Original Medicated Cream For Babies, Tenaten

PENATEN® Original Medicated Cream for Babies

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Cetirizina Medlineplus Medicinas, Cetaler

Cetirizina

?Para cuales condiciones o enfermedades se prescribe este medicamento?

La cetirizina se usa para aliviar temporalmente los sintomas de la fiebre del heno (alergia al polen, el polvo y otras sustancias suspendidas en el aire) y las alergias a otras sustancias (como acaros del polvo, caspa de animales, cucarachas y mohos). Entre los sintomas se encuentran: estornudos; escurrimiento nasal; comezon, enrojecimiento o lagrimeo de ojos; y comezon en la nariz o la garganta. La cetirizina se usa tambien para tratar la picazon y el enrojecimiento de la urticaria. Sin embargo, la cetirizina no previene la urticaria ni otras reacciones alergicas de la piel. La cetirizina pertenece a una clase de medicamentos llamados antihistaminicos. Actua bloqueando la accion de la histamina, una sustancia presente en el organismo que provoca los sintomas de alergia.

La cetirizina tambien se vende en combinacion con pseudoefedrina (Sudafed, otros). La informacion de esta monografia se refiere unicamente al uso de la cetirizina sola. Si esta tomando un producto mixto de cetirizina y pseudoefedrina, lea la informacion de la etiqueta del paquete o pidales mas informacion a su medico o a su farmaceutico.

?Como se debe usar este medicamento?

La cetirizina viene en forma de tabletas normales, tabletas masticables y jarabe (liquido) que se toman por via oral. Suele tomarse una vez al dia, con o sin alimentos. Tome la cetirizina mas o menos a la misma hora todos los dias. Siga cuidadosamente las instrucciones de la receta y pidales a su medico o farmaceutico que le expliquen cualquier cosa que no entienda. Tome la cetirizina tal como se lo indiquen. No aumente ni disminuya la dosis, ni la tome con mas frecuencia que la indicada en la etiqueta del envase o la recomendada por su medico.

No use cetirizina para tratar una urticaria con hematomas (moretones) o ampollas, de color extrano o que no da comezon. Si tiene estos tipos de urticaria, llame a su medico.

Deje de tomar la cetirizina y llame a su medico si su urticaria no mejora durante los 3 primeros dias de tratamiento o si dura mas de 6 semanas. Si desconoce la causa de su urticaria, llame a su medico.

Si esta tomando cetirizina para tratar la urticaria y aparece cualquiera de estos sintomas, solicite de inmediato asistencia medica de emergencia: dificultad para tragar, hablar o respirar; hinchazon en la boca y alrededor de ella o hinchazon de la lengua; sibilancia (jadeo); babeo; mareos, o perdida del conocimiento. Estos pueden ser sintomas de una reaccion alergica llamada anafilaxia, que pone la vida en riesgo. Si el medico sospecha que puede tener anafilaxia con la urticaria, quizas le recete un inyector de epinefrina (EpiPen). No use la cetirizina en lugar del inyector de epinefrina.

?Que otro uso se le da a este medicamento?

A veces se receta este medicamento para otros usos; pidale mas informacion a su medico o farmaceutico.

?Cuales son las precauciones especiales que debo seguir?

Antes de tomar cetirizina,

digales a su medico y a su farmaceutico si es alergico a la cetirizina, a la hidroxicina (Vistaril) o a otros medicamentos.

digales a su medico y a su farmaceutico que medicamentos con y sin receta, vitaminas, complementos nutricionales y productos herbales esta tomando o piensa tomar. No olvide mencionar ninguno de los siguientes: antidepresivos, medicamentos para la ansiedad, medicamentos para las enfermedades mentales, medicamentos para las convulsiones, otros medicamentos para el resfriado y la alergia, sedantes, pildoras para dormir, tranquilizantes, y teofilina (Theo-24, Theolair). Es posible que su medico deba cambiar la dosis de sus medicamentos o vigilarle estrechamente por si presentara efectos secundarios.

digale a su medico si tiene o ha tenido alguna enfermedad del rinon o el higado.

digale a su medico si esta embarazada, planea estarlo o esta lactando. Si queda embarazada mientras esta tomando cetirizina, llame a su medico.

tenga en cuenta que la cetirizina puede causar somnolencia. Evite conducir vehiculos u operar maquinas hasta que no sepa como le afecta este farmaco.

recuerde que el alcohol puede aumentar la somnolencia que este medicamento provoca. Evite las bebidas alcoholicas mientras este tomando este medicamento.

?Que dieta especial debo seguir mientras tomo este medicamento?

A menos que su medico le indique lo contrario, continue con su dieta normal.

?Que tengo que hacer si me olvido de tomar una dosis?

Si olvida tomar una dosis, tomela en cuanto se acuerde. No obstante, si ya casi es hora de la dosis siguiente, salte la que olvido y continue con su horario de medicacion normal. No tome una dosis doble para compensar la que olvido.

?Cuales son los efectos secundarios que podria provocar este medicamento?

La cetirizina puede provocar efectos secundarios. Avisele a su medico si cualquiera de estos sintomas es grave o no desaparece:

somnolencia

cansancio excesivo

sequedad en la boca

dolor de estomago

diarrea

vomitos

Algunos efectos secundarios pueden ser graves. Los siguientes sintomas son raros, pero si los tiene, llame a su medico de inmediato:

dificultad para respirar o tragar

La cetirizina puede provocar otros efectos secundarios. Llame a su medico si tiene algun problema inesperado mientras toma este medicamento.

Si desarrolla un efecto secundario grave, usted o su doctor puede enviar un informe al programa de divulgacion de efectos adversos 'MedWatch' de la Administracion de Alimentos y Medicamentos (FDA, por su sigla en ingles) en la pagina de Internet (http://www. fda. gov/Safety/MedWatch ) o por telefono al 1-800-332-1088.

?Como debo almacenar o desechar este medicamento?

Mantenga este producto en su envase original, perfectamente cerrado y fuera del alcance de los ninos. Guardelo a temperatura ambiente y en un lugar alejado del calor y la humedad excesivos (nunca en el cuarto de bano). Deseche todos los medicamentos vencidos o que ya no necesite. Preguntele a su farmaceutico cual es la manera adecuada de desechar los medicamentos.

?Que debo hacer en caso de una sobredosis?

En caso de una sobredosis, llame a la oficina local de control de envenenamiento al 1-800-222-1222. Si la victima esta inconsciente, o no respira, llame inmediatamente al 911.

Los sintomas de sobredosis son, entre otros:

intranquilidad

irritabilidad

somnolencia

?Que otra informacion de importancia deberia saber?

No falte a ninguna cita con su medico.

Hagale a su farmaceutico todas las preguntas que tenga sobre la cetirizina.

Es importante que Ud. mantenga una lista escrita de todas las medicinas que Ud. esta tomando, incluyendo las que recibio con receta medica y las que Ud. compro sin receta, incluyendo vitaminas y suplementos de dieta. Ud. debe tener la lista cada vez que visita su medico o cuando es admitido a un hospital. Tambien es una informacion importante en casos de emergencia.

Marcas comerciales

Medikamente Packungsbeilage Metodura Comp Tabletten, Metodura Comp

Wie wirkt der Inhaltsstoff? Das Medikament ist eine Kombination aus den Wirkstoffen Metoprolol 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. Fur eine Steigerung der Leistungsfahigkeit sorgt z. B. das Hormon Adrenalin. Am Herz dockt es an speziellen Bindungsstellen, den Beta-Rezeptoren, an und bewirkt dort eine Steigerung der Herzleistung und des Blutdrucks. An den Blutgefa?en bindet es sich an Alpha-Rezeptoren und verengt die Gefa?e. Auch dadurch steigt der Blutdruck.

Metoprolol ist ein Beta-Rezeptoren-Blocker. Er besetzt die Beta-Rezeptoren und verhindert damit die Wirkung von Adrenalin am Herzen. Das Herz schlagt langsamer und weniger kraftvoll, der Blutdruck sinkt. Der Herzmuskel verbraucht weniger Energie und Sauerstoff - Atembeklemmungen und Schmerzen in der Herzgegend, die bei der Herzenge (Angina pectoris ) auftreten, werden gebessert.

Hydrochlorothiazid ist ein Entwasserungsmittel (Diuretikum). Es fordert die Salz - und Wasserausscheidung durch die Nieren. 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.

Vor allem zu Beginn der Therapie werden Sie wohl haufiger die Toilette aufsuchen mussen. Um nachts ungestort schlafen zu konnen, empfiehlt es sich, das Medikament am Morgen einzunehmen.

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)? •Asthma bronchiale •Besondere Form der Herzrhythmusstorungen (AV-Block) •Besteht eine Uberempfindlichkeit gegen Antibiotika aus der Gruppe der Sulfonamide, kann auch bei Anwendung des o. g. Praparats eine Uberempfindlichkeit bestehen (Kreuzreaktion). •Gleichzeitige Einnahme von Medikamenten zur Behandlung der Depression aus der Arzneimittelgruppe der MAO-Hemmer •Schwere Durchblutungsstorungen •Schwere Herzschwache (Herzinsuffizienz) •Schwere Leber - und Nierenfunktionsstorungen •Storungen des Mineralstoff - und Wasserhaushalts •Verlangsamter Herzschlag, weniger als 50 Schlage pro Minute (Bradykardie) •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.

•Durchblutungsstorungen von Handen und Fu?en, Taubheits - und Kaltegefuhl in den Gliedma?en (Gelegentlich) •Storungen des Gehirns unterschiedlicher Ursache wie z. B. Empfindungsstorungen, Schwindel, Mudigkeit, Schlafstorungen, Stimmungsschwankungen, Verwirrtheit, Halluzinationen (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) •Mineralstoffverluste (Natrium, Kalium, Magnesium) (Gelegentlich) •Trockene Augen, z. B. mit Rotung, Brennen, Schmerzen, Fremdkorpergefuhl (Sandkorn im Auge). Beschwerden beim Tragen von Kontaktlinsen (Selten) Wechselwirkungen Beta-Blocker konnen die Empfindlichkeit gegenuber Allergenen erhohen und allergische Reaktionen verstarken.

Andere blutdrucksenkende Arzneimittel wie ACE-Hemmer, Kalzium-Antagonisten oder gefa?erweiternde Medikamente werden in ihrer blutdrucksenkenden Wirkung verstarkt.

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

Diabetesmedikamente mit Wirkstoffen aus der Gruppe der Sulfonylharnstoffe werden in ihrer Wirksamkeit vermindert. Der Wiederanstieg des Blutzuckerspiegels nach Gabe von Insulin oder oralen Antidiabetika wird verzogert. Das ruft verstarkt Unterzuckerreaktionen hervor. Da Metoprolol die Wirkung des Adrenalins unterdruckt, werden Warnsymptome des Korpers gegen Unterzuckerung (Herzklopfen) nicht wahrgenommen!

Da Hydrochlorothiazid den Mineralstoff Kalium aus dem Korper ausschwemmt, kann eine gleichzeitige Einnahme von Abfuhrmittel und Kortison, die ebenfalls zu einer Kaliumausscheidung fuhren, den Kaliumspiegel im Blut stark senken.

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 Azumetop® HCT Tabletten Beloc-Zok® comp Retardtabletten Meprolol® comp. Tabletten Meto AbZ comp. Tabletten Meto-ISIS® comp Tabletten meto-thiazid von ct Tabletten Metobeta® comp Tabletten Metohexal® comp Tabletten Metoprolol-ratiopharm comp. Tabletten Metostad® comp. Tabletten

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Interactions Between Alledryl Oral And Cyp2d6-Inhibitors-Tamoxifen, Alledryl

Interactions

Tamoxifen/CYP2D6 Inhibitors

This information is generalized and not intended as specific medical advice. Consult your healthcare professional before taking or discontinuing any drug or commencing any course of treatment.

Medical warning:

Serious. These medicines may interact and cause very harmful effects. Contact your healthcare professional (e. g. doctor or pharmacist) for more information.

How the interaction occurs:

Certain medications may decrease the effect of tamoxifen by interfering with how the body activates tamoxifen. Amiodarone, thioridazine, and tamoxifen can all affect your heart's rhythm.

What might happen:

Your tamoxifen may not work as well at preventing your breast cancer from returning. Taking amiodarone or thioridazine with tamoxifen may increase your risk of an irregular heartbeat, which may be life-threatening.

What you should do about this interaction:

Let your healthcare professionals (e. g. doctor or pharmacist) know that you are using these products together. Your doctor may want to change your medicine. Let your doctor know right away if you notice an irregular heartbeat or have any dizziness or fainting episodes. Your healthcare professionals may already be aware of this interaction and may be monitoring you for it. Do not start, stop, or change the dosage of any medicine before checking with them first.

References:

1.Stearns V, Johnson MD, Rae JM, Morocho A, Novielli A, Bhargava P, Hayes DF, Desta Z, Flockhart DA. Active tamoxifen metabolite plasma concentrations after coadministration of tamoxifen and the selective serotonin reuptake inhibitor paroxetine. J Natl Cancer Inst 2003 Dec 3; 95(23):1758-64.

2.Jin Y, Desta Z, Stearns V, Ward B, Ho H, Lee KH, Skaar T, Storniolo AM, Li L, Araba A, Blanchard R, Nguyen A, Ullmer L, Hayden J, Lemler S, Weinshilboum RM, Rae JM, Hayes DF, Flockhart DA. CYP2D6 genotype, antidepressant use, and tamoxifen metabolism during adjuvant breast cancer treatment. J Natl Cancer Inst 2005 Jan 5;97(1):30-9.

3.Johnson MD, Zuo H, Lee KH, Trebley JP, Rae JM, Weatherman RV, Desta Z, Flockhart DA, Skaar TC. Pharmacological characterization of 4-hydroxy-N-desmethyl tamoxifen, a novel active metabolite of tamoxifen. Breast Cancer Res Treat 2004 May;85(2):151-9.

4.Desta Z, Ward BA, Soukhova NV, Flockhart DA. Comprehensive evaluation of tamoxifen sequential biotransformation by the human cytochrome P450 system in vitro: prominent roles for CYP3A and CYP2D6. J Pharmacol Exp Ther 2004 Sep;310(3):1062-75.

5.Lim YC, Desta Z, Flockhart DA, Skaar TC. Endoxifen (4-hydroxy-N-desmethyl-tamoxifen) has anti-estrogenic effects in breast cancer cells with potency similar to 4-hydroxy-tamoxifen. Cancer Chemother Pharmacol 2005 May;55(5):471-8.

6.Coller JK, Krebsfaenger N, Klein K, Endrizzi K, Wolbold R, Lang T, Nussler A, Neuhaus P, Zanger UM, Eichelbaum M, Murdter TE. The influence of CYP2B6, CYP2C9 and CYP2D6 genotypes on the formation of the potent antioestrogen Z-4-hydroxy-tamoxifen in human liver. Br J Clin Pharmacol 2002 Aug;54(2):157-67.

7.Dehal SS, Kupfer D. CYP2D6 catalyzes tamoxifen 4-hydroxylation in human liver. Cancer Res 1997 Aug 15;57(16):3402-6.

8.Goetz MP, Kamal A, Ames MM. Tamoxifen pharmacogenomics: the role of CYP2D6 as a predictor of drug response. Clin Pharmacol Ther 2008 Jan;83(1):160-6.

9.Beverage JN, Sissung TM, Sion AM, Danesi R, Figg WD. CYP2D6 polymorphisms and the impact on tamoxifen therapy. J Pharm Sci 2007 Sep;96(9):2224-31.

10.Goetz MP, Knox SK, Suman VJ, Rae JM, Safgren SL, Ames MM, Visscher DW, Reynolds C, Couch FJ, Lingle WL, Weinshilboum RM, Fritcher EG, Nibbe AM, Desta Z, Nguyen A, Flockhart DA. Perez EA, Ingle JN. The impact of cytochrome P450 2D6 metabolism in women receiving adjuvant tamoxifen. Breast Cancer Res Treat 2007 Jan;101(1):113-21.

11.Goetz MP, Rae JM, Suman VJ, Safgren SL, Ames MM, Visscher DW, Reynolds C, Couch FJ, Lingle WL, Flockhart DA, Desta Z, Perez EA, Ingle JN. Pharmacogenetics of tamoxifen biotransformation is associated with clinical outcomes of efficacy and hot flashes. J Clin Oncol 2005 Dec 20; 23(36):9312-8.

12.Phan MT, Venitz J. Summary minutes of the Advisory Committee Pharmaceutical Science Clinical Pharmacology Subcommittee. Available at: http://www. fda. gov/ohrms/dockets/ac/06/minutes/2006-4248m1.pdf October 18-19, 2006.

13.Rahman NA. Personal communication. Division Director, Office of Clinical Pharmacology, US Food and Drug Administration March 4, 2008.

14.Schroth W, Goetz MP, Hamann U, Fasching PA, Schmidt M, Winter S, Fritz P, Simon W, Suman VJ, Ames MM, Safgren SL, Kuffel MJ, Ulmer HU, Bolander J, Strick R, Beckmann MW, Koelbl H. Weinshilboum RM, Ingle JN, Eichelbaum M, Schwab M, Brauch H. Association between CYP2D6 polymorphisms and outcomes among women with early stage breast cancer treated with tamoxifen. JAMA 2009 Oct 7;302(13):1429-36.

15.Onfi (clobazam) US prescribing information. Lundbeck, Inc. December, 2013.

16.Kelly CM, Pritchard KI. CYP2D6 genotype as a marker for benefit of adjuvant tamoxifen in postmenopausal women: lessons learned. J Natl Cancer Inst 2012 Mar 21;104(6):427-8.

17.Regan MM, Leyland-Jones B, Bouzyk M, Pagani O, Tang W, Kammler R, Dell'orto P, Biasi MO, Thurlimann B, Lyng MB, Ditzel HJ, Neven P, Debled M, Maibach R, Price KN, Gelber RD, Coates AS. Goldhirsch A, Rae JM, Viale G. CYP2D6 genotype and tamoxifen response in postmenopausal women with endocrine-responsive breast cancer: the breast international group 1-98 trial. J Natl Cancer Inst 2012 Mar 21;104(6):441-51.

18.Rae JM, Drury S, Hayes DF, Stearns V, Thibert JN, Haynes BP, Salter J, Sestak I, Cuzick J, Dowsett M. CYP2D6 and UGT2B7 genotype and risk of recurrence in tamoxifen-treated breast cancer patients. J Natl Cancer Inst 2012 Mar 21;104(6):452-60.

19.Drew BJ, Ackerman MJ, Funk M, Gibler WB, Kligfield P, Menon V, Philippides GJ, Roden DM, Zareba W. Prevention of torsade de pointes in hospital settings: a scientific statement from the American Heart Association and the American College of Cardiology Foundation. J Am Coll Cardiol 2010 Mar 2;55(9):934-47.

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Uses

Valacyclovir is used to treat infections caused by certain types of viruses. In children, it is used to treat cold sores around the mouth (caused by herpes simplex ) and chickenpox (caused by varicella zoster ). In adults, it is used to treat shingles (caused by herpes zoster ) and cold sores around the mouth .

Valacyclovir is also used to treat outbreaks of genital herpes. In people with frequent outbreaks, this medication is used to reduce the number of future episodes.

Valacyclovir is an antiviral drug. It stops the growth of certain viruses. However, it is not a cure for these infections. The viruses that cause these infections continue to live in the body even between outbreaks. Valacyclovir decreases the severity and length of these outbreaks. It helps the sores heal faster, keeps new sores from forming, and decreases pain/itching. This medication may also help reduce how long pain remains after the sores heal.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to prevent another type of viral infection (cytomegalovirus) in some people.

How to use valacyclovir

Read the Patient Information Leaflet if available from your pharmacist before you start taking valacyclovir and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take valacyclovir by mouth. with or without food, as directed by your doctor. Drink plenty of fluids while taking this medication to lower the chance of side effects.

The dosage and length of treatment are based on your type of infection, medical condition, and response to treatment. For treating chickenpox in children, the dosage is also based on weight .

This medication works best when started at the first sign of an outbreak, as directed by your doctor. It may not work as well if you delay treatment. For shingles or chickenpox, start taking valacyclovir at the first symptom or as soon as possible after the rash appears. For cold sores or genital herpes. start taking this medication at the first sign or as soon as you feel tingling, itching. or burning.

Valacyclovir works best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time(s) each day.

Continue to take this medication until the full prescribed amount is finished. Do not change your dose, skip any doses, or stop this medication early without your doctor's approval.

Tell your doctor if your condition persists or worsens.

Side Effects

Nausea. stomach pain. headache. or dizziness 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 agitation, confusion, hallucinations ), trouble speaking, shaky/unsteady movements, signs of kidney problems (such as change in the amount of urine).

This medication may rarely cause a life-threatening disorder that affects the blood cells. kidneys. and other parts of the body. This disorder is more likely to occur if you have conditions related to a weakened immune system (such as HIV disease, bone marrow transplant. kidney transplant ). Get medical help right away if you have any serious side effects, including: extreme tiredness, slow/fast/irregular heartbeat. easy bruising/bleeding, new fever, bloody/dark urine, severe stomach /abdominal pain, yellowing eyes /skin. sudden vision changes, loss of consciousness, seizures .

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

See also Side Effects section.

Before taking valacyclovir, tell your doctor or pharmacist if you are allergic to it; or to acyclovir ; 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 problems.

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

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

Do not have certain immunizations /vaccinations (such as vaccines against the varicella virus) without the consent of your doctor.

Older adults may be more sensitive to the side effects of this drug, especially mental/mood changes (such as confusion, agitation) and kidney problems (such as a change in the amount of urine).

Cold sores can spread easily. Avoid close physical contact with others (such as kissing) during an outbreak until the cold sores have completely healed. Try not to touch the cold sore. If you do, wash your hands afterward.

Valacyclovir does not prevent the spread of herpes. To lower the chance of giving genital herpes to your partner, do not have sexual contact during an outbreak or if you have symptoms. You can spread genital herpes even if you do not have symptoms. Therefore, always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.

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

This medication passes into breast milk, but is unlikely to harm a nursing infant. 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.

Some products that may interact with this drug include: other drugs that may cause kidney problems (including nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen, naproxen).

Valacyclovir is very similar to acyclovir. Do not use medications containing acyclovir while using valacyclovir.

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: change in the amount of urine, extreme tiredness, mental/mood changes, loss of consciousness, 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 infection 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 April 2016. Copyright(c) 2016 First Databank, Inc.

Images

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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Beahexol Description

Generic Beahexol is used to treat the stiffness, tremors, spasms, and poor muscle control of Parkinson's disease. It is also used to treat and prevent the same muscular conditions when they are caused by drugs such as chlorpromazine (Thorazine), fluphenazine (Prolixin), perphenazine (Trilafon), haloperidol (Haldol), thiothixene (Navane), and others.

Generic name of Generic Beahexol is Trihexyphenidyl.

Brand name of Generic Beahexol is Beahexol.

Beahexol Dosage

Generic Beahexol is available in:

2mg Standard Dosage

Take Generic Beahexol by mouth before or after meals.

If Generic Beahexol tends to dry your mouth excessively, it may be better to take it before meals, unless it causes nausea. If taken after meals, thirst can be improved by sucking hard sugarless candy, chewing gum, or drinking water.

If you want to achieve most effective results do not stop taking Generic Beahexol suddenly.

Beahexol Missing of dose

Do not take double dose. If you miss a dose you should take it as soon as you remember about your missing. If it is the time for the next dose you should continue your regular dosing schedule.

Beahexol Overdose

If you overdose Generic Beahexol and you don't feel good you should visit your doctor or health care provider immediately.

Beahexol Side effects

Generic Beahexol has its side effects. The most common are:

blurred visionconstipationdizzinessdrowsinessdry mouthheadacheincreased sensitivity of the eyes to lightlightheadednessloss of appetitenauseanervousnesstrembling of the handsvomitingweakness

Less common but more serious side effects during taking Generic Beahexol:

allergy reactions (urticaria, breathing difficulties, rash, and eruption)agitationchest painconfusiondelusionsdifficult swallowingdifficult urinationfacial pain or swellingfast or pounding heartbeatfever or chillshallucinationsmood or mental changessevere constipationswollen throat glandsuncontrolled movements

Side effects manifestations are not only depend on medicine you are taking but also depend on your health state and on the other factors.

Beahexol Contra-indications

Do not take Generic Beahexol if you are allergic to Generic Beahexol components.

Be very careful with Generic Beahexol if you are pregnant, planning to become pregnant or breast-feeding.

Generic Beahexol may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

Do not become overheated in hot weather or while you are being active. Heatstroke may occur.

Lab tests, including eye exams, may be performed while you use Generic Beahexol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Avoid driving machine.

It can be dangerous to stop Generic Beahexol taking suddenly.

Beahexol Frequently asked questions

Q: What is Generic Beahexol?

A: Generic Beahexol is used to treat the stiffness, tremors, spasms, and poor muscle control of Parkinson's disease. It is also used to treat and prevent the same muscular conditions when they are caused by drugs such as chlorpromazine (Thorazine), fluphenazine (Prolixin), perphenazine (Trilafon), haloperidol (Haldol), thiothixene (Navane), and others.

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Asmol Cfc-Free Inhaler, Asmol

Asmol Inhaler CFC-Free

contains the active ingredient salbutamol

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Asmol inhaler.

It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Asmol inhaler against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

This medicine is only part of a general plan to help you manage your asthma or other chest conditions. You should discuss this plan with your doctor. Ask your doctor to check your treatment regularly.

Keep this leaflet with your medicine. You may need to read it again.

What Asmol inhaler is used for

Asmol inhaler is used to help treat the symptoms of:

asthma

bronchitis

emphysema

other breathing problems.

In people who have difficulty breathing during exercise, Asmol inhaler may also be used before exercise to keep the air passages open.

Asmol inhaler contains a medicine called salbutamol. Each dose (puff) contains 100 micrograms of salbutamol. There are 200 doses in each Asmol inhaler.

Salbutamol belongs to a group of medicines called bronchodilators or beta-2 agonists. When your chest is tight or when you are wheezing, Asmol is inhaled into the lungs and works rapidly to open up the air passages in your lungs, helping you breathe more easily. Asmol inhaler gives fast relief from your chest symptoms and is often called a "reliever" medicine. You may also know it as a "reliever puffer".

Some people start wheezing or their chest starts to feel tight when they exercise. This is called exercise-induced asthma. If you have exercise-induced asthma, your doctor may tell you to take one or two puffs of your Asmol inhaler before you exercise. This can help prevent the symptoms of exercise-induced asthma.

Asmol inhaler helps to control your condition but does not cure it.

Your doctor may have prescribed Asmol inhaler for another reason. Ask your doctor if you have any questions about why Asmol inhaler has been prescribed for you.

There is no evidence that Asmol inhaler is addictive.

Before you use Asmol inhaler

When you must not use it

Do not use Asmol inhaler if you are allergic to medicines containing salbutamol or any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.

Do not use your Asmol inhaler to control miscarriage or premature labour.

Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

Before you start to use it

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you are pregnant or plan to become pregnant.

The ingredients of Asmol inhaler are known to cross the placenta during pregnancy. Your doctor will discuss the risks and benefits of using Asmol inhaler during pregnancy.

It is important that asthma is managed well during pregnancy and you should not stop taking your medicine without asking your doctor.

Tell your doctor if you are breastfeeding or wish to breastfeed. Your doctor will discuss the risks and benefits of using Asmol inhaler when breastfeeding.

Tell your doctor if you have any medical conditions, especially the following:

high blood pressure

heart problems

liver problems

kidney problems

thyroid conditions

diabetes.

Tell your doctor if you had to stop taking this or any other asthma medicine for any reason. Your doctor may want to take special care if you have any of these conditions.

If you have not told your doctor about any of the above, tell them before you start using Asmol inhaler.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may be affected by Asmol inhaler, or may affect how well it works. These include:

beta-blockers, medicines used to treat high blood pressure or heart conditions

some cough and cold preparations

some weight reducing medicines

some medicines used to treat depression or other mood disorders.

Your doctor can tell you what to do if you are taking any of these medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist. Your doctor and pharmacist have more information on medicines to be careful with or avoid while using Asmol inhaler.

How to use Asmol inhaler

How much to use

The usual Asmol inhaler dose is one or two puffs every four hours if needed. Your doctor may advise you to take a different dose. This depends on your condition and whether or not you are taking any other medicine.

Elderly patients may need smaller doses. If you have an Asthma Action Plan that you have agreed with your doctor, follow it closely at all times.

Follow all directions given to you by your doctor and pharmacist carefully.

How to use it

Instructions on how to use Asmol inhaler are included in the pack.

Read these instructions carefully before using Asmol inhaler. The pharmacist's label will usually tell you how many puffs to take and how often to use your Asmol inhaler. If you are not sure, ask your doctor or pharmacist.

Children may require adult supervision when using their Asmol inhaler.

If your Asmol inhaler is new, or if you have not used it for 5 days or more, point the mouthpiece away from you and spray two puff into the air before using it.

This will ensure that your inhaler will work properly.

You should visit your doctor or pharmacist regularly to check that you are using your Asmol inhaler in the right way. If you are not breathing the medicine in correctly, the medicine may not be helping you as much as it could be.

If you have trouble using your Asmol inhaler, talk to your doctor or pharmacist.

You may find using a spacer device with your Asmol inhaler helpful.

To use a spacer device, fit your Asmol inhaler into the spacer, spray one puff of Asmol into the spacer and then slowly breathe in as far as possible. Hold your breath for as long as comfortable, before breathing out slowly. Repeat this for each puff of your Asmol inhaler.

Most people will benefit from the use of a spacer device with their Asmol inhaler.

Use of a spacer will help more of the drug to reach your lungs and reduce the amount of drug deposited in the mouth and back of the throat. This will help to lessen your chance of getting local side effects such as mouth and throat irritation and hoarse voice.

Your pharmacist or doctor can help you with more information about spacer devices.

If you forget to use it

If you are using this medicine regularly and you miss a dose, take it as soon as you remember.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have any questions about this, check with your doctor or pharmacist.

If you use too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Asmol inhaler. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too many puffs of your Asmol inhaler, you may have a fast heart beat, feel shaky or have a headache. You may also have increased acid in the blood, which may cause an increased rate of breathing. These symptoms are usually mild side effects of using Asmol inhaler. However, if they are severe or do not go away, it may be that you have used too much Asmol.

While you are using Asmol inhaler

Things you must do

IMPORTANT: If your breathing suddenly becomes more difficult just after using Asmol inhaler, tell your doctor immediately or go to Accident and Emergency at the nearest hospital.

Your doctor may tell you to take extra puffs of your Asmol inhaler if your chest condition suddenly gets worse. If you take extra puffs and do not get relief, tell your doctor immediately.

Tell your doctor as soon as possible if:

your Asmol inhaler does not help your breathing as much as usual

the effect of your Asmol does not last as long as usual or lasts less than 3 hours

you need more puffs than usual of Asmol to get relief.

These may be signs that your chest condition is getting worse.

Your doctor may decide to add another medicine to your treatment if your Asmol puffer is not having the same effect as before.

Make sure you keep your Asmol inhaler with you at all times.

Before starting any new medicine, tell your doctor or pharmacist that you are using Asmol inhaler.

Tell all the doctors, dentists and pharmacists who are treating you that you are using Asmol inhaler.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used in surgery.

If you become pregnant while taking Asmol inhaler, tell your doctor.

Visit your doctor regularly so they can check on your condition. Your doctor or pharmacist may recommend the use of a peak flow meter to help monitor your condition at home.

Things you must not do

Do not stop using Asmol inhaler or lower the dose without checking with your doctor.

Do not let yourself run out of medicine over the weekend or on holidays.

Do not take any other medicines for your breathing problems without checking with your doctor.

Do not use Asmol inhaler to treat any other conditions unless your doctor tells you to.

Do not give Asmol inhaler to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful driving or operating machinery until you know how Asmol inhaler affects you. Asmol inhaler may cause fine tremors, dizziness or lightheadedness in some people. If any of these occur, do not drive, operate machinery or do anything else that could be dangerous.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Asmol inhaler. Like all other medicines, Asmol inhaler may have unwanted side effects in some people. Most of the side effects will be minor and temporary, but sometimes they are serious. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

muscle cramps

mouth or throat irritation

headache

trembling or shakiness, especially of the hands

fast heart beat

nausea or feeling sick

unusual feelings of warmth

restlessness in children.

Tell your doctor immediately if you notice any of the following:

skin rash, hives or itching

irregular heart beat, palpitations.

Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:

swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing

severe dizziness, fainting or collapse

increased wheezing or difficulty breathing after using Asmol inhaler.

In a few people, Asmol may cause a fall in potassium levels in a few people. Your doctor may do blood tests to check this.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.

After using Asmol inhaler

Straight after use, replace the mouthpiece cover firmly and click it into position.

Cleaning

Regular cleaning is required.

It is recommended that you clean your Asmol inhaler once a week.

Follow these steps to clean your inhaler:

Remove the metal can from the plastic holder of your inhaler and remove the mouthpiece cover.

Rinse the plastic holder and mouthpiece cover under warm running water.

Dry the plastic holder and mouthpiece cover thoroughly inside and out.

Put the can back into the plastic holder and replace the mouthpiece cover.

Do not put the metal can in water.

If you use a spacer device, clean it once each month. Wash the spacer in warm water and detergent then rinse clean with water. Allow it to air dry; do not use a cloth to dry it.

Storage

Keep Asmol inhaler where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Keep Asmol inhaler in a cool dry place where the temperature stays below 30°C.

Do not store Asmol inhaler or any other medicine in the bathroom or near a sink.

Do not leave Asmol inhaler in the car or on window sills. Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop using Asmol inhaler, or your medicine has passed its expiry date, ask your pharmacist what to do with the inhaler.

Do not burn or puncture the metal can, even when it is empty. The metal can is pressurised and may explode when punctured or burned.

You can recycle the plastic holder and the mouthpiece cover of your inhaler with other plastic things.

If you have any other questions, ask your doctor or pharmacist.

Product description

What it looks like

Asmol inhaler consists of a metal can inside a blue plastic holder with a dark blue mouthpiece cover.

Each Asmol inhaler contains 200 puffs.

Ingredients

The active ingredient in Asmol inhaler is salbutamol (sulfate). Each puff contains 100 micrograms of salbutamol.

Asmol inhaler also contains HFA-134a as the propellant. Asmol inhaler has no other additives.

Asmol inhaler is CFC-free.

Supplier

Asmol inhaler is supplied by: Alphapharm Pty Limited (ABN 93 002 359 739) Level 1, 30 The Bond 30 - 34 Hickson Road Millers Point NSW 2000 Phone: (02) 9298 3999 www. alphapharm. com. au

Australian Registration Number: Asmol CFC free inhaler - Aust R 65639

This leaflet was prepared on 7 October 2014.

Published by MIMS January 2015

Consumers should be aware that the information provided by the Consumer Medicines Information (CMI) search (CMI Search) is for information purposes only and consumers should continue to obtain professional advice from a qualified healthcare professional regarding any condition for which they have searched for CMI. CMIs are provided by MIMS Australia. CMI is supplied by the relevant pharmaceutical company for each consumer medical product. All copyright and responsibility for CMI is that of the relevant pharmaceutical company. MIMS Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date for each resource (e. g. Published by MIMS/myDr January 2007), the CMI provided was complete to the best of MIMS Australia's knowledge. The CMI and the CMI Search are not intended to be used by consumers to diagnose, treat, cure or prevent any disease or for any therapeutic purpose. Cirrus Media Pty Limited, its servants and agents shall not be responsible for the continued currency of the CMI, or for any errors, omissions or inaccuracies in the CMI and/or the CMI Search whether arising from negligence or otherwise or from any other consequence arising there from.

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29 August 2002, Rossendorf

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Last updated: 10th of October, 2008

Maxivir Kaufen - Maxivir (Lamivudine Zidovudine) Ohne Rezept, Lasovir

Combivir wird verwendet, um HIV, das die erworbenen Immunschwache (AIDS) verursacht behandeln. Dieses Medikament ist kein Heilmittel fur HIV oder AIDS.

Nehmen Combivir genau wie von Ihrem Arzt verordnet. Nicht in gro?eren oder kleineren Mengen oder langer als empfohlen zu nehmen. Befolgen Sie die Anweisungen auf dem Etikett Verschreibung.

Combivir kann mit oder ohne Nahrung eingenommen werden.

HIV / AIDS ist in der Regel mit einer Kombination von Medikamenten behandelt. Verwenden Sie alle Medikamente, wie von Ihrem Arzt verordnet wurde. Lesen Sie die Anleitung Medikamente oder Patient Anweisungen mit jedem Medikament zur Verfugung gestellt. Andern Sie nicht Ihre Dosen oder Medikamente Zeitplan ohne den Rat Ihres Arztes. Jede Person, die mit HIV oder AIDS sollten in der Obhut eines Arztes bleiben.

Combivir kann niedriger Blutzellen, die Ihrem Korper der Bekampfung von Infektionen. Dies kann es fur Sie einfacher zu bluten aus einer Verletzung oder krank werden, mit anderen, die krank sind. Ihr Blut Moglicherweise mussen Sie oft getestet werden. Besuchen Sie regelma?ig Ihren Arzt.

Wenn Sie Hepatitis B haben, konnen Sie entwickeln Leber-Symptome nach der Einnahme Combivir stoppen, auch Monate nach Beendigung. Ihr Arzt kann wollen, um Ihre Leberfunktion fur mehrere Monate uberprufen, nachdem Sie mit Combivir stoppen. Besuchen Sie regelma?ig Ihren Arzt.

Wenn Sie eine Dosis verpasst haben - nehmen Sie die vergessene Dosis so bald wie Sie sich erinnern. Uberspringen Sie die verpasste Dosis, wenn es fast Zeit fur Ihre nachste Dosis. Nehmen Sie keine zusatzlichen Medikamente, um die vergessene Dosis.

Erwachsene und Jugendliche mit einem Korpergewicht ? 30 kg

Die empfohlene orale Dosis von Combivir in HIV-1-infizierten Erwachsenen und Jugendlichen mit einem Gewicht von mehr als oder gleich 30 kg betragt 1 Tablette (mit 150 mg Lamivudin und 300 mg Zidovudin) zweimal taglich.

Die empfohlene Dosierung des oralen Bruchrille COMBIVIR Tabletten fur padiatrische Patienten, die gro?er als oder gleich 30 kg und fur welche eine feste orale Dosierungsform ist angebracht wiegen ist 1 Tablette zweimal taglich verabreicht wird.

Vor der Verschreibung COMBIVIR Tabletten sollten Kinder die Fahigkeit, Tabletten zu schlucken beurteilt werden. Wenn ein Kind nicht zuverlassig schlucken COMBIVIR Tablette, sollte die Flussigkeit orale Formulierungen verordnet werden: EPIVIR ® (Lamivudin) Losung zum Einnehmen und

Patienten, die eine Dosisanpassung

Da Combivir ist eine Fixkombination Tablette, sollte es nicht fur padiatrische Patienten mit einem Gewicht von weniger als 30 kg oder Patienten, die eine Dosisanpassung, wie Personen mit eingeschrankter Nierenfunktion (Kreatinin-Clearance von weniger als 50 ml / min), Patienten mit Leber verordnet werden Beeintrachtigung oder Patienten, bei denen Dosis-limitierenden Nebenwirkungen. Flussigen und festen oralen Formulierungen der einzelnen Komponenten COMBIVIR sind fur diese Populationen vorhanden.

Bewahren Sie dieses Medikament bei Raumtemperatur in einem dicht geschlossenen Behalter, weg von Hitze und Licht.

Tamsulosin Oral Uses, Side Effects, Interactions, Pictures, Warnings - Dosing, Tamsulosine

tamsulosin

GENERIC NAME(S): TAMSULOSIN HCL

Uses

Tamsulosin is used by men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia - BPH ). It does not shrink the prostate. but it works by relaxing the muscles in the prostate and the bladder. This helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate often or urgently (including during the middle of the night).

Tamsulosin belongs to a class of drugs known as alpha blockers.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Tamsulosin may also be used to help your body "pass," or get rid of, kidney stones through urination. It has also been used to help treat bladder problems in women.

How to use tamsulosin

Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily, 30 minutes after the same meal each day. Swallow this medication whole. Do not crush, chew, or open the capsules.

The dosage is based on your medical condition and response to treatment.

Tamsulosin may cause a sudden drop in your blood pressure. which could lead to dizziness or fainting. This risk is higher when you first start taking this drug, after your doctor increases your dose, or if you restart treatment after you stop taking it. During these times, avoid situations where you may be injured if you faint.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

If you have not taken this drug for several days, contact your doctor to see if you need to be restarted at a lower dose.

It may take up to 4 weeks before your symptoms improve. Tell your doctor if your condition does not improve or if it worsens.

Side Effects

Dizziness, lightheadedness, drowsiness, runny/stuffy nose, or ejaculation problems may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

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: fainting.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

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 tamsulosin, 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: low blood pressure. certain eye problems (cataracts. glaucoma ).

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. Limit alcoholic beverages.

Before having surgery (including cataract/glaucoma eye surgery), tell your doctor or dentist if you are taking or have ever taken this medication, and about all the other 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 dizziness and low blood pressure when getting up from a sitting or lying position. These side effects can increase the risk of falling.

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

It is unknown if this medication 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.

Some products that may interact with this drug include: other alpha blocker drugs (such as prazosin. terazosin ).

If you are also taking a drug to treat erectile dysfunction - ED or pulmonary hypertension (such as sildenafil, tadalafil), your blood pressure may get too low which can lead to dizziness or fainting. Your doctor may need to adjust your medications to minimize this risk.

Other medications can affect the removal of tamsulosin from your body, which may affect how tamsulosin works. Examples include azole antifungals (such as itraconazole. ketoconazole ), boceprevir. clarithromycin. cobicistat, HIV protease inhibitors (such as lopinavir, ritonavir ), among others.

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: severe dizziness, fainting.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as prostate exams, blood pressure) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

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 October 2015. Copyright(c) 2015 First Databank, Inc.

Images

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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Buy Feminova Levonorgestrel Ethinyl Online Without Prescriptions, Feminova

Levlen is used for preventing pregnancy. Levlen is a combination birth control pill. It works by preventing ovulation, altering the cervical mucus, and changing the lining of the uterus.

Use Levlen as directed by your doctor.

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

Begin taking Levlen on the first Sunday following the start of your period, unless otherwise directed by your doctor. If your period begins on a Sunday, begin taking Levlen on that day. Try to take Levlen at the same time every day, not more than 24 hours apart. After taking the last pill in the pack, start taking the first pill from a new pack the very next day.

For Levlen to be effective it must be taken every day. Do not skip doses.

If you miss a dose of Levlen and remember it on the same day, take it as soon as possible and go back to your regular dosing schedule. If you do not remember until the next day or if you miss more than 1 dose of Levlen, contact your doctor for further instructions. You may need to use an extra form of birth control (eg, condoms). If you are not sure about how to handle missed doses of Levlen, use an extra form of birth control (eg, condoms) until you talk with your doctor.

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

Store Levlen 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 Levlen out of the reach of children and away from pets.

Active Ingredients: Levonorgestrel and Ethinyl Estradiol.

Do NOT use Levlen if:

you are allergic to any ingredient in Levlen

you are pregnant or think you may be pregnant

you have a history of blood clotting problems, severe blood clots (eg, in the lungs, legs, eyes), certain blood vessel problems (eg, bleeding in the brain, heart attack, stroke), or breast cancer

you are at risk for developing severe blood clots or have certain heart problems (eg, certain heart valve problems, certain types of irregular heartbeat)

you have chest pain caused by angina; certain types of headaches or migraines with aura; severe or uncontrolled high blood pressure; endometrial, cervical, or vaginal cancer; estrogen-dependent growths; or undiagnosed abnormal vaginal bleeding; or diabetes that affects circulation

you have liver disease, liver tumors or cancer, or a history of yellowing of the eyes or skin caused by pregnancy or prior birth control use

you have had surgery and are or will be confined to a bed or a chair for an extended period of time

you are older than 35 years old and you smoke 15 or more cigarettes per day.

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

Some medical conditions may interact with Levlen. 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 endometriosis, growths in the uterus, abnormal mammogram, irregular menstrual periods, a lump in the breast, heart problems, diabetes, headaches or migraines, gallbladder problems, high blood cholesterol or lipid levels, high blood pressure, kidney problems, blood problems (eg, porphyria), blood in the urine, depression or other mental/mood problems, lupus, chorea, high blood calcium levels, yellowing of the eyes or skin, pancreas problems (eg, pancreatitis), seizures (eg, epilepsy), or a history of cancer

if you are overweight, you have not yet had your first menstrual period, or you use tobacco

if you have given birth or otherwise ended a pregnancy within the past 4 weeks.

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

Atorvastatin, indinavir, or troleandomycin because they may increase the risk of Levlen's side effects

Aprepitant, azole antifungals (eg, itraconazole, ketoconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, dexamethasone, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nevirapine, oxcarbazepine, penicillins (eg, amoxicillin), phenylbutazone, primidone, rifabutin, rifampin, St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease Levlen's effectiveness, resulting in breakthrough bleeding or pregnancy

Beta-blockers (eg, propranolol), corticosteroids (eg, prednisolone), cyclosporine, or theophylline because the risk of their side effects may be increased by Levlen

Clofibric acid, lamotrigine, morphine, salicylic acid, or temazepam because their effectiveness may be decreased by Levlen.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Levlen 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:

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

Follow your doctor's instructions for examining your own breasts, and report any lumps immediately.

If you will be having surgery or will be confined to a bed or chair for a long period of time (such as a long plane flight), notify your doctor 3 to 4 weeks ahead of time. Special precautions may need to be taken in these circumstances while taking Levlen.

You should usually not take Levlen within 4 weeks after giving birth or otherwise ending a pregnancy. Discuss any questions or concerns with your doctor.

Levlen may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or wear protective clothing when exposed to the sun, sunlamps, or tanning booths.

Use of Levlen will not protect against HIV infection or prevent the spread of sexually transmitted diseases (STDs).

Bleeding or spotting may occur while taking Levlen. Do not stop taking Levlen if this occurs. If bleeding or spotting continues for more than 7 days or is heavy, contact your doctor.

Smoking while using Levlen may increase your risk of stroke, heart attack, blood clots, high blood pressure, or other diseases of the heart and blood vessels.

Levlen may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Levlen.

Taking certain antibiotics, anticonvulsants, or other medicines, as listed in the interactions section, while you are using Levlen may decrease the effectiveness of Levlen. To prevent pregnancy, use an extra form of birth control (eg, condoms) until your next period.

If you wear contact lenses and you develop problems with them, contact your doctor.

If you miss your period during the week of inactive pills, call your doctor immediately. A missed period may indicate that you are pregnant.

Levlen may take time to wear off after your last dose. You may not be able to become pregnant for several months after stopping Levlen. Discuss any concerns with your doctor or pharmacist.

Lab tests, such as PAP tests, may be performed while you use Levlen. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Levlen should not be used in children who have not had their first menstrual period; safety and effectiveness in these children have not been confirmed.

Pregnancy and breast-feeding: Do not use Levlen if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Levlen is found in breast milk. Do not breastfeed while taking Levlen.

Types Of Seizures, Epilep

Types of Seizures

Seizures take many forms. Before your doctor can prescribe the right treatment, he or she must figure out which type (or types) of seizures you have. That's the purpose of all the tests discussed in the Diagnosis section—not just to tell whether you have epilepsy, but also to tell what kind of epilepsy you have.

Commonly Used Names for Seizure Types

Seizures are generally described in two major groups of seizures, primary generalized seizures and partial seizures. The difference between these types is in how and where they begin. A new way of naming seizures has been developed by epilepsy specialists, but most often these common names are still used.

Primary generalized seizures

Primary generalized seizures begin with a widespread electrical discharge that involves both sides of the brain at once. Hereditary factors are important in many of these seizures.

Partial seizures

Partial seizures begin with an electrical discharge in one limited area of the brain. Many different things can cause partial seizures. These include head injury, brain infection, stroke, tumor, or changes in the way an area of the brain was formed before birth (called cortical dysplasias). Many times, no known cause is found, but genetic factors may be important in some partial seizures.

Partial seizures can be broken down further, depending on whether a person's awareness or consciousness (the ability to respond and remember) is affected.

Nuvista Pharma, Traxyl

Nuvista Pharma Limited has been operating in Bangladesh since 1964 as Organon (Bangladesh) which was a subsidiary of Organon International, the human healthcare.

Launching of Microlon and Setfree Nuvista Pharma Limited (NPL) is pioneer in Oral Contraceptive market of Bangladesh for the last 40 years having the leading Brands like Ovostat Gold and Marvelon . As a continuation Ofmit Launching

Nuvista Pharma Limited has strengthened its position in Pharma Market with various therapeutic classes. Now we have reached a landmark and introduce for the first time a number of promising mole Annual Sales Conference-2015

Annual Sales Conference-2015 of Nuvista Pharma Limited was held on January 2016 at Cox’s Bazar. Managing Director, Directors, Departmental heads of other departments, everyone from Launching of Sagdon

Sagdon (Domperidone 10 mg) was launched at Annual Sales Conference-2015. D PECL Cricket Tournament-2015

Nuvista Pharma Ltd. Participated in the 6-A-Side Cricket Tournament 2015. It became Runner Up for the year of 2015 in the final match held at Armed Police Battalion Head Quarters Field, World Cancer Day-2015

An awareness program on World Cancer Day 2015 was observed. (by Zol Awareness campaign - ‘HELP STOP EVE TEASING’

An awareness campaign on ‘HELP STOP EVE TEASING’ was run by Nuvista Pharma Limited jointly with Dhaka Metropolitan Police (DMP) from our brand Visceralgine.

Marketing & Sales team were seen at 20th National Conference of Inauguration of sculpture - "Reflection"

This is our great pleasure that Nuvista Pharma Limited has launched Pulmont TM 10 on 25 December 2014. Pulmont TM 10 Launching of Corabon D

This is our great pleasure that Nuvista Pharma Limited has launched Corabon-D TM on 09 November 2014. Corabon-D TM is indicated for the treatment of Osteop Launching of GERDO

This is our great pleasure that Nuvista Pharma Limited has launched its 2 nd Proton Pump Inhibitor – GERDO ( Esomeprazole 20 mg) on 1 June 2014. GERDO is indicated for the Launching of Quinobid

Nuvista Pharma has entered into a new segment of antibiotic market & that is ‘Quinolone’. Quinolones are broad spectrum of antibiotic with bactericidal action. By launching a second generat Launching of Axibid

This is our great pleasure that Nuvista Pharma Limited has launched its 3rd antibiotic – Axibid (Cefuroxime Axetil 500 mg & 250 mg) a 2 nd generation Cephalosporin antibiotic on Annual Marketing & Sales Conference - 2014

Annual Marketing & Sales Conference 2014 was held at RAOWA Conference Center. All the Management staff of Marketing and Sales departments and the Departmental Heads of other departmen 50 Years Celebration of Nuvista Pharma Limited at Factory.

Celebration of 50 years of Nuvista Pharma Limited was held at it's Factory on 12 January 2014.

Nuvista Pharma Ltd. Participated in the 6-A - Side Cricket Tournament 2014. It became Runner Up for the year of 2014 in the final match held at Udayachal Cricket Club Ground, Lalmatia, Mohammadp Launching of Torimon Nuvista Pharma Limited launched a new Product named Torimon TM . Etoricoxib INN Tablet, in July 2013. TORIMON is a Gastro Intestinal safe treatment option with onc Cricket tournaments and friendly matches played by Nuvista Pharma in 2013

Nuvista Pharma Limited (NPL) became Runner-up in the 6-A Side Cricket Tournament-2013 organized by Pharmaceutical Executive Club Limited. NPL achieved the Runner-up Trophy under the leader 10th Congress of the SAARC-AA

10th Congress of the SAARC-AA was held in Dhaka (BICC & Sonargaon) on 22-24 February, 2013. Nuvista Pharma Limited was one of the sponsors of the program. Sales Manager Mr. Atiqur Rahm Annual Management Meeting 2013

Annual Management Meeting 2013 was held on 21-22 February 2013 in Jamuna Resort Limited, Tangail. All Management Employees of Nuvista Pharma Limited were present there

18th National Conference of Society of Nuclear Medicine, Bangladesh (SNMB)

18th National Conference of SNMB was held on January 25, 2013 at Pan Pacific Sonargaon Hotel, Dhaka. Sr. Product Group Managers, Product Group Managers and Product Executives, Annual Marketing and Sales Meeting 2013

Annual Marketing and Sales conference was held on 6-7 January 2013 at Cox’s Bazar. Everyone from Marketing and Sales department and also departmental heads of other departments were present i Launching Ceremony of Sanfix

NPL launched new product named Sanfix TM (Cefixime USP 200 mg capsule) on 18th July, 2012 at BICC (Bangabondhu Interanational Conference Center) Dhaka.

Launching of Freemax

NPL launched a new product named FREEMAX (Aceclofenac BP 100mg) on 31 st May, 2012 at monthly FMs & RSMs meeting in Red Fort Restaurant, Mascot Plaza, Dh

Diovan Uses, Dosage - Side Effects, Co-Diovane

Diovan

Diovan (valsartan) is an angiotensin II receptor antagonist. Valsartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Diovan is used to treat high blood pressure (hypertension) in adults and children who are at least 6 years old. It is also used in adults to treat heart failure, and to lower the risk of death after a heart attack.

Diovan is sometimes given together with other blood pressure medications.

Important information

Do not use Diovan if you are pregnant. Stop using and tell your doctor right away if you become pregnant. Valsartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

If you have diabetes, do not use Diovan together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).

In rare cases, Diovan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Before taking this medicine

You should not use Diovan if you are allergic to valsartan.

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

kidney disease (or if you are on dialysis);

a heart condition, other than one being treated with valsartan;

if you are on a low-salt-diet;

if you are dehydrated; or

if you have ever had a severe allergic reaction to any blood pressure medication.

Do not use Diovan if you are pregnant. Stop using and tell your doctor right away if you become pregnant. Valsartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control.

It is not known whether valsartan passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Diovan should not be given to a child younger than 6 years old.

How should I take Diovan?

Take Diovan exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Diovan with or without food. Take the medicine at the same time each day.

If a child taking Diovan cannot swallow a capsule whole, your pharmacist can mix the medicine into a liquid. Shake this liquid well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

You may have very low blood pressure while taking valsartan. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual.

Your blood pressure will need to be checked often. Your kidney function may also need to be checked.

It may take 2 to 4 weeks of using this medicine before your blood pressure is under control. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Talk with your doctor if your symptoms do not improve after 4 weeks of treatment.

Store at room temperature away from moisture and heat.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Diovan dosing information

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 40 mg orally twice a day. Maintenance dose: 80 to 160 mg twice daily. The dose should be increased to the highest dose tolerated by the patient.

Usual Adult Dose for Hypertension:

Initial dose: 80 to 160 mg orally once a day. Maintenance dose: 80 to 320 mg orally once a day.

Usual Adult Dose for Left Ventricular Dysfunction:

Initial dose: 20 mg orally twice a day. Maintenance dose: The initial dosage may be titrated upward within 7 days to 40 mg twice daily, with subsequent titrations to a target maintenance dose of 160 mg twice daily as tolerated by the patient. If symptomatic hypotension or renal dysfunction occurs, consideration should be given to a dosage reduction.

Diovan may be initiated as early as 12 hours after a myocardial infarction, and may be given with other standard postmyocardial infarction treatment, including thrombolytics, aspirin, beta blockers, and statins.

Usual Pediatric Dose for Hypertension:

6 to 16 years: Initial dose: 1.3 mg/kg once daily (up to 40 mg) Maintenance dose: up to 2.7 mg/kg (up to 160 mg) once daily titrated according to patient response

If the calculated dosage does not correspond to the available tablet strengths, or if children are unable to swallow tablets, the use of a suspension (which can be prepared from the tablets) is recommended. The Diovan dose may need to be increased if the suspension is replaced by a tablet.

No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate less than 30 mL/min.

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.

What should I avoid while taking Diovan?

Drinking alcohol can further lower your blood pressure and may increase certain side effects of Diovan.

Do not use potassium supplements or salt substitutes while you are taking Diovan, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Diovan side effects

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

In rare cases, Diovan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Also call your doctor at once if you have:

shortness of breath (even with mild exertion);

little or no urinating, swelling, rapid weight gain;

weakness, confusion, increased thirst, loss of appetite, vomiting;

pounding heartbeats or fluttering in your chest;

a light-headed feeling, like you might pass out; or

high potassium--slow heart rate, weak pulse, muscle weakness, tingly feeling.

Common Diovan side effects may include:

headache, dizziness, tired feeling;

stomach pain, diarrhea;

back pain, joint pain; or

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 Diovan?

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

a diuretic (water pill);

NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

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

More about Diovan (valsartan)

Consumer resources

Professional resources

Other formulations

Related treatment guides

Where can I get more information?

Your pharmacist can provide more information about Diovan.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Diovan 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: 2015-08-31, 4:23:04 PM.

Soccer News, Video Highlights, Fixtures And More, Sosser

Do we hear another Dos a cero?

The Americans know MAPFRE Stadium is a house of horrors for the Mexican side, so it makes complete sense to schedule a crucial home match there.

Read more

Donovan back on scoresheet

The all-time leading scorer in the MLS extends his mark as Landon Donovan netted a goal for the LA Galaxy against Sporting Kansas City.

Read more

Rapinoe stays consistent

The women's soccer star continues her protests while representing the national team.

Trending In soccer

Buy Allergies - Lorahexal (Brand Name Alavert) Online - Order Cheap Loratadine - Purchase Allergies

Loratadine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose. Alavert is used for relieving symptoms of seasonal allergies.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Do not crush, chew, or break the regular loratadine tablet. Swallow the pill whole. Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon.

Alavert is usually taken once per day. Follow your doctor's instructions.

To take Alavert orally disintegrating tablet:

Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.

Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

Using dry hands, remove the tablet and place it on your tongue. It will begin to dissolve right away.

Take Alavert by mouth with food.

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

You should not take Alavert if:

You are allergic to loratadine or to desloratadine (Clarinex). Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

kidney disease; Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

You should not take this medication if you are allergic to loratadine or to desloratadine (Clarinex).

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. Loratadine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Loratadine disintegrating tablets (Claritin Reditab, Alavert) may contain phenylalanine. Talk to your doctor before using this form of loratadine if you have phenylketonuria (PKU). Do not give this medication to a child younger than 6 years old without the advice of a doctor.

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:

fast or uneven heart rate;

feeling like you might pass out;

jaundice (yellowing of your skin or eyes);

seizures (convulsions).

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

Less serious side effects may include:

headache;

skin rash;

nervousness;

nosebleed;

feeling tired or drowsy;

eye redness, blurred vision;

stomach pain, diarrhea;

dry mouth, sore throat hoarseness.

Sinterol Ve - Detergents - Chemistry For The Textile Industry, Sinterol

Sinterol VE

SHELF LIFE: 1 year in closed premises, at normal weather conditions. At temperatures below 4 о С the product partially freezes. To be homogenized before application.

- Very good degreasing and dispersing activity; - Resistant to hard water, oxidizers and reducers; - Compatible with nonionic, anionic and cationic products; - The washed raw wool is soft and white.

WASHING OF RAW WOOL: Consumption of SINTEROL VE and sodium carbonate depends on the raw wool oiliness. With wool oiliness below 15%: 9-12 kg of SINTEROL VE and 25-30 kg of sodium carbonate is used per 1 ton of wool. With wool oiliness above 15%: 12-15 kg of SINTEROL VE and 35-40 kg sodium carbonate is used per 1 ton of wool.

WASHING OF WORSTED SLIVERS: 0,4-0,5 g/l. WASHING OF FABRICS FROM WOOL AND BLENDS: 0,5-1% of material’s total weight.

Blvd. Asen Yordanov 14 Sofia 1592, BULGARIA +359 /02/ 9651 313 +359 /02/ 9651 303 marketing@chimatech. bg

Phenhydan - Anticonvulsants, Atc N03ab02, Atc N03ab04, Atc N03ab05, Phenhydan

Phenhydan

Capsule (extended release); Liquid; Solution; Suspension; Tablet

Phenhydan Indication

For the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.

Phenhydan Pharmacology

Phenytoin is an antiepileptic drug which can be useful in the treatment of epilepsy. The primary site of action appears to be the motor cortex where spread of seizure activity is inhibited. Phenytoin reduces the maximal activity of brain stem centers responsible for the tonic phase of tonic-clonic (grand mal) seizures. Phenytoin acts to damp the unwanted, runaway brain activity seen in seizure by reducing electrical conductance among brain cells. It lacks the sedation effects associated with phenobarbital. There are some indications that phenytoin has other effects, including anxiety control and mood stabilization, although it has never been approved for those purposes by the FDA.

Phenhydan Absorption

Bioavailability 70-100% oral, 24.4% for rectal and intravenous administration. Rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours.

Phenhydan side effects and Toxicity

Oral, mouse: LD 50 = 150 mg/kg; Oral, rat: LD 50 = 1635 mg/kg. Symptoms of overdose include coma, difficulty in pronouncing words correctly, involuntary eye movement, lack of muscle coordination, low blood pressure, nausea, sluggishness, slurred speech, tremors, and vomiting.

Phenhydan Patient Information

Patients taking phenytoin should be advised of the importance of adhering strictly to the prescribed dosage regimen, and of informing the physician of any clinical condition in which it is not possible to take the drug orally as prescribed, eg, surgery, etc.

Patients should also be cautioned on the use of other drugs or alcoholic beverages without first seeking the physician's advice.

Patients should be instructed to call their physician if skin rash develops.

The importance of good dental hygiene should be stressed in order to minimize the development of gingival hyperplasia and its complications.

Do not use capsules which are discolored.

Phenhydan Organisms Affected

Humans and other mammals

Vast - Definition Of Vast By The Free Dictionary, Vastat

My lord, you scornfully bade me claim your daughter when I could boast as high a name and vast a fortune as the Count antonio.

The garden that had been so mysterious and vast. a place that with Seth beside her might have become the background for strange and wonderful adven - tures, now seemed no more than an ordinary Wines - burg back yard, quite definite and limited in its outlines.

She turned her face seaward to gather in an impression of space and solitude, which the vast expanse of water, meeting and melting with the moonlit sky, conveyed to her excited fancy.

At length the sun set in a flood of glory, behind the distant western hills, and as darkness drew its veil around the secluded spot the sounds of preparation diminished; the last light finally disappeared from the log cabin of some officer; the trees cast their deeper shadows over the mounds and the rippling stream, and a silence soon pervaded the camp, as deep as that which reigned in the vast forest by which it was environed.

We found every where abundance of wild beasts of all sorts, through this vast forest.

The disposition of these vast sums by gentlemen wearing patched breeches awakened no sense of the ludicrous, nor did any doubt, reservation, or contingency enter into the plans of the charming enthusiasts themselves.

The carcass of a deer, shot within twenty miles, had supplied material for the vast circumference of a pasty.

He was a person of very striking aspect, with a white, lofty, and impending brow; large, brown, melancholy eyes, and a mouth which, unless when he forcibly compressed it, was apt to be tremulous, expressing both nervous sensibility and a vast power of self restraint.

Steering north-eastward from the Crozetts, we fell in with vast meadows of brit, the minute, yellow substance, upon which the Right Whale largely feeds.

I should say that those New England rocks on the sea-coast, which Agassiz imagines to bear the marks of violent scraping contact with vast floating icebergs --I should say, that those rocks must not a little resemble the Sperm Whale in this particular.

So, the very next day I exposed my hidden schools, my mines, and my vast system of clandestine factories and workshops to an astonished world.

These two nations are very numerous, fierce, and unconquerable, inhabiting a country full of mountains, which are covered with woods, and hollowed by nature into vast caverns, many of which are capable of containing several numerous families, and hundreds of cows.

Tenormin - Heart Disease, Azectol

Common use Tenormin is a beta-adrenergic blocking agent. Its role is to block the effects of adrenergic drugs, such as adrenaline or epinephrine, on nerves of the sympathetic nervous system. Tenormin reduces the heart rate and is used for treatment of abnormally rapid heart rhythms, arterial hypertension, angina, acute myocardial infraction, tachycardia (different types), ventricular fibrillation and others.

Dosage and direction Take Tenormin before meals or at bedtime. Your dose depends on your condition and should be administered by your doctor. Take the medication exactly as prescribed. Do not change the dose and do not stop suddenly treatment even if you feel better as hypertension often has no symptoms. Avoid drinking alcohol. Let your surgeon know if you are taking Tenormin if you plan to be operated.

Precautions Do not take Tenormin if it was not Tenormin should be taken with a glass of water once a day at the same time. Do not stop taking the medication suddenly as it may worsen your condition. Continue taking the medication even if you feel fine as hypertension and diseases of a heart maybe a life long illness. Inform your surgeon if you take Tenormin, if you need to be operated.

Hypersensitivity, sick sinus syndrome, sinus bradycardia (rate slower than 50 per minute), atrioventricular block (degree II and III), arterial hypotension, acute or chronic heart failure, peripheral blood flow disorders, breastfeeding. Cautiousness should be exercised in patients with diabetes, hypopotassemia, pulmonary emphysema, asthma, liver and kidney diseases pregnancy and with other conditions.

Possible side effect Side effects are rare and transient if occur. They may include weakness, fatigue, dizziness, headache, depression, dreaming, insomnia, memory loss, abdominal cramps, diarrhea, constipation, nausea, fever, impotence, lightheadedness, slow heart rate, low blood pressure, numbness, tingling, cold extremities, and sore throat and also allergy.

Drug interaction Tenormin can aggravate conditions of patients with asthma, chronic bronchitis, or emphysema. In patients with slow heart rates and heart blocks, Tenormin can slow up heart rates considerably. Tenormin reduces the force of heart muscle contraction and worsens conditions of patients with heart failure. Non-steroidal anti-inflammatory drugs, estrogens, sympathomimetics, xanthines weaken hypotensive effect of Tenormin.

Missed dose Never take a double dose of this medication. If it is almost time of the next dose just skip the missed portion and continue taking the medicine according to the schedule.

Overdose Symptoms of an overdose are uneven heartbeats, shortness of breath, dizziness, weakness, fainting, bluish-colored fingernails, convulsions. If you experience this, call your doctor immediately.

Storage Tablets should be stored at room temperature between 25-25 C (68-70 F) 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 at 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.

Common use Tenormin is a beta-adrenergic blocking agent. Its role is to block the effects of adrenergic drugs, such as adrenaline or epinephrine, on nerves of the sympathetic nervous system. Tenormin reduces the heart rate and is used for treatment of abnormally rapid heart rhythms, arterial hypertension, angina, acute myocardial infraction, tachycardia (different types), ventricular fibrillation and others.

Dosage and direction Take Tenormin before meals or at bedtime. Your dose depends on your condition and should be administered by your doctor. Take the medication exactly as prescribed. Do not change the dose and do not stop suddenly treatment even if you feel better as hypertension often has no symptoms. Avoid drinking alcohol. Let your surgeon know if you are taking Tenormin if you plan to be operated.

Precautions Do not take Tenormin if it was not Tenormin should be taken with a glass of water once a day at the same time. Do not stop taking the medication suddenly as it may worsen your condition. Continue taking the medication even if you feel fine as hypertension and diseases of a heart maybe a life long illness. Inform your surgeon if you take Tenormin, if you need to be operated.

Hypersensitivity, sick sinus syndrome, sinus bradycardia (rate slower than 50 per minute), atrioventricular block (degree II and III), arterial hypotension, acute or chronic heart failure, peripheral blood flow disorders, breastfeeding. Cautiousness should be exercised in patients with diabetes, hypopotassemia, pulmonary emphysema, asthma, liver and kidney diseases pregnancy and with other conditions.

Possible side effect Side effects are rare and transient if occur. They may include weakness, fatigue, dizziness, headache, depression, dreaming, insomnia, memory loss, abdominal cramps, diarrhea, constipation, nausea, fever, impotence, lightheadedness, slow heart rate, low blood pressure, numbness, tingling, cold extremities, and sore throat and also allergy.

Drug interaction Tenormin can aggravate conditions of patients with asthma, chronic bronchitis, or emphysema. In patients with slow heart rates and heart blocks, Tenormin can slow up heart rates considerably. Tenormin reduces the force of heart muscle contraction and worsens conditions of patients with heart failure. Non-steroidal anti-inflammatory drugs, estrogens, sympathomimetics, xanthines weaken hypotensive effect of Tenormin.

Missed dose Never take a double dose of this medication. If it is almost time of the next dose just skip the missed portion and continue taking the medicine according to the schedule.

Overdose Symptoms of an overdose are uneven heartbeats, shortness of breath, dizziness, weakness, fainting, bluish-colored fingernails, convulsions. If you experience this, call your doctor immediately.

Storage Tablets should be stored at room temperature between 25-25 C (68-70 F) 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 at 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.

Trecator Oral Uses, Side Effects, Interactions, Pictures, Warnings - Dosing, Trecator

Trecator

Uses

Ethionamide is used with other medications to treat tuberculosis (TB). Ethionamide is an antibiotic and works by stopping the growth of bacteria.

This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold. flu ). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used with other medications to help treat a certain serious infection (Mycobacterium avium complex-MAC).

How to use Trecator

Take this medication by mouth with or without food, usually once daily or as directed by your doctor. If this medication causes stomach upset or nausea /vomiting. take this medication with meals. Also, discuss with your doctor if it may be helpful to divide your daily dose into smaller doses to be taken several times a day. Follow your doctor's instructions carefully.

The dosage is based on your age, weight. medical condition, and response to treatment.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time(s) each day.

Continue to take this medication (and other TB medications) until the full prescribed amount is finished, even if symptoms disappear. Stopping the medication too early or skipping doses may allow the bacteria to continue to grow, which may result in a return of the infection and cause the infection to be more difficult to treat (resistant).

Your doctor may also direct you to take vitamin B6 (pyridoxine) to help prevent certain side effects (such as nerve problems) from ethionamide. Follow your doctor's instructions carefully.

Tell your doctor if your condition persists or worsens.

Side Effects

Nausea, vomiting, diarrhea. abdominal/stomach pain. increased saliva. strange metallic taste in the mouth. loss of appetite, or sores in the mouth 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 may develop serious side effects, but with frequent visits to your doctor, this risk can be minimized.

Tell your doctor right away if any of these unlikely but serious side effects occur: unusual hunger. unusual sweating. shakiness, persistent nausea/vomiting, unusual tiredness/weakness. yellowing eyes /skin. dark urine, joint pain /swelling, slow heartbeat, mental/mood changes (such as nervousness, restlessness, depression ).

Tell your doctor right away if any of these rare but serious side effects occur: vision changes (such as blurred/decreased/double vision. color blindness ), eye pain. numbness/tingling of arms/legs.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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 ethionamide, 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.

Alcohol may increase the risk of liver disease or mental/mood changes. Avoid alcoholic beverages while using this medication.

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

If you have diabetes, this product may make it harder to control your blood sugar levels (cause low blood sugar). Check your blood sugar levels regularly as directed by your doctor. Tell your doctor right away if you have symptoms of low blood sugar, such as shakiness, unusual hunger, or unusual sweating. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

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.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as sputum test, eye/vision exams, liver/thyroid function, blood glucose, complete blood count) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to take each scheduled dose of this medication as directed. 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 between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.

Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.

Images

Piroxicam Indications, Side Effects, Warnings, Roxifen

Piroxicam

Generic Name: piroxicam (pir-OX-i-kam) Brand Name: Feldene

Piroxicam is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take piroxicam for a long time. Do not use piroxicam right before or after bypass heart surgery.

Piroxicam may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.

Piroxicam is used for:

Treating rheumatoid arthritis or osteoarthritis. It may also be used for other conditions as determined by your doctor.

Piroxicam is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.

Do NOT use piroxicam if:

you are allergic to any ingredient in piroxicam

you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (eg, ibuprofen, celecoxib)

you have recently had or will be having bypass heart surgery

you are in the last 3 months of pregnancy

you have active stomach or bowel bleeding

you are having problems becoming pregnant or you are having your fertility checked

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

Before using piroxicam:

Some medical conditions may interact with piroxicam. 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 a history of kidney or liver problems, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers)

if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation

if you have high blood pressure, blood disorders (eg, porphyria), bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases

if you have poor health, dehydration or low fluid volume, or low blood sodium levels, or if you smoke, you drink alcohol, or you have a history of alcohol abuse

Some MEDICINES MAY INTERACT with piroxicam. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin), aspirin, clopidogrel, corticosteroids (eg, prednisone), heparin, rivaroxaban, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased

Probenecid because it may increase the risk of piroxicam's side effects

Cholestyramine because it may decrease piroxicam's effectiveness

Bisphosphonates (eg, alendronate, risedronate), cyclosporine, hydantoins (eg, phenytoin), lithium, methotrexate, quinolones (eg, ciprofloxacin), sulfonamides (eg, sulfamethoxazole), or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by piroxicam

Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by piroxicam

This may not be a complete list of all interactions that may occur. Ask your health care provider if piroxicam 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 piroxicam:

Use piroxicam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Piroxicam comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get piroxicam refilled.

Take piroxicam by mouth. It may be taken with food if it upsets your stomach. This may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor if you have persistent stomach upset.

Take piroxicam with a full glass (8 oz [240 mL]) of water as directed by your doctor.

If you miss a dose of piroxicam 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. 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 piroxicam.

Important safety information:

Tell your doctor or dentist that you take piroxicam before you receive any medical or dental care, emergency care, or surgery.

Serious stomach ulcers or bleeding can occur with the use of piroxicam. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking piroxicam 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.

Piroxicam may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

Piroxicam is an NSAID. Before you start taking any new medicine, read the ingredients. If it also has an NSAID (eg, ibuprofen) in it, check with your doctor. If you are not sure, check with your doctor or pharmacist.

Do not take aspirin while you are using piroxicam unless your doctor tells you to.

A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have symptoms like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Severe and sometimes fatal liver problems have happened with this drug. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

Have an eye exam as you have been told by your doctor.

Piroxicam may lead to high blood pressure. Have your blood pressure checked as you have been told by your doctor.

Lab tests may be performed while you use piroxicam. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use piroxicam with caution in the ELDERLY; they may be more sensitive to its effects, including stomach bleeding and kidney problems.

NSAIDs like piroxicam may affect egg release (ovulation) in women. This may cause you to not be able to get pregnant. This goes back to normal when this drug is stopped. Discuss any questions or concerns with your doctor.

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

PREGNANCY and BREAST-FEEDING: Piroxicam may harm the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using piroxicam while you are pregnant. Piroxicam is found in breast milk. If you are or will be breast-feeding while you use piroxicam, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of piroxicam:

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:

Constipation; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach pain or upset; vomiting.

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

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; ringing in the ears; seizures; severe or persistent headache or dizziness; severe or persistent stomach pain, nausea, or vomiting; shortness of breath; sudden or unexplained weight gain; swelling of the hands, legs, or feet; symptoms of bleeding (eg, vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; unusual vaginal bleeding; bruises without a reason or that get bigger; any bleeding that is severe or that you cannot stop); symptoms of kidney problems (eg, blood in the urine, change in the amount of urine produced); unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes.

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 ( http://www. aapcc. org ), or emergency room immediately.

Proper storage of piroxicam:

Store piroxicam at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep piroxicam out of the reach of children and away from pets.

General information:

If you have any questions about piroxicam, please talk with your doctor, pharmacist, or other health care provider.

Piroxicam 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 piroxicam 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 piroxicam. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to piroxicam. 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 piroxicam.

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.

More about piroxicam

Enalapril And Hydrochlorothiazide Medlineplus Drug Information, Enaril

Enalapril and Hydrochlorothiazide

Enalapril and hydrochlorothiazide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

cough

dizziness

headache

excessive tiredness

muscle cramps

decrease in sexual ability

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

lightheadedness

swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs

hoarseness

difficulty breathing or swallowing

fever, sore throat, chills, and other signs of infection

yellowing of the skin or eyes

dry mouth

thirst

weakness

infrequent urination

upset stomach

vomiting

fainting

chest pain

fast or irregular heartbeat

Enalapril and hydrochlorothiazide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www. fda. gov/Safety/MedWatch ) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo. gl/c4Rm4p ) for more information if you do not have access to a take-back program.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly to determine your response to enalapril and hydrochlorothiazide. Your doctor may order certain lab tests to check your body's response to enalapril and hydrochlorothiazide.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names of combination products

Vaseretic ® (containing Enalapril, Hydrochlorothiazide)

Last Revised - 09/15/2015

American Society of Health-System Pharmacists, Inc. Disclaimer

AHFS ® Patient Medication Information. © Copyright, 2016. The American Society of Health-System Pharmacists, Inc. 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Linezolid Indications, Side Effects, Warnings, Lizolid

Linezolid

Treating certain bacterial infections.

Linezolid is an oxazolidinone antibiotic. It works by interfering with the production of proteins needed by bacteria to grow.

Do NOT use linezolid if:

you are allergic to any ingredient in linezolid

you are taking an amphetamine (eg, dextroamphetamine), an anorexiant (eg, phentermine), a catechol-O-methyltransferase (COMT) inhibitor (eg, entacapone), cyclobenzaprine, dexmethylphenidate, fentanyl, levodopa, meperidine, sibutramine, a sympathomimetic (eg, pseudoephedrine), tetrabenazine, or a triptan (eg, sumatriptan)

you are taking or have taken apraclonidine, bupropion, buspirone, dextromethorphan, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine, selegiline), nefazodone, a norepinephrine reuptake inhibitor (eg, atomoxetine), a serotonin-norepinephrine reuptake inhibitor (SNRI) (eg, duloxetine, venlafaxine), a selective serotonin reuptake inhibitor (SSRI) (eg, paroxetine), a tetracyclic antidepressant (eg, maprotiline, mirtazapine), trazodone, a tricyclic antidepressant (eg, amitriptyline, doxepin), or vilazodone within the past 14 days

you are taking or have taken fluoxetine within the past 5 weeks

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

Before using linezolid:

Some medical conditions may interact with linezolid. 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 a history of diabetes, high blood pressure, kidney problems, eye or vision problems, bone marrow problems (eg, low blood platelet levels), an adrenal gland tumor (pheochromocytoma), carcinoid syndrome, liver problems, seizures, or an overactive thyroid

if you have a prolonged infection that is currently or has been previously treated with another antibiotic medicine

if you are taking any medicine for depression

Some MEDICINES MAY INTERACT with linezolid. Tell your health care provider if you are taking any other medicines, especially any of the following:

Amphetamines (eg, dextroamphetamine), anorexiants (eg, phentermine), apraclonidine, beta-2 agonists (eg, albuterol), bupropion, buspirone, COMT inhibitors (eg, entacapone), cyclobenzaprine, dexmethylphenidate, dextromethorphan, fentanyl, ginseng, levodopa, MAOIs (eg, phenelzine, selegiline), meperidine, methylphenidate, nefazodone, norepinephrine reuptake inhibitors (eg, atomoxetine), propoxyphene, sibutramine, SNRIs (eg, duloxetine, venlafaxine), SSRIs (eg, fluoxetine, paroxetine), sympathomimetics (eg, pseudoephedrine), tetrabenazine, tetracyclic antidepressants (eg, maprotiline, mirtazapine), trazodone, tricyclic antidepressants (eg, amitriptyline, doxepin), triptans (eg, sumatriptan), tryptophan, or vilazodone because severe side effects, including severe headache, fever, high blood pressure, or mental or mood changes, may occur

Insulin or other diabetes medicines (eg, glyburide) because the risk of low blood sugar may be increased

Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), or rifamycins (eg, rifampin) because they may decrease linezolid's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if linezolid 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 linezolid:

Use linezolid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Linezolid is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using linezolid at home, a health care provider will teach you how to use it. Be sure you understand how to use linezolid. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

To clear up your infection completely, take linezolid for the full course of treatment. Keep taking it even if you feel better in a few days.

Do not use linezolid if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

If you miss a dose of linezolid, 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 linezolid.

Important safety information:

Linezolid may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use linezolid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Tell your doctor or dentist that you take linezolid before you receive any medical or dental care, emergency care, or surgery.

Be sure to use linezolid 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 linezolid 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 bloody stools occur. Do not treat diarrhea without first checking with your doctor.

Eating foods high in tyramine (eg, aged cheeses, red wines, beer, certain meats and sausages, liver, sour cream, soy sauce, raisins, bananas, avocados) while you use an MAOI may cause severe high blood pressure. This could occur for up to 2 weeks after you stop taking an MAOI. Do not eat foods high in tyramine while you take linezolid. Ask your health care provider for a complete list of foods you should avoid. Seek medical attention at once if symptoms of severe high blood pressure occur. These may include severe headache, fast or irregular heartbeat, sore or stiff neck, nausea, vomiting, sweating, enlarged pupils, or sensitivity to light.

Linezolid may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

Linezolid only works against bacteria; it does not treat viral infections (eg, the common cold).

Lactic acidosis has occurred with the use of linezolid. Contact your doctor if you have severe or persistent nausea, vomiting, stomach pain, or unusual tiredness or weakness.

Serious eye problems (eg, peripheral and optic neuropathy) have occurred with the use of linezolid. Contact your doctor if you experience vision changes (eg, decreased or blurred vision, changes in color vision, loss of vision).

Diabetes patients - Low blood sugar has been reported in patients taking linezolid along with insulin or other diabetes medicines. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or nondiet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.

Lab tests, including complete blood cell counts and eye exams, may be performed while you use linezolid. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using linezolid 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 linezolid, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of linezolid:

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:

Bad taste in mouth; constipation; diarrhea; dizziness; headache; nausea; trouble sleeping; 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); agitation; bloody stools; bloody vomit; chills, sore throat, or fever; confusion; exaggerated reflexes; excitation; fast heartbeat; loss of coordination; mental or mood changes; muscle spasms; prolonged or repeated nausea or vomiting; red, swollen, peeling, or blistered skin; seizures; severe or continuing diarrhea; severe or persistent headache or dizziness; stomach pain/cramps; sweating; swelling of the hands or feet; tingling or numbness of the hands or feet; unusual bleeding or bruising; unusual tiredness or weakness; vaginal irritation or unusual discharge; vision changes (including decreased or blurred vision, changes in color vision, loss of vision); white patches in the mouth.

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.

Proper storage of linezolid:

Linezolid is usually handled and stored by a health care provider. If you are using linezolid at home, store linezolid as directed by your pharmacist or health care provider. Store away from heat, moisture, and light. Do not store in the bathroom. Keep linezolid out of the reach of children and away from pets.

General information:

If you have any questions about linezolid, please talk with your doctor, pharmacist, or other health care provider.

Linezolid 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 linezolid 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 linezolid. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to linezolid. 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 linezolid.

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.

More about linezolid

Brufanic Generic Name Ibuprofen Online, Brufanic

Brufanic General Information

Brufanic - Pharmacology:

The exact mechanisms of action of Brufanic is unknown. Its antiinflammatory effects are believed to be due to inhibition of both cylooxygenase-1 (COX-1) and cylooxygenase-2 (COX-2) which leads to the inhibition of prostaglandin synthesis, and results in the inhibition of prostaglandin synthesis. Antipyretic effects may be due to action on the hypothalamus, resulting in an increased peripheral blood flow, vasodilation, and subsequent heat dissipation.

Brufanic for patients

Brufanic is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain and inflammation, reduce fever, and treat osteoarthritis, rheumatoid arthritis, and menstrual cramps. Inform your physician if you are pregnant or nursing. Brufanic should not be taken during the last three months of pregnancy. Inform your physician if you use alcohol chronically. Brufanic should not be taken with aspirin products. This medication should be taken with food, milk or antacids if stomach upset occurs. Brufanic may cause dizziness and drowsiness; use caution while driving or operating hazardous machinery. Brufanic may cause increased sensitivity to sunlight. Use sunscreens and wear protective clothing until degree of sensitivity is determined. Notify your physician if you develop stomach pain, bloody vomit, bloody or black tarry stools, cloudy urine, trouble breathing, rash or hives.

This description is suitable for active ingredient Ibuprofen

Brufanic Interactions

Coumarin-Type Anticoagulants: Several short-term controlled studies failed to wshow that ibuprofen significantly affected prothrombin times or a variety of other clotting factors when administered to individuals on coumarin-type anticoagulants. However, because bleeding has been reported when ibuprofen and other nonsteroidal anti-inflammatory agents have been administered to patients on coumarin-type anticoagulants, the physician should be cautious when administering ibuprofen to patients on anticoagulants.

Aspirin: Animal studies wshow that aspirin given with nonsteroidal anti-inflammatory agents, including ibuprofen, yields a net decrease in anti-inflammatory activity with lowered blood levels of the non-aspirin drug. Single dose bioavailability studies in normal volunteers have failed to wshow an effect of aspirin on ibuprofen blood levels. Correlative clinical studies have not been performed.

Methotrexate: Brufanic, as well as other nonsteroidal anti-inflammatory drugs, probably reduces the tubular secretion of methotrexate based on in vitro studies in rabbit kidney slices. This may indicate that ibuprofen could enhance the toxicity of methotrexate. Caution should be used if ibuprofen is administered concomitantly with methotrexate.

H-2 Antagonists: In studies with human volunteers, co-administration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations.

Furosemide: Clinical studies, as well as random observations, have shown that ibuprofen can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with ibuprofen, the patient should be observed closely for signs of renal failure, as well as to assure diuretic efficacy.

Lithium: Brufanic produced an elevation of plasma lithium levels and a reduction in renal lithium clearance in a study of eleven normal volunteers. The mean minimum lithium concentration increased 15% and the renal clearance of lithium was decreased by 19% during this period of concomitant drug administration.

This effect has been attributed to inhibition of renal prostaglandin synthesis by ibuprofen. Thus, when ibuprofen and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. (Read circulars for lithium preparation before use of such concurrent therapy).

Brufanic Contraindications

Brufanic tablets or ibuprofen childrens suspension should not be used in patients who have previously exhibited hypersensitivity to the drug, or in individuals with the syndrome of nasal polyps, angioedema, and bronchospastic reactivity to aspirin or other nonsteroidal anti-inflammatory agents. Anaphylactoid reactions have occurred in such patients.

This description is suitable for active ingredient Ibuprofen

Brufanic tags categories:

Nagafen - Esportspedia S Call Of Duty Wiki, Nagifen

Nagafen

Jared "Nagafen" Harrell is a professional Call of Duty player and is currently playing for Team eLevate in the United States.

Biography

Nagafen began to make his name known during Cal of Duty: Advanced Warfare. He and his teammates on team Revenge turned many heads during the MLG Pro League Season 2 qualification as well as NA Regionals for Call of Duty Championship 2015. It wasn't until Revenge's run at Call of Duty Championship 2015 until Nagafen was recognized. Aches, as he is known to do, recognized this talent in forming the Prophecy squad for Season 2, where he and Naga played alongside Apathy and his old teammate Aqua. The team failed to qualify for MLG Season 2 Playoffs. Nagafen was eventually replaced for Octane, another player recognized as new talent. Nagafen joined his former teammate on team Revenge, Remy, to form Epsilon. NA with Swanny an established EU pro and Royalty a new up and coming talent. The team quilifed for MLG Season 3 at the Season 2 Regulation finished 2nd place.

Trivia

Nagafen has never gotten 1st at a major event hence the "Silver Surfer"

Interviews

References

Nolaid, Nolaid

Roosters are raised with the hens

Basic Egg-ucation

Most recipes are portioned for large eggs, so be sure to consider this if you are using extra-large or medium-sized eggs in a dish.

Keep your eyes peeled for white, speckled, brown, blue and green eggs, but know the shell color simply points to a different breed of laying hen and has no impact on taste or nutrition.

Nearly all eggs you see in stores are Grade A, which means the eggs have been evaluated for shell shape and consistency, internal quality and have no dirt or stains on the shell and no blemishes on the yolk.

Organic eggs are from hens that receive only organic feed and live in a cage-free environment. Plus, they must meet all standards set by the USDA National Organic Program.

Omega-3 or DHA eggs are from chickens that have been fed a diet supplemented by a source of omega-3 fatty acids (often flax seed).

Spanish Tortilla with Roasted Peppers and Spinach

Whole Wheat German Pancake with Pears

Big Nutrition in Small Packages

One large egg has only about 70 calories, 6 grams of high-quality protein and loads of vitamins and minerals including B12 and iron.

If you are concerned about cholesterol in eggs, an egg a day may be part of a heart-healthy lifestyle as long as other sources of cholesterol and saturated fat are kept in check.

Much of an egg’s nutrition is concentrated in the yolk, and the yolk also contains the egg’s fat and cholesterol. Consider adding additional egg whites to a dish to lighten things up.

Parmigiano Reggiano Baked Eggs with Swiss Chard

Chickpea Deviled Eggs

Egg-Centered Cooking

Eggs are some of the most versatile items in our kitchens and can appear in any and every meal of the day from main dishes to desserts to sauces.

Eggs bind frittatas, add richness to noodles and custards and add height to cakes and popovers.

Boiled eggs are cooked in the shell in boiling or simmering water.

Boil older eggs first. The fresher the hard-boiled egg, the harder it is to peel.

To make it easier to remove the shell from hard-boiled eggs, immerse in cold water as soon as the eggs are removed from the heat.

Poached eggs are cooked by breaking the egg into simmering water with a touch of vinegar added. The vinegar helps to keep the white around the yolk, making a perfectly poached egg possible.

Baked eggs can be cooked whole in a prepared baking dish (nestled among cheeses and vegetables like the Parmigiano Reggiano Baked Eggs with Swiss Chard. above) or scrambled and combined with extras as part of frittata or strata (see recipes below).

Fried eggs are prepared out of the shell in a shallow pan with a touch of added fat to prevent sticking. Fry the freshest eggs. They’re more likely to hold their shape in the frying pan.

Scrambled eggs must be cracked and whisked together to combine the egg white and yolk.

Whisk eggs with a splash of water for light and fluffy results.

Stirring constantly at a lower temperature will result in smaller curds and a creamier texture, while stirring less frequently allows the eggs to cook in larger curds and the resulting eggs will be firmer in texture.

Omelets start as scrambled eggs but are carefully cooked in a flat plan then rolled or folded around a filling before serving.

Souffles consist of separated eggs and are lightened by folding whipped egg whites into the batter.

Portobello and Asparagus Egg Strata

Goat Cheese and Zucchini Frittata

Shortcuts to Egg-y Bliss

Crack eggs on a flat surface to avoid eggshell bits getting into the egg.

When adding eggs to a recipe, crack eggs into a separate liquid measuring cup or bowl so there will be no need to fish eggshells from the sauce or batter.

Try pasteurized eggs for recipes requiring lightly cooked eggs.

Hard-boil enough eggs to keep on hand for quick snacks, easy lunchtime salads and sandwiches and impromptu hors d’oeuvres. When refrigerated, hard-boiled eggs in the shell keep for 6-7 days, while peeled hard-boiled eggs keep for 4-5 das.

Breakfast Polenta Casserole

Quinoa Egg Bake with Thyme and Garlic

Egg Substitutes and Alternatives

Commercial egg replacers are potato starch-based and are great for binding baked goods.

1 tablespoon freshly ground flax seed and 3 tablespoons warm water approximate the texture and binding effect of an egg in vegan cooking and baking.

Bananas, applesauce and tofu can also act as egg substitutes in baked goods and casseroles.

Cheddar Ham Puff

Classic Scrambled Eggs

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Lexis Advance - Online Legal Research, Lexis

Lexis Advance ®

Trial Period Terms & Conditions

Use of this trial ID is limited to the individual user only and is subject to LexisNexis General Terms and Conditions located at http://www. lexisnexis. com/terms/general. aspx. Offer is valid for 7 consecutive days of use beginning with first issuance of the trial ID from LexisNexis. Credits will not be issued for use of promotional material accessed on user's regular LexisNexis ID. Unused portions of this offer will not be credited or extended for future access. LexisNexis may terminate this offer and/or your access to the trial for any reason. One Promotional ID per recipient. Void where prohibited. Subject to your employer's policies. Not available to employees of government entities, academic institutions or individual students. This offer will end on December 31, 2016. Other restrictions may apply.

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Better assess and understand the value of medical cases with the all-in-one interactive tool that combines case facts with medical and legal research.

Hyasol Pf By Dsm Nutritional Products, Llc - Personal Care - Cosmetics, Hyasol

HYASOL PF

Company:

HYASOL PF is an aqueous solution of high molecular mass hyaluronic acid for cosmetic application. The molecular mass of the hyaluron polymer is about 1.6 mDa. This product is preserved with 1.0% Phenoxyethanol. HYASOL PF is a cosmetic ingredient for skin care products. It can be processed either warm or cold and is incorporated into the aqueous phase of a cosmetic formulation. It can also form complexes with cationic compounds and proteins which my give rise to precipitation. For skin care preparations, the addition of 3 to 5% of HYASOL PF is recommended.

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Revealing the Power of Beauty: DSM Product Overview (English)

Skin Bioactives: Revealing the Power of Beautiful Appearance and Ultimate Sensation (English)

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DSM Personal Care provides innovative ingredients and solutions for skin, sun and hair care products. Their strong scientific footing, combined with consumer and market insights from all over the world, results in transformational products that help to build brands and benefit consumers.

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DSM Nutritional Products, LLC

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Limas

Limas

Los citricos existen desde hace 20 millones de anos y su origen esta en el sudeste asiatico, Persia (Iran), Malasia. De ahi durante la Edad Media y con las cruzadas llegaron a Espana y al norte de Africa. Desde entonces se han extendido por todo el mundo y han evolucionado de muy distintas maneras, saliendo muchas variedades.

Las Limas es una fruta de la familia de las Rutaceas del genero de los Citrus y existen muchas variedades. Es fruto del limero (Citrus aurantifolia), arbol pequeno muy ramificado, entre 4 y 5 metros de alto. Necesitan de climas templados y se estan cultivando en regiones tropicales y subtropicales.

Los principales paises productores de Limas son en Europa: Espana, Italia, Portugal. En el mundo: Brasil, Mexico, Estados Unidos Jamaica, Haiti, Martinica, Kenia, India y Egipto. En Espana hay pequenos cultivos de limeros en Andalucia (Malaga), Islas Canarias y en el litoral levantino (Murcia y Valencia),

La lima es una fruta de sabor amargo . Su pulpa carnosa, se encuentra dividida gajos muy jugosos y refrescantes . Su sabor es entre acido y dulce . segun la variedad. La lima es mas aromatica y perfumada que el limon, pero su jugo esta menos concentrado. La fruta de la lima posee singular aroma que le diferencia del resto de los citricos. Ademas tiene la ventaja de no poseer semillas (o en cantidad muy escasa). Puede llegar a rendir el doble de jugo que un limon. La lima constituye uno de los citricos exoticos mas populares, especialmente en algunos paises (Mexico, Brasil)

Propiedades de la fruta / Salud Limas

Variedades / Temporada Limas

Recetas de Limas

Las Limas contienen un 94% de agua, Hidratos de Carbono y nada de Fibra. Es excelente para las dietas adelgazantes por ser muy baja en calorias y debido al acido citrico que contiene.

Las Limas contienen:

Vitaminas: C.

Minerales: Potasio, Magnesio.

Otros: Acido Folico, Acido Citrico (muchisimo), flavoides, aceites esenciales, beta-caroteno, antioxidantes.

Propiedades y beneficios . Recomendada para

Problemas de retencion de liquidos (diuretico).

Anticancerigeno

Colageno, huesos, dientes.

Estres.

Desintoxicante y depurador.

Gota y heperuricemia artritis.

Transmision y generacion del impulso nervioso y muscular

Ayudan a quemar grasas.

Sistema inmunologico. Refuerza en la bajada de defensas.

Problemas cardiovasculares y degenerativos.

Anemia ferropatica.

Diarreas.

Reconstituyente, Tonifica (esfuerzos fisicos)

NO deben tomar esta fruta los que tiene problemas digestivos: gastritis, hernia de hiato, acidez, ulceras.

Articulos de interes:

Existen 1.500 especies de la familia de las Rutaceas. Del genero Citrus existen 20 especies de frutas comestibles.

Las variedades de fruta mas conocidas en los mercados (limas acidas):

Persian Lime (lima persia) de Brasil, es de tamano mediano /grande, de piel basta y una de las mas compradas por su precio mas asequible. Tambien es la que tiene mayor similitud con el limon tanto por su forma como por su color.

Lima Mexicana (40%): de Mexico, de menor tamano que la Persian Lime y de mayor calidad. la Lima mexicana tiene un aroma muy acentuado.

Limas dulces . Tambien se producen limas dulces en Oriente Medio, India y algunos paises de America Central, como la variedad Dulce de la India .

Consejos para su compra: Al comprarlas debemos tener cuenta, que sean pesadas porque eso significa que tienen mas jugo. Deben de tener la piel tersas, si la piel se arruga es una mala senal, quiere decir que esta mustiandose. En general, insistimos, es recomendable elegir las frutas que parezcan mas pesadas para su tamano, de color verde intenso.

Mejor epoca . Se pueden conseguir limas durante todo el ano. En Espana esta fruta se suele consumir mas en verano (especialmente Agosto) y en Diciembre.

Conservacion . Una vez en casa, las limas aguantan perfectamente en la nevera 3 semanas. Aunque es sensible al frio, para su mejor conservacion entre 8-10 ?C. A temperatura ambiente, durante una semana. El zumo y la cascara de la lima admiten congelacion

La Lima en la cocina se utiliza principalmente, para aderezar platos, alinar ensaladas en lugar del vinagre. En reposteria se utiliza la ralladura de su piel, para dar sabor a los pasteles y tartas.

Como fruta fresca es poco comun. Es muy buena potenciando el el sabor de otras frutas (mangos, papayas, etc.). la lima tambien es buena acompanante de carnes y es utilizada para rociar pescados y mariscos. La lima es muy apreciada en al cocina mexicana .

Tambien da excelentes mermeladas y jaleas, helados o sorbetes. En bebidas destaca en dos paises Mexico para el “ tequila ” y en Brasil para la “ caipirinha ”.

Las hojas del limero, sueler exhalar un fuerte aroma y se emplean en la cocina asiatica para perfumar dulces, postres y otras recetas .

Mas en Recetas de lima

Calorias de la lima (es muy diferentes formas de preparacion)

Fenicol - Patient Information, Description, Dosage And Directions, Fenicol

Drugs Information Online Drugs and diseases reference index

Drugs reference index « Fenicol »

Fenicol

Generic Name: chloramphenicol (Ophthalmic route)

Intravenous routePowder for Solution

Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are known to occur after the administration of chloramphenicol. In addition, there have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia. Blood dyscrasias have occurred after both short-term and prolonged therapy with this drug. Chloramphenicol must not be used when less potentially dangerous agents will be effective. It must not be used in the treatment of trivial infections or where it is not indicated, as in colds, influenza, infections of the throat; or as a prophylactic agent to prevent bacterial infections.

Precautions: It is essential that adequate blood studies be made during treatment with the drug. While blood studies may detect early peripheral blood changes, such as leukopenia, reticulocytopenia, or granulocytopenia, before they become irreversible, such studies cannot be relied on to detect bone marrow depression prior to development of aplastic anemia. To facilitate appropriate studies and observation during therapy, it is desirable that patients be hospitalized .

Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are known to occur after the administration of chloramphenicol. There have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia. Blood dyscrasias have occurred after both short-term and prolonged therapy with this drug. It is essential that adequate blood studies be made during treatment with the drug .

Intravenous routePowder for Solution

Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are known to occur after the administration of chloramphenicol. In addition, there have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia. Blood dyscrasias have occurred after both short-term and prolonged therapy with this drug. Chloramphenicol must not be used when less potentially dangerous agents will be effective. It must not be used in the treatment of trivial infections or where it is not indicated, as in colds, influenza, infections of the throat; or as a prophylactic agent to prevent bacterial infections.

Precautions: It is essential that adequate blood studies be made during treatment with the drug. While blood studies may detect early peripheral blood changes, such as leukopenia, reticulocytopenia, or granulocytopenia, before they become irreversible, such studies cannot be relied on to detect bone marrow depression prior to development of aplastic anemia. To facilitate appropriate studies and observation during therapy, it is desirable that patients be hospitalized .

Serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are known to occur after the administration of chloramphenicol. There have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia. Blood dyscrasias have occurred after both short-term and prolonged therapy with this drug. It is essential that adequate blood studies be made during treatment with the drug .

Commonly used brand name(s):

Ak-Chlor

Chloromycetin

Chloroptic

Fenicol

Isopto Fenicol

Minims Chloramphenicol 0.5%

Ophtho-Chloram

Pentamycetin Ophthalmic Solution 0.25%

Pentamycetin Ophthalmic Solution 0.5%

Pms-Chloramphenicol

Sopamycetin

Available Dosage Forms:

Therapeutic Class: Antibiotic

Chemical Class: Chloramphenicol (class)

Uses For Fenicol

Chloramphenicol belongs to the family of medicines called antibiotics. Chloramphenicol ophthalmic preparations are used to treat infections of the eye. This medicine may be given alone or with other medicines that are taken by mouth for eye infections.

Chloramphenicol is available only with your doctor's prescription.

Before Using Fenicol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of this medicine in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of this medicine in the elderly with use in other age groups.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Ceftazidime

Chlorpropamide

Cyclosporine

Dicumarol

Fosphenytoin

Phenytoin

Rifampin

Rifapentine

Tacrolimus

Tetanus Toxoid

Tolbutamide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of chloramphenicol

This section provides information on the proper use of a number of products that contain chloramphenicol. It may not be specific to Fenicol. Please read with care.

For patients using the eye drop form of chloramphenicol:

Although the bottle may not be full, it contains exactly the amount of medicine your doctor ordered.

To use:

First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to come into contact with the infection.

If you think you did not get the drop of medicine into your eye properly, use another drop.

To keep the medicine as germ-free as possible, do not touch the applicator tip or dropper to any surface (including the eye). Also, keep the container tightly closed.

To use the eye ointment form of chloramphenicol:

First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of ointment into this space. A 1-cm (approximately 1/3-inch) strip of ointment is usually enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the infection.

To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using chloramphenicol eye ointment, wipe the tip of the ointment tube with a clean tissue and keep the tube tightly closed.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For eye infection:

For ophthalmic ointment dosage form:

Adults and children—Use every three hours.

For ophthalmic solution (eye drops) dosage form:

Adults and children—One drop every one to four hours.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Fenicol

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

Fenicol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare - may also occur weeks or months after you stop using this medicine

Pale skin

sore throat and fever

unusual bleeding or bruising

unusual tiredness or weakness

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

Less common

Itching, redness, skin rash, swelling, or other sign of irritation not present before use of this medicine

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Burning or stinging

After application, eye ointments may be expected to cause your vision to blur for a few minutes.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs. com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs. com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.

Mefac - Nsaid - Pain Relief - Rowex - Prescription Products, Mefac

ACTIVE INGREDIENT: Mefenamic Acid

STRENGTH, PACK SIZE & GMS CODES: 250 mg Capsules x 100

500 mg Tablets x 100

As an anti-inflammatory analgesic for symptomatic relief of mild to moderate pain associated with rheumatic muscular or arthritic disorders (including rheumatoid arthritis, Still’s Disease and osteoarthritis), trauma, headache, dental pain, post - operative or post - partum states

For control of pyrexia in children

In the management of dysfunctional menorrhagia

Primary dysmenorrhoea

Premenstrual syndrome

Rifamate Indications, Side Effects, Warnings, Rifamate

Rifamate

Generic Name: isoniazid/rifampin (EYE-soe-NYE-a-zid/rif-AM-pin) Brand Name: Examples include Rifamate and Isonarif

Rifamate may cause severe and sometimes fatal liver problems (eg, hepatitis). The risk of liver problems is greater in patients over 35 years old. It may also be increased by daily use of alcohol, long-term liver problems, or unsanitary injectable drug use. Women, especially those who are black, are Hispanic, or have just had a baby, may also be at increased risk. Hepatitis can develop at any time during treatment, but usually occurs during the first 3 months. Your doctor will monitor your liver function and discuss your progress every month.

Contact your doctor right away if you develop unusual fatigue, weakness or fever that lasts longer than 3 days, general feeling of discomfort, loss of appetite, nausea, vomiting, numbness or tingling of the hands or feet, dark urine, yellowing of the skin or eyes, or stomach pain or tenderness.

Patients with active liver problems should not use Rifamate.

Rifamate is used for:

Treating tuberculosis (TB) of the lungs.

Rifamate is a combination of 2 antibacterial agents. It works by killing TB bacteria.

Do NOT use Rifamate if:

you are allergic to any ingredient in Rifamate or to any rifamycin (eg, rifabutin)

you have had severe side effects from isoniazid, such as drug fever, chills, or arthritis

you have severe liver damage, active liver disease, or liver damage from previous use of Rifamate

you have a history of hepatitis caused by any medicine

you are taking atazanavir, cabazitaxel, darunavir, delavirdine, dronedarone, etravirine, fosamprenavir, lurasidone, nifedipine praziquantel, ranolazine, saquinavir, tipranavir, a tyrosine kinase receptor inhibitor (eg, lapatinib), or voriconazole

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

Before using Rifamate:

Some medical conditions may interact with Rifamate. 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 diabetes, the blood disease porphyria, kidney problems, nerve problems (eg, neuropathy) or risk of nerve problems, HIV, severe diarrhea due to antibiotic use (pseudomembranous colitis), or a history of liver problems or gout

if you have a history of alcohol or other substance abuse, have unsanitary injectable drug habits, or drink alcohol daily

if you are over 35 years old, you have recently given birth, or you have previously taken Rifamate

if you wear contact lenses

Some MEDICINES MAY INTERACT with Rifamate. Tell your health care provider if you are taking any other medicines, especially any of the following:

Atazanavir, cabazitaxel, darunavir, delavirdine, dronedarone, etravirine, fosamprenavir, lurasidone, nifedipine, praziquantel, ranolazine, saquinavir, tipranavir, tyrosine kinase receptor inhibitors (eg, lapatinib), or voriconazole because their effectiveness may be decreased by Rifamate

Many prescription and nonprescription medicines (eg, used for alcoholism, asthma, cancer, infections, inflammation, aches and pains, heart problems, high blood pressure, high blood iron levels, high cholesterol, blood thinning, birth control, diabetes, HIV, hormone replacement, immune system suppression, irregular heartbeat, low sodium levels, low vitamin D levels, mental or mood problems, nausea and vomiting, Parkinson disease, seizures, sleep, thyroid) may interact with Rifamate, increasing the risk of side effects or decreasing effectiveness.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rifamate 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 Rifamate:

Use Rifamate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Rifamate by mouth on an empty stomach at least 1 hour before or 2 hours after eating.

If you also take an antacid, take Rifamate at least 1 hour before you take the antacid.

If you also take aminosalicylic acid granules, do not take it within 8 to 12 hours of Rifamate. Check with your doctor if you have questions.

Continue to take Rifamate even if you feel well. Do not miss any doses.

Do not stop taking Rifamate without checking with your doctor. Rarely, kidney problems have occurred when patients started taking Rifamate again after therapy was interrupted.

If you miss a dose of Rifamate, 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 Rifamate.

Important safety information:

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

Check with your doctor before drinking alcohol while taking Rifamate. Alcohol may increase the risk of liver problems. If you have a history of alcohol abuse, you may also be at increased risk of developing nerve problems from Rifamate. Notify your doctor if you notice any unusual tingling in your hands or feet.

If you have a history of diabetes, alcohol abuse, or poor nutrition, your doctor may recommend that you also take vitamin B 6 while you are taking Rifamate. This may help to decrease your risk of nerve problems. Discuss any questions with your doctor.

Rifamate may cause a reddish orange color of urine, stools, saliva, tears, sweat, sputum, and skin. This is normal and not a cause for concern.

Rifamate may cause a permanent reddish orange color of soft contact lenses.

Eating foods high in tyramine (eg, aged cheeses, red wines, beer, certain meats and sausages, liver, sour cream, soy sauce, raisins, bananas, avocados) while you use Rifamate may cause severe high blood pressure. Do not eat foods high in tyramine while you take Rifamate. Seek medical attention at once if symptoms of severe high blood pressure occur. These may include severe headache, fast or irregular heartbeat, sore or stiff neck, nausea, vomiting, sweating, enlarged pupils, or sensitivity to light.

Do not eat foods high in histamine while you take Rifamate. Eating foods high in histamine (eg, skipjack, tuna, tropical fish) while you use Rifamate may cause low blood pressure, irregular heartbeat, headache, sweating, or flushing. Contact your doctor at once if any of these symptoms occur.

Ask your health care provider for a complete list of foods you should avoid while you are taking Rifamate.

Hormonal birth control (eg, birth control pills, implants, patches) may not work as well while you are using Rifamate. To prevent pregnancy, use an extra form of birth control (eg, condoms).

Rifamate only works against TB bacteria; it does not treat viral infections (eg, the common cold).

Be sure to take Rifamate 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.

Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you take the antibiotic or within several months after you stop taking it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occurs. Do not treat diarrhea without first checking with your doctor.

Tell your doctor or dentist that you take Rifamate before you receive any medical or dental care, emergency care, or surgery.

Diabetes patients - Rifamate may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. You may also be at increased risk of developing nerve problems from Rifamate. Contact your doctor if you notice any unusual tingling in your hands or feet.

Rifamate may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Rifamate.

Lab tests, including complete blood cell counts, platelet counts, uric acid levels, kidney and liver function, and eye exams, may be performed while you take Rifamate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Rifamate with caution in BLACK and HISPANIC WOMEN; they may have a greater risk of severe liver problems from Rifamate.

Use Rifamate with caution in patients over 35 years old; they may have a greater risk of severe liver problems from Rifamate.

Rifamate 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 taking Rifamate while you are pregnant. Rifamate is found in breast milk. If you are or will be breast-feeding while you take Rifamate, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Rifamate:

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; dizziness; drowsiness; gas; headache; heartburn; mild stomach upset or cramps; nausea; trouble sleeping.

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); bloody or dark urine; change in the amount of urine produced; changes in vision; dark, tarry, or bloody stools; fever, chills, or sore throat; general feeling of discomfort; increased thirst or urination; joint pain or swelling; loss of appetite; memory problems; menstrual changes; mental or mood changes; muscle pain or weakness; seizures; severe diarrhea, nausea, or stomach cramps; shortness of breath; stomach pain or tenderness; swelling of the hands or legs; symptoms of low vitamin B 6 levels (eg, confusion, cracks in the corners of the mouth, irritability, mouth redness or soreness, scaly rash); tingling or numbness in the hands or feet; unusual bruising or bleeding; unusual tiredness or weakness; vomiting; 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. 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 blurred vision; hallucinations; loss of consciousness; seizures; severe dizziness or nausea; sluggishness; slurred speech; stomach pain or tenderness; symptoms of high blood sugar (eg, confusion, increased thirst or urination, rapid breathing, unusual drowsiness); very slow breathing; vomiting; yellowing of the skin or eyes.

Proper storage of Rifamate:

Store Rifamate 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 Rifamate out of the reach of children and away from pets.

General information:

If you have any questions about Rifamate, please talk with your doctor, pharmacist, or other health care provider.

Rifamate 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 Rifamate 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 Rifamate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Rifamate. 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 Rifamate.

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.

More about Rifamate (isoniazid / rifampin)

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Alendronate - Fda Prescribing Information, Side Effects And Uses, Alendromet

Alendronate

Treatment of Osteoporosis in Postmenopausal Women

Alendronate sodium tablets are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, Alendronate sodium tablets increase bone mass and reduce the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [See Clinical Studies (14.1) .]

Prevention of Osteoporosis in Postmenopausal Women

Alendronate sodium tablets are indicated for the prevention of postmenopausal osteoporosis [see Clinical Studies (14.2) ] .

Treatment to Increase Bone Mass in Men with Osteoporosis

Alendronate sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3) ] .

Treatment of Glucocorticoid-Induced Osteoporosis

Alendronate sodium tablets are indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density [see Clinical Studies (14.4) ] .

Treatment of Paget's Disease of Bone

Alendronate sodium tablets are indicated for the treatment of Paget’s disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone who have alkaline phosphatase at least two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease. [See Clinical Studies (14.5) .]

Important Limitations of Use

The optimal duration of use has not been determined. The safety and effectiveness of Alendronate sodium tablets for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

Alendronate Dosage and Administration

Treatment of Osteoporosis in Postmenopausal Women

The recommended dosage is:

one 70 mg tablet once weekly

Prevention of Osteoporosis in Postmenopausal Women

The recommended dosage is:

one 35 mg tablet once weekly

Treatment to Increase Bone Mass in Men with Osteoporosis

The recommended dosage is:

one 70 mg tablet once weekly

Treatment of Glucocorticoid-Induced Osteoporosis

The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.

Treatment of Paget's Disease of Bone

The recommended treatment regimen is 40 mg once a day for six months.

Re-treatment of Paget’s Disease

Re-treatment with Alendronate sodium tablets may be considered, following a six-month post-treatment evaluation period in patients who have relapsed, based on increases in serum alkaline phosphatase, which should be measured periodically. Re-treatment may also be considered in those who failed to normalize their serum alkaline phosphatase.

Important Administration Instructions

Instruct patients to do the following:

Take Alendronate sodium tablets at least one-half hour before the first food, beverage, or medication of the day with plain water only [see Patient Counseling Information (17.2) ]. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of Alendronate sodium tablets [see Drug Interactions (7.1) ]. Waiting less than 30 minutes, or taking Alendronate sodium tablets with food, beverages (other than plain water) or other medications will lessen the effect of Alendronate sodium tablets by decreasing its absorption into the body.

Take Alendronate sodium tablets upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, an Alendronate sodium tablet should be swallowed with a full glass of water (6 to 8 ounces). Patients should not lie down for at least 30 minutes and until after their first food of the day. Alendronate sodium tablets should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences [see Warnings and Precautions (5.1) and Patient Counseling Information (17.2) ] .

Recommendations for Calcium and Vitamin D Supplementation

Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2) ]. Patients at increased risk for vitamin D insufficiency (e. g. over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.

Administration Instructions for Missed Doses

If a once-weekly dose of Alendronate sodium tablets is missed, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.

Dosage Forms and Strengths

10 mg tablets are white to off-white, circular, biconvex, uncoated tablets debossed with ‘F’ on one side and ‘18’ on the other side.

35 mg tablets are white to off-white, oval shaped, biconvex, uncoated tablets debossed with ‘F’ on one side and ‘19’ on the other side.

70 mg tablets are white to off-white, oval shaped, biconvex, uncoated tablets debossed with ‘F’ on one side and ‘21’ on the other side.

Contraindications

Alendronate sodium tablets are contraindicated in patients with the following conditions:

Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see Warnings and Precautions (5.1) ] .

Inability to stand or sit upright for at least 30 minutes [see Dosage and Administration (2.6) ; Warnings and Precautions (5.1) ] .

Hypocalcemia [see Warnings and Precautions (5.2) ] .

Hypersensitivity to any component of this product. Hypersensitivity reactions including urticaria and angioedema have been reported [see Adverse Reactions (6.2) ] .

Warnings and Precautions

Upper Gastrointestinal Adverse Reactions

Alendronate sodium, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Alendronate sodium is given to patients with active upper gastrointestinal problems (such as known Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, or ulcers).

Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates including Alendronate sodium. In some cases these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue Alendronate sodium and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn.

The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates including Alendronate sodium and/or who fail to swallow oral bisphosphonates including Alendronate sodium with the recommended full glass (6 to 8 ounces) of water, and/or who continue to take oral bisphosphonates including Alendronate sodium after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient [see Dosage and Administration (2.6) ]. In patients who cannot comply with dosing instructions due to mental disability, therapy with Alendronate sodium should be used under appropriate supervision.

There have been postmarketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications, although no increased risk was observed in controlled clinical trials [see Adverse Reactions (6.2) ] .

Mineral Metabolism

Hypocalcemia must be corrected before initiating therapy with Alendronate sodium [see Contraindications (4) ]. Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated. In patients with these conditions, serum calcium and symptoms of hypocalcemia should be monitored during therapy with Alendronate sodium.

Presumably due to the effects of Alendronate sodium on increasing bone mineral, small, asymptomatic decreases in serum calcium and phosphate may occur, especially in patients with Paget’s disease, in whom the pretreatment rate of bone turnover may be greatly elevated, and in patients receiving glucocorticoids, in whom calcium absorption may be decreased.

Ensuring adequate calcium and vitamin D intake is especially important in patients with Paget’s disease of bone and in patients receiving glucocorticoids.

Musculoskeletal Pain

In postmarketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates that are approved for the prevention and treatment of osteoporosis [see Adverse Reactions (6.2) ]. This category of drugs includes Alendronate sodium. Most of the patients were postmenopausal women. The time to onset of symptoms varied from one day to several months after starting the drug. Discontinue use if severe symptoms develop. Most patients had relief of symptoms after stopping. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate.

In placebo-controlled clinical studies of Alendronate sodium, the percentages of patients with these symptoms were similar in the Alendronate sodium and placebo groups.

Osteonecrosis of the Jaw

Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with ​ tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including Alendronate sodium. Known risk factors for osteonecrosis of the jaw include invasive dental procedures (e. g. tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (e. g. chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders (e. g. periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill-fitting dentures). The risk of ONJ may increase with duration of exposure to bisphosphonates.

For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ. Clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit/risk assessment.

Patients who develop osteonecrosis of the jaw while on bisphosphonate therapy should receive care by an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of bisphosphonate therapy should be considered based on individual benefit/risk assessment.

Atypical Subtrochanteric and Diaphyseal Femoral Fractures

Atypical, low-energy, or low trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with bisphosphonates.

Atypical femur fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (e. g. prednisone) at the time of fracture.

Any patient with a history of bisphosphonate exposure who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of bisphosphonate therapy should be considered, pending a risk/benefit assessment, on an individual basis.

Renal Impairment

Alendronate sodium is not recommended for patients with creatinine clearance less than 35 mL/min.

Glucocorticoid-Induced Osteoporosis

The risk versus benefit of Alendronate for treatment at daily dosages of glucocorticoids less than 7.5 mg of prednisone or equivalent has not been established [see Indications and Usage (1.4) ]. Before initiating treatment, the gonadal hormonal status of both men and women should be ascertained and appropriate replacement considered.

A bone mineral density measurement should be made at the initiation of therapy and repeated after 6 to 12 months of combined Alendronate sodium and glucocorticoid treatment.

Adverse Reactions

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 to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Treatment of Osteoporosis in Postmenopausal Women

The safety of Alendronate sodium in the treatment of postmenopausal osteoporosis was assessed in four clinical trials that enrolled 7453 women aged 44 to 84 years. Study 1 and Study 2 were identically designed, three-year, placebo-controlled, double-blind, multicenter studies (United States and Multinational n=994); Study 3 was the three-year vertebral fracture cohort of the Fracture Intervention Trial [FIT] (n=2027) and Study 4 was the four-year clinical fracture cohort of FIT (n=4432). Overall, 3620 patients were exposed to placebo and 3432 patients exposed to Alendronate sodium. Patients with pre-existing gastrointestinal disease and concomitant use of non-steroidal anti-inflammatory drugs were included in these clinical trials. In Study 1 and Study 2 all women received 500 mg elemental calcium as carbonate. In Study 3 and Study 4 all women with dietary calcium intake less than 1000 mg per day received 500 mg calcium and 250 international units Vitamin D per day.

Among patients treated with Alendronate 10 mg or placebo in Study 1 and Study 2, and all patients in Study 3 and Study 4, the incidence of all-cause mortality was 1.8% in the placebo group and 1.8% in the Alendronate sodium group. The incidence of serious adverse event was 30.7% in the placebo group and 30.9% in the Alendronate sodium group. The percentage of patients who discontinued the study due to any clinical adverse event was 9.5% in the placebo group and 8.9% in the Alendronate sodium group. Adverse reactions from these studies considered by the investigators as possibly, probably, or definitely drug related in greater than or equal to 1% of patients treated with either Alendronate sodium or placebo are presented in Table 1.

Table 1: Osteoporosis Treatment Studies in Postmenopausal Women Adverse Reactions Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in Greater Than or Equal to 1% of Patients

United States/ Multinational Studies

Fracture Intervention Trial

Rash and erythema have occurred.

Gastrointestinal Adverse Reactions: One patient treated with Alendronate (10 mg/day), who had a history of peptic ulcer disease and gastrectomy and who was taking concomitant aspirin, developed an anastomotic ulcer with mild hemorrhage, which was considered drug related. Aspirin and Alendronate sodium were discontinued and the patient recovered. In the Study 1 and Study 2 populations, 49 to 54% had a history of gastrointestinal disorders at baseline and 54 to 89% used nonsteroidal anti-inflammatory drugs or aspirin at some time during the studies. [See Warnings and Precautions (5.1) .]

Laboratory Test Findings: In double-blind, multicenter, controlled studies, asymptomatic, mild, and transient decreases in serum calcium and phosphate were observed in approximately 18% and 10%, respectively, of patients taking Alendronate sodium versus approximately 12% and 3% of those taking placebo. However, the incidences of decreases in serum calcium to less than 8 mg/dL (2 mM) and serum phosphate to less than or equal to 2 mg/dL (0.65 mM) were similar in both treatment groups.

The safety of Alendronate 70 mg once weekly for the treatment of postmenopausal osteoporosis was assessed in a one-year, double-blind, multicenter study comparing Alendronate 70 mg once weekly and Alendronate 10 mg daily. The overall safety and tolerability profiles of once weekly Alendronate 70 mg and Alendronate 10 mg daily were similar. The adverse reactions considered by the investigators as possibly, probably, or definitely drug related in greater than or equal to 1% of patients in either treatment group are presented in Table 2.

Table 2: Osteoporosis Treatment Studies in Postmenopausal Women Adverse Reactions Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in Greater Than or Equal to 1% of Patients

Once Weekly Alendronate 70 mg % (n=519)

Alendronate 10 mg/day % (n=370)

Prevention of Osteoporosis in Postmenopausal Women

The safety of Alendronate 5 mg/day in postmenopausal women 40 to 60 years of age has been evaluated in three double-blind, placebo-controlled studies involving over 1,400 patients randomized to receive Alendronate for either two or three years. In these studies the overall safety profiles of Alendronate 5 mg/day and placebo were similar. Discontinuation of therapy due to any clinical adverse event occurred in 7.5% of 642 patients treated with Alendronate 5 mg/day and 5.7% of 648 patients treated with placebo.

The safety of Alendronate 35 mg once weekly compared to Alendronate 5 mg daily was evaluated in a one-year, double-blind, multicenter study of 723 patients. The overall safety and tolerability profiles of once weekly Alendronate 35 mg and Alendronate 5 mg daily were similar.

The adverse reactions from these studies considered by the investigators as possibly, probably, or definitely drug related in greater than or equal to 1% of patients treated with either once weekly Alendronate 35 mg, Alendronate 5 mg/day or placebo are presented in Table 3.

Table 3: Osteoporosis Prevention Studies in Postmenopausal Women Adverse Reactions Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in Greater Than or Equal to 1% of Patients

Concomitant Use with Estrogen/Hormone Replacement Therapy

In two studies (of one and two years’ duration) of postmenopausal osteoporotic women (total: n=853), the safety and tolerability profile of combined treatment with Alendronate 10 mg once daily and estrogen ± progestin (n=354) was consistent with those of the individual treatments.

Osteoporosis in Men

In two placebo-controlled, double-blind, multicenter studies in men (a two-year study of Alendronate 10 mg/day and a one-year study of once weekly Alendronate 70 mg) the rates of discontinuation of therapy due to any clinical adverse event were 2.7% for Alendronate 10 mg/day vs. 10.5% for placebo, and 6.4% for once weekly Alendronate 70 mg vs. 8.6% for placebo. The adverse reactions considered by the investigators as possibly, probably, or definitely drug related in greater than or equal to 2% of patients treated with either Alendronate sodium or placebo are presented in Table 4.

Table 4: Osteoporosis Studies in Men Adverse Reactions Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in Greater Than or Equal to 2% of Patients

In two, one-year, placebo-controlled, double-blind, multicenter studies in patients receiving glucocorticoid treatment, the overall safety and tolerability profiles of Alendronate 5 and 10 mg/day were generally similar to that of placebo. The adverse reactions considered by the investigators as possibly, probably, or definitely drug related in greater than or equal to 1% of patients treated with either Alendronate 5 or 10 mg/day or placebo are presented in Table 5.

Table 5: One-Year Studies in Glucocorticoid-Treated Patients Adverse Reactions Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in Greater Than or Equal to 1% of Patients

Alendronate 10 mg/day % (n=157)

Alendronate 5 mg/day % (n=161)

The overall safety and tolerability profile in the glucocorticoid-induced osteoporosis population that continued therapy for the second year of the studies (Alendronate sodium: n=147) was consistent with that observed in the first year.

Paget's Disease of Bone

In clinical studies (osteoporosis and Paget's disease), adverse events reported in 175 patients taking Alendronate 40 mg/day for 3 to 12 months were similar to those in postmenopausal women treated with Alendronate 10 mg/day. However, there was an apparent increased incidence of upper gastrointestinal adverse reactions in patients taking Alendronate 40 mg/day (17.7% Alendronate vs. 10.2% placebo). One case of esophagitis and two cases of gastritis resulted in discontinuation of treatment.

Additionally, musculoskeletal (bone, muscle or joint) pain, which has been described in patients with Paget's disease treated with other bisphosphonates, was considered by the investigators as possibly, probably, or definitely drug related in approximately 6% of patients treated with Alendronate 40 mg/day versus approximately 1% of patients treated with placebo, but rarely resulted in discontinuation of therapy. Discontinuation of therapy due to any clinical adverse events occurred in 6.4% of patients with Paget's disease treated with Alendronate 40 mg/day and 2.4% of patients treated with placebo.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Alendronate sodium. 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.

Body as a Whole: hypersensitivity reactions including urticaria and angioedema. Transient symptoms of myalgia, malaise, asthenia and fever have been reported with Alendronate sodium, typically in association with initiation of treatment. Symptomatic hypocalcemia has occurred, generally in association with predisposing conditions. Peripheral edema.

Gastrointestinal: esophagitis, esophageal erosions, esophageal ulcers, esophageal stricture or perforation, and oropharyngeal ulceration. Gastric or duodenal ulcers, some severe and with complications, have also been reported [see Dosage and Administration (2.6) ; Warnings and Precautions (5.1) ].

Localized osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection with delayed healing, has been reported [see Warnings and Precautions (5.4) ] .

Musculoskeletal: bone, joint, and/or muscle pain, occasionally severe, and incapacitating [see Warnings and Precautions (5.3) ]; joint swelling; low-energy femoral shaft and subtrochanteric fractures [see Warnings and Precautions (5.5) ].

Nervous System: dizziness and vertigo.

Pulmonary: acute asthma exacerbations.

Skin: rash (occasionally with photosensitivity), pruritus, alopecia, severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Special Senses: uveitis, scleritis or episcleritis. Cholesteatoma of the external auditory canal (focal osteonecrosis).

Drug Interactions

Calcium Supplements/Antacids

Coadministration of Alendronate sodium and calcium, antacids, or oral medications containing multivalent cations will interfere with absorption of Alendronate sodium. Therefore, instruct patients to wait at least one-half hour after taking Alendronate sodium before taking any other oral medications.

Aspirin

In clinical studies, the incidence of upper gastrointestinal adverse events was increased in patients receiving concomitant therapy with daily doses of Alendronate greater than 10 mg and aspirin-containing products.

Nonsteroidal Anti-Inflammatory Drugs

Alendronate sodium may be administered to patients taking nonsteroidal anti-inflammatory drugs (NSAIDs). In a 3-year, controlled, clinical study (n=2027) during which a majority of patients received concomitant NSAIDs, the incidence of upper gastrointestinal adverse events was similar in patients taking Alendronate 5 or 10 mg/day compared to those taking placebo. However, since NSAID use is associated with gastrointestinal irritation, caution should be used during concomitant use with Alendronate sodium.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C:

There are no studies in pregnant women. Alendronate sodium should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years. The amount of bisphosphonate incorporated into adult bone, and hence, the amount available for release back into the systemic circulation, is directly related to the dose and duration of bisphosphonate use. There are no data on fetal risk in humans. However, there is a theoretical risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on the risk has not been studied.

Reproduction studies in rats showed decreased postimplantation survival and decreased body weight gain in normal pups at doses less than half of the recommended clinical dose. Sites of incomplete fetal ossification were statistically significantly increased in rats beginning at approximately 3 times the clinical dose in vertebral (cervical, thoracic, and lumbar), skull, and sternebral bones. No similar fetal effects were seen when pregnant rabbits were treated with doses approximately 10 times the clinical dose.

Both total and ionized calcium decreased in pregnant rats at approximately 4 times the clinical dose resulting in delays and failures of delivery. Protracted parturition due to maternal hypocalcemia occurred in rats at doses as low as one tenth the clinical dose when rats were treated from before mating through gestation. Maternotoxicity (late pregnancy deaths) also occurred in the female rats treated at approximately 4 times the clinical dose for varying periods of time ranging from treatment only during pre-mating to treatment only during early, middle, or late gestation; these deaths were lessened but not eliminated by cessation of treatment. Calcium supplementation either in the drinking water or by minipump could not ameliorate the hypocalcemia or prevent maternal and neonatal deaths due to delays in delivery; intravenous calcium supplementation prevented maternal, but not fetal deaths.

Exposure multiples based on surface area, mg/m 2. were calculated using a 40 mg human daily dose. Animal dose ranged between 1 and 15 mg/kg/day in rats and up to 40 mg/kg/day in rabbits.

Nursing Mothers

It is not known whether Alendronate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Alendronate sodium is administered to nursing women.

Pediatric Use

Alendronate sodium is not indicated for use in pediatric patients.

The safety and efficacy of Alendronate sodium were examined in a randomized, double-blind, placebo-controlled two-year study of 139 pediatric patients, aged 4 to 18 years, with severe osteogenesis imperfecta (OI). One-hundred-and-nine patients were randomized to 5 mg Alendronate daily (weight less than 40 kg) or 10 mg Alendronate daily (weight greater than or equal to 40 kg) and 30 patients to placebo. The mean baseline lumbar spine BMD Z-score of the patients was -4.5. The mean change in lumbar spine BMD Z-score from baseline to Month 24 was 1.3 in the Alendronate sodium-treated patients and 0.1 in the placebo-treated patients. Treatment with Alendronate sodium did not reduce the risk of fracture. Sixteen percent of the Alendronate sodium patients who sustained a radiologically-confirmed fracture by Month 12 of the study had delayed fracture healing (callus remodeling) or fracture non-union when assessed radiographically at Month 24 compared with 9% of the placebo-treated patients. In Alendronate sodium-treated patients, bone histomorphometry data obtained at Month 24 demonstrated decreased bone turnover and delayed mineralization time; however, there were no mineralization defects. There were no statistically significant differences between the Alendronate sodium and placebo groups in reduction of bone pain. The oral bioavailability in children was similar to that observed in adults.

The overall safety profile of Alendronate sodium in osteogenesis imperfecta patients treated for up to 24 months was generally similar to that of adults with osteoporosis treated with Alendronate sodium. However, there was an increased occurrence of vomiting in osteogenesis imperfecta patients treated with Alendronate sodium compared to placebo. During the 24-month treatment period, vomiting was observed in 32 of 109 (29.4%) patients treated with Alendronate sodium and 3 of 30 (10%) patients treated with placebo.

In a pharmacokinetic study, 6 of 24 pediatric osteogenesis imperfecta patients who received a single oral dose of Alendronate 35 or 70 mg developed fever, flu-like symptoms, and/or mild lymphocytopenia within 24 to 48 hours after administration. These events, lasting no more than 2 to 3 days and responding to acetaminophen, are consistent with an acute-phase response that has been reported in patients receiving bisphosphonates, including Alendronate sodium. [See Adverse Reactions (6.2) .]

Geriatric Use

Of the patients receiving Alendronate sodium in the Fracture Intervention Trial (FIT), 71% (n=2302) were greater than or equal to 65 years of age and 17% (n=550) were greater than or equal to 75 years of age. Of the patients receiving Alendronate sodium in the United States and Multinational osteoporosis treatment studies in women, osteoporosis studies in men, glucocorticoid-induced osteoporosis studies, and Paget’s disease studies [see Clinical Studies (14.1). (14.3). (14.4). (14.5) ], 45%, 54%, 37%, and 70%, respectively, were 65 years of age or over. No overall differences in efficacy or safety were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Renal Impairment

Alendronate sodium is not recommended for patients with creatinine clearance less than 35 mL/min. No dosage adjustment is necessary in patients with creatinine clearance values between 35 to 60 mL/min [see Clinical Pharmacology (12.3) ] .

Hepatic Impairment

As there is evidence that Alendronate is not metabolized or excreted in the bile, no studies were conducted in patients with hepatic impairment. No dosage adjustment is necessary [see Clinical Pharmacology (12.3) ] .

Overdosage

Significant lethality after single oral doses was seen in female rats and mice at 552 mg/kg (3256 mg/m 2 ) and 966 mg/kg (2898 mg/m 2 ), respectively. In males, these values were slightly higher, 626 and 1280 mg/kg, respectively. There was no lethality in dogs at oral doses up to 200 mg/kg (4000 mg/m 2 ).

No specific information is available on the treatment of overdosage with Alendronate sodium. Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage. Milk or antacids should be given to bind Alendronate. Due to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright.

Dialysis would not be beneficial.

Alendronate Description

Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-­mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.

Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.

The molecular formula of Alendronate sodium is C 4 H 12 NNaO 7 P 2 •3H 2 O and its formula weight is 325.12. The structural formula is:

Alendronate sodium USP is a white, free-flowing powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.

Alendronate sodium tablets, USP for oral administration contain 13.052, 45.681, or 91.363 mg of Alendronate monosodium salt trihydrate, which is the molar equivalent of 10 mg, 35 mg, and 70 mg, respectively, of free acid, and the following inactive ingredients: corn starch, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.

Alendronate - Clinical Pharmacology

Mechanism of Action

Animal studies have indicated the following mode of action. At the cellular level, Alendronate shows preferential localization to sites of bone resorption, specifically under osteoclasts. The osteoclasts adhere normally to the bone surface but lack the ruffled border that is indicative of active resorption. Alendronate does not interfere with osteoclast recruitment or attachment, but it does inhibit osteoclast activity. Studies in mice on the localization of radioactive [ 3 H]Alendronate in bone showed about 10-fold higher uptake on osteoclast surfaces than on osteoblast surfaces. Bones examined 6 and 49 days after [ 3 H]Alendronate administration in rats and mice, respectively, showed that normal bone was formed on top of the Alendronate, which was incorporated inside the matrix. While incorporated in bone matrix, Alendronate is not pharmacologically active. Thus, Alendronate must be continuously administered to suppress osteoclasts on newly formed resorption surfaces. Histomorphometry in baboons and rats showed that Alendronate treatment reduces bone turnover (i. e. the number of sites at which bone is remodeled). In addition, bone formation exceeds bone resorption at these remodeling sites, leading to progressive gains in bone mass.

Pharmacodynamics

Alendronate is a bisphosphonate that binds to bone hydroxyapatite and specifically inhibits the activity of osteoclasts, the bone-resorbing cells. Alendronate reduces bone resorption with no direct effect on bone formation, although the latter process is ultimately reduced because bone resorption and formation are coupled during bone turnover.

Osteoporosis in Postmenopausal Women

Osteoporosis is characterized by low bone mass that leads to an increased risk of fracture. The diagnosis can be confirmed by the finding of low bone mass, evidence of fracture on x-ray, a history of osteoporotic fracture, or height loss or kyphosis, indicative of vertebral (spinal) fracture. Osteoporosis occurs in both males and females but is most common among women following the menopause, when bone turnover increases and the rate of bone resorption exceeds that of bone formation. These changes result in progressive bone loss and lead to osteoporosis in a significant proportion of women over age 50. Fractures, usually of the spine, hip, and wrist, are the common consequences. From age 50 to age 90, the risk of hip fracture in white women increases 50-fold and the risk of vertebral fracture 15- to 30-fold. It is estimated that approximately 40% of 50-year-old women will sustain one or more osteoporosis-related fractures of the spine, hip, or wrist during their remaining lifetimes. Hip fractures, in particular, are associated with substantial morbidity, disability, and mortality.

Daily oral doses of Alendronate (5, 20, and 40 mg for six weeks) in postmenopausal women produced biochemical changes indicative of dose-dependent inhibition of bone resorption, including decreases in urinary calcium and urinary markers of bone collagen degradation (such as deoxypyridinoline and cross-linked N-telopeptides of type I collagen). These biochemical changes tended to return toward baseline values as early as 3 weeks following the discontinuation of therapy with Alendronate and did not differ from placebo after 7 months.

Long-term treatment of osteoporosis with Alendronate 10 mg/day (for up to five years) reduced urinary excretion of markers of bone resorption, deoxypyridinoline and cross-linked N-telopeptides of type l collagen, by approximately 50% and 70%, respectively, to reach levels similar to those seen in healthy premenopausal women. Similar decreases were seen in patients in osteoporosis prevention studies who received Alendronate 5 mg/day. The decrease in the rate of bone resorption indicated by these markers was evident as early as one month and at three to six months reached a plateau that was maintained for the entire duration of treatment with Alendronate sodium. In osteoporosis treatment studies Alendronate 10 mg/day decreased the markers of bone formation, osteocalcin and bone specific alkaline phosphatase by approximately 50%, and total serum alkaline phosphatase by approximately 25 to 30% to reach a plateau after 6 to 12 months. In osteoporosis prevention studies Alendronate 5 mg/day decreased osteocalcin and total serum alkaline phosphatase by approximately 40% and 15%, respectively. Similar reductions in the rate of bone turnover were observed in postmenopausal women during one-year studies with once weekly Alendronate 70 mg for the treatment of osteoporosis and once weekly Alendronate 35 mg for the prevention of osteoporosis. These data indicate that the rate of bone turnover reached a new steady-state, despite the progressive increase in the total amount of Alendronate deposited within bone.

As a result of inhibition of bone resorption, asymptomatic reductions in serum calcium and phosphate concentrations were also observed following treatment with Alendronate sodium. In the long-term studies, reductions from baseline in serum calcium (approximately 2%) and phosphate (approximately 4 to 6%) were evident the first month after the initiation of Alendronate 10 mg. No further decreases in serum calcium were observed for the five-year duration of treatment; however, serum phosphate returned toward prestudy levels during years three through five. Similar reductions were observed with Alendronate 5 mg/day. In one-year studies with once weekly Alendronate 35 and 70 mg, similar reductions were observed at 6 and 12 months. The reduction in serum phosphate may reflect not only the positive bone mineral balance due to Alendronate sodium but also a decrease in renal phosphate reabsorption.

Osteoporosis in Men

Treatment of men with osteoporosis with Alendronate 10 mg/day for two years reduced urinary excretion of cross-linked N-telopeptides of type I collagen by approximately 60% and bone-specific alkaline phosphatase by approximately 40%. Similar reductions were observed in a one-year study in men with osteoporosis receiving once weekly Alendronate 70 mg.

Sustained use of glucocorticoids is commonly associated with development of osteoporosis and resulting fractures (especially vertebral, hip, and rib). It occurs both in males and females of all ages. Osteoporosis occurs as a result of inhibited bone formation and increased bone resorption resulting in net bone loss. Alendronate decreases bone resorption without directly inhibiting bone formation.

In clinical studies of up to two years’ duration, Alendronate 5 and 10 mg/day reduced cross-linked N-telopeptides of type I collagen (a marker of bone resorption) by approximately 60% and reduced bone-specific alkaline phosphatase and total serum alkaline phosphatase (markers of bone formation) by approximately 15 to 30% and 8 to 18%, respectively. As a result of inhibition of bone resorption, Alendronate 5 and 10 mg/day induced asymptomatic decreases in serum calcium (approximately 1 to 2%) and serum phosphate (approximately 1 to 8%).

Paget's Disease of Bone

Paget’s disease of bone is a chronic, focal skeletal disorder characterized by greatly increased and disorderly bone remodeling. Excessive osteoclastic bone resorption is followed by osteoblastic new bone formation, leading to the replacement of the normal bone architecture by disorganized, enlarged, and weakened bone structure.

Clinical manifestations of Paget’s disease range from no symptoms to severe morbidity due to bone pain, bone deformity, pathological fractures, and neurological and other complications. Serum alkaline phosphatase, the most frequently used biochemical index of disease activity, provides an objective measure of disease severity and response to therapy.

Alendronate sodium decreases the rate of bone resorption directly, which leads to an indirect decrease in bone formation. In clinical trials, Alendronate 40 mg once daily for six months produced significant decreases in serum alkaline phosphatase as well as in urinary markers of bone collagen degradation. As a result of the inhibition of bone resorption, Alendronate sodium induced generally mild, transient, and asymptomatic decreases in serum calcium and phosphate.

Pharmacokinetics

Relative to an intravenous reference dose, the mean oral bioavailability of Alendronate in women was 0.64% for doses ranging from 5 to 70 mg when administered after an overnight fast and two hours before a standardized breakfast. Oral bioavailability of the 10 mg tablet in men (0.59%) was similar to that in women when administered after an overnight fast and 2 hours before breakfast.

Alendronate 70 mg oral solution and Alendronate 70 mg tablet are equally bioavailable.

A study examining the effect of timing of a meal on the bioavailability of Alendronate was performed in 49 postmenopausal women. Bioavailability was decreased (by approximately 40%) when 10 mg Alendronate was administered either 0.5 or 1 hour before a standardized breakfast, when compared to dosing 2 hours before eating. In studies of treatment and prevention of osteoporosis, Alendronate was effective when administered at least 30 minutes before breakfast.

Bioavailability was negligible whether Alendronate was administered with or up to two hours after a standardized breakfast. Concomitant administration of Alendronate with coffee or orange juice reduced bioavailability by approximately 60%.

Preclinical studies (in male rats) show that Alendronate transiently distributes to soft tissues following 1 mg/kg intravenous administration but is then rapidly redistributed to bone or excreted in the urine. The mean steady-state volume of distribution, exclusive of bone, is at least 28 L in humans. Concentrations of drug in plasma following therapeutic oral doses are too low (less than 5 ng/mL) for analytical detection. Protein binding in human plasma is approximately 78%.

There is no evidence that Alendronate is metabolized in animals or humans.

Following a single intravenous dose of [ 14 C]Alendronate, approximately 50% of the radioactivity was excreted in the urine within 72 hours and little or no radioactivity was recovered in the feces. Following a single 10 mg intravenous dose, the renal clearance of Alendronate was 71 mL/min (64, 78; 90% confidence interval [CI]), and systemic clearance did not exceed 200 mL/min. Plasma concentrations fell by more than 95% within 6 hours following intravenous administration. The terminal half-life in humans is estimated to exceed 10 years, probably reflecting release of Alendronate from the skeleton. Based on the above, it is estimated that after 10 years of oral treatment with Alendronate (10 mg daily) the amount of Alendronate released daily from the skeleton is approximately 25% of that absorbed from the gastrointestinal tract.

Gender: Bioavailability and the fraction of an intravenous dose excreted in urine were similar in men and women.

Geriatric: Bioavailability and disposition (urinary excretion) were similar in elderly and younger patients. No dosage adjustment is necessary in elderly patients.

Race: Pharmacokinetic differences due to race have not been studied.

Renal Impairment: Preclinical studies show that, in rats with kidney failure, increasing amounts of drug are present in plasma, kidney, spleen, and tibia. In healthy controls, drug that is not deposited in bone is rapidly excreted in the urine. No evidence of saturation of bone uptake was found after 3 weeks dosing with cumulative intravenous doses of 35 mg/kg in young male rats. Although no formal renal impairment pharmacokinetic study has been conducted in patients, it is likely that, as in animals, elimination of Alendronate via the kidney will be reduced in patients with impaired renal function. Therefore, somewhat greater accumulation of Alendronate in bone might be expected in patients with impaired renal function.

No dosage adjustment is necessary for patients with creatinine clearance 35 to 60 mL/min. Alendronate sodium is not recommended for patients with creatinine clearance less than 35 mL/min due to lack of experience with Alendronate in renal failure.

Hepatic Impairment: As there is evidence that Alendronate is not metabolized or excreted in the bile, no studies were conducted in patients with hepatic impairment. No dosage adjustment is necessary.

Intravenous ranitidine was shown to double the bioavailability of oral Alendronate. The clinical significance of this increased bioavailability and whether similar increases will occur in patients given oral H 2 - antagonists is unknown.

In healthy subjects, oral prednisone (20 mg three times daily for five days) did not produce a clinically meaningful change in the oral bioavailability of Alendronate (a mean increase ranging from 20 to 44%).

Products containing calcium and other multivalent cations are likely to interfere with absorption of Alendronate.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Harderian gland (a retro-orbital gland not present in humans) adenomas were increased in high-dose female mice (p=0.003) in a 92-week oral carcinogenicity study at doses of Alendronate of 1, 3, and 10 mg/kg/day (males) or 1, 2, and 5 mg/kg/day (females). These doses are equivalent to approximately 0.1 to 1 times a maximum recommended daily dose of 40 mg (Paget’s disease) based on surface area, mg/m 2. The relevance of this finding to humans is unknown.

Parafollicular cell (thyroid) adenomas were increased in high-dose male rats (p=0.003) in a 2-year oral carcinogenicity study at doses of 1 and 3.75 mg/kg body weight. These doses are equivalent to approximately 0.3 and 1 times a 40 mg human daily dose based on surface area, mg/m 2. The relevance of this finding to humans is unknown.

Alendronate was not genotoxic in the in vitro microbial mutagenesis assay with and without metabolic activation, in an in vitro mammalian cell mutagenesis assay, in an in vitro alkaline elution assay in rat hepatocytes, and in an in vivo chromosomal aberration assay in mice. In an in vitro chromosomal aberration assay in Chinese hamster ovary cells, however, Alendronate gave equivocal results.

Alendronate had no effect on fertility (male or female) in rats at oral doses up to 5 mg/kg/day (approximately 1 times a 40 mg human daily dose based on surface area, mg/m 2 ).

Animal Toxicology and/or Pharmacology

The relative inhibitory activities on bone resorption and mineralization of Alendronate and etidronate were compared in the Schenk assay, which is based on histological examination of the epiphyses of growing rats. In this assay, the lowest dose of Alendronate that interfered with bone mineralization (leading to osteomalacia) was 6000-fold the antiresorptive dose. The corresponding ratio for etidronate was one to one. These data suggest that Alendronate administered in therapeutic doses is highly unlikely to induce osteomalacia.

Clinical Studies

Treatment of Osteoporosis in Postmenopausal Women

The efficacy of Alendronate 10 mg daily was assessed in four clinical trials. Study 1, a three-year, multicenter double-blind, placebo-controlled, U. S. clinical study enrolled 478 patients with a BMD T-score at or below minus 2.5 with or without a prior vertebral fracture; Study 2, a three-year, multicenter, double-blind placebo controlled Multinational clinical study enrolled 516 patients with a BMD T-score at or below minus 2.5 with or without a prior vertebral fracture; Study 3, the Three-Year Study of the Fracture Intervention Trial (FIT) a study which enrolled 2027 postmenopausal patients with at least one baseline vertebral fracture; and Study 4, the Four-Year Study of FIT: a study which enrolled 4432 postmenopausal patients with low bone mass but without a baseline vertebral fracture.

Effect on Fracture Incidence

To assess the effects of Alendronate sodium on the incidence of vertebral fractures (detected by digitized radiography; approximately one third of these were clinically symptomatic), the U. S. and Multinational studies were combined in an analysis that compared placebo to the pooled dosage groups of Alendronate (5 or 10 mg for three years or 20 mg for two years followed by 5 mg for one year). There was a statistically significant reduction in the proportion of patients treated with Alendronate sodium experiencing one or more new vertebral fractures relative to those treated with placebo (3.2% vs. 6.2%; a 48% relative risk reduction). A reduction in the total number of new vertebral fractures (4.2 vs. 11.3 per 100 patients) was also observed. In the pooled analysis, patients who received Alendronate sodium had a loss in stature that was statistically significantly less than was observed in those who received placebo (-3 mm vs. -4.6 mm).

The Fracture Intervention Trial (FIT) consisted of two studies in postmenopausal women: the Three-Year Study of patients who had at least one baseline radiographic vertebral fracture and the Four-Year Study of patients with low bone mass but without a baseline vertebral fracture. In both studies of FIT, 96% of randomized patients completed the studies (i. e. had a closeout visit at the scheduled end of the study); approximately 80% of patients were still taking study medication upon completion.

Fracture Intervention Trial: Three-Year Study (patients with at least one baseline radiographic vertebral fracture)

This randomized, double-blind, placebo-controlled, 2027-patient study (Alendronate sodium, n=1022; placebo, n=1005) demonstrated that treatment with Alendronate sodium resulted in statistically significant reductions in fracture incidence at three years as shown in Table 6.

Table 6: Effect of Alendronate Sodium on Fracture Incidence in the Three-Year Study of FIT (patients with vertebral fracture at baseline)

Percent of Patients

Furthermore, in this population of patients with baseline vertebral fracture, treatment with Alendronate sodium significantly reduced the incidence of hospitalizations (25% vs. 30.7%).

In the Three-Year Study of FIT, fractures of the hip occurred in 22 (2.2%) of 1005 patients on placebo and 11 (1.1%) of 1022 patients on Alendronate sodium, p=0.047. Figure 1 displays the cumulative incidence of hip fractures in this study.

Fracture Intervention Trial: Four-Year Study (patients with low bone mass but without a baseline radiographic vertebral fracture)

This randomized, double-blind, placebo-controlled, 4432-patient study (Alendronate sodium, n=2214; placebo, n=2218) further investigated the reduction in fracture incidence due to Alendronate sodium. The intent of the study was to recruit women with osteoporosis, defined as a baseline femoral neck BMD at least two standard deviations below the mean for young adult women. However, due to subsequent revisions to the normative values for femoral neck BMD, 31% of patients were found not to meet this entry criterion and thus this study included both osteoporotic and non-osteoporotic women. The results are shown in Table 7 for the patients with osteoporosis.

Table 7: Effect of Alendronate Sodium on Fracture Incidence in Osteoporotic* Patients in the Four-Year Study of FIT (patients without vertebral fracture at baseline)

Percent of Patients

Fracture Results Across Studies

In the Three-Year Study of FIT, Alendronate sodium reduced the percentage of women experiencing at least one new radiographic vertebral fracture from 15% to 7.9% (47% relative risk reduction, p<0.001); in the Four-Year Study of FIT, the percentage was reduced from 3.8% to 2.1% (44% relative risk reduction, p=0.001); and in the combined U. S./Multinational studies, from 6.2% to 3.2% (48% relative risk reduction, p=0.034).

Alendronate sodium reduced the percentage of women experiencing multiple (two or more) new vertebral fractures from 4.2% to 0.6% (87% relative risk reduction, p<0.001) in the combined U. S./Multinational studies and from 4.9% to 0.5% (90% relative risk reduction, p<0.001) in the Three-Year Study of FIT. In the Four-Year Study of FIT, Alendronate sodium reduced the percentage of osteoporotic women experiencing multiple vertebral fractures from 0.6% to 0.1% (78% relative risk reduction, p=0.035).

Thus, Alendronate sodium reduced the incidence of radiographic vertebral fractures in osteoporotic women whether or not they had a previous radiographic vertebral fracture.

Effect on Bone Mineral Density

The bone mineral density efficacy of Alendronate 10 mg once daily in postmenopausal women, 44 to 84 years of age, with osteoporosis (lumbar spine bone mineral density [BMD] of at least 2 standard deviations below the premenopausal mean) was demonstrated in four double-blind, placebo-controlled clinical studies of two or three years’ duration.

Figure 2 shows the mean increases in BMD of the lumbar spine, femoral neck, and trochanter in patients receiving Alendronate 10 mg/day relative to placebo-treated patients at three years for each of these studies.

At three years significant increases in BMD, relative both to baseline and placebo, were seen at each measurement site in each study in patients who received Alendronate 10 mg/day. Total body BMD also increased significantly in each study, suggesting that the increases in bone mass of the spine and hip did not occur at the expense of other skeletal sites. Increases in BMD were evident as early as three months and continued throughout the three years of treatment. (See Figure 3 for lumbar spine results.) In the two-year extension of these studies, treatment of 147 patients with Alendronate 10 mg/day resulted in continued increases in BMD at the lumbar spine and trochanter (absolute additional increases between years 3 and 5: lumbar spine, 0.94%; trochanter, 0.88%). BMD at the femoral neck, forearm and total body were maintained. Alendronate sodium was similarly effective regardless of age, race, baseline rate of bone turnover, and baseline BMD in the range studied (at least 2 standard deviations below the premenopausal mean).

In patients with postmenopausal osteoporosis treated with Alendronate 10 mg/day for one or two years, the effects of treatment withdrawal were assessed. Following discontinuation, there were no further increases in bone mass and the rates of bone loss were similar to those of the placebo groups.

Bone histology in 270 postmenopausal patients with osteoporosis treated with Alendronate at doses ranging from 1 to 20 mg/day for one, two, or three years revealed normal mineralization and structure, as well as the expected decrease in bone turnover relative to placebo. These data, together with the normal bone histology and increased bone strength observed in rats and baboons exposed to long-term Alendronate treatment, support the conclusion that bone formed during therapy with Alendronate sodium is of normal quality.

Effect on Height

Alendronate sodium, over a three - or four-year period, was associated with statistically significant reductions in loss of height vs. placebo in patients with and without baseline radiographic vertebral fractures. At the end of the FIT studies the between-treatment group differences were 3.2 mm in the Three-Year Study and 1.3 mm in the Four-Year Study.

The therapeutic equivalence of once weekly Alendronate 70 mg (n=519) and Alendronate 10 mg daily (n=370) was demonstrated in a one-year, double-blind, multicenter study of postmenopausal women with osteoporosis. In the primary analysis of completers, the mean increases from baseline in lumbar spine BMD at one year were 5.1% (4.8, 5.4%; 95% CI) in the 70 mg once-weekly group (n=440) and 5.4% (5, 5.8%; 95% CI) in the 10 mg daily group (n=330). The two treatment groups were also similar with regard to BMD increases at other skeletal sites. The results of the intention-to-treat analysis were consistent with the primary analysis of completers.

Concomitant Use with Estrogen/Hormone Replacement Therapy (HRT)

The effects on BMD of treatment with Alendronate 10 mg once daily and conjugated estrogen (0.625 mg/day) either alone or in combination were assessed in a two-year, double-blind, placebo-controlled study of hysterectomized postmenopausal osteoporotic women (n=425). At two years, the increases in lumbar spine BMD from baseline were significantly greater with the combination (8.3%) than with either estrogen or Alendronate sodium alone (both 6%).

The effects on BMD when Alendronate sodium was added to stable doses (for at least one year) of HRT (estrogen ± progestin) were assessed in a one-year, double-blind, placebo-controlled study in postmenopausal osteoporotic women (n=428). The addition of Alendronate 10 mg once daily to HRT produced, at one year, significantly greater increases in lumbar spine BMD (3.7%) vs. HRT alone (1.1%).

In these studies, significant increases or favorable trends in BMD for combined therapy compared with HRT alone were seen at the total hip, femoral neck, and trochanter. No significant effect was seen for total body BMD.

Histomorphometric studies of transiliac biopsies in 92 subjects showed normal bone architecture. Compared to placebo there was a 98% suppression of bone turnover (as assessed by mineralizing surface) after 18 months of combined treatment with Alendronate sodium and HRT, 94% on Alendronate sodium alone, and 78% on HRT alone. The long-term effects of combined Alendronate sodium and HRT on fracture occurrence and fracture healing have not been studied.

Prevention of Osteoporosis in Postmenopausal Women

Prevention of bone loss was demonstrated in two double-blind, placebo-controlled studies of postmenopausal women 40 to 60 years of age. One thousand six hundred nine patients (Alendronate 5 mg/day; n=498) who were at least six months postmenopausal were entered into a two-year study without regard to their baseline BMD. In the other study, 447 patients (Alendronate 5 mg/day; n=88), who were between six months and three years postmenopause, were treated for up to three years. In the placebo-treated patients BMD losses of approximately 1% per year were seen at the spine, hip (femoral neck and trochanter) and total body. In contrast, Alendronate 5 mg/day prevented bone loss in the majority of patients and induced significant increases in mean bone mass at each of these sites (see Figure 4). In addition, Alendronate 5 mg/day reduced the rate of bone loss at the forearm by approximately half relative to placebo. Alendronate 5 mg/day was similarly effective in this population regardless of age, time since menopause, race and baseline rate of bone turnover.

Bone histology was normal in the 28 patients biopsied at the end of three years who received Alendronate at doses of up to 10 mg/day.

The therapeutic equivalence of once weekly Alendronate 35 mg (n=362) and Alendronate 5 mg daily (n=361) was demonstrated in a one-year, double-blind, multicenter study of postmenopausal women without osteoporosis. In the primary analysis of completers, the mean increases from baseline in lumbar spine BMD at one year were 2.9% (2.6, 3.2%; 95% CI) in the 35 mg once-weekly group (n=307) and 3.2% (2.9, 3.5%; 95% CI) in the 5 mg daily group (n=298). The two treatment groups were also similar with regard to BMD increases at other skeletal sites. The results of the intention-to-treat analysis were consistent with the primary analysis of completers.

Treatment to Increase Bone Mass in Men with Osteoporosis

The efficacy of Alendronate sodium in men with hypogonadal or idiopathic osteoporosis was demonstrated in two clinical studies.

A two-year, double-blind, placebo-controlled, multicenter study of Alendronate 10 mg once daily enrolled a total of 241 men between the ages of 31 and 87 (mean, 63). All patients in the trial had either a BMD T-score less than or equal to -2 at the femoral neck and less than or equal to -1 at the lumbar spine, or a baseline osteoporotic fracture and a BMD T-score less than or equal to -1 at the femoral neck. At two years, the mean increases relative to placebo in BMD in men receiving Alendronate 10 mg/day were significant at the following sites: lumbar spine, 5.3%; femoral neck, 2.6%; trochanter, 3.1%; and total body, 1.6%. Treatment with Alendronate sodium also reduced height loss (Alendronate sodium, -0.6 mm vs. placebo, -2.4 mm).

A one-year, double-blind, placebo-controlled, multicenter study of once weekly Alendronate 70 mg enrolled a total of 167 men between the ages of 38 and 91 (mean, 66). Patients in the study had either a BMD T-score less than or equal to -2 at the femoral neck and less than or equal to -1 at the lumbar spine, or a BMD T-score less than or equal to -2 at the lumbar spine and less than or equal to -1 at the femoral neck, or a baseline osteoporotic fracture and a BMD T-score less than or equal to -1 at the femoral neck. At one year, the mean increases relative to placebo in BMD in men receiving Alendronate 70 mg once weekly were significant at the following sites: lumbar spine, 2.8%; femoral neck, 1.9%; trochanter, 2%; and total body, 1.2%. These increases in BMD were similar to those seen at one year in the 10 mg once-daily study.

In both studies, BMD responses were similar regardless of age (greater than or equal to 65 years vs. less than 65 years), gonadal function (baseline testosterone less than 9 ng/dL vs. greater than or equal to 9 ng/dL), or baseline BMD (femoral neck and lumbar spine T-score less than or equal to -2.5 vs. greater than -2.5).

Treatment of Glucocorticoid-Induced Osteoporosis

The efficacy of Alendronate 5 and 10 mg once daily in men and women receiving glucocorticoids (at least 7.5 mg/day of prednisone or equivalent) was demonstrated in two, one-year, double-blind, randomized, placebo

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KONTRA INDIKASI Hipersensitif, kerusakan ginjal dan hati, anemia, kehamilan trimester ke-3, menyusui.

PERHATIAN Hamil dan menyusui. Bayi prematur dan bayi baru lahir. Interaksi obat. Dikumarol, Fenitoin, Tolbutamid, Fenobarbital.

EFEK SAMPING Diskrasia darah, anemia aplastik, reaksi hipersensitif seperti anafilaktik, biduran/kaligata, gangguan saluran pencernaan.

INDEKS KEAMANAN PADA WANITA HAMIL Penelitian pada hewan menunjukkan efek samping pada janin ( teratogenik atau embriosidal atau lainnya) dan belum ada penelitian yang terkendali pada wanita atau penelitian pada wanita dan hewan belum tersedia. Obat seharusnya diberikan bila hanya keuntungan potensial memberikan alasan terhadap bahaya potensial pada janin.

KEMASAN Kapsul 250 mg x 10 x 10 biji.

DOSIS Dewasa. 3-4 kali sehari 1-2 kapsul.

PENYAJIAN Dikonsumsi pada perut kosong (1 atau 2 jam sebelum/sesudah makan)

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