption (patients on high doses of inhaled corticosteroids should be assessed periodically for signs of increased bruising, weight gain, cushingoid features, acneform lesions, and cataracts )

Note: Some clinically important cases of growth suppression have been reported for orally inhaled corticosteroids. See also Pediatrics section. Use of corticosteroids in immunosuppressant doses is associated with a higher risk of infection, with the potential for those infections to be of a more serious nature. Care should be taken in adults and children to avoid exposure to viral infections, especially chickenpox and measles, if the patient has not already had the disease or been immunized against it. Infections such as ear, eye, flu-like, sinus, urinary tract, viral, and yeast infections have occurred in a small number of patients on inhaled corticosteroids. Transfer of patients from systemic to inhalation corticosteroid therapy may unmask allergic conditions which were previously suppressed, such as conjunctivitis, eczema, and rhinitis, due to a lower level of systemic corticosteroids. Pulmonary infiltrates with eosinophilia have occurred in patients receiving inhaled corticosteroids. While this effect probably occurs as a result of withdrawal of the systemic corticosteroid, a causative role of the inhaled corticosteroids or their vehicles cannot be ruled out.

Note: If use of this medication causes bronchospasm . the medication should be immediately discontinued and replaced with an alternative therapy.

Those occurring principally during long-term use indicating need for medical attention Osteoporosis (pain in back, ribs, arms, or legs)

Overdose Clinical effects of overdose The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive: Acute Suppression of hypothalamic-pituitary-adrenal (HPA) function — the potential for toxicity is low

Treatment of overdose For acute overdose, no emergency action is required. Inhaled corticosteroid therapy should be continued at recommended doses to control asthma. HPA function should return to normal range within one or two days.

For chronic overdose, treatment consists of decreasing the dose of the inhaled corticosteroid and then returning to the inhaled corticosteroid therapy slowly .

Patient Consultation As an aid to patient consultation, refer to Advice for the Patient, Corticosteroids (Inhalation) . In providing consultation, consider emphasizing the following selected information ( » = major clinical significance): Before using this medication » Conditions affecting use, especially: Sensitivity to corticosteroids

Use in children—Use of inhaled corticosteroids may result in decreased growth velocity and reduced cortisol secretion; monitoring of growth and development and adrenal function is important. Except for budesonide powder for inhalation, the use of a spacer is necessary for better compliance and improved airway delivery. Budesonide inhalation suspension should be administered via jet nebulizer connected to an air compressor. Ultrasonic nebulizers are not recommended. Exposure to chickenpox or measles should be avoided

Proper use of this medication » Not using to relieve acute asthma attack; continuing use even if using other medication for asthma attack

» Importance of not using more medication than the amount prescribed

» Compliance with therapy by using every day in regularly spaced doses; patients who are not taking systemic corticosteroids when inhalation therapy started may require up to 4 to 6 weeks for initial improvement and several months for full benefits

Gargling and rinsing mouth with water after each dose; not swallowing rinse water

» Reading patient instructions carefully; checking frequently with health care professional for proper use of inhaler nebulizer

» Proper dosing Missed dose: Using as soon as possible; using any remaining doses for that day at regularly spaced intervals

Checking with pharmacist to determine availability of refills for aerosol inhalers; saving inhaler if refills available

» Proper storage The canister should be stored at room temperature for best results. The dose delivered may be decreased if the canister is cold.

For beclomethasone, flunisolide, or triamcinolone inhalation aerosol dosage form Testing or priming the inhaler before using first time

Proper administration technique

Proper administration technique with use of spacer device

Proper cleaning procedure for inhaler

For beclomethasone capsule for inhalation dosage form » Not swallowing capsules; medication not effective if swallowed

Proper loading technique for inhaler

Proper administration technique

Proper cleaning procedure for inhaler

For beclomethasone powder for inhalation dosage form Proper loading technique for inhaler

Proper administration technique

Proper cleaning procedure for inhaler

For budesonide powder for inhalation dosage form Proper loading technique for inhaler

Prime inhaler before initial use

Proper administration technique

For budesonide suspension for inhalation dosage form Using in a power-operated nebulizer with an adequate flow rate and equipped with face mask or mouthpiece

Preparation of medication for use in nebulizer

Proper administration technique

Proper cleaning procedure for nebulizer Precautions while using this medication » Checking with physician if:

• Unusual physical stress occurs, such as surgery, injury, or infections

• Exposure to the chickenpox or measles occurs

• Asthma attack is not responsive to bronchodilator

• Any sign indicating possible mouth, throat, or lung infection occurs

• Symptoms do not improve or condition becomes worse

Carrying medical identification card stating that supplemental systemic corticosteroid therapy may be required in emergency situations, periods of unusual stress, or acute asthma attack

» Caution if any kind of surgery or emergency treatment is required; informing physician or dentist in charge that inhalation corticosteroid is being used

Avoid spraying in eyes

For patients receiving systemic corticosteroid therapy » Importance of not discontinuing systemic corticosteroid therapy without physician's advice; carefully reducing dose or discontinuing treatment if so directed

» Importance of regular visits to physician during time that systemic corticosteroid therapy is being withdrawn; obtaining physicians instructions to follow if severe asthma attack occurs, medical or surgical treatment is needed, or symptoms of corticosteroid withdrawal occur

Side/adverse effects Signs of potential side effects, especially bruising; chest pain; cystitis; dysphonia; edema; fatigue; itching, rash, or hives; malaise; oropharyngeal candidiasis or thrush; palpitations or tachycardia; sinus problems; stomach or abdominal pain; vertigo; weight gain; adrenal insufficiency; bronchospasm; cataracts; esophageal candidiasis; fever; gastroenteritis; growth inhibition; hypercorticism; hyperglycemia; hypersensitivity reactions such as angioedema, bronchospasm, rash, or urticaria; hypertension; menstrual disturbances; numbness; pneumonia; psychological disturbances such as, aggressive reactions, anxiety, behavioral changes, depression, psychosis, and restlessness; rectal hemorrhage; syncope; and osteoporosis

General Dosing Information Pharmacologic doses of inhaled corticosteroids should be carefully titrated to minimum effective doses to control asthma symptoms and prevent systemic effects. This is especially important for pediatric patients. See also Pediatrics section.

Gargling and rinsing the mouth with water after each dose are recommended to help prevent hoarseness, throat irritation, and oral candidiasis; the rinse water should not be swallowed. Rinsing the mouth without swallowing can also significantly reduce the amount of inhaled corticosteroid absorbed from the gastrointestinal tract.

The use of a spacer device with a metered dose inhaler may decrease the incidence of some adverse effects, especially oropharyngeal candidiasis and dysphonia. By reducing the need for proper coordination of timing of inhalation with activation of the inhaler and reducing the velocity and mean diameter of the aerosol particles . a spacer reduces the amount of medication deposited in the upper airways and increases the amount deposited in the lower respiratory tract. This enhances the local efficacy of the inhaled corticosteroid without significantly increasing systemic activity. Budesonide powder for inhalation can not be used with a spacer device.

Some patients may require relatively high doses of inhaled corticosteroids to prevent severe asthma relapse. For this purpose, the highly concentrated beclomethasone aerosol inhalation product available outside the U. S. facilitates the clinical use of high doses. The risk of local side effects, such as thrush and oropharyngeal candidiasis, may be minimized by twice-daily dosing and the use of a spacer device. However, these measures do not eliminate the risk of systemic side effects associated with prolonged use of high doses.

Patients whose asthma is controlled by their usual dose of inhaled corticosteroids may require temporary emergency use of systemic corticosteroids if their asthma control is rapidly deteriorating. The use of peak flow monitoring at home once or twice daily will provide objective information to the patient and the physician when this is necessary.

A short-acting inhaled bronchodilator is necessary to provide relief for the acute symptoms of asthma, such as bronchospasm.

Patients who use bronchodilators should administer the bronchodilator prior to the inhaled corticosteroid to enhance penetration of the corticosteroid into the bronchial tree. The inhaled bronchodilator should be used several minutes before the inhaled corticosteroid to allow time for bronchodilation and to reduce the potential for toxicity from fluorocarbon propellants of the inhaled corticosteroid.

If inhaled corticosteroid therapy requires discontinuation, the dosing regimen should be tapered off gradually and not stopped abruptly.

It is recommended that the 250-mcg-per-metered-spray product of beclomethasone be used only when the total daily dose is between 500 mcg and 1000 mcg.

When transferring a patient from systemic corticosteroid therapy to inhaled corticosteroid therapy, the patient's asthmatic condition should be relatively stable. When initiating the transfer, the patient should add the inhaled corticosteroid to existing systemic therapy. After a week to ten days of concurrent therapy, the systemic agent should be withdrawn gradually by reducing the daily or alternate-daily dose. The reductions should be made at intervals of 1 to 2 weeks, depending on how well the patient responds to the withdrawal. A slow rate of withdrawal is strongly urged. As a rule, the reductions should not exceed 2.5 mg of prednisone or its equivalent at one time.

Some patients may not be able to discontinue use of systemic corticosteroids. A minimal oral maintenance dose may be required along with the inhaled corticosteroid.

During the period of hypothalamic-pituitary-adrenal (HPA) function recovery, the patient may show signs of adrenal insufficiency when exposed to stressors, such as trauma, surgery, or infections, especially gastroenteritis or other conditions which involve a loss of electrolytes over a short period of time. While the inhaled corticosteroid may control the symptoms of asthma during these episodes, it does not supply a sufficient amount of systemic corticosteroids to cope with these emergencies. Therefore, patients who have had systemic corticosteroid therapy withdrawn recently should be instructed to resume large doses of systemic corticosteroid for these periods of stress, or for an acute asthma attack, and to contact their physician for further instruction.

Severe asthma relapse may occur upon withdrawal of the systemic corticosteroid. Reinstitution of systemic therapy may be required if a severe asthma attack occurs. Frequent pulmonary function monitoring (peak expiratory flow rate measurements) may be needed for some patients for as long as 4 to 8 months after discontinuation of the systemic corticosteroid.

A syndrome of pseudo-rheumatism (consisting of joint or muscle pain, joint swelling, peripheral edema, lethargy, anorexia, and nausea) may occur when systemic corticosteroid is withdrawn. This syndrome can be avoided or minimized if the dosage of systemic corticosteroids is reduced slowly, using an alternate-day regimen. If the syndrome occurs, the symptoms may be alleviated by treatment with acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs) in asthmatic patients who are not sensitive to NSAIDs . Resumption of systemic corticosteroid therapy may not be required. For treatment of adverse effects For laryngeal or pharyngeal candidiasis—Recommended treatment includes:

• Administration of an oral or systemic antifungal medication. • Change in frequency of inhaled corticosteroid dosing from four to two times a day without decreasing the total daily dose. This may allow recovery and clearing of thrush or prevent its occurrence while maintaining therapeutic efficacy. • Discontinuation of the inhaled corticosteroid is rarely necessary.

Inhalation Dosage Forms BECLOMETHASONE DIPROPIONATE INHALATION AEROSOL Usual adult and adolescent dose Antiasthmatic

For the 42- or 50-mcg-per-metered-spray products: Oral inhalation, 2 inhalations (84 or 100 mcg) three or four times a day. Alternatively, a dosage of 4 inhalations two times a day has been shown to be effective for some patients.

For severe asthma: Oral inhalation, initially, 12 to 16 inhalations a day. Dosage should then be decreased according to the patient's response.

For the 84-mcg-per-metered-spray product: Oral inhalation, 2 inhalations (168 mcg) two times a day .

For severe asthma: Oral inhalation, initially, 6 to 8 inhalations a day. Dosage should then be decreased according to the patient's response .

Usual adult and adolescent prescribing limits For the 42- or 50-mcg-per-metered-spray products—20 inhalations (840 or 1000 mcg) per day .

For the 84-mcg-per-metered-spray product—10 inhalations (840 mcg) per day . Usual pediatric dose Antiasthmatic

Children up to 6 years of age: Dosage has not been established.

Children 6 to 12 years of age:

For the 42- or 50-mcg-per-metered-spray products— Oral inhalation, 1 or 2 inhalations three or four times a day. Alternatively, a dosage of 4 inhalations two times a day has been shown to be effective for some patients.

For the 84-mcg-per-metered-spray product— Oral inhalation, 2 inhalations two times a day.

Note: The 250-mcg-per-metered-spray product is not recommended for children up to 16 years of age.

Usual pediatric prescribing limits For the 42- or 50-mcg-per-metered-spray products—10 inhalations (420 or 500 mcg per day.

For the 84-mcg-per-metered-spray product—5 inhalations (420 mcg) per day. Strength(s) usually available U. S.—

84 mcg (0.084 mg) per metered spray (Rx) [ Vanceril 84 mcg Double Strength (chlorofluorocarbons)]

Note: The 84-mcg-per-metered spray must be primed by spraying twice into the air before the initial use and when the product has not been used for more than 7 days. Each 6.7 gram canister contains medication for 80 inhalations. Each 16.8 gram canister contains medication for about 200 inhalations.

50 mcg (0.05 mg) per metered spray (Rx) [ Beclovent ] [ Vanceril ]

250 mcg (0.25 mg) per metered spray (Rx) [ Becloforte ]

Note: The 50-mcg-per-metered-spray product is available in two sizes that contain medication for 80 or 200 inhalations per canister. The 250-mcg-per-metered-spray product is available in two sizes that contain medication for 80 or 200 inhalations per canister.

Packaging and storage: Store between 15° and 30° C (59° and 86° F). If medication is not used within this range of temperature, the dose may not be accurate. Auxiliary labeling: • Shake well before using . • For oral inhalation only. • Store away from heat and direct sunlight. Note: Include patient instructions when dispensing. Demonstrate administration technique.

Additional information: In Canada, metered dose inhalers are labeled according to the amount of beclomethasone delivered at the valve; in the U. S. metered dose inhalers are labeled according to the amount of beclomethasone delivered at the mouthpiece or actuator. Thus, 50 mcg of beclomethasone delivered at the valve is equivalent to 42 mcg delivered at the mouthpiece.

These products contains dichlorodifluoromethane and trichloromonofluoromethane, substances that harm public health and the environment by destroying ozone in the upper atmosphere.

BECLOMETHASONE DIPROPIONATE HFA INHALATION AEROSOL Usual adult and adolescent dose Antiasthmatic

For the 40-mcg-per-metered-spray product: For patients who have previously used bronchodilators alone— Oral inhalation, 1 (40 mcg) or 2 (80 mcg) inhalations twice daily.

For patients who have previously used inhaled corticosteroids— Oral inhalation, 1 (40 mcg) to 4 (160 mcg) inhalations twice daily.

For the 50-mcg-per-metered-spray product: Mild asthma— Oral inhalation, 1 (50 mcg) or 2 (100 mcg) inhalations twice daily.

Moderate asthma—Oral inhalation 2 (100 mcg) to 5 (250 mcg) inhalations twice daily.

For the 80-mcg-per-metered-spray product: For patients who have previously used bronchodilators alone— Oral inhalation, 1 inhalation (80 mcg) two times a day.

For patients who have previously used inhaled corticosteroids— Oral inhalation, 1 or 2 inhalations (80 or 160 mcg) two times a day.

For the 100-mcg-per-metered-spray product: Severe asthma— Oral inhalation, 3 (300 mcg) or 4 (400 mcg) inhalations twice daily.

Note: The prescribing information in Canada includes a suggested conversion of doses for patients switching from CFC-beclomethasone dipropionate (CFC-BDP) to HFA-beclomethasone dipropionate (HFA-BDP). For patients using 200 mcg per day of CFC-BDP, use 100 mcg per day of HFA-BDP. For patients using 400 to 500 mcg per day of CFC-BDP, use 200 mcg per day of HFA-BDP. For patients using 600 to 750 mcg per day of CFC-BDP, use 300 mcg per day of HFA-BDP. For patients using 800 to 1000 mcg per day of CFC-BDP, use 400 mcg per day of HFA-BDP.

Usual adult and adolescent prescribing limits For the 40 mcg-per-metered-spray product—16 inhalations (640 mcg) per day.

For the 50 mcg-per-metered-spray product—10 inhalations (500 mcg) per day.

For the 80-mcg-per-metered-spray product—8 inhalations (640 mcg) per day. .

For the 100 mcg-per-metered-spray product—8 inhalations (800 mcg) per day. Usual pediatric dose Antiasthmatic Children up to 5 years of age: Dosage has not been established.

Children 5 to 11 years of age: Oral inhalation, 1 (40 mcg) inhalation twice daily.

Usual pediatric prescribing limits For the 40 mcg-per-metered-spray product—2 inhalations (80 mcg) per day. Strength(s) usually available U. S.—

40 mcg (0.04 mg) per metered spray (Rx) [ QVAR ]

80 mcg (0.08 mg) per metered spray (Rx) [ QVAR (tetrafluoroethane) (ethanol)]

Note: The 40-mcg-per-metered spray and 80-mcg-per-metered spray must be primed by spraying twice into the air (avoid eyes and face) before the initial use and when the product has not been used for more than 10 days. Each 7.3 gram canister contains medication for 100 inhalations

50 mcg (0.05 mg) per metered spray (Rx) [ QVAR ] [ QVAR ]

100 mcg (0.1 mg) per metered spray (Rx) [ QVAR ]

Note: The 50-mcg-per-metered-spray product is available in two sizes that contain medication for 100 (6.5 grams) and 200 (12.4 grams) inhalations per canister. The 100-mcg-per-metered-spray product is available in two sizes that contain medication for 100 (6.5 grams) and 200 (12.4 grams) inhalations per canister.

Packaging and storage: Store between 25° C (77° F). Excursions permitted between 15° and 30° C (59° and 86° F). If medication is not used within this range of temperature, the dose may not be accurate. . Auxiliary labeling: • For oral inhalation only. • Store away from heat and direct sunlight. • Store the canister on the concave end with the plastic actuator on top • Exposure to temperatures above 49° C (120° F) may cause bursting. Note: Include patient instructions when dispensing. Shaking the canister prior to administration is not necessary for this aerosol solution formulation. Demonstrate administration technique.

Additional information: In Canada, metered dose inhalers are labeled according to the amount of beclomethasone delivered at the valve; in the U. S. metered dose inhalers are labeled according to the amount of beclomethasone delivered at the mouthpiece or actuator. Thus, 50 mcg of beclomethasone dipropionate delivered at the valve is equivalent to 40 mcg delivered at the mouthpiece and 100 mcg of beclomethasone dipropionate delivered at the valve is equivalent to 80 mcg delivered at the mouthpiece.

While the beclomethasone dipropionate HFA was developed for use without a spacer device being necessary, the AeroChamber® is a suitable device for use with beclomethasone dipropionate HFA metered dose inhaler to maintain the extrafine particle fraction.

BECLOMETHASONE DIPROPIONATE FOR INHALATION (CAPSULES) Usual adult dose Antiasthmatic Oral inhalation, 200 mcg (0.2 mg) three or four times a day. Dosage should then be decreased according to patient response; many patients may be maintained on 400 mcg (0.4 mg) a day.

Usual adult prescribing limits 1000 mcg (1 mg) per day. Usual pediatric dose Antiasthmatic Children up to 6 years of age: Dosage has not been established.

Children 6 to 14 years of age: Oral inhalation, 100 mcg (0.1 mg) two to four times a day. Dosage should then be decreased according to patient response.

Usual pediatric prescribing limits 500 mcg (0.5 mg) per day. Strength(s) usually available U. S.— Not commercially available.

100 mcg (0.1 mg) per capsule (Rx) [ Beclovent Rotacaps (lactose)]

200 mcg (0.2 mg) per capsule (Rx) [ Beclovent Rotacaps (lactose)] Packaging and storage: Store below 30 °C (86 °F) and in a dry place. Auxiliary labeling: • Do not swallow capsule. Note: Include patient instructions when dispensing. Demonstrate administration technique. Use of beclomethasone for oral inhalation (capsules) requires a special device that separates the capsule into halves and releases the medication. Each capsule should be inserted into the device only immediately prior to use. If this instruction is not followed, the delivery of the medicine may be affected.

100 mcg (0.1 mg) per blister (Rx) [ Beclodisk ]

200 mcg (0.2 mg) per blister (Rx) [ Beclodisk ] Packaging and storage: Store below 30 °C (86 °F), in a well-closed container, unless otherwise specified by manufacturer. Note: Include patient instructions when dispensing. Demonstrate administration technique. Use of beclomethasone for oral inhalation (powder) requires a special device that penetrates the blister and releases the medication.

Inhalation Dosage Forms

Note: Bracketed information in the Dosage Forms section refer to categories of use and/or indications that are not included in U. S. product labeling.

BUDESONIDE POWDER FOR INHALATION Usual adult dose Antiasthmatic

Previous asthma therapy consisting of bronchodilators alone: Oral inhalation, 1 to 2 inhalations (200 to 400 mcg) two times a day.

Previous asthma therapy including inhaled corticosteroids: Oral inhalation, 1 to 2 inhalations (200 to 400 mcg) two times a day. Dosage may be increased as needed and as tolerated to a maximum of 4 inhalations (800 mcg) two times a day.

Note: Once-daily dosing with 200 mcg or 400 mcg may be considered in patients with mild to moderate asthma who are well controlled on inhaled corticosteroids. This dose may be administered once daily either in the morning or in the evening. If the asthma symptoms are not controlled adequately with the once-daily treatment, the total daily dose should be increased and/or administered as a divided dose.

Previous asthma therapy including systemic corticosteroids: Oral inhalation, 2 to 4 inhalations (400 to 800 mcg) two times a day .

Usual adult prescribing limits 1600 mcg a day for patients previously treated with inhaled or systemic corticosteroids or 800 mcg a day for patients previously treated with bronchodilators alone . Usual pediatric dose Antiasthmatic

Children up to 6 years of age: Use is not recommended . However, studies have shown that [children 3 months to 6 years of age] 1 have benefited from inhaled budesonide, at a dosage of 1 to 2 inhalations (200 to 400 mcg) daily, with a spacer (i. e. Nebuhaler, Inhaler), after which the dosage is adjusted as needed and as tolerated, to a maximum of 2 inhalations (400 mcg) daily.

Children 6 years of age and older: Oral inhalation, 1 inhalation (200 mcg) two times a day. Dosage may be increased as needed and as tolerated to a maximum of 2 inhalations (400 mcg) two times a day.

Note: Once-daily dosing with 200 mcg or 400 mcg may be considered in patients with mild to moderate asthma who are well controlled on inhaled corticosteroids. This dose may be administered once daily either in the morning or in the evening. If the asthma symptoms are not controlled adequately with the once-daily treatment, the total daily dose should be increased and/or administered as a divided dose.

Usual pediatric prescribing limits 800 mcg a day . Strength(s) usually available U. S.—

Note: Product is an inhalation-driven, multi-dose, dry powder inhaler .

100 mcg (0.1 mg) (Rx) [ Pulmicort Turbuhaler ]

200 mcg (0.2 mg) (Rx) [ Pulmicort Turbuhaler ]

400 mcg (0.4 mg) (Rx) [ Pulmicort Turbuhaler ] Packaging and storage: Store between 20 and 25 °C (68 and 77 °F). Protect from light. Auxiliary labeling: • For oral inhalation only.

BUDESONIDE SUSPENSION FOR INHALATION Usual adult and adolescent dose [Antiasthmatic] Initial: Oral inhalation, 1 to 2 mg, diluted with sterile sodium chloride inhalation solution, if necessary, to a volume of two to four mL, and administered via nebulization over a period of ten to fifteen minutes two times a day.

Note: For severe asthma, dosage may be increased according to patient response.

Maintenance: After the desired clinical effect has been obtained, the maintenance dose should be reduced gradually to the smallest dose necessary for control of symptoms.

Usual pediatric dose Antiasthmatic Children 12 months to 8 years of age: Previous Therapy: Bronchodilators alone— 0.5 mg total daily dose via jet nebulizer, either as a single dose or twice daily in divided doses.

Previous Therapy: Inhaled Corticosteroids— 0.5 mg total daily dose via jet nebulizer, either as a single dose or twice daily in divided doses.

Previous Therapy: Oral Corticosteroids—1 mg total daily dose via jet nebulizer, either as a single 1 mg dose or twice daily in divided doses of 0.5 mg.

Children up to 12 months of age: Dosage has not been established.

Note: In Canada, children 3 months to 12 years of age: Initial—Oral inhalation, 250 mcg (0.25 mg) to 1 mg, diluted with sterile sodium chloride inhalation solution, if necessary, to a volume of two to four mL, and administered via nebulization over a period of ten to fifteen minutes two times a day . Maintenance—After the desired clinical effect has been obtained, the maintenance dose should be reduced gradually to the smallest dose necessary for control of symptoms . Dosage has not been established for children younger than 3 months of age.

125 mcg (0.125 mg) per mL (250 mcg per 2-mL ampul) (Rx) [ Pulmicort Respules (disodium edetate) (sodium chloride) (sodium citrate) (citric acid) (polysorbate 80) (water for injection)]

250 mcg (0.25 mg) per mL (500 mcg per 2-mL ampul) (Rx) [ Pulmicort Respules (disodium edetate) (sodium chloride) (sodium citrate) (citric acid) (polysorbate 80) (water for injection)]

125 mcg (0.125 mg) per mL (250 mcg per 2-mL ampul) (Rx) [ Pulmicort Nebuamp ]

250 mcg (0.25 mg) per mL (500 mcg per 2-mL ampul) (Rx) [ Pulmicort Nebuamp ]

500 mcg (0.5 mg) per mL (1000 mcg per 2-mL ampul) (Rx) [ Pulmicort Nebuamp ] Packaging and storage: Store between 5 and 30 °C (41 and 86 °F) in an upright position . unless otherwise specified by manufacturer. Protect from freezing. Protect from light. Stability: Ampuls in an opened envelope should be stored in the envelope, protected from light, and used within 2 weeks.

Any opened ampul must be used promptly.

Note: For Canadian products, any unused suspension remaining in an opened ampul may be stored for later use as long as it is protected from light and is used within 12 hours after the ampul was opened. The entire contents of an ampul must be used within 12 hours after it is first opened. Ampuls in an opened envelope should be used within 3 months.

Auxiliary labeling: • For oral inhalation only. • Shake gently before using. • Do not freeze. Note: When dispensing, include patient instructions for preparation of solution.

Additional information: For nebulization of budesonide inhalation suspension, a gas flow (oxygen or compressed air) of 6 to 10 liters per minute should be used. Nebulizers with either a facemask or mouthpiece have been used. Ultrasonic nebulizers are not recommended.

Inhalation Dosage Forms FLUNISOLIDE INHALATION AEROSOL Usual adult and adolescent dose Antiasthmatic Oral inhalation, 500 mcg (0.5 mg—2 metered sprays) two times a day, morning and evening.

Usual adult prescribing limits Oral inhalation, 2 mg per day (4 metered sprays twice a day). At the 2-mg-per-day dosage, the patient should be monitored at appropriate intervals for HPA suppression. Usual pediatric dose Antiasthmatic Children up to 6 years of age: Dosage has not been established.

Note: Doses higher than 1 mg per day have not been studied in children 4 to 15 years of age. In Canada the pediatric dosing is established for children 4 years of age and older.

Strength(s) usually available U. S.—

250 mcg (0.25 mg) per metered spray (Rx) [ AeroBid ] [ AeroBid-M (menthol)]

250 mcg (0.25 mg) per metered spray (Rx) [ Bronalide ]

Packaging and storage: Store below 49 °C (120 °F) . preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Auxiliary labeling: • Shake well before using. • For oral inhalation only. Note: Include patient instructions when dispensing. Demonstrate administration technique.

Additional information: These products contain dichlorodifluoromethane, trichloromonofluoromethane, and dichlorotetrafluoroethane, substances that harm public health and the environment by destroying ozone in the upper atmosphere.

Inhalation Dosage Forms TRIAMCINOLONE ACETONIDE INHALATION AEROSOL Usual adult and adolescent dose Antiasthmatic Initial: Oral inhalation, 200 mcg (0.2 mg—2 metered sprays) three or four times a day . or four inhalations twice a day . For severe asthma: Oral inhalation, 1.2 to 1.6 mg (12 to 16 metered sprays) a day.

Maintenance: Dosage to be decreased according to patient response; maintenance may be achieved in some patients by administering the total daily dose in two divided doses.

Usual adult prescribing limits 1.6 mg (16 metered sprays) per day. Usual pediatric dose Antiasthmatic Children up to 6 years of age: Dosage has not been established.

Children 6 to 12 years of age: Oral inhalation, 100 to 200 mcg (0.1 to 0.2 mg—1 or 2 metered sprays) three or four times a day . or 200 to 400 mcg (2 or 4 metered sprays) twice a day. Dosage must be adjusted according to patient response.

Usual pediatric prescribing limits 1.2 mg (12 metered sprays) per day. Strength(s) usually available U. S.—

100 mcg (0.1 mg) per metered spray (Rx) [ Azmacort (alcohol 1%)]

200 mcg (0.2 mg) per metered spray (Rx) [ Azmacort (alcohol 1%)] Note: In Canada, metered dose inhalers are labeled according to the amount of medication delivered at the valve; in the U. S. metered dose inhalers are labeled according to the amount of medication delivered from the mouthpiece or actuator. Thus, 200 mcg of triamcinolone delivered at the valve is equivalent to 100 mcg delivered at the mouthpiece. Each 60 gram canister delivers at least 240 inhalations. Canister should not be used after 240 inhalations. After 240 actuations, the dose may not be accurate.

Packaging and storage: Store at temperatures below 49 °C (120 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Auxiliary labeling: • Shake well before using. • For oral inhalation only. Note: Include patient instructions when dispensing. Demonstrate administration technique.

Additional information: Each actuation releases approximately 200 mcg of triamcinolone acetonide, of which approximately 100 mcg are delivered from the unit.

This product contains dichlorodifluoromethane, a substance that harms public health and the environment by destroying ozone in the upper atmosphere.

References

Fleeger CA, editor. USAN 1994. USAN and the USP dictionary of drug names. Rockville, MD: The United States Pharmacopeial Convention, Inc. 1993.

No reference

No reference

No reference

Beclovent package insert (Glaxo—US), Rev 3/87.

Beclovent package insert (Glaxo—US), Rev 2/88.

Beclovent package insert (Glaxo—US), Rev 11/88.

Beclovent product monograph (A & H). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 23rd ed. Ottawa: Canadian Pharmaceutical Association, 1988.

Beclovent 100 (box) labeling (A & H—Canada).

Beclovent 200 (box) labeling (A & H—Canada).

Beclovent inhaler (box) labeling (A & H—Canada).

Beclovent patient instruction leaflet (A & H—Canada).

Vanceril package insert (Schering—US), Rev 9/85.

Vanceril package insert (Schering—US), Rev 9/88.

Vanceril (Schering). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 23rd ed. Ottawa: Canadian Pharmaceutical Association, 1988.

Decadron package insert (MSD—US), Rev 4/85.

Decadron package insert (MSD—US), Rev 3/88.

Aerobid package insert (Key—US), Rec 12/7/87, Rev 8/86.

Aerobid (Key). In: PDR Physicians' desk reference. 43rd ed. 1989. Oradell, NJ: Medical Economics Company, 1989.

Bronalide (Syntex). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 23rd ed. Ottawa: Canadian Pharmaceutical Association, 1988.

Azmacort package insert (Rorer—US).

Azmacort package insert (Rorer). In: PDR Physicians' desk reference. 43rd ed. Oradell, NJ: Medical Economics Company, 1989.

Azmacort labeling (box) (Rorer—US), Rec 11/20/87.

Reviewer comment, 10/12/88.

Reviewer comment, 9/26/88.

Lozewicz S, et al. Inflammatory cells in the airways in mild asthma. Br Med J 1988; 297: 1515-6.

Johnson CE. Aerosol corticosteroids for the treatment of asthma. Drug Intell Clin Pharm 1987; 21: 784-90.

Higgins LC. Use of inhaled steroids still lags. Med World News 1988 Jun 27: 55-6.

Simon PA. Asthma in children. Guidelines for pharmacotherapy. Drug Topics 1989 Mar 6: 80-6.

Nassif E, et al. Extrapulmonary effects of maintenance corticosteroid therapy with alternate-day prednisone and inhaled beclomethasone in children with chronic asthma. J Allergy Clin Immunol 1987; 80: 518-29.

Salzman GA, Pyszcynski DR, [Candidiasis: incidence study. In: Ractions 7 May 1988, 5]. J Allergy Clin Immunol 1988; 81(2): 424-8.

Settipane GA et. al. (Beclomethasone: hoarseness and candidiasis-incidence study.) New England and Regional Allergy Proceeding 1987; 8: 95-7.

Kesten S. Esophageal candidiasis associated with beclomethasone dipropionate aerosol therapy. Drug Intell Clin Pharm 1988; 22: 568-9.

Tandon MK. High dose beclomethasone in the management of elderly patients with corticosteroid dependent chronic obstructive pulmonary disease. Med J Aust 1987; 147: 314-5.

Littlewood JM et al. Growth retardation in asthmatic children treated with inhaled beclomethasone dipropionate. Lancet 1988 Jan 16: 115-6.

Law CM, et al. Nocturnal adrenal suppression in asthmatic children taking inhaled beclomethasone dipropionate. Lancet 1986 Apr 26: 944.

Law CM, et al. Nocturnal adrenal suppression in asthmatic children taking inhaled beclomethasone dipropionate. Lancet 1987 Jun 6: 1321.

Ventura A, et al. Systemic effects and inhaled beclomethasone dipropionate. Lancet 1986 Jun 14: 1393.

Munch EP, et al. Dose frequency in the treatment of asthmatics with inhaled topical steroids: comparison between a twice daily and once daily dosing regimen. Eur J Respir Dis 1985; 67: 254-60.

Meltzer, et al. Effect of dosing schedule on efficacy of beclomethasone dipropionate aerosol in chronic asthma. Am Rev Respir Dis 1985; 131: 732-6.

Tukiainen H. Comparison of twice-daily and four-times daily administration of beclomethasone dipropionate in patients with severe chronic bronchial asthma. Eur J Clin Pharmacol 1986; 30: 319-22.

Ebden P, Davies BH. High-dose corticosteroid inhalers for asthma. Lancet 1984 Sep 8: 576.

Henry RL. Dysphonia following inhalation resolving with volumatic spacer device use: 2 case reports. [In: Reactions Annual 1987: 29]. Med J Austr 1987 Oct 5: 147.

Beasley R, et al. Beclomethasone: exacerbation of asthma, follow-up comment. 1986. [In: Reactions Annual 1987: 29]. Lancet 1986 Nov 22; 2: 1277.

Tarlo SM, et al. Six-month double-blind, controlled trial of high dose, concentrated beclomethasone dipropionate in the treatment of severe chronic asthma. Chest 1988; 93(5): 998-1002.

Broder I, et al. Safety and efficacy of long-term treatment with inhaled beclomethasone dipropionate in steroid-dependent asthma. Can Med Assoc J 1987; 136(2): 129-35.

Hollman GA, Allen DB. Overt glucocorticoid excess due to inhaled corticosteroid therapy. Pediatrics 1988; 81(3): 452-5.

Meltzer ED. Flunisolide aerosol for treatment of severe, chronic asthma in steroid-independent children. Pediatrics 1982; 69: 340-5.

Shapiro GG, et al. Short-term double-blind evaluation of flunisolide aerosol for steroid-dependent asthmatic children and adolescents. Chest 1981; 80(6): 671-5.

Panel comment, Panel survey date 7/5/89.

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Panel comment, Panel survey date 7/5/89.

Panel comment, Panel survey date 7/5/89.

Wyngaarden MD, Smith LH. Cecil textbook of medicine. 18th ed. Philadelphia: W. B. Saunders Company, 1988: 403-10.

Rakel RE, editor. Conn's current therapy 1988. Philadelphia: W. B. Saunders Company, 1988.

Barnes PJ, Rodger IW, Thomson NC. Asthma: basic mechanisms and clinical management. San Diego, CA: Academic Press, 1988: 81-95, 131-42, 653-97.

Panel comment, Panel survey date 7/5/89.

Panel comment, Panel survey date 7/5/89.

Panel comment, Facsimile response 10/3/89.

Panel comment, Panel survey date 7/5/89.

Budesonide suspension for inhalation product monograph (Pulmicort Nebuamp, Astra—Canada), Rev 8/96.

Beclovent package insert (Allen and Hanburys—US), Rev 3/93, Rec 6/30/93.

Beclodisk box/label and patient instructions (Glaxo—Canada), Rec. 9/2/93.

Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 172-3.

Pulmicort Nebuamp product m

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Old Larimer Street Tattoo - 14 Photos & 18 Reviews - Tattoo - 2229 Larimer St, Northwest, Denver, Co

Old Larimer Street Tattoo

Recently came here for the first time, following my favorite artist to her new home (Kristy rocks!). As usual her work was awesome, her… Read More

Recently came here for the first time, following my favorite artist to her new home (Kristy rocks!). As usual her work was awesome, her attitude was great and the whole experience went smoothly! I'm so glad we (hubby & I) found her after she left Tribe!

This place has a great vibe - we'll be back!

Kristie Latimore is the shit. Cannot recommend her enough, she's an incredibly talented artist, both with her tattoos and fine art. I'll… Read More

Kristie Latimore is the shit. Cannot recommend her enough, she's an incredibly talented artist, both with her tattoos and fine art. I'll never go to another tattoo artist and you shouldn't either! All of the tattoos she's given me have turned out better than I originally imagined them. Do yourself a favor and get tattooed by Kristie!

So impressed! My friend and I decided to get tattooed on a whim on a Friday afternoon and we were ale to get in right away. All I knew was… Read More

So impressed! My friend and I decided to get tattooed on a whim on a Friday afternoon and we were ale to get in right away. All I knew was the text and location that I wanted for my new ink, no font or anything. The artist (Henry) drew me up a gorgeous custom font (all I told him was "make it metal"), and it was better than anything I could have imagined. And for an outer hand tattoo, he made it as quick and painless as possible, and he was easy to chat with. My friend also got tattooed with me that day, and he asked for a solid black skull. The artist found a few examples for him to choose from to get an idea on he style and then drew up a custom version from there. The final work was amazing! I'd highly recommend coming here. The shop minimum ($75) is a little higher than most other places I've been to, but, as everyone knows, good tattoos aren't cheap, and cheap tattoos aren't good!

In addition to the friendly and talented staff, this place is worth checking out just for the decor! It's a really neat little shop with tall ceilings and killer artwork all over the walls. They also have a nice display case of jewelry to choose from if you go the piercing route instead. I'll certainly be coming here for more ink the next time I am in Denver.

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Buspimen Generic Name Buspirone Online, Buspimen

Buspimen General Information

Buspimen - Pharmacology:

Buspimen binds to 5-HT type 1A serotonin receptors on presynaptic neurons in the dorsal raphe and on postsynaptic neurons in the hippocampus, thus inhibiting the firing rate of 5-HT-containing neurons in the dorsal raphe. Buspimen also binds at dopamine type 2 (DA2) receptors, blocking presynaptic dopamine receptors. Buspimen increases firing in the locus ceruleus, an area of brain where norepinephrine cell bodies are found in high concentration. The net result of buspirone actions is that serotonergic activity is suppressed while noradrenergic and dopaminergic cell firing is enhanced.

Buspimen for patients

Buspimen is used for the treatment of nervousness and anxiety. Optimum results are usually seen after three to four weeks of treatment. This medication may be taken with or without food. Inform your physican if you are pregnant or nursing. Buspimen may cause dizziness and drowsiness; use caution while driving or operating hazardous machinery. Do not take any other sedating drugs or drink alcohol while taking this medication. Do not take this medication with a monoamine oxidase inhibitor. Notify physician if you develop muscle spasms, uncontrolled twitching in the face and body, or uncontrolled tongue movements.

This description is suitable for active ingredient Buspirone

Buspimen Interactions

It is recommended that buspirone hydrochloride not be used concomitantly with MAO inhibitors Because the effects of concomitant administration of buspirone HCl with most other psychotropic drugs have not been studied, the concomitant use of buspirone HCl with other CNS-active drugs should be approached with caution.

There is one report suggesting that the concomitant use of trazodone hydrochloride (Desyrel) and buspirone HCl may have caused 3- to 6-fold elevations on SGPT (ALT) in a few patients. In a similar study, attempting to replicate this finding, no interactive effect on hepatic transaminases was identified.

In a study in normal volunteers, concomitant administration of buspirone HCl and haloperidol resulted in increased serum haloperidol concentrations. The clinical significance of this finding is not clear.

In vitro, buspirone does not displace tightly bound drugs like phenytoin, propranolol, and warfarin from serum proteins. However, there has been one report of prolonged prothrombin time when buspirone was added to the regimen of a patient treated with warfarin. The patient was also chronically receiving phenytoin, phenobarbital, digoxin, and levothyroxine sodium. In vitro, buspirone may displace less firmly bound drugs like digoxin. The clinical significance of this property is unknown.

Buspimen Contraindications

Acheter Anesderm Lidocaine En Ligne Sans Prescriptions, Neo-Xylestesin

Lidocaine injection is used to numb an area of your body to help reduce pain or discomfort caused by invasive medical procedures such as surgery, needle punctures, or insertion of a catheter or breathing tube.

Lidocaine injection is also given in an epidural (spinal block) to reduce the discomfort of contractions during labor.

Lidocaine injection is sometimes used to treat irregular heart rhythms that may signal a possible heart attack.

Lidocaine injection may also be used for other purposes not listed in this medication guide.

Lidocaine is given as an injection through a needle placed into a vein or directly into the body area to be numbed. Your doctor, nurse, or other healthcare provider will give you this injection. Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are receiving lidocaine injection in a hospital setting.

To treat irregular heart rhythms, you may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.

The LidoPen auto-injector is a prefilled automatic injection device to be used in an emergency. Keep the device with you at all times. Your doctor will describe the signs and symptoms to watch for when deciding when it's time to use the injection. Never use the LidoPen auto-injector without first calling your doctor.

Do not use the auto-injector in or near a vein or into your buttocks. Inject the medication only in your upper thigh or upper arm.

With the LidoPen auto-injector you will also receive a CardioBeeper. This device is used to transmit your heart rate and rhythm to your doctor over a telephone. Read all provided instructions and practice using the CardioBeeper so you will be able to quickly use it in an emergency.

Use Lidocaine as directed by your doctor

Store the LidoPen auto-injector at room temperature away from moisture and extreme hot or cold.

Active ingredient: Lidocaine

You should not receive this medication if you are allergic to lidocaine or any other type of numbing medicine.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use lidocaine injection:

coronary artery disease, circulation problems; or

a history of malignant hyperthermia.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether lidocaine injection passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Important safety information

There may be other drugs that can interact with lidocaine injection. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have any of these serious side effects:

feeling anxious, shaky, dizzy, restless, or depressed;

drowsiness, vomiting, ringing in your ears, blurred vision;

confusion, twitching, seizure (convulsions);

fast heart rate, rapid breathing, feeling hot or cold;

weak or shallow breathing, slow heart rate, weak pulse; or

feeling like you might pass out.

Less serious side effects include:

mild bruising, redness, itching, or swelling where the medication was injected;

numbness in places where the medicine is accidentally applied.

This is not a complete list of side effects and others may occur.

Call your doctor for medical advice about side effects.

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Sumatriptan - Fda Prescribing Information, Side Effects And Uses, Sutriptan

Sumatriptan

Indications and Usage for Sumatriptan

Sumatriptan tablets, USP are indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use:

• Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with Sumatriptan tablets, USP, reconsider the diagnosis of migraine before Sumatriptan tablets, USP are administered to treat any subsequent attacks. • Sumatriptan tablets, USP are not indicated for the prevention of migraine attacks. • Safety and effectiveness of Sumatriptan tablets have not been established for cluster headache.

Sumatriptan Dosage and Administration

Dosing Information

The recommended dose of Sumatriptan tablets is 25 mg, 50 mg, or 100 mg. Doses of 50 mg and 100 mg may provide a greater effect than the 25 mg dose, but doses of 100 mg may not provide a greater effect than the 50 mg dose. Higher doses may have a greater risk of adverse reactions [see Clinical Studies (14)] .

If the migraine has not resolved by 2 hours after taking Sumatriptan tablets, or returns after a transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose is 200 mg in a 24-hour period.

Use after Sumatriptan injection. If the migraine returns following an initial treatment with Sumatriptan succinate injection, additional single Sumatriptan tablets (up to 100 mg/day) may be given with an interval of at least 2 hours between tablet doses.

The safety of treating an average of more than 4 headaches in a 30-day period has not been established.

Dosing in Patients With Hepatic Impairment

If treatment is deemed advisable in the presence of mild to moderate hepatic impairment, the maximum single dose should not exceed 50 mg [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)] .

Dosage Forms and Strengths

25 mg Tablets: White to off-white, round, biconvex, uncoated tablets, debossed with “ RI61 ” on one side and plain on the other side.

50 mg Tablets: White to off-white, round, biconvex, uncoated tablets, debossed with “ RI62 ” on one side and plain on the other side.

100 mg Tablets: White to off-white, capsule-shaped, biconvex, uncoated tablets, debossed with “ RB97 ” on one side and plain on the other side.

Contraindications

Sumatriptan tablets are contraindicated in patients with:

• Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina [see Warnings and Precautions (5.1)] • Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions (5.2)] • History of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see Warnings and Precautions (5.4)] • Peripheral vascular disease [see Warnings and Precautions (5.5)] • Ischemic bowel disease [see Warnings and Precautions (5.5)] • Uncontrolled hypertension [see Warnings and Precautions (5.8)] • Recent use (i. e. within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine 1 (5-HT 1 ) agonist [see Drug Interactions (7.1, 7.3)] • Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)] • Hypersensitivity to Sumatriptan (angioedema and anaphylaxis seen) [see Warnings and Precautions (5.9)] • Severe hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]

Warnings and Precautions

Myocardial Ischemia, Myocardial Infarction, and Prinzmetal’s Angina

The use of Sumatriptan tablets is contraindicated in patients with ischemic or vasospastic CAD. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of Sumatriptan tablets. Some of these reactions occurred in patients without known CAD. Sumatriptan tablets may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD.

Perform a cardiovascular evaluation in triptan-naive patients who have multiple cardiovascular risk factors (e. g. increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving Sumatriptan tablets. If there is evidence of CAD or coronary artery vasospasm, Sumatriptan tablets are contraindicated. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of Sumatriptan tablets in a medically supervised setting and performing an electrocardiogram (ECG) immediately following administration of Sumatriptan tablets. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of Sumatriptan tablets.

Arrhythmias

Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT 1 agonists. Discontinue Sumatriptan tablets if these disturbances occur. Sumatriptan tablets are contraindicated in patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders.

Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure

Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with Sumatriptan tablets and are usually non-cardiac in origin. However, perform a cardiac evaluation if these patients are at high cardiac risk. The use of Sumatriptan tablets is contraindicated in patients with CAD and those with Prinzmetal’s variant angina.

Cerebrovascular Events

Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT 1 agonists, and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT 1 agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine when they were not. Also, patients with migraine may be at increased risk of certain cerebrovascular events (e. g. stroke, hemorrhage, TIA). Discontinue Sumatriptan tablets if a cerebrovascular event occurs.

Before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, exclude other potentially serious neurological conditions. Sumatriptan tablets are contraindicated in patients with a history of stroke or TIA.

Other Vasospasm Reactions

Sumatriptan tablets may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud’s syndrome. In patients who experience symptoms or signs suggestive of non-coronary vasospasm reaction following the use of any 5-HT 1 agonist, rule out a vasospastic reaction before receiving additional Sumatriptan tablets.

Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT 1 agonists. Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5-HT 1 agonists have not been clearly established.

Medication Overuse Headache

Overuse of acute migraine drugs (e. g. ergotamine, triptans, opioids, or combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.

Serotonin Syndrome

Serotonin syndrome may occur with Sumatriptan tablets, particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors [see Drug Interactions (7.4)]. Serotonin syndrome symptoms may include mental status changes (e. g. agitation, hallucinations, coma), autonomic instability (e. g. tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e. g. hyperreflexia, incoordination), and/or gastrointestinal symptoms (e. g. nausea, vomiting, diarrhea). The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Discontinue Sumatriptan tablets if serotonin syndrome is suspected.

Increase in Blood Pressure

Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients treated with 5-HT 1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with Sumatriptan. Sumatriptan tablets are contraindicated in patients with uncontrolled hypertension.

Anaphylactic/Anaphylactoid Reactions

Anaphylactic/anaphylactoid reactions have occurred in patients receiving Sumatriptan. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens. Sumatriptan tablets are contraindicated in patients with a history of hypersensitivity reaction to Sumatriptan.

Seizures

Seizures have been reported following administration of Sumatriptan. Some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures. There are also reports in patients where no such predisposing factors are apparent. Sumatriptan tablets should be used with caution in patients with a history of epilepsy or conditions associated with a lowered seizure threshold.

Adverse Reactions

The following adverse reactions are discussed in more detail in other sections of the prescribing information:

• Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina [see Warnings and Precautions (5.1)] • Arrhythmias [see Warnings and Precautions (5.2)] • Chest, throat, neck, and/or jaw pain/tightness/pressure [see Warnings and Precautions (5.3)] • Cerebrovascular events [see Warnings and Precautions (5.4)] • Other vasospasm reactions [see Warnings and Precautions (5.5)] • Medication overuse headache [see Warnings and Precautions (5.6)] • Serotonin syndrome [see Warnings and Precautions (5.7)] • Increase in blood pressure [see Warnings and Precautions (5.8)] • Hypersensitivity reactions [see Contraindications (4) and Warnings and Precautions (5.9)] • Seizures [see Warnings and Precautions (5.10)]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Table 1 lists adverse reactions that occurred in placebo-controlled clinical trials in patients who took at least 1 dose of study drug. Only treatment-emergent adverse reactions that occurred at a frequency of 2% or more in any group treated with Sumatriptan tablets and that occurred at a frequency greater than the placebo group are included in Table 1.

Table 1. Adverse Reactions Reported by at Least 2% of Patients Treated With Sumatriptan Tablets and at a Greater Frequency Than Placebo

The incidence of adverse reactions in controlled clinical trials was not affected by gender or age of the patients. There were insufficient data to assess the impact of race on the incidence of adverse reactions.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Sumatriptan tablets, Sumatriptan nasal spray, and Sumatriptan injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to Sumatriptan or a combination of these factors.

Cardiovascular. Hypotension, palpitations.

Neurological. Dystonia, tremor.

Drug Interactions

Ergot-Containing Drugs

Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and Sumatriptan tablets within 24 hours of each other is contraindicated.

Monoamine Oxidase-A Inhibitors

MAO-A inhibitors increase systemic exposure by 7-fold. Therefore, the use of Sumatriptan tablets in patients receiving MAO-A inhibitors is contraindicated [see Clinical Pharmacology (12.3)] .

Other 5-HT 1 Agonists

Because their vasospastic effects may be additive, co-administration of Sumatriptan tablets and other 5-HT 1 agonists (e. g. triptans) within 24 hours of each other is contraindicated.

Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors and Serotonin Syndrome

Cases of serotonin syndrome have been reported during co-administration of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7)] .

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C: There are no adequate and well-controlled trials in pregnant women. In developmental toxicity studies in rats and rabbits, oral administration of Sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route to pregnant rabbits, Sumatriptan was embryolethal. Sumatriptan tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Oral administration of Sumatriptan to pregnant rats during the period of organogenesis resulted in an increased incidence of fetal blood vessel (cervicothoracic and umbilical) abnormalities. The highest no-effect dose for embryofetal developmental toxicity in rats was 60 mg/kg/day, or approximately 3 times the maximum recommended human dose (MRHD) of 200 mg/day on a mg/m 2 basis. Oral administration of Sumatriptan to pregnant rabbits during the period of organogenesis resulted in increased incidences of embryolethality and fetal cervicothoracic vascular and skeletal abnormalities. Intravenous administration of Sumatriptan to pregnant rabbits during the period of organogenesis resulted in an increased incidence of embryolethality. The highest oral and intravenous no-effect doses for developmental toxicity in rabbits were 15 (approximately 2 times the MRHD on a mg/m 2 basis) and 0.75 mg/kg/day, respectively.

Oral administration of Sumatriptan to rats prior to and throughout gestation resulted in embryofetal toxicity (decreased body weight, decreased ossification, increased incidence of skeletal abnormalities). The highest no-effect dose was 50 mg/kg/day, or approximately 2 times the MRHD on a mg/m 2 basis. In offspring of pregnant rats treated orally with Sumatriptan during organogenesis, there was a decrease in pup survival. The highest no-effect dose for this effect was 60 mg/kg/day, or approximately 3 times the MRHD on a mg/m 2 basis. Oral treatment of pregnant rats with Sumatriptan during the latter part of gestation and throughout lactation resulted in a decrease in pup survival. The highest no-effect dose for this finding was 100 mg/kg/day, or approximately 5 times the MRHD on a mg/m 2 basis.

Nursing Mothers

Sumatriptan is excreted in human milk following subcutaneous administration. Infant exposure to Sumatriptan can be minimized by avoiding breastfeeding for 12 hours after treatment with Sumatriptan tablets.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Sumatriptan tablets are not recommended for use in patients younger than 18 years of age.

Two controlled clinical trials evaluated Sumatriptan nasal spray (5 to 20 mg) in 1,248 adolescent migraineurs aged 12 to 17 years who treated a single attack. The trials did not establish the efficacy of Sumatriptan nasal spray compared with placebo in the treatment of migraine in adolescents. Adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults.

Five controlled clinical trials (2 single-attack trials, 3 multiple-attack trials) evaluating oral Sumatriptan (25 to 100 mg) in pediatric patients aged 12 to 17 years enrolled a total of 701 adolescent migraineurs. These trials did not establish the efficacy of oral Sumatriptan compared with placebo in the treatment of migraine in adolescents. Adverse reactions observed in these clinical trials were similar in nature to those reported in clinical trials in adults. The frequency of all adverse reactions in these patients appeared to be both dose - and age-dependent, with younger patients reporting reactions more commonly than older adolescents.

Postmarketing experience documents that serious adverse reactions have occurred in the pediatric population after use of subcutaneous, oral, and/or intranasal Sumatriptan. These reports include reactions similar in nature to those reported rarely in adults, including stroke, visual loss, and death. A myocardial infarction has been reported in a 14-year-old male following the use of oral Sumatriptan; clinical signs occurred within 1 day of drug administration. Clinical data to determine the frequency of serious adverse reactions in pediatric patients who might receive subcutaneous, oral, or intranasal Sumatriptan are not presently available.

Geriatric Use

Clinical trials of Sumatriptan tablets did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

A cardiovascular evaluation is recommended for geriatric patients who have other cardiovascular risk factors (e. g. diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving Sumatriptan tablets [see Warnings and Precautions (5.1)] .

Hepatic Impairment

The maximum single dose in patients with mild to moderate hepatic impairment should not exceed 50 mg. Sumatriptan tablets are contraindicated in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)] .

Overdosage

Patients in clinical trials (N = 670) received single oral doses of 140 to 300 mg without significant adverse reactions. Volunteers (N = 174) received single oral doses of 140 to 400 mg without serious adverse reactions.

Overdose in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation.

The elimination half-life of Sumatriptan is approximately 2.5 hours [see Clinical Pharmacology (12.3)]. and therefore monitoring of patients after overdose with Sumatriptan tablets should continue for at least 12 hours or while symptoms or signs persist.

It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of Sumatriptan.

Sumatriptan Description

Sumatriptan tablets, USP contain Sumatriptan succinate, a selective 5-HT 1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:

The molecular formula is C 14 H 21 N 3 O 2 S•C 4 H 6 O 4. representing a molecular weight of 413.5. Sumatriptan succinate, USP is a white or almost white powder that is freely soluble in water, sparingly soluble in methanol and practically insoluble in methylene chloride.

Each Sumatriptan tablet, USP for oral administration contains 35, 70, or 140 mg of Sumatriptan succinate, USP equivalent to 25, 50, or 100 mg of Sumatriptan, respectively. Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and talc.

Sumatriptan - Clinical Pharmacology

Mechanism of Action

Sumatriptan binds with high affinity to human cloned 5-HT 1B/1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5-HT 1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.

Pharmacodynamics

Blood Pressure. Significant elevation in blood pressure, including hypertensive crisis, has been reported in patients with and without a history of hypertension [see Warnings and Precautions (5.8)].

Peripheral (Small) Arteries. In healthy volunteers (N = 18), a trial evaluating the effects of Sumatriptan on peripheral (small vessel) arterial reactivity failed to detect a clinically significant increase in peripheral resistance.

Heart Rate. Transient increases in blood pressure observed in some patients in clinical trials carried out during Sumatriptan’s development as a treatment for migraine were not accompanied by any clinically significant changes in heart rate.

Pharmacokinetics

Absorption and Bioavailability. The mean maximum concentration following oral dosing with 25 mg is 18 ng/mL (range: 7 to 47 ng/mL) and 51 ng/mL (range: 28 to 100 ng/mL) following oral dosing with 100 mg of Sumatriptan. This compares with a C max of 5 and 16 ng/mL following dosing with a 5 and 20 mg intranasal dose, respectively. The mean C max following a 6 mg subcutaneous injection is 71 ng/mL (range: 49 to 110 ng/mL). The bioavailability is approximately 15%, primarily due to presystemic metabolism and partly due to incomplete absorption. The C max is similar during a migraine attack and during a migraine-free period, but the T max is slightly later during the attack, approximately 2.5 hours compared with 2 hours. When given as a single dose, Sumatriptan displays dose proportionality in its extent of absorption (area under the curve [AUC]) over the dose range of 25 to 200 mg, but the C max after 100 mg is approximately 25% less than expected (based on the 25 mg dose).

A food effect trial involving administration of Sumatriptan tablets 100 mg to healthy volunteers under fasting conditions and with a high-fat meal indicated that the C max and AUC were increased by 15% and 12%, respectively, when administered in the fed state.

Distribution. Protein binding, determined by equilibrium dialysis over the concentration range of 10 to 1,000 ng/mL is low, approximately 14% to 21%. The effect of Sumatriptan on the protein binding of other drugs has not been evaluated. The apparent volume of distribution is 2.7 L/kg.

Metabolism. In vitro studies with human microsomes suggest that Sumatriptan is metabolized by MAO, predominantly the A isoenzyme. Most of a radiolabeled dose of Sumatriptan excreted in the urine is the major metabolite indole acetic acid (IAA) or the IAA glucuronide, both of which are inactive.

Elimination. The elimination half-life of Sumatriptan is approximately 2.5 hours. Radiolabeled 14 C-Sumatriptan administered orally is largely renally excreted (about 60%) with about 40% found in the feces. Most of the radiolabeled compound excreted in the urine is the major metabolite, indole acetic acid (IAA), which is inactive, or the IAA glucuronide. Only 3% of the dose can be recovered as unchanged Sumatriptan.

Special Populations. Age. The pharmacokinetics of Sumatriptan in the elderly (mean age: 72 years, 2 males and 4 females) and in subjects with migraine (mean age: 38 years, 25 males and 155 females) were similar to that in healthy male subjects (mean age: 30 years).

Renal Impairment: The effect of renal impairment on the pharmacokinetics of Sumatriptan has not been examined.

Hepatic Impairment: The liver plays an important role in the presystemic clearance of orally administered Sumatriptan. Accordingly, the bioavailability of Sumatriptan following oral administration may be markedly increased in patients with liver disease. In one small trial of patients with moderate liver impairment (n = 8) matched for sex, age, and weight with healthy subjects (n = 8), the hepatically-impaired patients had an approximately 70% increase in AUC and C max and a T max 40 minutes earlier compared to the healthy subjects.

The pharmacokinetics of Sumatriptan in patients with severe hepatic impairment has not been studied. The use of Sumatriptan tablets in this population is contraindicated [see Contraindications (4) and Use in Specific Populations (8.6)] .

Gender: In a trial comparing females to males, no pharmacokinetic differences were observed between genders for AUC, C max. T max. and half-life.

Race. The systemic clearance and C max of subcutaneous Sumatriptan were similar in black (n = 34) and Caucasian (n = 38) healthy male subjects. Oral Sumatriptan has not been evaluated for race differences.

Drug Interaction Studies. Monoamine Oxidase-A Inhibitors: Treatment with MAO-A inhibitors generally leads to an increase of Sumatriptan plasma levels [see Contraindications (4) and Drug Interactions (7.2)] .

Due to gut and hepatic metabolic first-pass effects, the increase of systemic exposure after co-administration of an MAO-A inhibitor with oral Sumatriptan is greater than after co-administration of the MAO inhibitors with subcutaneous Sumatriptan.

In a trial of 14 healthy females, pretreatment with an MAO-A inhibitor decreased the clearance of subcutaneous Sumatriptan, resulting in a 2-fold increase in the area under the Sumatriptan plasma concentration-time curve (AUC), corresponding to a 40% increase in elimination half-life.

A small trial evaluating the effect of pretreatment with an MAO-A inhibitor on the bioavailability from a 25 mg oral Sumatriptan tablet resulted in an approximately 7-fold increase in systemic exposure.

Alcohol: Alcohol consumed 30 minutes prior to Sumatriptan ingestion had no effect on the pharmacokinetics of Sumatriptan.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis. In carcinogenicity studies in mouse and rat, Sumatriptan was administered orally for 78 and 104 weeks, respectively, at doses up to 160 mg/kg/day (the high dose in rat was reduced from 360 mg/kg/day during week 21). There was no evidence in either species of an increase in tumors related to Sumatriptan administration. Plasma exposures (AUC) at the highest doses tested were 20 and 8 times that in humans at the maximum recommended human dose (MRHD) of 200 mg/day.

Mutagenesis. Sumatriptan was negative in in vitro (bacterial reverse mutation [Ames], gene cell mutation in Chinese hamster V79/HGPRT, chromosomal aberration in human lymphocytes) and in vivo (rat micronucleus) assays.

Impairment of Fertility. When Sumatriptan (5, 50, 500 mg/kg/day) was administered orally to male and female rats prior to and throughout the mating period, there was a treatment-related decrease in fertility secondary to a decrease in mating in animals treated with doses greater than 5 mg/kg/day (less than the MRHD on a mg/m 2 basis). It is not clear whether this finding was due to an effect on males or females or both.

Animal Toxicology and/or Pharmacology

Corneal Opacities. Dogs receiving oral Sumatriptan developed corneal opacities and defects in the corneal epithelium. Corneal opacities were seen at the lowest dose tested, 2 mg/kg/day, and were present after 1 month of treatment. Defects in the corneal epithelium were noted in a 60-week study. Earlier examinations for these toxicities were not conducted and no-effect doses were not established. Plasma exposure at the lowest dose tested was approximately 2 times that in humans at the MRHD.

Clinical Studies

The efficacy of Sumatriptan tablets in the acute treatment of migraine headaches was demonstrated in 3, randomized, double-blind, placebo-controlled trials. Patients enrolled in these 3 trials were predominately female (87%) and Caucasian (97%), with a mean age of 40 years (range of 18 to 65 years). Patients were instructed to treat a moderate to severe headache. Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed up to 4 hours after dosing. Associated symptoms such as nausea, photophobia, and phonophobia were also assessed. Maintenance of response was assessed for up to 24 hours postdose. A second dose of Sumatriptan tablets or other medication was allowed 4 to 24 hours after the initial treatment for recurrent headache. Acetaminophen was offered to patients in Trials 2 and 3 beginning at 2 hours after initial treatment if the migraine pain had not improved or worsened. Additional medications were allowed 4 to 24 hours after the initial treatment for recurrent headache or as rescue in all 3 trials. The frequency and time to use of these additional treatments were also determined. In all trials, doses of 25, 50, and 100 mg were compared with placebo in the treatment of migraine attacks. In 1 trial, doses of 25, 50, and 100 mg were also compared with each other.

In all 3 trials, the percentage of patients achieving headache response 2 and 4 hours after treatment was significantly greater among patients receiving Sumatriptan tablets at all doses compared with those who received placebo. In 1 of the 3 trials, there was a statistically significant greater percentage of patients with headache response at 2 and 4 hours in the 50 mg or 100 mg group when compared with the 25 mg dose groups. There were no statistically significant differences between the 50 mg and 100 mg dose groups in any trial. The results from the 3 controlled clinical trials are summarized in Table 2.

Table 2. Percentage of Patients With Headache Response (Mild or No Headache) 2 and 4 Hours Following Treatment

a P < 0.05 in comparison with placebo.

b P < 0.05 in comparison with 25 mg.

The estimated probability of achieving an initial headache response over the 4 hours following treatment in pooled

Figure 1. Estimated Probability of Achieving Initial Headache Response Within 4 Hours of Treatment in Pooled Trials 1, 2, and 3 a

a The figure shows the probability over time of obtaining headache response (no or mild pain) following treatment with oral Sumatriptan. The averages displayed are based on pooled data from the 3 clinical controlled trials providing evidence of efficacy. Kaplan-Meier plot with patients not achieving response and/or taking rescue within 240 minutes censored to 240 minutes.

For patients with migraine-associated nausea, photophobia, and/or phonophobia at baseline, there was a lower incidence of these symptoms at 2 hours (Trial 1) and at 4 hours (Trials 1, 2, and 3) following administration of Sumatriptan tablets compared with placebo.

As early as 2 hours in Trials 2 and 3, or as early as 4 hours in Trial 1, through 24 hours following the initial dose of study treatment, patients were allowed to use additional treatment for pain relief in the form of a second dose of study treatment or other medication. The estimated probability of patients taking a second dose or other medication for migraine over the 24 hours following the initial dose of study treatment is summarized in Figure 2.

Figure 2. The Estimated Probability of Patients Taking a Second Dose of Sumatriptan Tablets or Other Medication to Treat Migraine Over the 24 Hours Following the Initial Dose of Study Treatment in Pooled Trials 1, 2, and 3 a

a Kaplan-Meier plot based on data obtained in the 3 clinical controlled trials providing evidence of efficacy with patients not using additional treatments censored to 24 hours. Plot also includes patients who had no response to the initial dose. No remedication was allowed within 2 hours postdose.

There is evidence that doses above 50 mg do not provide a greater effect than 50 mg. There was no evidence to suggest that treatment with Sumatriptan tablets was associated with an increase in the severity of recurrent headaches. The efficacy of Sumatriptan tablets was unaffected by presence of aura; duration of headache prior to treatment; gender, age, or weight of the subject; relationship to menses; or concomitant use of common migraine prophylactic drugs (e. g. beta-blockers, calcium channel blockers, tricyclic antidepressants). There were insufficient data to assess the impact of race on efficacy.

How Supplied/Storage and Handling

Sumatriptan tablets, USP, 25 mg, 50 mg, and 100 mg of Sumatriptan (base) as the succinate.

Sumatriptan tablets, USP, 25 mg, are white to off-white, round, biconvex, uncoated tablets, debossed with “ RI61 ” on one side and plain on the other side.

NDC 63304-097-45 Bottles of 5

NDC 63304-097-13 Bottles of 120

NDC 63304-097-19 Blisters of 9

Sumatriptan tablets, USP, 50 mg, are white to off-white, round, biconvex, uncoated tablets, debossed with “ RI62 ” on one side and plain on the other side.

NDC 63304-098-45 Bottles of 5

NDC 63304-098-13 Bottles of 120

NDC 63304-098-19 Blisters of 9

Sumatriptan tablets, USP, 100 mg, are white to off-white, capsule-shaped, biconvex, uncoated tablets, debossed with “ RB97 ” on one side and plain on the other side.

NDC 63304-099-09 Bottles of 9

NDC 63304-099-13 Bottles of 120

NDC 63304-099-19 Blisters of 9

Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature].

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Risk of Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events. Inform patients that Sumatriptan tablets, USP may cause serious cardiovascular side effects such as myocardial infarction or stroke. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness, and slurring of speech, and should ask for medical advice if any indicative sign or symptoms are observed. Apprise patients of the importance of this follow-up [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5, 5.8)] .

Anaphylactic/Anaphylactoid Reactions. Inform patients that anaphylactic/anaphylactoid reactions have occurred in patients receiving Sumatriptan tablets, USP. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens [see Contraindications (4) and Warnings and Precautions (5.9)] .

Concomitant Use With Other Triptans or Ergot Medications. Inform patients that use of Sumatriptan tablets, USP within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated [see Contraindications (4), Drug Interactions (7.1, 7.3)] .

Serotonin Syndrome. Caution patients about the risk of serotonin syndrome with the use of Sumatriptan tablets, USP or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7), Drug Interactions (7.4)] .

Medication Overuse Headache. Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e. g. by keeping a headache diary) [see Warnings and Precautions (5.6)] .

Pregnancy. Inform patients that Sumatriptan tablets, USP should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations (8.1)].

Nursing Mothers. Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use in Specific Populations (8.3)] .

Ability to Perform Complex Tasks. Treatment with Sumatriptan tablets, USP may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of Sumatriptan tablets, USP.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

Sumatriptan TABLETS, USP

PHARMACIST: Dispense the enclosed patient information leaflet.

100 mg 9's Carton

PATIENT INFORMATION

Sumatriptan TABLETS, USP

Read this Patient Information before you start taking Sumatriptan tablets, USP and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is the most important information I should know about Sumatriptan tablets, USP?

Sumatriptan tablets, USP can cause serious side effects, including:

Heart attack and other heart problems. Heart problems may lead to death.

Stop taking Sumatriptan tablets, USP and get emergency medical help right away if you have any of the following symptoms of a heart attack:

• discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw • pain or discomfort in your arms, back, neck, jaw, or stomach • shortness of breath with or without chest discomfort • breaking out in a cold sweat • nausea or vomiting • feeling lightheaded

Sumatriptan tablets, USP are not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:

• have high blood pressure • have high cholesterol levels • smoke • are overweight • have diabetes • have a family history of heart disease

What are Sumatriptan tablets, USP?

Sumatriptan tablets, USP are a prescription medicine used to treat acute migraine headaches with or without aura in adults.

Sumatriptan tablets, USP are not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines.

Sumatriptan tablets, USP are not used to prevent or decrease the number of migraine headaches you have.

It is not known if Sumatriptan tablets, USP are safe and effective to treat cluster headaches.

It is not known if Sumatriptan tablets, USP are safe and effective in children under 18 years of age.

Who should not take Sumatriptan tablets, USP?

Do not take Sumatriptan tablets, USP if you have:

• heart problems or a history of heart problems • narrowing of blood vessels to your legs, arms, stomach, or kidneys (peripheral vascular disease) • uncontrolled high blood pressure • severe liver problems • hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider. • had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation • taken any of the following medicines in the last 24 hours: • almotriptan (AXERT ® ) • eletriptan (RELPAX ® ) • frovatriptan (FROVA ® ) • naratriptan (AMERGE ® ) • rizatriptan (MAXALT ®. MAXALT-MLT ® ) • Sumatriptan and naproxen (TREXIMET ® ) • ergotamines (CAFERGOT ®. ERGOMAR ®. MIGERGOT ® ) • dihydroergotamine (D. H.E. 45 ®. MIGRANAL ® )

Ask your healthcare provider if you are not sure if your medicine is listed above.

• an allergy to Sumatriptan or any of the ingredients in Sumatriptan tablets, USP. See the end of this leaflet for a complete list of ingredients in Sumatriptan tablets, USP.

What should I tell my healthcare provider before taking Sumatriptan tablets, USP?

Before you take Sumatriptan tablets, USP, tell your healthcare provider about all of your medical conditions, including if you:

• have high blood pressure • have high cholesterol • have diabetes • smoke • are overweight • have heart problems or family history of heart problems or stroke • have kidney problems • have liver problems • have had epilepsy or seizures • are not using effective birth control • become pregnant while taking Sumatriptan tablets, USP. • are breastfeeding or plan to breastfeed. Sumatriptan succinate passes into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take Sumatriptan tablets, USP.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Sumatriptan tablets, USP and certain other medicines can affect each other, causing serious side effects.

Especially tell your healthcare provider if you take anti-depressant medicines called:

• selective serotonin reuptake inhibitors (SSRIs) • serotonin norepinephrine reuptake inhibitors (SNRIs) • tricyclic antidepressants (TCAs) • monoamine oxidase inhibitors (MAOIs)

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take Sumatriptan tablets, USP?

• Certain people should take their first dose of Sumatriptan tablets, USP in their healthcare provider’s office or in another medical setting. Ask your healthcare provider if you should take your first dose in a medical setting. • Take Sumatriptan tablets, USP exactly as your healthcare provider tells you to take it. • Your healthcare provider may change your dose. Do not change your dose without first talking to your healthcare provider. • Take Sumatriptan tablets, USP whole with water or other liquids. • If you do not get any relief after your first tablet, do not take a second tablet without first talking with your healthcare provider. • If your headache comes back or you only get some relief from your headache, you can take a second tablet 2 hours after the first tablet. • Do not take more than 200 mg of Sumatriptan tablets, USP in a 24-hour period. • If you take too much Sumatriptan tablets, USP, call your healthcare provider or go to the nearest hospital emergency room right away. • You should write down when you have headaches and when you take Sumatriptan tablets, USP so you can talk with your healthcare provider about how Sumatriptan tablets, USP is working for you.

What should I avoid while taking Sumatriptan tablets, USP?

Sumatriptan tablets, USP can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.

What are the possible side effects of Sumatriptan tablets, USP?

Sumatriptan tablets, USP may cause serious side effects. See “What is the most important information I should know about Sumatriptan tablets, USP?”

These serious side effects include:

• changes in color or sensation in your fingers and toes (Raynaud’s syndrome) • stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include: • sudden or severe stomach pain • stomach pain after meals • weight loss • nausea or vomiting • constipation or diarrhea • bloody diarrhea • fever • problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include: • cramping and pain in your legs or hips • feeling of heaviness or tightness in your leg muscles • burning or aching pain in your feet or toes while resting • numbness, tingling, or weakness in your legs • cold feeling or color changes in 1 or both legs or feet • hives (itchy bumps); swelling of your tongue, mouth, or throat • medication overuse headaches. Some people who use too many Sumatriptan tablets, USP may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with Sumatriptan tablets, USP. • serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using Sumatriptan tablets, USP, especially if Sumatriptan tablets, USP are used with anti-depressant medicines called SSRIs or SNRIs.

Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:

• mental changes such as seeing things that are not there (hallucinations), agitation, or coma • fast heartbeat • changes in blood pressure • high body temperature • tight muscles • trouble walking

• seizures. Seizures have happened in people taking Sumatriptan tablets, USP who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take Sumatriptan tablets, USP.

The most common side effects of Sumatriptan tablets, USP include:

• tingling or numbness in your fingers or toes • warm or cold feeling • feeling weak, drowsy, or tired • pain, discomfort, or stiffness in your neck, throat, jaw, or chest • dizziness

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Sumatriptan tablets, USP. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 .

How should I store Sumatriptan tablets, USP?

Store Sumatriptan tablets, USP between 68° F to 77° F (20° C to 25° C).

Keep Sumatriptan tablets, USP and all medicines out of the reach of children.

General information about the safe and effective use of Sumatriptan tablets, USP.

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use Sumatriptan tablets, USP for a condition for which it was not prescribed. Do not give Sumatriptan tablets, USP to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Sumatriptan tablets, USP. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Sumatriptan tablets, USP that is written for healthcare professionals.

For more information, call 1-888-RANBAXY (726-2299).

What are the ingredients in Sumatriptan tablets, USP?

Active ingredient: Sumatriptan succinate, USP

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and talc

This Patient Information has been approved by the U. S. Food and Drug Administration.

The brands listed are trademarks of their respective owners.

Ranbaxy Pharmaceuticals Inc.

Jacksonville, FL 32257 USA

January 2014 FDA-10

Ketanrift, Ketanrift

Ketanrift

Pharmacology of Ketanrift

Ketanrift, a structural analog of the natural purine base hypoxanthine, is used to prevent gout and renal calculi due to either uric acid or calcium oxalate and to treat uric acid nephropathy, hyperuricemia, and some solid tumors.

Ketanrift for patients

Patients should be informed of the following:

They should be cautioned to discontinue allopurinol and to consult their physician immediately at the first sign of a skin rash, painful urination, blood in the urine. irritation of the eyes, or swelling of the lips or mouth.

They should be reminded to continue drug therapy prescribed for gouty attacks since optimal benefit of allopurinol may be delayed for two to six weeks.

They should be encouraged to increase fluid intake during therapy to prevent renal stones.

If a single dose of allopurinol is occasionally forgotten, there is no need to double the dose at the next scheduled time.

There may be certain risks associated with the concomitant use of allopurinol and dicumarol, sulfinpyrazone, mercaptopurine, azathioprine, ampicillin, amoxicillin and thiazide diuretics, and they should follow the instructions of their physician.

Due to the occasional occurrence of drowsiness, patients should take precautions when engaging in activities where alertness is mandatory.

Patients may wish to take allopurinol after meals to minimize gastric irritation.

Ketanrift Interactions

The following drug interactions were observed in some patients undergoing treatment with oral allopurinol. Although the pattern of use for oral allopurinol includes longer term therapy, particularly for gout and renal calculi, the experience gained may be relevant.

Mercaptopurine/Azathioprine: Allopurinol inhibits the enzymatic oxidation of mercaptopurine and azathioprine to 6-thiouric acid. This oxidation, which is catalyzed by xanthine oxidase, inactivates mercaptopurine. In patients receiving mercaptopurine (Purinethol) or azathioprine (Imuran), the concomitant administration of 300-600 mg of allopurinol per day will require a reduction in dose to approximately one-third to one-fourth of the usual dose of mercaptopurine or azathioprine. Subsequent adjustment of doses of mercaptopurine or azathioprine should be made on the basis of therapeutic response and the appearance of toxic effects.

Dicumarol: It has been reported that allopurinol prolongs the half-life of the anticoagulant, dicumarol. The clinical basis of this drug interaction has not been established but should be noted when allopurinol is given to patients already on dicumarol therapy. Consequently, prothrombin time should be reassessed periodically in patients receiving both drugs.

Uricosuric Agents: Since the excretion of oxipurinol is similar to that of urate, uricosuric agents, which increase the excretion of urate, are also likely to increase the excretion of oxipurinol and thus lower the degree of inhibition of xanthine oxidase. The concomitant administration of uricosuric agents and allopurinol has been associated with a decrease in the excretion of oxypurines (hypoxanthine and xanthine) and an increase in urinary uric acid excretion compared with that observed with allopurinol alone. Although clinical evidence to date has not demonstrated renal precipitation of oxypurines in patients either on allopurinol alone or in combination with uricosuric agents, the possibility should be kept in mind.

Thiazide Diuretics: The reports that the concomitant use of allopurinol and thiazide diuretics may contribute to the enhancement of allopurinol toxicity in some patients have been reviewed in an attempt to establish a cause-and-effect relationship and a mechanism of causation. Review of these case reports indicates that the patients were mainly receiving thiazide diuretics for hypertension and that tests to rule out decreased renal function secondary to hypertensive nephropathy were not often performed. In those patients in whom renal insufficiency was documented, however, the recommendation to lower the dose of allopurinol was not followed. Although a causal mechanism and a cause-and-effect relationship have not been established, current evidence suggests that renal function should be monitored in patients on thiazide diuretics and allopurinol even in the absence of renal failure, and dosage levels should be even more conservatively adjusted in those patients on such combined therapy if diminished renal function is detected..

Ampicillin/Amoxicillin: An increase in the frequency of skin rash has been reported among patients receiving ampicillin or amoxicillin concurrently with allopurinol compared to patients who are not receiving both drugs. The cause of the reported association has not been established.

Cytotoxic Agents: Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic agents has been reported among patients with neoplastic disease, except leukemia, in the presence of allopurinol. However, in a well-controlled study of patients with lymphoma on combination therapy, allopurinol did not increase the marrow toxicity of patients treated with cyclophosphamide, doxorubicin, bleomycin, procarbazine and/or mechlorethamine.

Chlorpropamide: Chlorpropamide's plasma half-life may be prolonged by allopurinol, since allopurinol and chlorpropamide may compete for excretion in the renal tubule. The risk of hypoglycemia secondary to this mechanism may be increased if allopurinol and chlorpropamide are given concomitantly in the presence of renal insufficiency.

Cyclosporin: Reports indicate that cyclosporine levels may be increased during concomitant treatment with allopurinol sodium for injection. Monitoring of cyclosporine levels and possible adjustment of cyclosporine dosage should be considered when these drugs are co-administered.

Tolbutamide's conversion to inactive metabolites has been shown to be catalyzed by xanthine oxidase from rat liver. The clinical significance, if any, of these observations is unknown.

Ketanrift Contraindications

Patients who have developed a severe reaction to allopurinol should not be restarted on the drug.

Additional information about Ketanrift

Ketanrift Indication: For the treatment of hyperuricemia associated with primary or secondary gout. Mechanism Of Action: Ketanrift inhibits the enzyme xanthine oxidase, blocking the conversion of the oxypurines hypoxanthine and xanthine to uric acid. Elevated concentrations of oxypurine and oxypurine inhibition of xanthine oxidase through negative feedback results in a decrease in the concentrations of uric acid in the blood and urine. Ketanrift also facilitates the incorporation of hypoxanthine and xanthine into DNA and RNA, resulting in further reductions of serum uric acid concentrations. Drug Interactions: Anisindione Ketanrift increases the anticoagulant effect Azathioprine Ketanrift increases the effect of thiopurine Cyclosporine Ketanrift increases the effect and toxicity of cyclosporine Dicumarol Ketanrift increases the anticoagulant effect Warfarin Ketanrift increases the anticoagulant effect Mercaptopurine Ketanrift increases the effect of thiopurine Acenocoumarol Increases the anticoagulant effect Food Interactions: Take with a full glass of water. Take with food. Avoid alcohol. Generic Name: Allopurinol Synonyms: Allopurinolum [Inn-Latin]; Allopurinol Sodium; Alopurinol [Inn-Spanish] Drug Category: Free Radical Scavengers; Enzyme Inhibitors Antimetabolites; Gout Suppressants Drug Type: Small Molecule; Approved Other Brand Names containing Allopurinol: 7HP; Adenock; Ailural; Allo-Puren; Allopur; Allozym; Allural; Aloprim; Aloral; Alositol; Aluline; Anoprolin; Anzief; Apo-Allopurinol; Apulonga; Apurin; Apurol; Atisuril; Bleminol; Bloxanth; Caplenal; Cellidrin; Cosuric; Dabrosin; Dabroson; Dura Al; Embarin; Epidropal; Epuric; Foligan; Geapur; Gichtex; Gotax; HPP; Hamarin; Hexanuret; Ketanrift; Ketobun-A; Ledopur; Lopurin; Lysuron; Milurit; Miniplanor; Monarch; Nektrohan; Progout; Purinol; Remid; Riball; Sigapurol; Suspendol; Takanarumin; Urbol; Uricemil; Uriprim; Uripurinol; Uritas; Urobenyl; Urolit; Urosin; Urtias; Urtias 100; Xanturat; Zyloprim; Zyloric; Allohexal; Absorption: Approximately 90% absorbed from the gastrointestinal tract. Toxicity (Overdose): LD 50 =214 mg/kg (in mice) Protein Binding: Negligible Biotransformation: Hepatic Half Life: 1-2 hours Dosage Forms of Ketanrift: Tablet Oral Chemical IUPAC Name: 1,2-dihydropyrazolo[4,3-e]pyrimidin-4-one Chemical Formula: C5H4N4O Allopurinol on Wikipedia: http://en. wikipedia. org/wiki/Allopurinol Organisms Affected: Humans and other mammals

Ketanrift

Important Notice: The Drugs. com international database is in BETA release. This means it is still under development and may contain inaccuracies. It is not intended as a substitute for the expertise and judgement of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that the use of any medication in any country is safe, appropriate or effective for you. Consult with your healthcare professional before taking any medication.

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Visit To Baymont Hotel - Review Of Baymont Inn - Suites Dallas, Romisan

Baymont Inn & Suites Dallas/Love Field is a boutique styled Wyndham Group Hotel located.

Baymont Inn & Suites Dallas/Love Field is a boutique styled Wyndham Group Hotel located centrally to both Dallas/Love field and Dallas Fort Worth International Airports while being only 10 minutes away from downtown Dallas attractions and downtown Market center and business districts. Guests are welcomed to enjoy our distinct brand of "Home away from Home" touch of high service and attention to guest experience. From the contemporarily designed lobby and lounge area to the relaxing, spacious guest rooms, the business or pleasure traveler will enjoy the overall experience in this Dallas hotel. Guest room rate includes a full, hot breakfast buffet, WIFI with 24hr technical support, hotel parking and use of indoor pool and jacuzzi, a modern appointed fitness center, and 24hr business center. The Baymont Hotel is accessible to nearby BACHMAN DART station for easy access to American Airline Center, downtown Dallas venues and Orange line into DFW airport. With close proximity to so many attractions nearby, our guest service agents are equipped to guide you to your best experience while staying in Dallas at the Baymont Inn & Suites Dallas Love Field.

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Meat Grinder Electric 2, Ginatex

Meat Grinder Electric 2.6 HP 2000 Watt Industrial Meat Grinder Butcher Shop New

About this item

Important Made in USA Origin Disclaimer: For certain items sold by Walmart on Walmart. com, the displayed country of origin information may not be accurate or consistent with manufacturer information. For updated, accurate country of origin data, it is recommended that you rely on product packaging or manufacturer information.

The grinder is suitable for any kitchen or supermarket, and has a stainless steel and cast aluminum construction

It features a 2.6 HP motor and precision gear drive, plus a forward and reverse switch

The on, half, & reverse settings allow for the user to feel the meat grinding power (Red stop & reset button to the left)

Ground meats can be done freshly instead of going to the market and getting it pre-ground in the package

Product Dimensions: 15.5"(L) x 6.25"(W) x 13.75"(H)

About this item

Important Made in USA Origin Disclaimer: For certain items sold by Walmart on Walmart. com, the displayed country of origin information may not be accurate or consistent with manufacturer information. For updated, accurate country of origin data, it is recommended that you rely on product packaging or manufacturer information.

The grinder is suitable for any kitchen or supermarket, and has a stainless steel and cast aluminum construction

It features a 2.6 HP motor and precision gear drive, plus a forward and reverse switch

The on, half, & reverse settings allow for the user to feel the meat grinding power (Red stop & reset button to the left)

Ground meats can be done freshly instead of going to the market and getting it pre-ground in the package

Product Dimensions: 15.5"(L) x 6.25"(W) x 13.75"(H)

Best Choice Products is proud to present to you this brand new Meat Grinder. The grinder is suitable for any kitchen or supermarket, and has a stainless steel and cast aluminum construction. It features a 2.6 HP motor and precision gear drive, plus a forward and reverse switch. The on, half, & reverse settings allow for the user to feel the meat grinding power (Red stop & reset button to the left). Ground meats can be done freshly instead of going to the market and getting it pre-ground in the package. Buy this grinder for your next food adventure! NEW PRODUCT WITH FACTORY PACKAGING

The grinder is suitable for any kitchen or supermarket, and has a stainless steel and cast aluminum construction

It features a 2.6 HP motor and precision gear drive, plus a forward and reverse switch

The on, half, & reverse settings allow for the user to feel the meat grinding power (Red stop & reset button to the left)

Ground meats can be done freshly instead of going to the market and getting it pre-ground in the package

Product Dimensions: 15.5"(L) x 6.25"(W) x 13.75"(H)SPECIFICATIONS2000W peak output (2.6HP) rated motor110V/ 60HZCast aluminum feeding hopperCast aluminum auger & auger housing3 speeds (high, low, & reverse)Electronic stop & resetIncludes (3) heavy-duty steel cutting plates (fine, medium, coarse)Food pusher and kubbe attachmentSausage filler not includedPLEASE NOTE:Our digital images are as accurate as possible. However, different monitors may cause colors to vary slightly. Some of our items are handcrafted and/or hand finished. Color can vary and slight imperfections are normal for metal as the hand finishing process as we feel, adds character and authenticity to those items.

Specifications

Walmart Product Care Plans A limited product warranty is included free for most items. With an optional Walmart Care Plan you can enhance the manufacturer's coverage from the date of purchase. Walmart Product Care Plans cover 100% of the cost for repair or replacement, including shipping charges for the exchange.

We'll show you Care Plan options and pricing at checkout if applicable, or go to www. walmart. com/careplans for more information.

Warranty Information: All of our items are covered under a 60 day warranty period.

Melora - Dragon Age Wiki, Melora

Melora

If you have failed a Stealing attempt in the Dalish Camp. Melora will ambush you in the Wooded Hills. a world map encounter that occurs when travelling to the Brecilian Outskirts on a subsequent visit.

Melora is accompanied by four hunters: three Lieutenants and one Normal. There are several leghold traps in the field and two chests in the camp area. In total, upwards of 600 XP may be gained from this encounter.

To deliberately trigger the encounter, have a character with very low Cunning and one rank in the Stealing skill attempt to steal from one of the more powerful Dalish, such as Zathrian.

Sarel and other Dalish NPCs will sometimes comment on Melora's rashness and absence in idle chatter, hoping she will return safely.

Loot Edit

Notes Edit

This encounter will still occur even if you sided against the elves.

Panowen is often confused for Melora.

Biotamoxal, Biotamoxal

Common use It is is a broad-spectrum antibiotic which destroys bacteria. It is active against many aerobic (those developing in presence of oxygen) and anaerobic (those developing in absence of oxygen) gram positive and aerobic gram negative microorganisms including strains which produce beta-lactamase (the enzyme which destroys penicillin). Clavulanate potassium comprised in the content of this medication provides resistance of Augmentin to activity of bacterial beta-lactamases. This medication is used to treat pneumonia and other infectious diseases of respiratory, gastrointestinal systems, urogenital systems, infections which appear after surgery and others.

Dosage and directions Doses are administered individually depending on your condition, localization of infection and susceptibility of the pathogen. Do not take it in larger amounts or longer than recommended. Swallow the whole tablet. If it is the Augmentin Chewable tablet then chew it before swallowing. Augmentin should be taken at evenly spaced interval.

Precautions Do not use it if you are allergic to any other penicillin antibiotic, if you have liver or kidney failure or mononucleosis.

Contraindications Do not use the medicine if you have allergy to its components or another penicillin antibiotics, if you have infectious mononucleosis, a history of liver problems or yellowing of the eyes or skin caused by Augmentin.

Possible side effect Dyspepsia, abdominal discomfort, bloating, gas nausea, vomiting, liver function disorders, hepatitis, jaundice caused by stagnation of bile, vaginal itching and also symptoms of allergy (hives, rash, swelling). Cautiousness should be exercised in patients with liver failure. The medication is not recommended for pregnant (especially third trimester) and breastfeeding women.

Treatment with Augmentin and other antibiotics can change the normal bacteria flora of the colon and permit overgrowth of C. difficile, a bacteria which causes pseudomembranous colitis. Probenecid which is used to treat gout may slow excretion of Augmentin by kidneys and result in increase of its toxicity.

Missed dose If you missed a dose take it as soon as you remember, but not if it is almost time of the next intake by your schedule. If so skip the missed dose. Do not try to compensate a missed dose by taking an extra one.

Overdose If you suppose that took too much of Augmentin and experience such symptoms as nausea, vomiting, stomach pain, diarrhea, skin rash, drowsiness, and hyperactivity, seek immediate medical help.

Storage Store at room temperature of 59-86F (15-30C) away from light and moisture.

Disclaimer We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information on the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care advisor or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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Amoxicillin (Amoxicillin)

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DISCLAIMER: MediGuard is not intended to be a substitute for professional medical advice. MediGuard cannot and does not take into consideration every possible interaction or account for individual responses to medicine. Different individuals may respond to medication in different ways. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective, or appropriate for any given patient. Always seek the advice of a qualified health provider with any questions you may have before making any changes to your treatment. The use of the MediGuard site and its content is at your own risk. The MediGuard site and the information contained in it is intended for users in the United States and information in other countries may be different.

© Quintiles 2016

Common use It is is a broad-spectrum antibiotic which destroys bacteria. It is active against many aerobic (those developing in presence of oxygen) and anaerobic (those developing in absence of oxygen) gram positive and aerobic gram negative microorganisms including strains which produce beta-lactamase (the enzyme which destroys penicillin). Clavulanate potassium comprised in the content of this medication provides resistance of Augmentin to activity of bacterial beta-lactamases. This medication is used to treat pneumonia and other infectious diseases of respiratory, gastrointestinal systems, urogenital systems, infections which appear after surgery and others.

Dosage and directions Doses are administered individually depending on your condition, localization of infection and susceptibility of the pathogen. Do not take it in larger amounts or longer than recommended. Swallow the whole tablet. If it is the Augmentin Chewable tablet then chew it before swallowing. Augmentin should be taken at evenly spaced interval.

Precautions Do not use it if you are allergic to any other penicillin antibiotic, if you have liver or kidney failure or mononucleosis.

Contraindications Do not use the medicine if you have allergy to its components or another penicillin antibiotics, if you have infectious mononucleosis, a history of liver problems or yellowing of the eyes or skin caused by Augmentin.

Possible side effect Dyspepsia, abdominal discomfort, bloating, gas nausea, vomiting, liver function disorders, hepatitis, jaundice caused by stagnation of bile, vaginal itching and also symptoms of allergy (hives, rash, swelling). Cautiousness should be exercised in patients with liver failure. The medication is not recommended for pregnant (especially third trimester) and breastfeeding women.

Treatment with Augmentin and other antibiotics can change the normal bacteria flora of the colon and permit overgrowth of C. difficile, a bacteria which causes pseudomembranous colitis. Probenecid which is used to treat gout may slow excretion of Augmentin by kidneys and result in increase of its toxicity.

Missed dose If you missed a dose take it as soon as you remember, but not if it is almost time of the next intake by your schedule. If so skip the missed dose. Do not try to compensate a missed dose by taking an extra one.

Overdose If you suppose that took too much of Augmentin and experience such symptoms as nausea, vomiting, stomach pain, diarrhea, skin rash, drowsiness, and hyperactivity, seek immediate medical help.

Storage Store at room temperature of 59-86F (15-30C) away from light and moisture.

Disclaimer We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information on the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care advisor or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

Common use It is is a broad-spectrum antibiotic which destroys bacteria. It is active against many aerobic (those developing in presence of oxygen) and anaerobic (those developing in absence of oxygen) gram positive and aerobic gram negative microorganisms including strains which produce beta-lactamase (the enzyme which destroys penicillin). Clavulanate potassium comprised in the content of this medication provides resistance of Augmentin to activity of bacterial beta-lactamases. This medication is used to treat pneumonia and other infectious diseases of respiratory, gastrointestinal systems, urogenital systems, infections which appear after surgery and others.

Dosage and directions Doses are administered individually depending on your condition, localization of infection and susceptibility of the pathogen. Do not take it in larger amounts or longer than recommended. Swallow the whole tablet. If it is the Augmentin Chewable tablet then chew it before swallowing. Augmentin should be taken at evenly spaced interval.

Precautions Do not use it if you are allergic to any other penicillin antibiotic, if you have liver or kidney failure or mononucleosis.

Contraindications Do not use the medicine if you have allergy to its components or another penicillin antibiotics, if you have infectious mononucleosis, a history of liver problems or yellowing of the eyes or skin caused by Augmentin.

Possible side effect Dyspepsia, abdominal discomfort, bloating, gas nausea, vomiting, liver function disorders, hepatitis, jaundice caused by stagnation of bile, vaginal itching and also symptoms of allergy (hives, rash, swelling). Cautiousness should be exercised in patients with liver failure. The medication is not recommended for pregnant (especially third trimester) and breastfeeding women.

Treatment with Augmentin and other antibiotics can change the normal bacteria flora of the colon and permit overgrowth of C. difficile, a bacteria which causes pseudomembranous colitis. Probenecid which is used to treat gout may slow excretion of Augmentin by kidneys and result in increase of its toxicity.

Missed dose If you missed a dose take it as soon as you remember, but not if it is almost time of the next intake by your schedule. If so skip the missed dose. Do not try to compensate a missed dose by taking an extra one.

Overdose If you suppose that took too much of Augmentin and experience such symptoms as nausea, vomiting, stomach pain, diarrhea, skin rash, drowsiness, and hyperactivity, seek immediate medical help.

Storage Store at room temperature of 59-86F (15-30C) away from light and moisture.

Disclaimer We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information on the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care advisor or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

Priadel 200mg Prolonged Release Tablets - Summary Of Product Characteristics (Spc), Priadel Retard

Both strengths have break lines therefore they can be divided accurately to provide dosage requirements as small as 100mg. Serum lithium levels should be monitored weekly until stabilisation is achieved. The serum level should not exceed 1.5 mmol/l.

The tablets should be taken at the same time every day. A double dose to make up for a dose that has been missed should not be taken.

4. Lithium therapy should not be initiated unless adequate facilities for routine monitoring of serum concentrations are available. Following stabilisation of serum lithium levels, the period between subsequent measurements can be increased gradually, but should not normally exceed two to three months. Additional measurements should be made following alteration of dosage, on development of intercurrent disease, signs of manic or depressive relapse, following significant change in sodium or fluid intake, or if signs of lithium toxicity occur (see Section 4.9).

5. Whilst a high proportion of acutely ill patients may respond within three to seven days of the commencement of Priadel therapy, Priadel should be continued through any recurrence of the affective disturbance. This is important as the full prophylactic effect may not occur for 6 to 12 months after the initiation of therapy.

6. In patients who show a positive response to Priadel therapy, treatment is likely to be long term. Careful clinical appraisal of the patient should be exercised throughout medication (see precautions).

7. If lithium is to be discontinued, particularly in cases of high doses, the dose should be reduced gradually.

Prophylactic treatment of bipolar affective disorders and control of aggressive behaviour or intentional self harm . It is recommended that the described treatment schedule is followed. The dosage needed may vary from patient to patient. As a general rule, serum lithium levels should be maintained within the range of 0.5 to 1.0 mmol/L, and should not exceed 1.5mmol/L. Optimal maintenance serum lithium levels may vary from patient to patient.

Treatment of acute manic or hypomanic episodes and recurrent depressive disorders . It is likely that a higher than normal Priadel intake may be necessary during an acute phase and divided doses would be required here. As a general rule the monitoring should maintain serum levels at 0.8 - 1.2 mmol/l until acute symptoms have been controlled. In all other details the described treatment schedule is recommended. The dosage needed may vary from patient to patient. Serum lithium levels should be monitored (see above) and should not exceed 1.5 mmol/L. Once clinical control is achieved, dosage should be reduced to the prophylactic dose.

Elderly patients or those below 50kg in weight, often require lower lithium dosage to achieve therapeutic serum lithium levels. Starting doses of 200mg to 400mg are recommended. Dosage increments of 200 to 400mg every 3 to 5 days are usual. Total daily doses of 800 to 1800mg may be necessary to achieve effective blood lithium levels of 0.8 to 1.0 mmol/l. For prophylaxis, the dosage necessary to reach a blood lithium level of 0.4 to 0.8 mmol/l is generally in the range of 600 to 1200 mg/day.

Children and adolescents .

In patients with mild and moderate renal insufficiency treated with lithium, serum lithium levels must be closely monitored and the dose should be adjusted accordingly to maintain serum lithium levels within the recommended range (see Section 4.4).

Lithium is contraindicated in patients with severe renal insufficiency (see Section 4.3).

• Hypersensitivity to lithium or to any of the excipients.

• Cardiac disease.

• Cardiac insufficiency.

• Severe renal impairment.

• Untreated hypothyroidism.

• Patients with low body sodium levels, including for example dehydrated patients or those on low sodium diets.

• Addison's disease.

• Brugada syndrome or family history of Brugada syndrome.

4.4 Special warnings and precautions for use

When considering Priadel therapy, it is necessary to ascertain whether patients are receiving lithium in any other form. If so, check serum levels before proceeding.

The minimum clinically effective dose of lithium should always be used (see Section 4.2). Clear instructions regarding the symptoms of impending toxicity should be given by the physician to patients receiving long-term lithium therapy (see Section 4.9). They should be warned of the urgency of immediate action should these symptoms appear, and also of the need to maintain a constant and adequate salt and water intake. At the first sign of toxicity, the patient should consult a physician and lithium levels should be checked. Treatment should be discontinued immediately on the first signs of toxicity (see Section 4.9).

• Monitoring recommendations

Before starting treatment with lithium, renal function, cardiac function and thyroid function should be evaluated. Patients should be euthyroid before initiation of lithium therapy. Lithium therapy is contraindicated in patients with severe renal insufficiency or cardiac insufficiency (see Section 4.3).

Renal, cardiac and thyroid functions should be re-assessed regularly during treatment with lithium.

For monitoring recommendations of lithium serum levels see Section 4.2.

• Renal Impairment

Since lithium is primarily excreted via the renal route, significant accumulation of lithium may occur in patients with renal insufficiency. Therefore, if patients with mild or moderate renal impairment are being treated with lithium, serum lithium levels should be closely monitored (see Section 4.2) and the dose should be adjusted accordingly. If very regular and close monitoring of serum lithium levels and plasma creatinine levels is not possible, lithium should not be prescribed in this population. Lithium is contraindicated in patients with severe renal insufficiency (see Section 4.3).

The possibility of hypothyroidism and renal dysfunction arising during prolonged treatment should be borne in mind and periodic assessments made.

Patients should be warned to report if polyuria or polydipsia develop. In patients who develop polyuria and/or polydipsia (see Section 4.8), renal function should be monitored in addition to the routine serum lithium assessment.

Renal tumours: Cases of microcysts, oncocytomas and collecting duct renal carcinoma have been reported in patients with severe renal impairment who received lithium for more than 10 years (see section 4.8).

• Fluid/electrolyte balance

If episodes of nausea, vomiting, diarrhoea, excessive sweating, and/or other conditions leading to salt/water depletion (including severe dieting) occur, lithium dosage should be closely monitored and dosage adjustments made as necessary. Drugs likely to upset electrolyte balance such as diuretics should also be reported. Indeed, sodium depletion increases the lithium plasma concentration (due to competitive reabsorption at the renal level). In these cases, lithium dosage should be closely monitored and reduction of dosage may be necessary.

Caution should be exercised to ensure that diet and fluid intake are normal in order to maintain a stable electrolyte balance. This may be of special importance in very hot weather or work environment. Infectious diseases including colds, influenza, gastro-enteritis and urinary infections may alter fluid balance and thus affect serum lithium levels. Treatment discontinuation should be considered during any intercurrent infection.

• Risk of convulsions

The risk of convulsions may be increased in case of co-administration of lithium with drugs that lower the epileptic threshold, or in epileptic patients (see sections 4.5 and 4.8).

• Benign intracranial hypertension

There have been case reports of benign intracranial hypertension (see Section 4.8). Patients should be warned to report persistent headache and/or visual disturbances.

• QT prolongation

As a precautionary measure, lithium should be avoided in patients with congenital long QT syndrome, and caution should be exercised in patients with risk factors such as QT interval prolongation (e. g. uncorrected hypokalaemia, bradycardia), and in patients concomitantly treated with drugs that are known to prolong the QT interval (see Sections 4.5 and 4.8).

• Brugada syndrome

Lithium may unmask or aggravate Brugada syndrome, a hereditary disease of the cardiac sodium channel with characteristic electrocardiographic changes (right bundle branch block and ST segment elevation in right precordial leads), which may lead to cardiac arrest or sudden death. Lithium should not be administered to patients with Brugada Syndrome or a family history of Brugada Syndrome (see Section 4.3). Caution is advised in patients with a family history of cardiac arrest or sudden death.

• Elderly patients

Elderly patients are particularly liable to lithium toxicity and may exhibit adverse reactions at serum levels ordinarily tolerated by younger patients. Caution is also advised since lithium excretion may be reduced in the elderly due to age related disease in renal function (see Sections 4.2 and 5.2).

The use in children is not recommended.

4.5 Interaction with other medicinal products and other forms of interaction

Interactions which increase lithium concentrations:

Serum lithium levels may be increased if one of the following drugs is co-administered. When appropriate, either lithium dosage should be adjusted or concomitant treatment stopped.

• Metronidazole may reduce lithium renal clearance.

• Non-steroidal anti-inflammatory drugs, including cyclo-oxygenase (COX) 2 inhibitors (monitor serum lithium concentrations more frequently if NSAID therapy is initiated or discontinued).

• Angiotensin-converting enzyme (ACE) inhibitors.

• Angiotensin II receptor antagonists.

• Diuretics (thiazides show a paradoxical antidiuretics effect resulting in possible water retention and lithium intoxication). If a thiazide diuretic has to be prescribed for a lithium-treated patient, lithium dosage should first be reduced and the patient re-stabilised with frequent monitoring. Similar precautions should be exercised on diuretic withdrawal. Loop diuretics seem less likely to increase lithium levels.

• Other drugs affecting electrolyte balance, e. g. steroids , may alter lithium excretion and should therefore be avoided.

Interactions which decrease serum lithium concentrations:

Serum lithium levels may be decreased due to an increase in lithium renal clearance in case of concomitant administration of one of the following drugs:

• Xanthines (theophylline, caffeine).

• Sodium bicarbonate containing products.

• Diuretics (osmotic and carbonic anhydrase inhibitors).

Interactions causing neurotoxicity:

Co-administration of the following drugs may increase the risk of neurotoxicity:

• Antipsychotics (particularly haloperidol at higher dosages), flupentixol, diazepam, thioridazine, fluphenazine, chlorpromazine and clozapine may lead in rare cases to severe neurotoxicity with symptoms such as confusion, disorientation, lethargy, tremor, extra-pyramidal symptoms and myoclonus. Increased lithium levels were present in some of the reported cases. Co-administration of antipsychotics and lithium may increase the risk of Neuroleptic Malignant Syndrome, which may be fatal. Discontinuation of both drugs is recommended at the first signs of neurotoxicity.

• Triptan derivatives and/or serotonergic antidepressants such as Selective Serotonin Re-uptake Inhibitors (e. g. fluvoxamine and fluoxetine) as this combination may precipitate a serotoninergic syndrome *. which justifies immediate discontinuation of treatment.

• Calcium channel blockers may lead to neurotoxicity with symptoms such as ataxia, confusion and somnolence. Lithium concentrations may be increased.

• Carbamazepine may lead to dizziness, somnolence, confusion and cerebellar symptoms such as ataxia.

Caution is advised if lithium is co-administered with other drugs that prolong the QT interval (see Sections 4.4 and 4.8), e. g. Class IA (e. g. quinidine, disopyramide), or Class III (e. g. amiodarone) antiarrhythmic agents, cisapride, antibiotics such as erythromycin, antipsychotics such as thioridazine or amisulpride. The list is not comprehensive.

Caution is advised if lithium is co-administered with drugs that lower the epileptic threshold (see Section 4.4), e. g. antidepressants such as SSRIs, tricyclic antidepressants, antipsychotics, anaesthetics, theophylline. The list is not comprehensive

Lithium may prolong the effects of neuromuscular blocking agents. There have been reports of interaction between lithium and phenytoin, indomethacin and other prostaglandin-synthetase inhibitors.

Serotonin syndrome is a potentially life-threatening adverse reaction, with is caused by an excess of serotonin (e. g. from overdose or concomitant use of serotonergic drugs), necessitating hospitalisation and even causing death.

Symptoms may include:

- Mental status changes (agitation, confusion, hypomania, eventually coma)

- Neuromuscular abnormalities (myoclonus, tremor, hyperreflexia, rigidity, akathisia)

- Autonomic hyperactivity (hypo or hypertonia, tachycardia, shivering, hyperthermia, diaphoresis)

- Gastrointestinal symptoms (diarrhoea)

Strict adherence to the recommended doses is an essential factor for the prevention of the occurrence of this syndrome.

4.6 Fertility, pregnancy and lactation

Lithium therapy should not be used during pregnancy, especially during the first trimester, unless considered essential. There is epidemiological evidence that it may be harmful to the foetus in human pregnancy. Lithium crosses the placental barrier. In animal studies lithium has been reported to interfere with fertility, gestation and foetal development. Cardiac especially Ebstein anomaly, and other malformations have been reported. Therefore, a pre-natal diagnosis such as ultrasound and electrocardiogram examination is strongly recommended. In certain cases where a severe risk to the patient could exist if treatment were stopped, lithium has been continued during pregnancy.

If it is considered essential to maintain lithium treatment during pregnancy, serum lithium levels should be closely monitored and measured frequently since renal function changes gradually during pregnancy and suddenly at parturition. Dosage adjustments are required. It is recommended that lithium be discontinued shortly before delivery and reinitiated a few days post-partum.

Neonates may show signs of lithium toxicity including symptoms such as lethargy, flaccid muscle tone, or hypotonia. Careful clinical observation of the neonate exposed to lithium during pregnancy is recommended and lithium levels may need to be monitored as necessary.

Women of child-bearing potential

Women of child-bearing potential should use effective contraceptive methods during treatment with lithium.

Lithium is secreted in breast milk and there have been case reports of neonates showing signs of lithium toxicity. Therefore lithium should not be used during breast-feeding (see Section 4.3). A decision should be made whether to discontinue lithium therapy or to discontinue breast-feeding, taking into account the importance of the drug to the mother and the importance of breast-feeding to the infant.

4.7 Effects on ability to drive and use machines

Lithium may cause disturbances of the CNS. Since lithium may slow reaction time, and considering the adverse reactions profile of lithium (see Section 4.8), patients should be warned of the possible hazards when driving or operating machinery.

4.8 Undesirable effects

Side effects are usually related to serum lithium concentration and are less common in patients with plasma lithium concentrations below 1.0 mmol/l. The adverse reactions usually subside with a temporary reduction or discontinuation of lithium treatment. Mild gastrointestinal effects such as nausea, a general discomfort and vertigo, may occur initially, but frequently disappear after the first few days of lithium administration. Fine hand tremors, polyuria and mild thirst may persist.

• Blood and lymphatic system disorders

• Endocrine disorders

Long-term adverse effects may include thyroid function disturbances such as euthyroid goitre and/or hypothyroidism and thyrotoxicosis. Lithium-induced hypothyroidism may be managed successfully with concurrent thyroxine.

Hypercalcaemia, hypermagnesaemia, hyperparathyroidism have been reported.

• Metabolism and nutrition disorders

Weight increase, hyperglycaemia.

• Psychiatric disorders

• Nervous system disorders

Ataxia, hyperactive deep tendon reflexes, slurred speech, dizziness, stupor, coma, myasthenia gravis, giddiness, dazed feeling, memory impairment.

Tremor, especially fine hand tremors, dysarthria, myoclonus, benign intracranial hypertension (see Section 4.4).

Vertigo, impaired consciousness, abnormal reflexes, convulsions (see Sections 4.4 and 4.5), extrapyramidal disorders, encephalopathy, cerebellar syndrome (usually reversible), nystagmus.

The above symptoms may result in fall.

Peripheral neuropathy may occur on long-term treatment and is usually reversible at cessation of lithium.

• Cardiac disorders

Cardiac arrhythmia, mainly bradycardia, sinus node dysfunction, peripheral circulatory collapse, hypotension, ECG changes such as reversible flattening or inversion of T-waves and QT prolongation (see Sections 4.4 and 4.5), AV block, cardiomyopathy.

• Gastrointestinal disorders

Abdominal discomfort, taste disorder, nausea, vomiting, diarrhoea, gastritis, salivary hypersecretion, dry mouth, anorexia.

• Skin and subcutaneous tissue disorders

Folliculitis, pruritus, papular skin disorders, acne or acneform eruptions, aggravation or occurrence of psoriasis, allergic rashes, alopecia, cutaneous ulcers.

• Musculoskeletal and connective tissue disorders

Muscle weakness, rhabdomyolysis

• Renal and urinary disorders

Polydipsia and/or polyuria and nephrogenic diabetes insipidus, histological renal changes with interstitial fibrosis after long term treatment have been reported (see Section 4.4). This is usually reversible on lithium withdrawal.

Long-term treatment with lithium may result in permanent changes in kidney histology, and impairment of renal function.

High serum concentrations of lithium including episodes of acute lithium toxicity may aggravate these changes.

Rare cases of nephrotic syndrome have been reported.

Frequency unknown: Microcysts, oncocytoma and collecting duct renal carcinoma (in long-term therapy) (see Section 4.4).

• General disorders and administration site conditions

Urticaria and angioedema, attributed to some excipients such as acacia powder (or Arabic gum)

Dysgeusia, blurred vision, scotomata.

If any of the above symptoms appear, treatment should be stopped immediately and arrangements made for serum lithium measurement.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www. mhra. gov. uk/yellowcard

In patients with a raised lithium concentration, the risk of toxicity is greater in those with the following underlying medical conditions: hypertension, diabetes, congestive heart failure, chronic renal failure, schizophrenia, Addison's disease.

A single acute overdose usually carries low risk and patients tend to show mild symptoms only, irrespective of their serum lithium concentration. However more severe symptoms may occur after a delay if lithium elimination is reduced because of renal impairment, particularly if a slow-release preparation has been taken. The fatal dose, in a single overdose, is probably over 5g.

If an acute overdose has been taken by a patient on chronic lithium therapy, this can lead to serious toxicity occurring even after a modest overdose as the extravascular tissues are already saturated with lithium.

Lithium toxicity can also occur in chronic accumulation for the following reasons: Acute or chronic overdosage; dehydration e. g. due to intercurrent illness, deteriorating renal function, drug interactions, most commonly involving a thiazide diuretic or a non-steroidal anti-inflammatory drug (NSAID).

The onset of symptoms may be delayed, with peak effects not occurring for as long as 24 hours, especially in patients who are not receiving chronic lithium therapy or following the use of a sustained release preparation.

Symptoms of lithium intoxication include:

Mild . Nausea, diarrhoea, blurred vision, polyuria, light headedness, fine resting tremor, muscular weakness and drowsiness.

Moderate: Increasing confusion, blackouts, fasciculation and increased deep tendon reflexes, myoclonic twitches and jerks, choreoathetoid movements, urinary or faecal incontinence, increasing restlessness followed by stupor. Hypernatraemia.

Severe: Coma, convulsions, cerebellar signs, cardiac dysrythmias including sinoatrial block, sinus and junctional bradycardia and first degree heart block. Hypotension or rarely hypertension, circulatory collapse and renal failure.

Gastrointestinal disorders: increasing anorexia and vomiting.

Nervous system disorders: Encephalopathy, cerebellar syndrome with symptoms such as muscle weakness, lack of coordination, drowsiness or lethargy, giddiness, ataxia, nystagmus, coarse tremor. Tinnitus, dysarthria, twitching, myoclonus, extrapyramidal disorders.

ECG changes (flat or inverted T waves, QT prolongation), AV block, dehydration and electrolyte disturbances.

At blood levels above 2-3 mmol/l, there may be a large output of dilute urine and renal insufficiency, with increasing confusion, convulsions, coma and death.

There is no specific antidote to lithium. In the event of lithium overdose, lithium should be discontinued and lithium serum levels monitored closely.

Supportive treatment should be initiated, which includes correction of fluid and electrolyte balance, if necessary.

Diuretics should not be used (see Section 4.5). All patients should be observed for a minimum of 24 hours. ECG should be monitored in symptomatic patients. Steps should be taken to correct hypotension.

Consider gastric lavage for non-sustained-release preparations if more than 4 g has been ingested by an adult within 1 hour or definite ingestion of a significant amount by a child. Slow-release tablets do not disintegrate in the stomach and most are too large to pass up a lavage tube. Gut decontamination is not useful for chronic accumulation. Activated charcoal does not adsorb lithium.

Haemodialysis is the treatment of choice for severe lithium intoxication (especially in patients manifesting with severe nervous system disorders), or in cases of overdose accompanied by renal impairment.

Haemodialysis should be continued until there is no lithium in the serum or dialysis fluid. Serum lithium levels should be monitored for at least another week to take account of any possible rebound in serum lithium levels as a result of delayed diffusion from the body tissues.

In cases of acute on chronic overdose or in cases of chronic lithium toxicity if the lithium concentration is >4.0 mmol/l, discuss with your local poisons service.

Clinical improvement generally takes longer than reduction of serum lithium concentrations regardless of the method used.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Psycholeptics; Lithium, ATC code: N05AN01

Lithium is an alkali metal available for medical use as lithium carbonate or lithium citrate. The exact mechanism of action of lithium in the treatment of bipolar disorders is not known.

The mode of action of lithium is still not fully understood. However, lithium modifies the production and turnover of certain neurotransmitters, particularly serotonin, and it may also block dopamine receptors.

It modifies concentrations of some electrolytes, particularly calcium and magnesium, and it may reduce thyroid activity.

5.2 Pharmacokinetic properties

Time to peak serum level for prolonged release Priadel tablets is about 2 hours and approximately 90% bioavailability would be expected.

Lithium is rapidly absorbed from the gastrointestinal tract.

Steady-state lithium levels may not be obtained until 4-6 days.

Lithium has a low volume of distribution (0.7 to 0.9 L/kg).

It is not bound to plasma proteins.

Lithium crosses the placenta and is excreted in breast milk.

Lithium is not metabolised in the liver.

Lithium is primarily excreted by the kidneys (>95% of the dose).

Elimination half-life ranges from 18 to 36 hours.

Lithium can be eliminated by haemodialysis.

Elimination half-life may be increased in elderly patients due to age related decrease in renal function and also in patients with renal impairment (see Sections 4.2 and 4.4).

5.3 Preclinical safety data

Nothing of therapeutic relevance.

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Esidrix

Esidrix, hydrochlorothiazide USP, is a diuretic and antihypertensive available as 25-mg and 50-mg tablets for oral administration. Its chemical name is 6-chloro-3,4-dihydro-2 H -1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide, and its structural formula is

Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water, freely soluble in sodium hydroxide solution, in n - butylamine and in dimethylformamide, sparingly soluble in methanol, and insoluble in ether, in chloroform, and in dilute mineral acids. Its molecular weight is 297.73.

Inactive Ingredients. Colloidal silicon dioxide, D&C Yellow No. 10 (50-mg tablets), FD&C Red No. 40 and FD&C Yellow No. 6 (25- mg tablets), lactose, starch, stearic acid, and sucrose.

Esidrix - Clinical Pharmacology

Thiazides affect the renal tubular mechanisms of electrolyte reabsorption. At maximal therapeutic dosage all thiazides are approximately equal in their diuretic potency. Thiazides increase excretion of sodium and chloride in approximately equivalent amounts. Natriuresis causes a secondary loss of potassium.

The mechanism of the antihypertensive effect of thiazides is unknown. Thiazides do not affect normal blood pressure.

Onset of action of thiazides occurs in 2 hours and the peak effect at about 4 hours. Its action persists for approximately 6 to 12 hours. Thiazides are eliminated rapidly by the kidney.

Indications and Usage for Esidrix

Hypertension

In the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension.

Edema

As adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.

Esidrix has also been found useful in edema due to various forms of renal dysfunction, such as the nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.

Usage in Pregnancy. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.

Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (however, see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease) but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.

Contraindications

Anuria; hypersensitivity to this or other sulfonamide-derived drugs.

Warnings

Use with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.

Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte imbalance may precipitate hepatic coma.

Thiazides may add to or potentiate the action of other antihypertensive drugs. Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.

Sensitivity reactions are more likely to occur in patients with a history of allergy or bronchial asthma.

The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.

PRECAUTIONS

General

All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance: namely, hyponatremia, hypochloremic alkalosis, and hypokalemia (see Laboratory Tests and Drug/Drug Interactions). Warning signs are dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbance such as nausea or vomiting.

Hypokalemia may develop, especially with brisk diuresis or when severe cirrhosis is present.

Interference with adequate oral intake of electrolytes will also contribute to hypokalemia. Hypokalemia may be avoided or treated by use of potassium supplements or foods with a high potassium content.

Any chloride deficit is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in liver disease or renal disease). Dilutional hyponatremia may occur in edematous patients in hot weather; appropriate therapy is water restriction rather than administration of salt, except in rare instances when the hyponatremia is life-threatening. In actual salt depletion, appropriate replacement is the therapy of choice.

Hyperuricemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.

Latent diabetes may become manifest during thiazide administration (see Drug/Drug Interactions).

The antihypertensive effects of the drug may be enhanced in the postsympathectomy patient.

If progressive renal impairment becomes evident, withholding or discontinuing diuretic therapy should be considered.

Calcium excretion is decreased by thiazides. Pathological changes in the parathyroid gland with hypercalcemia and hypophosphatemia have been observed in a few patients on prolonged thiazide therapy. The common complications of hyperparathyroidism such as renal lithiasis, bone resorption, and peptic ulceration have not been seen.

Thiazide diuretics have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.

Information for Patients

Patients should be informed of possible side effects and advised to take the medication regularly and continuously as directed.

Laboratory Tests

Initial and periodic determinations of serum electrolytes to detect possible electrolyte imbalance should be performed at appropriate intervals.

Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids.

Drug/Drug Interactions

Hypokalemia can sensitize or exaggerate the response of the heart to the toxic effects of digitalis (e. g. increased ventricular irritability).

Hypokalemia may develop during concomitant use of steroids or ACTH.

Insulin requirements in diabetic patients may be increased, decreased, or unchanged.

Thiazides may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use.

Thiazide drugs may increase the responsiveness to tubocurarine.

Lithium renal clearance is reduced by thiazides, increasing the risk of lithium toxicity.

There have been rare reports in the literature of hemolytic anemia occurring with the concomitant use of hydrochlorothiazide and methyldopa.

Concurrent administration of some nonsteroidal anti-inflammatory agents may reduce the diuretic, natriurefic and anti-hypertensive effects of thiazide diuretics.

Cholestyramine and colestipol resins: Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively.

Drug/Laboratory Test Interactions

Thiazides may decrease serum PBI levels without signs of thyroid disturbance.

Thiazides should be discontinued before carrying out tests for parathyroid function (see PRECAUTIONS, General, calcium excretion).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Two-year feeding studies in mice and rats conducted under the auspices of the National Toxicology Program (NTP) uncovered no evidence of a carcinogenic potential of hydrochlorothiazide in female mice (at doses of up to approximately 600 mg/kg/day) or in male and female rats (at doses of up to approximately 100 mg/kg/day). The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice.

Hydrochlorothiazide was not genotoxic in in vitro assays using strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 of Salmonella typhimurium (Ames assay) and in the Chinese Hamster Ovary (CHO) test for chromosomal aberrations, or in in vivo assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene. Positive test results were obtained only in the in vitro CHO Sister Chromatid Exchange (clastogenicity) and in the Mouse Lymphoma Cell (mutagenicity) assays, using concentrations of hydrochlorothiazide from 43 to 1300 µg/mL, and in the Aspergillus nidulans nondisjunction assay at an unspecified concentration.

Hydrochlorothiazide had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg/day, respectively, prior to mating and throughout gestation.

Pregnancy

Teratogenic Effects. Pregnancy Category B

Studies in which hydrochlorothiazide was orally administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3000 and 1000 mg/kg/day, respectively, provided no evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

Nursing Mothers

Thiazides are excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Esidrix, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Adverse Reactions

Adverse reactions are usually reversible upon reduction of dosage or discontinuation of Esidrix. Whenever adverse reactions are moderate or severe, it may be necessary to discontinue the drug.

The following adverse reactions have been observed, but there has not been enough systematic collection of data to support an estimate of their frequency. Consequently the reactions are categorized by organ systems and are listed in decreasing order of severity and not frequency.

Digestive. Pancreatitis, jaundice (intrahepatic cholestatic), sialadenitis, vomiting, diarrhea, cramping, nausea, gastric irritation, constipation, anorexia.

Cardiovascular. Orthostatic hypotension (may be potentiated by alcohol, barbiturates, or narcotics).

Neurologic. Vertigo, dizziness, transient blurred vision, headache, paresthesia, xanthopsia, weakness, restlessness.

Musculoskeletal. Muscle spasm.

Hematologic. Aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia.

Metabolic. Hyperglycemia, glycosuria, hyperuricemia.

Hypersensitive Reactions. Necrotizing angiitis, Stevens - Johnson syndrome, respiratory distress including pneumonitis and pulmonary edema, purpura, urticaria, rash, photosensitivity.

Overdosage

Acute Toxicity

No deaths due to acute poisoning with Esidrix have been reported.

Highest known doses ingested: children, 500 mg (14-year-old girl); young children, 125 mg (2 1/2-year-old child).

Oral LD 50 in rats: >2750 mg/kg.

Signs and Symptoms

The most prominent feature of poisoning with Esidrix is acute loss of fluid and electrolytes.

Cardiovascular. Tachycardia, hypotension, shock.

Neuromuscula r: Weakness, confusion, dizziness, cramps of the calf muscles, paresthesia, fatigue, impairment of consciousness.

Gastrointestinal. Nausea, vomiting, thirst.

Renal. Polyuria, oliguria or anuria (due to hemoconcentration).

Laboratory Findings. Hypokalemia, hyponatremia, hypochloremia, alkalosis, increased BUN (especially in patients with renal insufficiency).

Combined Poisoning. Signs and symptoms may be aggravated or modified by concomitant intake of antihypertensive medication, barbiturates, curare, digitalis (hypokalemia), corticosteroids, narcotics, or alcohol.

Treatment

There is no specific antidote.

Elimination of the drug. Induction of vomiting, gastric lavage.

Measures to reduce absorption. Activated charcoal.

Hypotension, shock. The patient’s legs should be kept raised, and lost fluid and electrolytes (potassium, sodium) should be replaced.

Surveillance. Fluid and electrolyte balance (especially serum potassium) and renal function should be monitored until conditions become normal.

Esidrix Dosage and Administration

Therapy should be individualized according to patient response.

Dosage should be titrated to gain maximal therapeutic response as well as the minimal dose possible to maintain that therapeutic response.

ADULTS

Hypertension

To Initiate Therapy. Usual dosage is 50-100 mg daily. May be given as a single dose every morning.

Maintenance. After a week dosage may be adjusted downward to as little as 25 mg a day, or upward. Rarely patients may require up to 200 mg daily in divided doses.

Combined Therapy. When necessary, other antihypertensive agents may be added cautiously. Since this drug potentiates the antihypertensive effect of other agents, such additions should be gradual. Dosages of ganglionic blockers in particular should be halved initially.

Edema

To Initiate Diuresis. 25 to 200 mg daily for several days, or until dry weight is attained.

Maintenance. 25 to 100 mg daily or intermittently depending on the patient’s response. A few refractory patients may require up to 200 mg daily.

INFANTS AND CHILDREN

The usual pediatric dosage is administered twice daily.

The total daily dosage for infants up to 2 years of age: 12.5 to 37.5 mg; for children 2 to12 years of age: 37.5 to100 mg. Dosages should be based on body weight at the rate of 1 mg per pound, but infants below 6 months of age may require 1.5 mg per pound.

How is Esidrix Supplied

Tablets 25 mg – round, pink, scored (imprinted CIBA 22)

Bottles of 100. NDC 0083-0022-30

Tablets 50 mg – round, yellow, scored (imprinted CIBA 46)

Bottles of 100. NDC 0083-0046-30

Do not store above 86ºF (30ºC).

Dispense in tight, light-resistant container (USP).

Anacin - Pain Relief, Lisoflu

Anacin is a pain reliever intended for the temporary relief of minor aches and pains. Anacin is a combination salicylate and stimulant. It works by blocking several different chemical processes within the body that cause pain, inflammation, and fever. It also reduces the tendency for blood to clot.

Availability: In Stock (17 packs)

Anacin is used for treating pain including, headache, muscle aches, sprains, tooth extraction and toothache, menstrual cramps, arthritis and rheumatism, and pain and fever of the common cold. It may also be used for other conditions as determined by your doctor.

Use Anacin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Anacin by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Taking it with food may not decrease the risk of stomach or bowel problems (eg, bleeding, ulcers) that may occur while taking Anacin.

Take Anacin with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Anacin.

Use Anacin exactly as directed on the package, unless instructed differently by your doctor. If you are taking Anacin without a prescription, follow any warnings and precautions on the label.

If you miss a dose of Anacin and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Anacin.

Store Anacin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Anacin out of the reach of children and away from pets.

Anacin may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Anacin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate). This includes any medicines that contain caffeine.

Anacin has aspirin in it. Before you start any new medicine, check the label to see if it has aspirin in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Talk to your doctor before you take Anacin or other pain relievers/fever reducers if you drink more than 3 drinks with alcohol per day. Serious stomach ulcers or bleeding can occur with the use of Anacin. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Anacin with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Taking more than the recommended dose or taking Anacin regularly may be habit-forming.

Anacin may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.

Aspirin has been linked to a serious illness called Reye syndrome. Do not give Anacin to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.

Diabetes patients - Anacin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

If Anacin has a strong vinegar-like smell upon opening, do not use. It means the medicine is breaking down. Throw the bottle away safely and out of the reach of children; contact your pharmacist and replace.

Tell your doctor or dentist that you take Anacin before you receive any medical or dental care, emergency care, or surgery.

Do not take Anacin for at least 7 days after any surgery unless directed by your health care provider.

Do not take Anacin for more than 10 days for pain or for more than 3 days for fever unless directed to do so by your health care provider.

Different brands of Anacin may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.

Do NOT use Anacin if:

you are allergic to any ingredient in Anacin

you are a child or teenager with influenza (flu) or chickenpox

you have bleeding problems such as hemophilia, von Willebrand disease, or low blood platelets, or you have active severe bleeding

you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to aspirin, tartrazine, or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)

you are taking anticoagulants (eg, heparin, warfarin) or methotrexate

Before using Anacin:

Some medical conditions may interact with Anacin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have alcoholism or if you consume 3 or more alcohol-containing drinks every day

if you have asthma, bleeding or clotting problems, growths in the nose (nasal polyps), kidney or liver problems, stomach or intestinal problems (eg, ulcer, inflammation), heart problems, heartburn, upset stomach, stomach pain, hives, influenza (flu) or chickenpox, or vitamin K deficiency

if you have anxiety, trouble sleeping, or heart problems

if you are a child with a stroke, a weakened blood vessel (cerebral aneurysm) or bleeding in the brain, rheumatic disease (eg, rheumatoid arthritis), or Kawasaki syndrome (a rare inflammation causing heart problems in children)

Some MEDICINES MAY INTERACT with Anacin. Tell your health care provider if you are taking any other medicines.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Anacin while you are pregnant. Anacin is not recommended during the last 3 months (third trimester) of pregnancy because it may cause harm to the fetus. Anacin is found in breast milk. If you are or will be breast-feeding while you use Anacin, check with your doctor. Discuss any possible risks to your baby.

All medicines may cause side effects, but many people have no, or minor, side effects. Anacin's side effects may include dizziness, heartburn, irritability, nausea, nervousness, rashes, hives, bloody stools, drowsiness, hearing loss, ringing in the ears, and trouble sleeping.

Check with your doctor if any of the listed above most COMMON side effects persist or become bothersome.

Seek medical attention right away if any of these SEVERE side effects occur: severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; confusion; diarrhea; drowsiness; hearing loss; ringing in the ears; severe or persistent dizziness; severe or persistent stomach pain or heartburn; shakiness; trouble sleeping; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects.

Anacin is used for treating pain including, headache, muscle aches, sprains, tooth extraction and toothache, menstrual cramps, arthritis and rheumatism, and pain and fever of the common cold. It may also be used for other conditions as determined by your doctor.

Use Anacin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Anacin by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Taking it with food may not decrease the risk of stomach or bowel problems (eg, bleeding, ulcers) that may occur while taking Anacin.

Take Anacin with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Anacin.

Use Anacin exactly as directed on the package, unless instructed differently by your doctor. If you are taking Anacin without a prescription, follow any warnings and precautions on the label.

If you miss a dose of Anacin and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Anacin.

Store Anacin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Anacin out of the reach of children and away from pets.

Anacin may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Anacin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate). This includes any medicines that contain caffeine.

Anacin has aspirin in it. Before you start any new medicine, check the label to see if it has aspirin in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Talk to your doctor before you take Anacin or other pain relievers/fever reducers if you drink more than 3 drinks with alcohol per day. Serious stomach ulcers or bleeding can occur with the use of Anacin. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Anacin with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Taking more than the recommended dose or taking Anacin regularly may be habit-forming.

Anacin may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.

Aspirin has been linked to a serious illness called Reye syndrome. Do not give Anacin to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.

Diabetes patients - Anacin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

If Anacin has a strong vinegar-like smell upon opening, do not use. It means the medicine is breaking down. Throw the bottle away safely and out of the reach of children; contact your pharmacist and replace.

Tell your doctor or dentist that you take Anacin before you receive any medical or dental care, emergency care, or surgery.

Do not take Anacin for at least 7 days after any surgery unless directed by your health care provider.

Do not take Anacin for more than 10 days for pain or for more than 3 days for fever unless directed to do so by your health care provider.

Different brands of Anacin may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.

Do NOT use Anacin if:

you are allergic to any ingredient in Anacin

you are a child or teenager with influenza (flu) or chickenpox

you have bleeding problems such as hemophilia, von Willebrand disease, or low blood platelets, or you have active severe bleeding

you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to aspirin, tartrazine, or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)

you are taking anticoagulants (eg, heparin, warfarin) or methotrexate

Before using Anacin:

Some medical conditions may interact with Anacin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have alcoholism or if you consume 3 or more alcohol-containing drinks every day

if you have asthma, bleeding or clotting problems, growths in the nose (nasal polyps), kidney or liver problems, stomach or intestinal problems (eg, ulcer, inflammation), heart problems, heartburn, upset stomach, stomach pain, hives, influenza (flu) or chickenpox, or vitamin K deficiency

if you have anxiety, trouble sleeping, or heart problems

if you are a child with a stroke, a weakened blood vessel (cerebral aneurysm) or bleeding in the brain, rheumatic disease (eg, rheumatoid arthritis), or Kawasaki syndrome (a rare inflammation causing heart problems in children)

Some MEDICINES MAY INTERACT with Anacin. Tell your health care provider if you are taking any other medicines.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Anacin while you are pregnant. Anacin is not recommended during the last 3 months (third trimester) of pregnancy because it may cause harm to the fetus. Anacin is found in breast milk. If you are or will be breast-feeding while you use Anacin, check with your doctor. Discuss any possible risks to your baby.

All medicines may cause side effects, but many people have no, or minor, side effects. Anacin's side effects may include dizziness, heartburn, irritability, nausea, nervousness, rashes, hives, bloody stools, drowsiness, hearing loss, ringing in the ears, and trouble sleeping.

Check with your doctor if any of the listed above most COMMON side effects persist or become bothersome.

Seek medical attention right away if any of these SEVERE side effects occur: severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; confusion; diarrhea; drowsiness; hearing loss; ringing in the ears; severe or persistent dizziness; severe or persistent stomach pain or heartburn; shakiness; trouble sleeping; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects.

Anacin is a pain reliever intended for the temporary relief of minor aches and pains. Anacin is a combination salicylate and stimulant. It works by blocking several different chemical processes within the body that cause pain, inflammation, and fever. It also reduces the tendency for blood to clot.

Availability: In Stock (17 packs)

Other names of Anacin:

Anacin is used for treating pain including, headache, muscle aches, sprains, tooth extraction and toothache, menstrual cramps, arthritis and rheumatism, and pain and fever of the common cold. It may also be used for other conditions as determined by your doctor.

Use Anacin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Anacin by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Taking it with food may not decrease the risk of stomach or bowel problems (eg, bleeding, ulcers) that may occur while taking Anacin.

Take Anacin with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Anacin.

Use Anacin exactly as directed on the package, unless instructed differently by your doctor. If you are taking Anacin without a prescription, follow any warnings and precautions on the label.

If you miss a dose of Anacin and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Anacin.

Store Anacin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Anacin out of the reach of children and away from pets.

Anacin may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Anacin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate). This includes any medicines that contain caffeine.

Anacin has aspirin in it. Before you start any new medicine, check the label to see if it has aspirin in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Talk to your doctor before you take Anacin or other pain relievers/fever reducers if you drink more than 3 drinks with alcohol per day. Serious stomach ulcers or bleeding can occur with the use of Anacin. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Anacin with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Taking more than the recommended dose or taking Anacin regularly may be habit-forming.

Anacin may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.

Aspirin has been linked to a serious illness called Reye syndrome. Do not give Anacin to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.

Diabetes patients - Anacin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

If Anacin has a strong vinegar-like smell upon opening, do not use. It means the medicine is breaking down. Throw the bottle away safely and out of the reach of children; contact your pharmacist and replace.

Tell your doctor or dentist that you take Anacin before you receive any medical or dental care, emergency care, or surgery.

Do not take Anacin for at least 7 days after any surgery unless directed by your health care provider.

Do not take Anacin for more than 10 days for pain or for more than 3 days for fever unless directed to do so by your health care provider.

Different brands of Anacin may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.

Do NOT use Anacin if:

you are allergic to any ingredient in Anacin

you are a child or teenager with influenza (flu) or chickenpox

you have bleeding problems such as hemophilia, von Willebrand disease, or low blood platelets, or you have active severe bleeding

you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to aspirin, tartrazine, or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)

you are taking anticoagulants (eg, heparin, warfarin) or methotrexate

Before using Anacin:

Some medical conditions may interact with Anacin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have alcoholism or if you consume 3 or more alcohol-containing drinks every day

if you have asthma, bleeding or clotting problems, growths in the nose (nasal polyps), kidney or liver problems, stomach or intestinal problems (eg, ulcer, inflammation), heart problems, heartburn, upset stomach, stomach pain, hives, influenza (flu) or chickenpox, or vitamin K deficiency

if you have anxiety, trouble sleeping, or heart problems

if you are a child with a stroke, a weakened blood vessel (cerebral aneurysm) or bleeding in the brain, rheumatic disease (eg, rheumatoid arthritis), or Kawasaki syndrome (a rare inflammation causing heart problems in children)

Some MEDICINES MAY INTERACT with Anacin. Tell your health care provider if you are taking any other medicines.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Anacin while you are pregnant. Anacin is not recommended during the last 3 months (third trimester) of pregnancy because it may cause harm to the fetus. Anacin is found in breast milk. If you are or will be breast-feeding while you use Anacin, check with your doctor. Discuss any possible risks to your baby.

All medicines may cause side effects, but many people have no, or minor, side effects. Anacin's side effects may include dizziness, heartburn, irritability, nausea, nervousness, rashes, hives, bloody stools, drowsiness, hearing loss, ringing in the ears, and trouble sleeping.

Check with your doctor if any of the listed above most COMMON side effects persist or become bothersome.

Seek medical attention right away if any of these SEVERE side effects occur: severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; confusion; diarrhea; drowsiness; hearing loss; ringing in the ears; severe or persistent dizziness; severe or persistent stomach pain or heartburn; shakiness; trouble sleeping; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects.

Reanimed Teknik Ve T?bbi Sistemler, Ranimed

WELCOME TO REANIMED

With an expert team of Engineers with more than 20 years experience ReaniMed institutions to meet the demands of the highest level, creative and flexible solutions with demonstrate success in various areas of the healthcare industry.

For years American companies have reanimed European Investment Trust as a company "know-how" and manufacturing units that are established with the following issues in the design, production, sales, installation and after-sales services with European standards conducts.

Medical Gas Systems For security reasons our country is no longer a fixture in a hospital in which medical gas systems must be designed in accordance with standards, operating rooms, services and installations should be equipped with devices that control the distribution of the other sections. Repairs and expansions also necessitates the closure of some parts of the system. More

Bed-Head Units ReaniMed hospital in the project planning phase of the architectural project from the owner of the hospital in line with the demands of the suitability of the premises, More

Intensive Care Units Carrier cars (rotary and lateral motion), blood pressure and serum straps, the device shelves, infusion pump holders, etc. with accessories double-sided ceiling-mounted horizontal intensive care units are specially manufactured to place. More

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Buy Doprovet Online Without Prescriptions, Doprovet

Doxycycline is used for treating infections caused by certain bacteria. It may be used in combination with other medicines to treat certain amoeba infections. It may also be used to prevent or slow the progression of anthrax after exposure. Doxycycline is a tetracycline antibiotic. It works by slowing the growth of bacteria. Slowing bacteria's growth allows the body's immune system to destroy the bacteria.

Take Doxycycline exactly as it was prescribed for you.

Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take Doxycycline with a full glass of water (8 ounces).

Do not take the medication with milk or other dairy products, unless your doctor has told you to. Dairy products can make it harder for your body to absorb the medicine.

Do not crush, break, or open a capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

Take Doxycycline for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

Doxycycline will not treat a viral infection such as the common cold or flu.

Do not give this medicine to another person, even if they have the same condition you have.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking Doxycycline. You may need to stop using the medicine for a short time.

Do not take any Doxycycline after the expiration date printed on the label. Using expired Doxycycline can cause damage to your kidneys.

Do not give Doxycycline to a child younger 8 years. It can cause permanent yellowing or graying of the teeth, and it can affect a child's growth.

If you miss a dose of Doxycycline, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Doxycycline.

Store Doxycycline at room temperature between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed container. Brief periods at temperatures of 59 to 86 degrees F (15 to 30 degrees C) are permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Doxycycline out of the reach of children and away from pets.

Do NOT use Doxycycline if:

you are allergic to any ingredient in Doxycycline, or to similar medicines such as demeclocycline (Declomycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap)

you are taking acitretin, isotretinoin, or a penicillin (eg, amoxicillin)

you have recently received or will be receiving a live oral typhoid vaccine.

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Doxycycline. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have diarrhea, a stomach or intestinal infection, a history of lupus, or the blood disease porphyria

if you have liver or kidney disease, you may need a dose adjustment or special tests to safely take Doxycycline.

Some medicines may interact with Doxycycline. Tell your health care provider if you are taking any other medicines, especially any of the following:

Barbiturates (eg, phenobarbital), carbamazepine, or hydantoins (eg, phenytoin) because they may decrease Doxycycline's effectiveness

Acitretin or isotretinoin because side effects, such as increased pressure inside the skull (resulting in severe headaches and vision problems) may occur

Anticoagulants (eg, warfarin), digoxin, methotrexate, or methoxyflurane because the risk of their side effects may be increased by Doxycycline

Live oral typhoid vaccine, hormonal birth control (eg, birth control pills), or penicillins (eg, amoxicillin) because their effectiveness may be decreased by Doxycycline.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Doxycycline may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

Be sure to use Doxycycline for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.

Long-term or repeated use of Doxycycline may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.

Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or blood stools occur. Do not treat diarrhea without first checking with your doctor.

Doxycycline may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Doxycycline. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

Tell your doctor or dentist that you take Doxycycline before you receive any medical or dental care, emergency care, or surgery.

Hormonal birth control (eg, birth control pills) may not work as well while you are using Doxycycline. To prevent pregnancy, use an extra form of birth control (eg, condoms).

Doxycycline may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Doxycycline.

Pregnancy and breast-feeding: Doxycycline has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Doxycycline while you are pregnant. Doxycycline is found in breast milk. Do not breastfeed while taking Doxycycline.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Loss of appetite; nausea; sensitivity to sunlight; vomiting.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody stools; chest pain; dark urine; decreased urination; fever, chills, or sore throat; moderate to severe sunburn; severe diarrhea; severe or persistent headache; stomach pain or cramps; throat irritation; trouble swallowing; unusual bruising or bleeding; unusual joint pain; unusual tiredness; vaginal irritation or discharge; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

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Benzoyl Peroxide, Eryth

Benzoyl peroxide/ erythromycin gel

Benzoyl peroxide/ erythromycin gel is used for:

Treating severe acne. It may be used with other acne medications.

Benzoyl peroxide/erythromycin gel is a combination macrolide antibiotic and keratolytic (drying) agent with antibacterial actions. The effectiveness of benzoyl peroxide appears to be due to its antibacterial, peeling (keratolytic), and drying actions. How topical erythromycin treats acne is not fully known. It is thought that the improvement in acne is due to the ability of topically applied erythromycin to slow the growth on the skin of bacteria that cause the acne.

Do NOT use benzoyl peroxide/ erythromycin gel if:

you are allergic to any ingredient in benzoyl peroxide/erythromycin gel

Contact your doctor or health care provider right away if any of these apply to you.

Before using benzoyl peroxide/ erythromycin gel:

Some medical conditions may interact with benzoyl peroxide/erythromycin gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have liver problems or a blood disorder

Some MEDICINES MAY INTERACT with benzoyl peroxide/erythromycin gel. Because little, if any, of benzoyl peroxide/erythromycin gel is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if benzoyl peroxide/erythromycin gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use benzoyl peroxide/ erythromycin gel:

Use benzoyl peroxide/erythromycin gel as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

Before using benzoyl peroxide/erythromycin gel, thoroughly wash, rinse with warm water, and gently dry your skin.

Apply and rub in a thin film of medicine to the affected skin and surrounding areas using the fingertips or applicator provided.

Wash your hands after using benzoyl peroxide/erythromycin gel.

Benzoyl peroxide/erythromycin gel works best if used at the same time(s) each day.

If you miss a dose of benzoyl peroxide/erythromycin gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use benzoyl peroxide/erythromycin gel.

Important safety information:

Certain acne products that contain benzoyl peroxide or salicylic acid can rarely cause serious and sometimes life-threatening allergic reactions or severe irritation. Before first use, you may need to follow certain steps to make sure you do not have an allergic reaction. Use benzoyl peroxide/erythromycin gel as you were told by your doctor or read the package label. Discuss any questions or concerns with your doctor.

Use on the skin only. Avoid getting benzoyl peroxide/erythromycin gel in your eyes, on the inside of your nose or mouth, on highly inflamed or damaged skin, or on your lips. If you get benzoyl peroxide/erythromycin gel in your eyes, immediately wash them out with cool tap water.

Avoid applying benzoyl peroxide/erythromycin gel to raw or irritated skin, including sunburns and open wounds.

If applying another medicine for acne, wait at least 1 hour before applying the second medicine.

Once you begin using benzoyl peroxide/erythromycin gel, it may take 3 to 8 weeks before you begin to see improvement. If your symptoms do not improve by 12 weeks or if they become worse, check with your doctor.

While you are using benzoyl peroxide/erythromycin gel, use only water-based cosmetics.

Talk with your doctor before you use any other medicines or special cleansers on your skin.

Benzoyl peroxide/erythromycin gel may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to benzoyl peroxide/erythromycin gel. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

Benzoyl peroxide/erythromycin gel may cause bleaching. Avoid contact with hair, fabrics, or carpeting.

Benzoyl peroxide/erythromycin gel should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using benzoyl peroxide/erythromycin gel while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use benzoyl peroxide/erythromycin gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of benzoyl peroxide/ erythromycin gel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dryness; feeling of warmth; hives; irritation; itching; peeling; redness; stinging; swelling of the skin.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; dizziness; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); excessive burning, itching, redness, or tenderness of the skin; extreme dryness; severe irritation; sloughing of the skin; swelling of the treated areas.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA .

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center. or emergency room immediately. Symptoms may include excessive scaling, flushing, redness, and swelling of the skin.

Proper storage of benzoyl peroxide/erythromycin gel:

Storage of Pak: Store benzoyl peroxide/erythromycin gel at room temperature at 68 to 77 degrees F (20 to 25 degrees C). Store in a tightly closed container after it has been mixed. Do not freeze. Discard unused medicine after 3 months. Keep benzoyl peroxide/erythromycin gel out of the reach of children and away from pets.

Storage of Jar: Store benzoyl peroxide/erythromycin gel in the refrigerator at 36 to 46 degrees F (2 to 8 degrees C). Store in a tightly closed container after it has been mixed. Do not freeze. Discard unused medicine after 3 months. Keep benzoyl peroxide/erythromycin gel out of the reach of children and away from pets.

General information:

If you have any questions about benzoyl peroxide/erythromycin gel, please talk with your doctor, pharmacist, or other health care provider.

Benzoyl peroxide/erythromycin gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take benzoyl peroxide/erythromycin gel or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about benzoyl peroxide/erythromycin gel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to benzoyl peroxide/erythromycin gel. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using benzoyl peroxide/erythromycin gel.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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