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An antilipemic agent which reduces both cholesterol and triglycerides in the blood. [PubChem]

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Proctofene is a lipid regulating agent indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Proctofene is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Fenofibric acid, the active metabolite of Proctofene, produces reductions in total cholesterol, LDL cholesterol, apolipoprotein B, total triglycerides and triglyceride rich lipoprotein (VLDL) in treated patients. In addition, treatment with fenofibrate results in increases in high density lipoprotein (HDL) and apoproteins apoAI and apoAII.

Proctofene for patients

Proctofene Interactions

CAUTION SHOULD BE EXERCISED WHEN COUMARIN ANTICOAGULANTS ARE GIVEN IN CONJUNCTION WITH TRICOR. THE DOSAGE OF THE ANTICOAGULANTS SHOULD BE REDUCED TO MAINTAIN THE PROTHROMBIN TIME/INR AT THE DESIRED LEVEL TO PREVENT BLEEDING COMPLICATIONS. FREQUENT PROTHROMBIN TIME/INR DETERMINATIONS ARE ADVISABLE UNTIL IT HAS BEEN DEFINITELY DETERMINED THAT THE PROTHROMBIN TIME/INR HAS STABILIZED.

HMG-CoA reductase inhibitors

The combined use of TRICOR and HMG-CoA reductase inhibitors should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the increased risk of this drug combination.

Since bile acid sequestrants may bind other drugs given concurrently, patients should take TRICOR at least 1 hour before or 4-6 hours after a bile acid binding resin to avoid impeding its absorption.

Because cyclosporine can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including TRICOR, there is a risk that an interaction will lead to deterioration. The benefits and risks of using TRICOR with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dose employed.

In vitro studies using human liver microsomes indicate that fenofibrate and fenofibric acid are not inhibitors of cytochrome (CYP) P450 isoforms CYP3A4, CYP2D6, CYP2E1, or CYP1A2. They are weak inhibitors of CYP2C19 and CYP2A6, and mild-to-moderate inhibitors of CYP2C9 at therapeutic concentrations.

Potentiation of coumarin-type anticoagulants has been observed with prolongation of the prothrombin time/INR.

Bile acid sequestrants have been shown to bind other drugs given concurrently. Therefore, fenofibrate should be taken at least 1 hour before or 4-6 hours after a bile acid binding resin to avoid impeding its absorption.

Concomitant administration of fenofibrate (equivalent to 145mg TRICOR) with pravastatin (40 mg) once daily for 10 days has been shown to increase the mean C max and AUC values for pravastatin by 36% (range from 69% decrease to 321% increase) and 28% (range from 54% decrease to 128% increase), respectively, and for 3α-hydroxy-iso-pravastatin by 55% (range from 32% decrease to 314% increase) and 39% (range from 24% decrease to 261% increase), respectively in 23 healthy adults.

A single dose of pravastatin had no clinically important effect on the pharmacokinetics of fenofibric acid.

Concomitant administration of fenofibrate (equivalent to 145 mg TRICOR) with atorvastatin (20 mg) once daily for 10 days resulted in approximately 17% decrease (range from 67% decrease to 44% increase) in atorvastatin AUC values in 22 healthy males. The atorvastatin C max values were not significantly affected by fenofibrate. The pharmacokinetics of fenofibric acid were not significantly affected by atorvastatin.

Proctofene Contraindications

TRICOR is contraindicated in patients who exhibit hypersensitivity to fenofibrate.

TRICOR is contraindicated in patients with hepatic or severe renal dysfunction, including primary biliary cirrhosis, and patients with unexplained persistent liver function abnormality.

TRICOR is contraindicated in patients with preexisting gallbladder disease.

Additional information about Proctofene

Proctofene Indication: For use as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb) Mechanism Of Action: Proctofene exerts its therapeutic effects through activation of peroxisome proliferator activated receptor a (PPARa). This increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apoprotein C-III. The resulting fall in triglycerides produces an alteration in the size and composition of LDL from small, dense particles, to large buoyant particles. These larger particles have a greater affinity for cholesterol receptors and are catabolized rapidly. Drug Interactions: Anisindione The fibrate increases the anticoagulant effect Dicumarol The fibrate increases the anticoagulant effect Acenocoumarol The fibrate increases the anticoagulant effect Warfarin The fibrate increases the anticoagulant effect Atorvastatin Increased risk of myopathy/rhabdomyolysis Cerivastatin Increased risk of myopathy/rhabdomyolysis Fluvastatin Increased risk of myopathy/rhabdomyolysis Lovastatin Increased risk of myopathy/rhabdomyolysis Pravastatin Increased risk of myopathy/rhabdomyolysis Simvastatin Increased risk of myopathy/rhabdomyolysis Rosuvastatin Rosuvastatin possibly increases the effect of the fibrate Ursodeoxycholic acid The fibric acid derivative decreases the effect of ursodiol Food Interactions: Increased absorption - take with meals. Generic Name: Fenofibrate Synonyms: Fenofibrato [Inn-Spanish]; Fenofibratum [Inn-Latin]; FNF; Finofibrate Drug Category: Antilipemic Agents; Fribic Acid Derivatives Drug Type: Small Molecule; Approved Other Brand Names containing Fenofibrate: Ankebin; Antara; Elasterate; Elasterin; Fenobrate; Fenogal; Fenotard; Lipanthyl; Lipantil; Lipidex; Lipidil; Lipidil Micro; Lipidil Supra; Lipifen; Lipirex; Lipoclar; Lipofene; Liposit; Lipsin; Lofibra; Luxacor; Nolipax; Procetofen; Proctofene; Protolipan; Secalip; Sedufen; Tricor; Triglide; Absorption: Fenofibrate is well absorbed from the gastrointestinal tract. After absorption, fenofibrate is mainly excreted in the urine in the form of metabolites, primarily fenofibric acid and fenofibric acid glucuronide Toxicity (Overdose): LD 50 =1600 mg/kg (Oral, in mice); Investigated as a teratogen and reproductive hazard. Protein Binding:

99% (Serum protein binding) Biotransformation: Not Available Half Life: 20 hours Dosage Forms of Proctofene: Tablet Oral Capsule Oral Chemical IUPAC Name: propan-2-yl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate Chemical Formula: C20H21ClO4 Fenofibrate on Wikipedia: http://en. wikipedia. org/wiki/Fenofibrate Organisms Affected: Humans and other mammals

Standard Reference Data Program

Fenofibrate

Formula : C 20 H 21 ClO 4

Molecular weight : 360.831

IUPAC Standard InChI: InChI=1S/C20H21ClO4/c1-13(2)24-19(23)20(3,4)25-17-11-7-15(8-12-17)18(22)14-5-9-16(21)10-6-14/h5-13H,1-4H3

IUPAC Standard InChIKey: YMTINGFKWWXKFG-UHFFFAOYSA-N

CAS Registry Number: 49562-28-9

Chemical structure: View the 3d structure.

Other names: Tricor; Propanoic acid, 2-[4-(4-chlorobenzoyl)phenoxy]-2-methyl-, 1-methylethyl ester; Proctofene; Sedufen; 2-(4-(4-Chlorobenzoyl)phenoxy)-2-methylpropanoic acid 1-methylethyl ester; Isopropyl (4'-(p-chlorobenzoyl)-2-phenoxy-2-methyl)propionate; Lipanthyl; Lipantil; Lipidex; Lipifen; Lipoclar; Lipofene; Lipsin; Procetofen; Procetoken; Secalip; Isopropyl 2-[p-(p-chlorobenzoyl)phenoxy]-2-methylpropionate; Ankebin; Elasterin; Fenobrate; Fenotard; Lipidil; Liposit; Nolipax; Procetofene; Protolipan; Antara; Fenogal; Lipirex; NSC 281319; 2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropanoic acid, isopropyl ester (fenofibrate)

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Standard Reference Data Program



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FIVASA (ASACOL) INDICATIONS

Fivasa (mesalamine delayed-release tablets) tablets are indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis.

FIVASA (ASACOL) INSTRUCTIONS

Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without first checking with your doctor.

Keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.

You should take the delayed-release tablets with food. All other brands of capsules and tablets can be taken with or without food.

Swallow the capsule or tablet whole. Do not open, break, crush, or chew it before swallowing.

Do not change to another brand without checking with your doctor. The number of capsules or tablets that you take depends on the brand and strength of the medicine. If you refill your medicine and it looks different, check with your pharmacist. One tablet of Fivasa® HD 800 milligrams (mg) tablet may not work the same way as two Fivasa® 400 mg tablets.

If you are taking the extended-release capsule or the delayed-release tablet, part of the capsule or tablet may pass into your stool after your body has absorbed the medicine. This is normal and nothing to worry about.

If you miss a dose of this medicine, take 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. Do not double doses.

FIVASA (ASACOL) STORAGE

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 the treatment of mildly to moderately active ulcerative colitis:

The usual dosage in adults is two 400-mg tablets to be taken three times a day for a total daily dose of 2.4 grams for a duration of 6 weeks.

For the maintenance of remission of ulcerative colitis:

The recommended dosage in adults is 1.6 grams daily, in divided doses. Treatment duration in the prospective, well-controlled trial was 6 months.

Two Fivasa (mesalamine delayed-release tablets) 400 mg tablets have not been shown to be bioequivalent to one Fivasa® HD (mesalamine) delayed-release 800 mg tablet.

FIVASA (ASACOL) STORAGE

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

Store the delayed-release tablets in a tightly-closed container to protect them from moisture. Putting desiccant pouches in the container may also help to keep the tablets from getting moist.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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.

Before using Fivasa

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Izdaje se na liječnički recept Informacije za zdravstvene djelatnike

SASTAV 1 ml otopine sadržava 5 mg levobunolol hidroklorida i 0.04 mg benzalkonij klorida.

Pomoćni sastojci: dinatrijev edetat, natrijev metabisulfit, dinatrijev hidrogenfosfat, polivinil alkohol, kalijev dihidrogenfosfat, natrijev klorid, natrijev hi-droksid, solna kiselina i voda za injekcije.

FARMAKOTERAPIJSKA GRUPA VISTAGANŽ Liquifilm sadržava levobunolol, neselektivni antagonist beta-adrenergičnih receptora bez intrinzičnoga simpatomime-tičkog djelovanja. Pri lokalnoj uporabi u oku djelotvorno smanjuje očni tlak, sprječavajući nastajanje očne vodice u području cilijarnih resica. Podloga pripravka - Liquifilm (umjetne suze) - osigurava dobro podnošenje.

TERAPIJSKE INDIKACIJE Povećani očni tlak, kronični glaukom otvorenog kuta.

KONTRAINDIKACIJE Bronhijalna astma, bronhijalna astma u anamnezi, teška kronična opstruktivna bolest pluća, sinusna bradikardija, atrioventrikularni blok drugog i trećeg stupnja, dekompenzirana srčana insuficijencija, kardiogeni šok i preosjetljivost na bilo koji od sastojaka lijeka ili na blokatore beta-adre-nergičkih receptora.

MJERE OPREZA

Moguća je sistemska resorpcija levobunolola iz očnih kapi. Pri tome se mogu pojaviti jednake nuspojave kao i kod sistemske primjene blokatora beta-adrenergičkih receptora.

Poseban oprez potreban je kod bolesnika sa srčanom insuficijencijom, opstruktivnom bolešću pluća i dijabetesom, kod kojih je sistemska uporaba blokatora beta-adrener-gičkih receptora kontraindicirana.

Srčana insuficijencija: blokada beta-adre-nergičkih receptora može ubrzati teže zatajivanje srca. Takvim se bolesnicima mora često kontrolirati srčana frekvencija i krvni tlak.

Opstruktivne bolesti pluća: opasnost bronhospazma.

Šećerna bolest: VISTAGAN Ž Liquifilm se uz oprez daje bolesnicima koji su skloni spontanoj hipoglikemiji i dijabetičarima koji uzimaju peroralne hipoglikemike ili inzulin. Blokator beta-adrenergičkih receptora može maskirati znakove i simptome hipoglikemije.

Tijekom istovremene primjene kortikoste-roida mora se redovito kontrolirati očni tlak i stanje rožnice. Oprez je potreban i kod bolesnika koji istovremeno uzimaju psihotropne lijekove s adrenergičnim nuspojavama.

Do sada nema iskustva s primjenom VISTAGANŽ-a afakičnim bolesnicima

Bolesnicima s kroničnom upalom VISTAGANŽ se daje samo u strogo određenoj indikaciji i uz redovite oftalmološke kontrole.

Kada se VISTAGANŽ primjenjuje nakon operacije oka, mora se brižljivo i u kraćim vremenskim razmacima kontrolirati očni tlak.

Obzirom da nema dovoljno iskustava, ne savjetuje se primjena kod djece.

INTERAKCIJE Moguće je sinergističko djelovanje sa sistemskim antihipertenzivima, što dovodi do smanjenja krvnog tlaka. Peroralni blokatori beta-adrenergičkih receptora mogu potencirati djelovanje VISTAGANŽ-a. a posljedica toga je prejako smanjenje očnog tlaka. Pri istovremenoj primjeni peroralnih hipoglikemika ili inzulina i VISTAGANŽ-a moguć je pojačani hipoglikemični učinak pa i prikrivanje ranih simptoma akutne hipoglikemije.

TRUDNOĆA I DOJENJE Obzirom da nema dovoljno iskustava, primjena VISTAGANŽ-a ne savjetuje se kod trudnica i dojilja.

DOZIRANJE I NAčIN PRIMJENE Uobičajena doza je 2 puta na dan po jedna kap u bolesno oko. Kod blažih oblika očne hipertenzije dovoljna je samo jedna doza na dan. Kod vrlo teških oblika očne hipertenzije, VISTAGANŽ se može kombinirati s drugim lijekovima za liječenje glaukoma. Kada se jedna doza izostavi, sljedeći put se daje nepromijenjena doza (1 kap). Preporučuje se postupno napuštanje liječenja (doza se smanjuje nekoliko dana uzastopce). Bolesnici s kontaktnim lećama prije ukapavanja moraju odstraniti leće i ponovo ih smiju staviti nakon 15 minuta.

NUSPOJAVE Prolazna pekuća bol u oku, a rjeđe blefaro-konjunktivitis. Povremeno može doći do smanjenja krvnog tlaka i usporenja srčane frekvencije. Vrlo rijetko se javlja iridociklitis, glavobolja, prolazna ataksija, umor, omaglica, urtikarija i svrbež. Mogu se pojaviti i nuspojave koje su svojstvene sistemskoj uporabi blokatora beta-adrenergičkih receptora. O svakoj nuspojavi potrebno je izvijestiti liječnika ili Ijekarnika.

PREDOZIRANJE U slučaju predoziranja mogu se javiti sistemski učinci levobunolola (bradikardija, hipotenzija) pa se u tom slučaju preporučuje ispiranje oka vodom ili fiziološkom otopinom i simptomatsko liječenje.

čUVANJE I ROK VALJANOSTI Lijek se čuva zaštićen od svjetla na temperaturi do 25? C. Lijek treba čuvati izvan dosega djece! Rok valjanosti naveden je na kutiji i nakon tog datuma lijek se ne smije primjenjivati. Nakon prvog otvaranja bočice, lijek se smije primjenjivati još 4 tjedna.

NAčIN IZDAVANJA Izdaje se na liječnički recept.

OPREMA Kutija s plastičnom bočicom sa 5 ml 0.5%-tne otopine.



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Booking Details for Housekeeper’s Cottage

House Keepers Cottage: Sleeps 2 + 2

4 nights low season ?250. 7 nights low season ?450.

4 nights high season ?350. 7 nights high season ?650

Low season 2nd Saturday in September to Saturday before Easter. High Season includes weekend before Christmas to the end of weekend after New Year.

Trevina House (inc Housekeeper’s Cottage)

4 nights low season ?1500. 7 nights low season ?2000.

4 night high season ?1800. 7 nights high season ?2800.

Changeover We do not specify specific changeover dates as we offer both short breaks as well as traditional stays. We would suggest wherever possible to avoid the high season Friday/Saturday traffic jams on the A30.

Balance: payable on booking

Payments: accepted by cheque, or BACS .

Arrival/Departure: Guests can arrive from 4pm and should vacate the property by 10am on the day of departure, however, guests are welcome to use the grounds and gardens until 3pm of the day of departure.

Cottage Prices Include: rental, logs for fire, electricity, use of bed linen & towels. Also inc. Satellite HD package. Use of Internet Wifi & Nintendo Wii Games Console.

We can take in a supermarket delivery prior to arrival

Please check the full Terms and Conditions for further details and our Cancellation Policy

You can book Housekeeper’s Cottage either by calling us (Kevin and Sue) on 01579 321359 or by emailing us at kevin@trevina. com

Smoking is not permitted within Housekeepers Cottage. Pets are not permitted within Housekeepers Cottage or within the immediate garden around the House and Housekeeper’s Cottage

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Nexcital

Nexcital - Nexcital is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Nexcital affects chemicals in the brain that may become unbalanced and cause depression or anxiety.

Nexcital is used to treat anxiety in adults and major depressive disorder in adults and adolescents who are at least 12 years old.

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

Nexcital is an antidepressant. This medication selectively inhibits the reuptake of serotonin, increases the concentration of the neurotransmitter in the synaptic cleft, prolongs and enhances the action of serotonin on postsynaptic receptors. Nexcital practically does not bind to serotonin (5-HT), dopamine (D1 and D2) receptors, alpha-adrenergic-, m-cholinergic receptors, with benzodiazepine and opioid receptors.

Antidepressant effect of this drug is usually develops within 2-4 weeks after starting treatment. The maximum therapeutic effect of the treatment of panic disorder is reached at about 3 months after starting treatment.

Nexcital is one of a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). It is used to treat the depression associated with mood disorders. It is also used on occassion in the treatment of body dysmorphic disorder and anxiety. The antidepressant, antiobsessive-compulsive, and antibulimic actions of Nexcital are presumed to be linked to its inhibition of CNS neuronal uptake of serotonin. In vitro studies show that Nexcital is a potent and selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake. Nexcital has no significant affinity for adrenergic (alpha1, alpha2, beta), cholinergic, GABA, dopaminergic, histaminergic, serotonergic (5HT), or benzodiazepine receptors; antagonism of such receptors has been hypothesized to be associated with various anticholinergic, sedative, and cardiovascular effects for other psychotropic drugs. The chronic administration of Nexcital was found to downregulate brain norepinephrine receptors, as has been observed with other drugs effective in the treatment of major depressive disorder. Nexcital does not inhibit monoamine oxidase.

Nexcital is used to treat depression. It can also be used to treat anxiety disorders such as panic disorder, social anxiety disorder or obsessive-compulsive disorder (OCD). Nexcital belongs to a group of antidepressants known as Selective Serotonin Re-uptake Inhibitors (SSRIs).

Oral Depression

Adult: 10 mg once daily, increased if necessary. Max: 20 mg daily.

Elderly: Half the adult dose. Hepatic impairment: Dosage adjustments may be required.

Oral Obsessive compulsive disorder

Adult: 10 mg once daily, increased if necessary. Max: 20 mg daily.

Elderly: Half the adult dose. Hepatic impairment: Dosage adjustments may be required.

Oral Anxiety

Adult: 10 mg once daily, increased if necessary. Max: 20 mg daily.

Elderly: Half the adult dose. Hepatic impairment: Dosage adjustments may be required.

Oral Panic disorder

Adult: Initially, 5 mg daily, increased to 10 mg daily after 7 days. Max: 20 mg daily.

Elderly: Half the adult dose. Hepatic impairment: Dosage adjustments may be required.

Adult: PO Depression ; Anxiety ; Obsessive compulsive disorder 10 mg once daily. Max: 20 mg/day. Panic disorder Initial: 5 mg/day, up to 10 mg/day after 7 days if needed. Max: 20 mg/day.

Nexcital is used to treat depression and generalized anxiety disorder (GAD). It is an antidepressant that belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines work by increasing the activity of the chemical serotonin in the brain.

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Product Description Common use Prednisone is a corticosteroid used to reduce inflammation and alleviate symptoms in a variety of disorders, including rheumatoid arthritis and severe cases of asthma. Prednisone decreases or prevents tissues from responding to inflammation and also modifies the body's response to certain immune stimulation.

Dosage and direction Take it orally with or without food (it's recommended that prednisone be taken with food). Commonly used dosage is various from 5 to 60 mg per day and often is adjusted based on the response of the condition being treated. Corticosteroids should be used for several days for best result. Prolonged therapy with this drug causes the adrenal glands to atrophy and stop producing cortisol, so when Prednisone is discontinued after a period of prolonged therapy, the dose of Prednisone must be tapered to allow the adrenal glands time to recover. Note: this instruction presented here just for review. It's very necessary to consult your doctor before using. It will help you to get the best results.

Precautions You should not start taking Prednisone if you are suffering from a severe bacterial, fungal or viral infection. Do not use this drug without doctor's permission if your medical history includes: kidney disease, a psychiatric condition, heart disease or high blood pressure, liver disease, Diverticulitis, Ulcerative Colitis, or stomach ulcers, hypothyroidism, diabetes mellitus, Myasthenia gravis, osteoporosis or any other medical disorders. Do not stop taking Prednisone suddenly because your own adrenal glands cannot quickly produce enough cortisone. Also note that this drug increases appetite! So you must control your meal. Use caution in children because Prednisone can affect growth. Prednisone should not be used during pregnancy, becoming pregnant or lactating without doctor's advice. Do not use before breast-feeding without doctor's advice.

Contraindications Prednisone is not allowed to people who are hypersensitive to any components of this medicine. Also Prednisone contraindicated in the presence of infections, especially tuberculosis, fungal infectons, amebiasis, vaccinia and varicella, and antibiotic-resistant infections; lactation.

Possible side effect They may include all types of an allergic reaction. Also the most serious side effects include: problems with your vision; swelling, rapid weight gain, feeling short of breath; severe depression, unusual thoughts or behavior, seizure; bloody or tarry stools, coughing up blood; pancreatitis; low potassium; dangerously high blood pressure. Less serious include: sleep problems, mood changes; acne, dry skin, thinning skin, bruising or discoloration; slow wound healing; increased sweating; headache, dizziness, spinning sensation; nausea, stomach pain, bloating; changes in the shape or location of body fat. If you experience one of them stop using Prednisone and tell your doctor as soon as possible. Also consult with your doctor about any side effect that seems unusual.

Drug interaction Prednisine interacts with the following dugs: aspirin; a diuretic; a blood thinner such as warfarin; cyclosporine; insulin or diabetes medications you take by mouth; ketoconazole; rifampin; seizure medications such as phenytoin or phenobarbital. Also note that interaction between two medications does not always mean that you must stop taking one of them. As usual it affects the the effect of drugs, so consult with your doctor about how it interactions are being managed or should be managed.

Missed dose If you forgot to take your dose in time, please do it as soon as you remember. But do not take if it is too late or almost time for your next dose. Do not increase your recommended dose. Take your usually dose next day in the same regularly time.

Overdose Symptoms of Prednisone overdose may include thinning skin, easy bruising, changes in the shape or location of body fat, increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex. If you experience one of them or any unusual symptoms call your doctor immediately.

Storage Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture, kids and pets. Do not use after expiration term.

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.

Product Description Common use Prednisone is a corticosteroid used to reduce inflammation and alleviate symptoms in a variety of disorders, including rheumatoid arthritis and severe cases of asthma. Prednisone decreases or prevents tissues from responding to inflammation and also modifies the body's response to certain immune stimulation.

Dosage and direction Take it orally with or without food (it's recommended that prednisone be taken with food). Commonly used dosage is various from 5 to 60 mg per day and often is adjusted based on the response of the condition being treated. Corticosteroids should be used for several days for best result. Prolonged therapy with this drug causes the adrenal glands to atrophy and stop producing cortisol, so when Prednisone is discontinued after a period of prolonged therapy, the dose of Prednisone must be tapered to allow the adrenal glands time to recover. Note: this instruction presented here just for review. It's very necessary to consult your doctor before using. It will help you to get the best results.

Precautions You should not start taking Prednisone if you are suffering from a severe bacterial, fungal or viral infection. Do not use this drug without doctor's permission if your medical history includes: kidney disease, a psychiatric condition, heart disease or high blood pressure, liver disease, Diverticulitis, Ulcerative Colitis, or stomach ulcers, hypothyroidism, diabetes mellitus, Myasthenia gravis, osteoporosis or any other medical disorders. Do not stop taking Prednisone suddenly because your own adrenal glands cannot quickly produce enough cortisone. Also note that this drug increases appetite! So you must control your meal. Use caution in children because Prednisone can affect growth. Prednisone should not be used during pregnancy, becoming pregnant or lactating without doctor's advice. Do not use before breast-feeding without doctor's advice.

Contraindications Prednisone is not allowed to people who are hypersensitive to any components of this medicine. Also Prednisone contraindicated in the presence of infections, especially tuberculosis, fungal infectons, amebiasis, vaccinia and varicella, and antibiotic-resistant infections; lactation.

Possible side effect They may include all types of an allergic reaction. Also the most serious side effects include: problems with your vision; swelling, rapid weight gain, feeling short of breath; severe depression, unusual thoughts or behavior, seizure; bloody or tarry stools, coughing up blood; pancreatitis; low potassium; dangerously high blood pressure. Less serious include: sleep problems, mood changes; acne, dry skin, thinning skin, bruising or discoloration; slow wound healing; increased sweating; headache, dizziness, spinning sensation; nausea, stomach pain, bloating; changes in the shape or location of body fat. If you experience one of them stop using Prednisone and tell your doctor as soon as possible. Also consult with your doctor about any side effect that seems unusual.

Drug interaction Prednisine interacts with the following dugs: aspirin; a diuretic; a blood thinner such as warfarin; cyclosporine; insulin or diabetes medications you take by mouth; ketoconazole; rifampin; seizure medications such as phenytoin or phenobarbital. Also note that interaction between two medications does not always mean that you must stop taking one of them. As usual it affects the the effect of drugs, so consult with your doctor about how it interactions are being managed or should be managed.

Missed dose If you forgot to take your dose in time, please do it as soon as you remember. But do not take if it is too late or almost time for your next dose. Do not increase your recommended dose. Take your usually dose next day in the same regularly time.

Overdose Symptoms of Prednisone overdose may include thinning skin, easy bruising, changes in the shape or location of body fat, increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex. If you experience one of them or any unusual symptoms call your doctor immediately.

Storage Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture, kids and pets. Do not use after expiration term.

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.

Product Description Common use Prednisone is a corticosteroid used to reduce inflammation and alleviate symptoms in a variety of disorders, including rheumatoid arthritis and severe cases of asthma. Prednisone decreases or prevents tissues from responding to inflammation and also modifies the body's response to certain immune stimulation.

Dosage and direction Take it orally with or without food (it's recommended that prednisone be taken with food). Commonly used dosage is various from 5 to 60 mg per day and often is adjusted based on the response of the condition being treated. Corticosteroids should be used for several days for best result. Prolonged therapy with this drug causes the adrenal glands to atrophy and stop producing cortisol, so when Prednisone is discontinued after a period of prolonged therapy, the dose of Prednisone must be tapered to allow the adrenal glands time to recover. Note: this instruction presented here just for review. It's very necessary to consult your doctor before using. It will help you to get the best results.

Precautions You should not start taking Prednisone if you are suffering from a severe bacterial, fungal or viral infection. Do not use this drug without doctor's permission if your medical history includes: kidney disease, a psychiatric condition, heart disease or high blood pressure, liver disease, Diverticulitis, Ulcerative Colitis, or stomach ulcers, hypothyroidism, diabetes mellitus, Myasthenia gravis, osteoporosis or any other medical disorders. Do not stop taking Prednisone suddenly because your own adrenal glands cannot quickly produce enough cortisone. Also note that this drug increases appetite! So you must control your meal. Use caution in children because Prednisone can affect growth. Prednisone should not be used during pregnancy, becoming pregnant or lactating without doctor's advice. Do not use before breast-feeding without doctor's advice.

Contraindications Prednisone is not allowed to people who are hypersensitive to any components of this medicine. Also Prednisone contraindicated in the presence of infections, especially tuberculosis, fungal infectons, amebiasis, vaccinia and varicella, and antibiotic-resistant infections; lactation.

Possible side effect They may include all types of an allergic reaction. Also the most serious side effects include: problems with your vision; swelling, rapid weight gain, feeling short of breath; severe depression, unusual thoughts or behavior, seizure; bloody or tarry stools, coughing up blood; pancreatitis; low potassium; dangerously high blood pressure. Less serious include: sleep problems, mood changes; acne, dry skin, thinning skin, bruising or discoloration; slow wound healing; increased sweating; headache, dizziness, spinning sensation; nausea, stomach pain, bloating; changes in the shape or location of body fat. If you experience one of them stop using Prednisone and tell your doctor as soon as possible. Also consult with your doctor about any side effect that seems unusual.

Drug interaction Prednisine interacts with the following dugs: aspirin; a diuretic; a blood thinner such as warfarin; cyclosporine; insulin or diabetes medications you take by mouth; ketoconazole; rifampin; seizure medications such as phenytoin or phenobarbital. Also note that interaction between two medications does not always mean that you must stop taking one of them. As usual it affects the the effect of drugs, so consult with your doctor about how it interactions are being managed or should be managed.

Missed dose If you forgot to take your dose in time, please do it as soon as you remember. But do not take if it is too late or almost time for your next dose. Do not increase your recommended dose. Take your usually dose next day in the same regularly time.

Overdose Symptoms of Prednisone overdose may include thinning skin, easy bruising, changes in the shape or location of body fat, increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex. If you experience one of them or any unusual symptoms call your doctor immediately.

Storage Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture, kids and pets. Do not use after expiration term.

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.

Metformin is used for treating type 2 diabetes. It is used along with diet and exercise. It may be used alone or with other anti-diabetic medicines.

Use Metformin as directed by your doctor.

Take Metformin by mouth with food. Take Metformin on a regular schedule to get the most benefit from it. Taking Metformin at the same time each day will help you remember to take it. Continue taking Metformin even if you feel good. Do not miss any doses. Ask your health care provider any questions you may have about its usage.

Drug Class and Mechanism

Metformin is a biguanide antidiabetic. It works by decreasing the amount of sugar that the liver produces and the intestines absorb. It also helps to make your body more sensitive to the insulin that you naturally produce.

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

Store Metformin between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Metformin out of the reach of children and away from pets.

Do not use Metformin if:

you are allergic to any ingredient in Metformin; you have congestive heart failure that is treated by medicine; you have a severe infection, low blood oxygen levels, kidney or liver problems, high blood ketone or acid levels (e. g. diabetic ketoacidosis), or severe dehydration; you have had a stroke or a recent heart attack, or you are in shock; you are 80 years old or older and have not had a kidney function test; you will be having surgery or certain lab procedures. Contact your doctor or health care provider right away if any of these apply to you.

Important : Dizziness may occur while you are taking Metformin. This effect may be worse if you take it with alcohol or certain medicines. Use Metformin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Follow the diet and exercise program given to you by your health care provider. Do not drink large amounts of alcohol while you use Metformin. Talk to your doctor or health care provider before you drink alcohol while you use Metformin. Tell your doctor or dentist that you take Metformin before you receive any medical or dental care, emergency care, or surgery. Be careful not to become dehydrated, especially during hot weather or while you are being active. Dehydration may increase the risk of Metformin 's side effects. Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Metformin exactly as prescribed, tell your doctor. This medicine does not usually lower your blood sugar levels. Low blood sugar may be more likely to occur if you skip a meal, exercise heavily, or drink alcohol. It may also be more likely if you take Metformin along with certain medicines for diabetes (e. g. sulfonylureas, insulin). It is a good idea to carry a reliable source of glucose (e. g. 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 non-diet 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. Fever, infection, injury, or surgery may increase your risk for high or low blood sugar levels. If any of these occur, check your blood sugar closely and tell your doctor right away. Metformin may commonly cause stomach upset, indigestion, nausea, vomiting, or diarrhea at the beginning of treatment. If you develop unusual or unexpected stomach problems, or if you develop stomach problems later during treatment, contact your doctor at once. This may be a sign of lactic acidosis. Lab tests, including kidney function, fasting blood glucose, hemoglobin A1c, and blood counts, may be performed while you use Metformin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Metformin with caution in the elderly; they may be more sensitive to its effects. Low blood sugar levels may also be more difficult to recognize in the elderly. Metformin should not be used in children younger than 10 years old; safety and effectiveness in these children have not been confirmed. Pregnancy and breast-feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Metformin while you are pregnant. It is not known if Metformin is found in breast milk. Do not breast-feed while taking Metformin.

Possible Side Effects

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

Diarrhea; gas; headache; indigestion; nausea; stomach upset; temporary metallic taste; 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); chest pain or discomfort; dizziness or lightheadedness; fast or difficult breathing; feeling of being unusually cold; fever, chills, or persistent sore throat; general feeling of being unwell; muscle pain or weakness; slow or irregular heartbeat; unusual drowsiness; unusual or persistent stomach pain or discomfort; unusual tiredness or weakness.

If you have any questions about Hydrochlorothiazide, please talk with your doctor, pharmacist, or other health care provider. Metformin is to be used only by the patient for whom it is prescribed. Do not share it with other people.



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Spiroctan General Information

Spiroctan - Pharmacology:

Spiroctan is a specific pharmacologic antagonist of aldosterone, acting primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule. Spiroctan causes increased amounts of sodium and water to be excreted, while potassium is retained. Spiroctan acts both as a diuretic and as an antihypertensive drug by this mechanism. It may be given alone or with other diuretic agents which act more proximally in the renal tubule.

Spiroctan for patients

Patients who receive Aldactone should be advised to avoid potassium supplements and foods containing high levels of potassium including salt substitutes.

This description is suitable for active ingredient Spironolactone

Spiroctan Interactions

ACE inhibitors: Concomitant administration of ACE inhibitors with potassium-sparing diuretics has been associated with severe hyperkalemia.

Alcohol, barbiturates, or narcotics: Potentiation of orthostatic hypotension may occur.

Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia, may occur.

Pressor amines (eg, norepinephrine): Spiroctan reduces the vascular responsiveness to norepinephrine. Therefore, caution should be exercised in the management of patients subjected to regional or general anesthesia while they are being treated with Aldactone.

Skeletal muscle relaxants, nondepolarizing (eg, tubocurarine): Possible increased responsiveness to the muscle relaxant may result.

Lithium: Lithium generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity.

Nonsteroidal anti-inflammatory drugs (NSAIDs): In some patients, the administration of an NSAID can reduce the diuretic, natriuretic, and antihypertensive effect of loop, potassium-sparing and thiazide diuretics. Combination of NSAIDs, eg, indomethacin, with potassium-sparing diuretics has been associated with severe hyperkalemia. Therefore, when Aldactone and NSAIDs are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.

Digoxin: Spiroctan has been shown to increase the half-life of digoxin. This may result in increased serum digoxin levels and subsequent digitalis toxicity. It may be necessary to reduce the maintenance and digitalization doses when spironolactone is administered, and the patient should be carefully monitored to avoid over - or underdigitalization.

Drug/Laboratory Test Interactions

Several reports of possible interference with digoxin radioimmunoassays by spironolactone, or its metabolites, have appeared in the literature. Neither the extent nor the potential clinical significance of its interference (which may be assay-specific) has been fully established.

Spiroctan Contraindications

Aldactone is contraindicated for patients with anuria, acute renal insufficiency, significant impairment of renal excretory function, or hyperkalemia.

This description is suitable for active ingredient Spironolactone

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Cefaclor

Chemical Name

5-tia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[(aminophenylacetyl)amino]-3-chloro-8-oxo-, [6R-[6?,7?(R*)]]-

Foreign Names

Cefaclorum (Latin)

Cefaclor (German)

Cefaclor (French)

Cefaclor (Spanish)

Generic Names

Cefaclor (OS: USAN, JAN, BAN)

Cefacloro (OS: DCIT)

Cefeaclor (OS: DCF)

Cephaclor (IS)

Compound 99638 (IS: Lilly)

Cefaclor (PH: JP XVI, USP 38)

Cephaclor-1-Wasser (IS)

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Cefaclor (PH: BP 2016, Ph. Eur. 8, USP 38)

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Brand Names



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Lerin Name Meaning & Origin

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Comments and insights on the name Lerin: | Edit

If you want soemthing with this name on it, it has to be custom made. Look at this as you will, but for me growing up, it was somewhat of a drawback. Though, I did find an online clothing store and a winery/wine named Lerin!

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My name is Lerin. It rhymes with Erin. My dad came up with it when my mother was pregnant with me. I love having an unusual name. I'm a Lerin, too. I was enjoying being the only one until adulthood when I found another one. As far as unique goes, no other name beats it. I always get comments on my name. It is timeless. I love my name, as long as people learn to pronounce it correctly.

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European Medicines Agency, Bicaluplex

Bicaluplex

Bicaluplex and associated names, 150 mg, film-coated tablet, is an oral anti-androgen used in the management of prostate cancer.

Ingers Industrials Solutions s. r.o submitted applications for mutual recognition of Bicaluplex and associated names, 150 mg, film-coated tablet on the basis of the marketing authorisation granted by Czech Republic on 30 November 2005. The Mutual Recognition Procedure started on 21 September 2006. The Reference Member State was Czech Republic and the Concerned Member States were Austria, Denmark, Germany, Estonia, Greece, France, Hungary, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Sweden, Slovenia, Slovak Republic and the United Kingdom. These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State. Czech Republic referred the reasons for disagreement to the EMEA on 30 March 2007.

Significant differences have been identified with regard to the benefit/risk ratio of the product. This refers to two indications (treatment of locally advanced prostatic carcinoma without metastases, for which surgical castration or other type of medical intervention is not indicated or unacceptable; and as monotherapy in early treatment or as an adjunct to treatment with radiotherapy or radical prostatectomy in patients with prostatic carcinoma (T3-T4, any Stage N, M0) and this was considered to be of serious public health concern.

The arbitration procedure started on 26 April 2007 with the adoption of a list of questions. The Rapporteur was Dr Ondrej Slanar and Co-Rapporteur was Dr Matthew Thatcher. The Marketing Authorisation Holder provided written explanations on 20 July 2007.

During their September 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Bicaluplex and associated names, that the objections raised by Germany should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended. A positive opinion was adopted by consensus on 20 September 2007.

The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.

The final opinion was converted into a Decision by the European Commission on 22 November 2007.

Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions

Summary of Opinion - contains the CHMP opinion of the referred medicine(s)

List of the medicines affected by the referral (Annex I)

Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes have been recommended by the Committee

Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status: European Commission final decision

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We're sorry. The page you are looking for was not found. We apologize for any inconvenience.

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We're sorry. The page you are looking for was not found. We apologize for any inconvenience.

Here are some links that may be helpful in finding what you are looking for:

FFIEC Information

FFIEC Home Page - The main entry point into the FFIEC Web site.

Site Index - The site map is a listing of all documents on the site.

HMDA Information

FFIEC HMDA Home Page - The main entry point into the FFIEC HMDA Web site.

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Antibiotics - Aelxim-cl (Brand name: cefixime)

Cefixime is used to treat many different types of infections caused by bacteria. Cefixime may also be used for other purposes not listed in this medication guide.

Use Cefixime as directed by your doctor.

Take this medicine with a full glass of water. Cefixime works best if you take it with a meal or within 30 minutes of a meal. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time. Ask your health care provider any questions you may have about how to use Cefixime.

Drug Class and Mechanism

Cefixime is in a group of drugs called cephalosporin (SEF a low spor in) antibiotics. It works by fighting bacteria in your body.

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

Store Cefixime at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep Cefixime out of the reach of children and away from pets. Warnings/Precautions

Do not use Cefixime if:

you are allergic to any ingredient in Cefixime or to other cephalosporins (e. g. cephalexin); you will be having a live typhoid vaccine. Contact your doctor or health care provider right away if any of these apply to you.

Important : Cefixime may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Cefixime with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Cefixime only works against bacteria; it does not treat viral infections (eg, the common cold). Be sure to use Cefixime 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 Cefixime may cause a second infection. Tell your doctor if signs of a second infection occur. 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. Cefixime may reduce the ability of your blood to clot. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bleeding or bruising or dark, tarry, or bloody stools. Diabetes patients - Cefixime may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine. Cefixime may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Cefixime. Pregnancy and breast-feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cefixime while you are pregnant. It is not known if Cefixime is found in breast milk. If you are or will be breast-feeding while you use Cefixime, check with your doctor or pharmacist. Discuss any possible risks to your baby.

Possible Side Effects

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

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Cefixime 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.



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Carbamazepine

SERIOUS DERMATOLOGIC REACTIONS AND HLA-B * 1502 ALLELE

SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC EPIDERMAL NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING TREATMENT WITH CARBAMAZEPINE. THESE REACTIONS ARE ESTIMATED TO OCCUR IN 1 TO 6 PER 10,000 NEW USERS IN COUNTRIES WITH MAINLY CAUCASIAN POPULATIONS, BUT THE RISK IN SOME ASIAN COUNTRIES IS ESTIMATED TO BE ABOUT 10 TIMES HIGHER. STUDIES IN PATIENTS OF CHINESE ANCESTRY HAVE FOUND A STRONG ASSOCIATION BETWEEN THE RISK OF DEVELOPING SJS/TEN AND THE PRESENCE OF HLA-B*1502, AN INHERITED ALLELIC VARIANT OF THE HLA-B GENE. HLA-B*1502 IS FOUND ALMOST EXCLUSIVELY IN PATIENTS WITH ANCESTRY ACROSS BROAD AREAS OF ASIA. PATIENTS WITH ANCESTRY IN GENETICALLY AT-RISK POPULATIONS SHOULD BE SCREENED FOR THE PRESENCE OF HLA-B*1502 PRIOR TO INITIATING TREATMENT WITH CARBAMAZEPINE. PATIENTS TESTING POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH Carbamazepine UNLESS THE BENEFIT CLEARLY OUTWEIGHS THE RISK (SEE WARNINGS AND PRECAUTIONS, LABORATORY TESTS ).

APLASTIC ANEMIA AND AGRANULOCYTOSIS

APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF CARBAMAZEPINE. DATA FROM A POPULATION-BASED CASE CONTROL STUDY DEMONSTRATE THAT THE RISK OF DEVELOPING THESE REACTIONS IS 5 TO 8 TIMES GREATER THAN IN THE GENERAL POPULATION. HOWEVER, THE OVERALL RISK OF THESE REACTIONS IN THE UNTREATED GENERAL POPULATION IS LOW, APPROXIMATELY SIX PATIENTS PER ONE MILLION POPULATION PER YEAR FOR AGRANULOCYTOSIS AND TWO PATIENTS PER ONE MILLION POPULATION PER YEAR FOR APLASTIC ANEMIA.

ALTHOUGH REPORTS OF TRANSIENT OR PERSISTENT DECREASED PLATELET OR WHITE BLOOD CELL COUNTS ARE NOT UNCOMMON IN ASSOCIATION WITH THE USE OF CARBAMAZEPINE, DATA ARE NOT AVAILABLE TO ESTIMATE ACCURATELY THEIR INCIDENCE OR OUTCOME. HOWEVER, THE VAST MAJORITY OF THE CASES OF LEUKOPENIA HAVE NOT PROGRESSED TO THE MORE SERIOUS CONDITIONS OF APLASTIC ANEMIA OR AGRANULOCYTOSIS.

BECAUSE OF THE VERY LOW INCIDENCE OF AGRANULOCYTOSIS AND APLASTIC ANEMIA, THE VAST MAJORITY OF MINOR HEMATOLOGIC CHANGES OBSERVED IN MONITORING OF PATIENTS ON Carbamazepine ARE UNLIKELY TO SIGNAL THE OCCURRENCE OF EITHER ABNORMALITY. NONETHELESS, COMPLETE PRETREATMENT HEMATOLOGICAL TESTING SHOULD BE OBTAINED AS A BASELINE. IF A PATIENT IN THE COURSE OF TREATMENT EXHIBITS LOW OR DECREASED WHITE BLOOD CELL OR PLATELET COUNTS, THE PATIENT SHOULD BE MONITORED CLOSELY. DISCONTINUATION OF THE DRUG SHOULD BE CONSIDERED IF ANY EVIDENCE OF SIGNIFICANT BONE MARROW DEPRESSION DEVELOPS.

Before prescribing carbamazepine, the physician should be thoroughly familiar with the details of this prescribing information, particularly regarding use with other drugs, especially those which accentuate toxicity potential.

Carbamazepine Description

Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as chewable tablets of 100 mg and tablets of 100 mg, 200 mg, 300 mg, 400 mg. Its chemical name is 5H - dibenz[ b, f ]azepine-5-carboxamide, and its structural formula is:

Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27.

Carbamazepine tablets, USP, 100 mg, 200 mg, 300 mg and 400 mg contain the inactive ingredients: colloidal silicon dioxide, FD&C Red #40 aluminum lake, hypromellose, magnesium stearate, pregelatinized maize starch, corn starch, and sodium starch glycolate.

Carbamazepine tablets, USP, (chewable) contain the inactive ingredients: artificial flavors, colloidal silicon dioxide, compressible sugar, corn starch, FD&C Red #40 aluminum lake, hydroxypropyl methyl cellulose, magnesium stearate, and sodium starch glycolate.

Carbamazepine tablets, USP, 100 mg, 200 mg, 300 mg, and 400 mg meet USP Dissolution Test 2 and Carbamazepine Tablets USP (Chewable), 100 mg meet USP Dissolution Test 1.

Carbamazepine - Clinical Pharmacology

In controlled clinical trials, Carbamazepine has been shown to be effective in the treatment of psychomotor and grand mal seizures, as well as trigeminal neuralgia.

Mechanism of Action

Carbamazepine has demonstrated anticonvulsant properties in rats and mice with elec trically and chemically induced seizures. It appears to act by reducing polysynaptic responses and blocking the post-tetanic potentiation. Carbamazepine greatly reduces or abolishes pain induced by stimulation of the infraorbital nerve in cats and rats. It depresses thalamic potential and bulbar and polysynaptic reflexes, including the lin guomandibular reflex in cats. Carbamazepine is chemically unrelated to other anticonvulsants or other drugs used to control the pain of trigeminal neuralgia. The mechanism of action remains unknown.

The principal metabolite of carbamazepine, carbamazepine-10,11-epoxide, has anticon vulsant activity as demonstrated in several in vivo animal models of seizures. Though clinical activity for the epoxide has been postulated, the significance of its activity with respect to the safety and efficacy of Carbamazepine has not been established.

Pharmacokinetics

In clinical studies, Carbamazepine suspension, conventional tablets, and extended-release tablets delivered equivalent amounts of drug to the systemic circulation. However, the suspension was absorbed somewhat faster, and the extended-release tablet slightly slower, than the conventional tablet. The bioavailability of the extended-release tablet was 89% compared to suspension. Following a b. i.d. dosage regimen, the suspension provides higher peak levels and lower trough levels than those obtained from the conventional tablet for the same dosage regimen. On the other hand, follow ing a t. i.d. dosage regimen, Carbamazepine suspension affords steady-state plasma levels comparable to Carbamazepine tablets given b. i.d. when administered at the same total mg daily dose. Following a b. i.d. dosage regimen, carbamazepine-extended - release tablets afford steady-state plasma levels comparable to conventional Carbamazepine tablets given q. i.d. when administered at the same total mg daily dose. Carbamazepine in blood is 76% bound to plasma proteins. Plasma levels of carba mazepine are variable and may range from 0.5 to 25 mcg/mL, with no apparent relationship to the daily intake of the drug. Usual adult therapeutic levels are between 4 and 12 mcg/mL. In polytherapy, the concentration of Carbamazepine and concomitant drugs may be increased or decreased during therapy, and drug effects may be altered (see PRE CAUTIONS, Drug Interactions). Following chronic oral administration of suspension, plasma levels peak at approximately 1.5 hours compared to 4 to 5 hours after adminis tration of conventional Carbamazepine tablets, and 3 to 12 hours after administration of carbamazepine-extended-release tablets. The CSF/serum ratio is 0.22, similar to the 24% unbound Carbamazepine in serum. Because Carbamazepine induces its own metabolism, the half-life is also variable. Autoinduction is completed after 3 to 5 weeks of a fixed dosing regimen. Initial half-life values range from 25 to 65 hours, decreasing to 12 to 17 hours on repeated doses. Carbamazepine is metabolized in the liver. Cytochrome P450 3A4 was identified as the major isoform responsible for the formation of carba mazepine-10,11-epoxide from carbamazepine. Human microsomal epoxide hydrolase has been identified as the enzyme responsible for the formation of the 10,11-transdiol derivative from carbamazepine-10,11 epoxide. After oral administration of 14 C-carbamazepine, 72% of the administered radioactivity was found in the urine and 28% in the feces. This urinary radioactivity was composed largely of hydroxylated and conjugated metabolites, with only 3% of unchanged carbamazepine.

The pharmacokinetic parameters of Carbamazepine disposition are similar in children and in adults. However, there is a poor correlation between plasma concentrations of Carbamazepine and Carbamazepine dose in children. Carbamazepine is more rapidly metabolized to carbamazepine-10,11-epoxide (a metabolite shown to be equipotent to Carbamazepine as an anticonvulsant in animal screens) in the younger age groups than in adults. In children below the age of 15, there is an inverse relationship between CBZ - E/CBZ ratio and increasing age (in one report from 0.44 in children below the age of 1 year to 0.18 in children between 10 to 15 years of age).

The effects of race and gender on Carbamazepine pharmacokinetics have not been systematically evaluated.

Indications and Usage for Carbamazepine

Epilepsy

Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of Carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types:

Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types.

Generalized tonic-clonic seizures (grand mal).

Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by Carbamazepine (see PRECAUTIONS, General ).

Trigeminal Neuralgia

Carbamazepine is indicated in the treatment of the pain associated with true trigeminal neuralgia.

Beneficial results have also been reported in glossopharyngeal neuralgia.

This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains.

Contraindications

Carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc. Likewise, on theoretical grounds its use with monoamine oxidase (MAO) inhibitors is not recommended. Before administration of carbamazepine, MAO inhibitors should be dis continued for a minimum of 14 days, or longer if the clinical situation permits.

Coadministration of Carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Coadministration of Carbamazepine with nefazodone is contraindicated.

Warnings

Serious Dermatologic Reactions

Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported with Carbamazepine treatment. The risk of these events is estimated to be about 1 to 6 per 10,000 new users in countries with mainly Caucasian populations. However, the risk in some Asian countries is estimated to be about 10 times higher. Carbamazepine should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered.

SJS/TEN and HLA-B*1502 Allele

Retrospective case-control studies have found that in patients of Chinese ancestry there is a strong association between the risk of developing SJS/TEN with Carbamazepine treatment and the presence of an inherited variant of the HLA-B gene, HLA-B * 1502. The occurrence of higher rates of these reactions in countries with higher frequencies of this allele suggests that the risk may be increased in allele-positive individuals of any ethnicity.

Across Asian populations, notable variation exists in the prevalence of HLA-B*1502. Greater than 15% of the population is reported positive in Hong Kong, Thailand, Malaysia, and parts of the Philippines, compared to about 10% in Taiwan and 4% in North China. South Asians, including Indians, appear to have intermediate prevalence of HLA-B*1502, averaging 2% to 4%, but higher in some groups. HLA-B*1502 is pres ent in less than 1% of the population in Japan and Korea.

HLA-B*1502 is largely absent in individuals not of Asian origin (e. g. Caucasians, African-Americans, Hispanics, and Native Americans).

Prior to initiating Carbamazepine therapy, testing for HLA-B * 1502 should be performed in patients with ancestry in populations in which HLA-B * 1502 may be present. In deciding which patients to screen, the rates provided above for the prevalence of HLA-B * 1502 may offer a rough guide, keeping in mind the limitations of these figures due to wide variability in rates even within ethnic groups, the difficulty in ascertaining ethnic ancestry, and the likelihood of mixed ancestry. Carbamazepine should not be used in patients positive for HLA-B * 1502 unless the benefits clearly outweigh the risks. Tested patients who are found to be negative for the allele are thought to have a low risk of SJS/TEN (see BOXED WARNING and PRECAUTIONS, Laboratory Tests ).

Over 90% of Carbamazepine treated patients who will experience SJS/TEN have this reaction within the first few months of treatment. This information may be taken into consideration in determining the need for screening of genetically at-risk patients currently on carbamazepine.

The HLA-B*1502 allele has not been found to predict risk of less severe adverse cuta-neous reactions from Carbamazepine such as maculopapular eruption (MPE) or to predict Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

Limited evidence suggests that HLA-B*1502 may be a risk factor for the development of SJS/TEN in patients of Chinese ancestry taking other antiepileptic drugs associated with SJS/TEN, including phenytoin. Consideration should be given to avoiding use of other drugs associated with SJS/TEN in HLA-B*1502 positive patients, when alternative therapies are otherwise equally acceptable.

Hypersensitivity Reactions and HLA-A*3101 Allele

Retrospective case-control studies in patients of European, Korean, and Japanese ancestry have found a moderate association between the risk of developing hypersensitivity reactions and the presence of HLA-A*3101, an inherited allelic variant of the HLA-A gene, in patients using carbamazepine. These hypersensitivity reactions include SJS/TEN, maculopapular eruptions, and Drug Reaction with Eosinophilia and Systemic Symptoms (see DRESS/Multiorgan hypersensitivity below).

HLA-A*3101 is expected to be carried by more than 15% of patients of Japanese, Native American, Southern Indian (for example, Tamil Nadu) and some Arabic ancestry; up to about 10% in patients of Han Chinese, Korean, European, Latin American, and other Indian ancestry; and up to about 5% in African-Americans and patients of Thai, Taiwanese, and Chinese (Hong Kong) ancestry.

The risks and benefits of Carbamazepine therapy should be weighed before considering Carbamazepine in patients known to be positive for HLA-A*3101.

Application of HLA genotyping as a screening tool has important limitations and must never substitute for appropriate clinical vigilance and patient management. Many HLA-B*1502-positive and HLA-A*3101-positive patients treated with Carbamazepine will not develop SJS/TEN or other hypersensitivity reactions, and these reactions can still occur infrequently in HLA-B*1502-negative and HLA-A*3101-negative patients of any ethnicity. The role of other possible factors in the development of, and morbidity from, SJS/TEN and other hypersensitivity reactions, such as antiepileptic drug (AED) dose, compliance, concomitant medications, comorbidities, and the level of dermatologic monitoring, have not been studied.

Aplastic Anemia and Agranulocytosis

Aplastic anemia and agranulocytosis have been reported in association with the use of Carbamazepine (see Boxed Warning). Patients with a history of adverse hematologic reaction to any drug may be particularly at risk of bone marrow depression.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has occurred with carbamazepine. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy, in association with other organ system involvement, such as hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. Eosinophilia is often present. This disorder is variable in its expression, and other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity (e. g. fever, lymphadenopathy) may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. Carbamazepine should be discontinued if an alternative etiology for the signs or symptoms cannot be established.

Hypersensitivity reactions to Carbamazepine have been reported in patients who previously experienced this reaction to anticonvulsants including phenytoin, primidone, and phenobarbital. If such history is present, benefits and risks should be carefully considered and, if Carbamazepine is initiated, the signs and symptoms of hypersensitivity should be carefully monitored.

Patients should be informed that about a third of patients who have had hypersensitivity reactions to Carbamazepine also experience hypersensitivity reactions with oxcarbazepine (Trileptal ® ).

Suicidal Behavior and Ideation

Antiepileptic drugs (AEDs), including carbamazepine, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Pooled analyses of 199 placebo-controlled clinical trials (mono - and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.

The increased risk of suicidal thoughts or behavior with AEDs was observed as early as one week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.

The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed. Table 1 shows absolute and relative risk by indication for all evaluated AEDs.

Table 1 Risk by Indication for Antiepileptic Drugs in the Pooled Analysis

Placebo Patients with Events Per 1,000 Patients

The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.

Anyone considering prescribing Carbamazepine or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

General

Carbamazepine has shown mild anticholinergic activity that may be associated with increased intraocular pressure; therefore, patients with increased intraocular pressure should be closely observed during therapy.

Because of the relationship of the drug to other tricyclic compounds, the possibility of activation of a latent psychosis and, in elderly patients, of confusion or agitation should be borne in mind.

The use of Carbamazepine should be avoided in patients with a history of hepatic por phyria (e. g. acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda). Acute attacks have been reported in such patients receiving Carbamazepine therapy. Carbamazepine administration has also been demonstrated to increase porphyrin precur sors in rodents, a presumed mechanism for the induction of acute attacks of porphyria.

As with all antiepileptic drugs, Carbamazepine should be withdrawn gradually to mini mize the potential of increased seizure frequency.

Hyponatremia can occur as a result of treatment with carbamazepine. In many cases, the hyponatremia appears to be caused by the syndrome of inappropriate antidiuretic hormone secretion (SIADH). The risk of developing SIADH with Carbamazepine treatment appears to be dose-related. Elderly patients and patients treated with diuretics are at greater risk of developing hyponatremia. Consider discontinuing Carbamazepine in patients with symptomatic hyponatremia. Signs and symptoms of hyponatremia include headache, new or increased seizure frequency, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls. Consider discontinuing Carbamazepine in patients with symptomatic hyponatremia.

Usage in Pregnancy

Carbamazepine can cause fetal harm when administered to a pregnant woman.

Epidemiological data suggest that there may be an association between the use of carba mazepine during pregnancy and congenital malformations, including spina bifida. There have also been reports that associate Carbamazepine with developmental disorders and congenital anomalies (e. g. craniofacial defects, cardiovascular malformations, and anom alies involving various body systems). Developmental delays based on neurobehavioral assessments have been reported. When treating or counseling women of childbearing poten tial, the prescribing physician will wish to weigh the benefits of therapy against the risks. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Retrospective case reviews suggest that, compared with monotherapy, there may be a higher prevalence of teratogenic effects associated with the use of anticonvulsants in combination therapy. Therefore, if therapy is to be continued, monotherapy may be preferable for pregnant women.

In humans, transplacental passage of Carbamazepine is rapid (30 to 60 minutes), and the drug is accumulated in the fetal tissues, with higher levels found in liver and kidney than in brain and lung.

Carbamazepine has been shown to have adverse effects in reproduction studies in rats when given orally in dosages 10 to 25 times the maximum human daily dosage (MHDD) of 1200 mg on a mg/kg basis or 1.5 to 4 times the MHDD on a mg/m 2 basis. In rat tera tology studies, 2 of 135 offspring showed kinked ribs at 250 mg/kg and 4 of 119 offspring at 650 mg/kg showed other anomalies (cleft palate, 1; talipes, 1; anophthal mos, 2). In reproduction studies in rats, nursing offspring demonstrated a lack of weight gain and an unkempt appearance at a maternal dosage level of 200 mg/kg.

Antiepileptic drugs should not be discontinued abruptly in patients in whom the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In individual cases where the severity and frequency of the seizure disorder are such that removal of medication does not pose a serious threat to the patient, discontinuation of the drug may be considered prior to and during pregnancy, although it cannot be said with any confidence that even minor seizures do not pose some hazard to the developing embryo or fetus.

Tests to detect defects using currently accepted procedures should be considered a part of routine prenatal care in childbearing women receiving carbamazepine.

There have been a few cases of neonatal seizures and/or respiratory depression associated with maternal Carbamazepine and other concomitant anticonvulsant drug use. A few cases of neonatal vomiting, diarrhea, and/or decreased feeding have also been reported in association with maternal Carbamazepine use. These symptoms may represent a neonatal withdrawal syndrome.

To provide information regarding the effects of in utero exposure to carbamazepine, physicians are advised to recommend that pregnant patients taking Carbamazepine enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www. aedpregnancyregistry. org/.

Precautions

General

Before initiating therapy, a detailed history and physical examination should be made.

Carbamazepine should be used with caution in patients with a mixed seizure disorder that includes atypical absence seizures, since in these patients Carbamazepine has been associated with increased frequency of generalized convulsions (see INDICATIONS AND USAGE ).

Therapy should be prescribed only after critical benefit-to-risk appraisal in patients with a history of cardiac conduction disturbance, including second - and third-degree AV heart block; cardiac, hepatic, or renal damage; adverse hematologic or hypersensitivity reaction to other drugs, including reactions to other anticonvulsants; or interrupted courses of therapy with carbamazepine.

AV heart block, including second - and third-degree block, have been reported following Carbamazepine treatment. This occurred generally, but not solely, in patients with underlying EKG abnormalities or risk factors for conduction disturbances.

Hepatic effects, ranging from slight elevations in liver enzymes to rare cases of hepatic failure have been reported (see ADVERSE REACTIONS and PRECAUTIONS, Laboratory Tests). In some cases, hepatic effects may progress despite discontinuation of the drug. In addition rare instances of vanishing bile duct syndrome have been reported. This syndrome consists of a cholestatic process with a variable clinical course ranging from fulminant to indolent, involving the destruction and disappearance of the intrahepatic bile ducts. Some, but not all, cases are associated with features that overlap with other immunoallergenic syndromes such as multiorgan hypersensitivity (DRESS syndrome) and serious dermatologic reactions. As an example there has been a report of vanishing bile duct syndrome associated with Stevens-Johnson syndrome and in another case an association with fever and eosinophilia.

Information for Patients

Patients should be informed of the availability of a Medication Guide and they should be instructed to read the Medication Guide before taking carbamazepine.

Patients should be made aware of the early toxic signs and symptoms of a potential hematologic problem, as well as dermatologic, hypersensitivity or hepatic reactions. These symptoms may include, but are not limited to, fever, sore throat, rash, ulcers in the mouth, easy bruising, lymphadenopathy and petechial or purpuric hemorrhage, and in the case of liver reactions, anorexia, nausea/vomiting, or jaundice. The patient should be advised that, because these signs and symptoms may signal a serious reaction, that they must report any occurrence immediately to a physician. In addition, the patient should be advised that these signs and symptoms should be reported even if mild or when occurring after extended use.

Patients should be advised that serious skin reactions have been reported in association with carbamazepine. In the event a skin reaction should occur while taking carbamazepine, patients should consult with their physician immediately (see WARNINGS).

Patients, their caregivers, and families should be counseled that AEDs, including carbamazepine, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Carbamazepine may interact with some drugs. Therefore, patients should be advised to report to their doctors the use of any other prescription or nonprescription medications or herbal products.

Caution should be exercised if alcohol is taken in combination with Carbamazepine therapy, due to a possible additive sedative effect.

Since dizziness and drowsiness may occur, patients should be cautioned about the hazards of operating machinery or automobiles or engaging in other potentially dangerous tasks.

Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 (see WARNINGS, Usage in Pregnancy subsection).

Laboratory Tests

For genetically at-risk patients (see WARNINGS), high-resolution ' HLA-B*1502 typing ' is recommended. The test is positive if either one or two HLA-B*1502 alleles are detected and negative if no HLA-B*1502 alleles are detected.

Complete pretreatment blood counts, including platelets and possibly reticulocytes and serum iron, should be obtained as a baseline. If a patient in the course of treatment exhibits low or decreased white blood cell or platelet counts, the patient should be monitored closely. Discontinuation of the drug should be considered if any evidence of significant bone marrow depression develops.

Baseline and periodic evaluations of liver function, particularly in patients with a history of liver disease, must be performed during treatment with this drug since liver damage may occur (see PRECAUTIONS, General and ADVERSE REACTIONS). Carbamazepine should be discontinued, based on clinical judgment, if indicated by newly occurring or worsening clinical or laboratory evidence of liver dysfunction or hepatic damage, or in the case of active liver disease.

Baseline and periodic eye examinations, including slit-lamp, funduscopy, and tonometry, are recommended since many phenothiazines and related drugs have been shown to cause eye changes.

Baseline and periodic complete urinalysis and BUN determinations are recommended for patients treated with this agent because of observed renal dysfunction.

Monitoring of blood levels (see CLINICAL PHARMACOLOGY) has increased the efficacy and safety of anticonvulsants. This monitoring may be particularly useful in cases of dramatic increase in seizure frequency and for verification of compliance. In addition, measurement of drug serum levels may aid in determining the cause of toxicity when more than one medication is being used.

Thyroid function tests have been reported to show decreased values with carba mazepine administered alone.

Interference with some pregnancy tests has been reported.

Drug Interactions

Clinically meaningful drug interactions have occurred with concomitant medications and include (but are not limited to) the following:

Agents That May Affect Carbamazepine Plasma Levels

When Carbamazepine is given with drugs that can increase or decrease Carbamazepine levels, close monitoring of Carbamazepine levels is indicated and dosage adjustment may be required.

Agents That Increase Carbamazepine Levels

CYP3A4 inhibitors inhibit Carbamazepine metabolism and can thus increase plasma Carbamazepine levels. Drugs that have been shown, or would be expected, to increase plasma Carbamazepine levels include aprepitant, cimetidine, ciprofloxacin, danazol, diltiazem, macrolides, erythromycin, troleandomycin, clarithromycin, fluoxetine, fluvoxamine, trazodone, olanzapine, loratadine, terfenadine, omeprazole, oxybutynin, dantrolene, isoniazid, niacinamide, nicotinamide, ibuprofen, propoxyphene, azoles (e. g. ketaconazole, itraconazole, fluconazole, voriconazole), acetazolamide, verapamil, ticlopidine, grapefruit juice, and protease inhibitors.

Human microsomal epoxide hydrolase has been identified as the enzyme responsible for the formation of the 10,11-transdiol derivative from carbamazepine-10,11 epoxide. Coadministration of inhibitors of human microsomal epoxide hydrolase may result in increased carbamazepine-10,11 epoxide plasma concentrations. Accordingly, the dosage of Carbamazepine should be adjusted and/or the plasma levels monitored when used concomitantly with loxapine, quetiapine, or valproic acid.

Agents That Decrease Carbamazepine Levels

CYP3A4 inducers can increase the rate of Carbamazepine metabolism. Drugs that have been shown, or that would be expected, to decrease plasma Carbamazepine levels include

cisplatin. doxorubicin HCl, felbamate, fosphenytoin, rifampin, phenobarbital, phenytoin, primidone, methsuximide, theophylline, aminophylline.

Effect of Carbamazepine on Plasma Levels of Concomitant Agents

Decreased Levels of Concomitant Medications

Carbamazepine is a potent inducer of hepatic 3A4 and is also known to be an inducer of CYP1A2, 2B6, 2C9/19 and may therefore reduce plasma concentrations of co-medications mainly metabolized by CYP 1A2, 2B6, 2C9/19 and 3A4, through induction of their metabolism. When used concomitantly with carbamazepine, monitoring of concentrations or dosage adjustment of these agents may be necessary:

When Carbamazepine is added to aripiprazole, the aripiprazole dose should be doubled. Additional dose increases should be based on clinical evaluation. If Carbamazepine is later withdrawn, the aripiprazole dose should be reduced.

When Carbamazepine is used with tacrolimus, monitoring of tacrolimus blood concentrations and appropriate dosage adjustments are recommended.

The use of concomitant strong CYP3A4 inducers such as Carbamazepine should be avoided with temsirolimus. If patients must be coadministered Carbamazepine with temsirolimus, an adjustment of temsirolimus dosage should be considered.

The use of Carbamazepine with lapatinib should generally be avoided. If Carbamazepine is started in a patient already taking lapatinib, the dose of lapatinib should be gradually titrated up. If Carbamazepine is discontinued, the lapatinib dose should be reduced.

Concomitant use of Carbamazepine with nefazodone results in plasma concentrations of nefazodone and its active metabolite insufficient to achieve a therapeutic effect. Coadministration of Carbamazepine with nefazodone is contraindicated (see CONTRAINDICATIONS).

Monitor concentrations of valproate when Carbamazepine is introduced or withdrawn in patients using valproic acid.

In addition, Carbamazepine causes, or would be expected to cause, decreased levels of the following drugs, for which monitoring of concentrations or dosage adjustment may be necessary: acetaminophen, albendazole, alprazolam, aprepitant, buprenorphone, bupropion, citalopram, clonazepam, clozapine, corticosteroids (e. g. prednisolone, dexamethasone), cyclosporine, dicumarol, dihydropyridine calcium channel blockers (e. g. felodipine), doxycycline, ethosuximide, everolimus, haloperidol, imatinib, itraconazole, lamotrigine, levothyroxine, methadone, methsuximide, mianserin, midazolam, olanzapine, oral and other hormonal contraceptives, oxcarbazepine, paliperidone, phensuximide, phenytoin, praziquantel, protease inhibitors, risperidone, sertraline, sirolimus, tadalafil, theophylline, tiagabine, topiramate, tramadol, trazodone, tricyclic antidepressants (e. g. imipramine, amitriptyline, nortriptyline), valproate, warfarin, ziprasidone, zonisamide.

Other Drug Interactions

Cyclophosphamide is an inactive prodrug and is converted to its active metabolite in part by CYP3A. The rate of metabolism and the leukopenic activity of cyclophosphamide are reportedly increased by chronic coadministration of CYP3A4 inducers. There is a potential for increased cyclophosphamide toxicity when coadministered with carbamazepine.

Concomitant administration of Carbamazepine and lithium may increase the risk of neurotoxic side effects.

Concomitant use of Carbamazepine and isoniazid has been reported to increase isoniazid-induced hepatotoxicity.

Alterations of thyroid function have been reported in combination therapy with other anticonvulsant medications.

Concomitant use of Carbamazepine with hormonal contraceptive products (e. g. oral, and levonorgestrel subdermal implant contraceptives) may render the contraceptives less effective because the plasma concentrations of the hormones may be decreased. Breakthrough bleeding and unintended pregnancies have been reported. Alternative or back-up methods of contraception should be considered.

Resistance to the neuromuscular blocking action of the nondepolarizing neuromuscular blocking agents pancuronium, vecuronium, rocuronium and cisatracurium has occurred in patients chronically administered carbamazepine. Whether or not Carbamazepine has the same effect on other non-depolarizing agents is unknown. Patients should be monitored closely for more rapid recovery from neuromuscular blockade than expected, and infusion rate requirements may be higher.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carbamazepine, when administered to Sprague-Dawley rats for two years in the diet at doses of 25, 75, and 250 mg/kg/day, resulted in a dose-related increase in the incidence of hepatocellular tumors in females and of benign interstitial cell adenomas in the testes of males.

Carbamazepine must, therefore, be considered to be carcinogenic in Sprague-Dawley rats. Bacterial and mammalian mutagenicity studies using Carbamazepine produced negative results. The significance of these findings relative to the use of Carbamazepine in humans is, at present, unknown.

Usage in Pregnancy

Labor and Delivery

The effect of Carbamazepine on human labor and delivery is unknown.

Nursing Mothers

Carbamazepine and its epoxide metabolite are transferred to breast milk. The ratio of the concentration in breast milk to that in maternal plasma is about 0.4 for carba mazepine and about 0.5 for the epoxide. The estimated doses given to the newborn during breastfeeding are in the range of 2 to 5 mg daily for Carbamazepine and 1 to 2 mg daily for the epoxide.

Because of the potential for serious adverse reactions in nursing infants from carbamazepine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Substantial evidence of carbamazepine's effectiveness for use in the management of children with epilepsy (see INDICATIONS AND USAGE for specific seizure types) is derived from clinical investigations performed in adults and from studies in several in vitro systems which support the conclusion that (1) the pathogenetic mechanisms underlying seizure prop agation are essentially identical in adults and children, and (2) the mechanism of action of Carbamazepine in treating seizures is essentially identical in adults and children.

Taken as a whole, this information supports a conclusion that the generally accepted therapeutic range of total Carbamazepine in plasma (i. e. 4 to 12 mcg/mL) is the same in children and adults.

The evidence assembled was primarily obtained from short-term use of carba mazepine. The safety of Carbamazepine in children has been systematically studied up to 6 months. No longer-term data from clinical trials is available.

Geriatric Use

No systematic studies in geriatric patients have been conducted.

Adverse Reactions

If adverse reactions are of such severity that the drug must be discontinued, the physi cian must be aware that abrupt discontinuation of any anticonvulsant drug in a responsive epileptic patient may lead to seizures or even status epilepticus with its life-threatening hazards.

The most severe adverse reactions have been observed in the hemopoietic system and skin (see boxed WARNING), the liver, and the cardiovascular system.

The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the lowest dosage recommended.

The following additional adverse reactions have been reported:

Hemopoietic System: Aplastic anemia, agranulocytosis, pancytopenia, bone marrow depression, thrombocytopenia, leukopenia, leukocytosis, eosinophilia, acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda.

Skin: Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) (see BOXED WARNING), Acute Generalized Exanthematous Pustulosis (AGEP), pruritic and erythematous rashes, urticaria, photosensitivity reac tions, alterations in skin pigmentation, exfoliative dermatitis, erythema multiforme and nodosum, purpura, aggravation of disseminated lupus erythematosus, alopecia, diaphoresis, onychomadesis and hirsutism. In certain cases, discontinuation of therapy may be necessary.

Cardiovascular System: Congestive heart failure, edema, aggravation of hypertension, hypotension, syncope and collapse, aggravation of coronary artery disease, arrhythmias and AV block, thrombophlebitis, thromboembolism (e. g. pulmonary embolism), and adenopathy or lymphadenopathy.

Some of these cardiovascular complications have resulted in fatalities. Myocardial infarction has been associated with other tricyclic compounds.

Liver: Abnormalities in liver function tests, cholestatic and hepatocellular jaundice, hepatitis, very rare cases of hepatic failure.

Respiratory System: Pulmonary hypersensitivity characterized by fever, dyspnea, pneumonitis, or pneumonia.

Genitourinary System: Urinary frequency, acute urinary retention, oliguria with ele vated blood pressure, azotemia, renal failure, and impotence. Albuminuria, glycosuria, elevated BUN, and microscopic deposits in the urine have also been reported. There have been rare reports of impaired male fertility and/or abnormal spermatogenesis.

Testicular atrophy occurred in rats receiving Carbamazepine orally from 4 to 52 weeks at dosage levels of 50 to 400 mg/kg/day. Additionally, rats receiving Carbamazepine in the diet for 2 years at dosage levels of 25, 75, and 250 mg/kg/day had a dose-related inci dence of testicular atrophy and aspermatogenesis. In dogs, it produced a brownish discoloration, presumably a metabolite, in the urinary bladder at dosage levels of 50 mg/kg and higher. Relevance of these findings to humans is unknown.

Nervous System: Dizziness, drowsiness, disturbances of coordination, confusion, headache, fatigue, blurred vision, visual hallucinations, transient diplopia, oculomotor dis turbances, nystagmus, speech disturbances, abnormal involuntary movements, peripheral neuritis and paresthesias, depression with agitation, talkativeness, tinnitus, hyperacusis, neuroleptic malignant syndrome.

There have been reports of associated paralysis and other symptoms of cerebral arte rial insufficiency, but the exact relationship of these reactions to the drug has not been established.

Isolated cases of neuroleptic malignant syndrome have been reported both with and without concomi tant use of psychotropic drugs.

Digestive System: Nausea, vomiting, gastric distress and abdominal pain, diarrhea, constipation, anorexia, and dryness of the mouth and pharynx, including glossitis and stomatitis.

Eyes: Scattered punctate cortical lens opacities, increased intraocular pressure (see WARNINGS, General)as well as conjunctivitis, have been reported. Although a direct causal relationship has not been established, many phe nothiazines and related drugs have been shown to cause eye changes.

Musculoskeletal System: Aching joints and muscles, and leg cramps.

Metabolism: Fever and chills. Hyponatremia (see WARNINGS, General). Decreased levels of plasma calcium have been reported. Osteoporosis has been reported.

Isolated cases of a lupus erythematosus-like syndrome have been reported. There have been occasional reports of elevated levels of cholesterol, HDL cholesterol, and triglyc erides in patients taking anticonvulsants.

A case of aseptic meningitis, accompanied by myoclonus and peripheral eosinophilia, has been reported in a patient taking Carbamazepine in combination with other med ications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine.

Drug Abuse and Dependence

No evidence of abuse potential has been associated with carbamazepine, nor is there evidence of psychological or physical dependence in humans.

Overdosage

Acute Toxicity

Lowest known lethal dose: adults, 3.2 g (a 24-year-old woman died of a cardiac arrest and a 24-year-old man died of pneumonia and hypoxic encephalopathy); children, 4 g (a 14-year-old girl died of a cardiac arrest), 1.6 g (a 3-year-old girl died of aspiration pneumonia).

Oral LD 50 in animals (mg/kg): mice, 1100 to 3750; rats, 3850 to 4025; rabbits, 1500 to 2680; guinea pigs, 920.

Signs and Symptoms

The first signs and symptoms appear after 1 to 3 hours. Neuromuscular disturbances are the most prominent. Cardiovascular disorders are generally milder, and severe cardiac complications occur only when very high doses (greater than 60 g) have been ingested.

Respiration: Irregular breathing, respiratory depression.

Cardiovascular System: Tachycardia, hypotension or hypertension, shock, conduction disorders.

Nervous System and Muscles: Impairment of consciousness ranging in severity to deep coma. Convulsions, especially in small children. Motor restlessness, muscular twitching, tremor, athetoid movements, opisthotonos, ataxia, drowsiness, dizziness, mydriasis, nystagmus, adiadochokinesia, ballism, psychomotor disturbances, dysmetria. Initial hyperreflexia, followed by hyporeflexia.

Gastrointestinal Tract: Nausea, vomiting.

Kidneys and Bladder: Anuria or oliguria, urinary retention.

Laboratory Findings: Isolated instances of overdosage have included leukocytosis, reduced leukocyte count, glycosuria, and acetonuria. EEG may show dysrhythmias.

Combined Poisoning: When alcohol, tricyclic antidepressants, barbiturates, or hydantoins are taken at the same time, the signs and symptoms of acute poisoning with Carbamazepine may be aggravated or modified.

Treatment

The prognosis in cases of severe poisoning is critically dependent upon prompt elimination of the drug, which may be achieved by inducing vomiting, irrigating the stomach, and by taking appropriate steps to diminish absorption. If these measures cannot be implemented without risk on the spot, the patient should be transferred at once to a hospital, while ensuring that vital functions are safeguarded. There is no specific antidote.

Elimination of the Drug: Induction of vomiting.

Gastric lavage. Even when more than 4 hours have elapsed following ingestion of the drug, the stomach should be repeatedly irrigated, especially if the patient has also consumed alcohol.

Measures to Reduce Absorption: Activated charcoal, laxatives.

Measures to Accelerate Elimination: Forced diuresis.

Dialysis is indicated only in severe poisoning associated with renal failure. Replacement transfusion is indicated in severe poisoning in small children.

Respiratory Depression: Keep the airways free; resort, if necessary, to endotracheal intubation, artificial respiration, and administration of oxygen.

Hypotension, Shock: Keep the patient’s legs raised and administer a plasma expander. If blood pressure fails to rise despite measures taken to increase plasma volume, use of vasoactive substances should be considered.

Convulsions: Diazepam or barbiturates.

Warning: Diazepam or barbiturates may aggravate respiratory depression (especially in children), hypotension, and coma. However, barbiturates should not be used if drugs that inhibit monoamine oxidase have also been taken by the patient either in overdosage or in recent therapy (within 1 week).

Surveillance: Respiration, cardiac function (ECG monitoring), blood pressure, body temperature, pupillary reflexes, and kidney and bladder function should be monitored for several days.

Treatment of Blood Count Abnormalities: If evidence of significant bone marrow depression develops, the following recommendations are suggested: (1) stop the drug, (2) perform daily CBC, platelet, and reticulocyte counts, (3) do a bone marrow aspiration and trephine biopsy immediately and repeat with sufficient frequency to monitor recovery.

Special periodic studies might be helpful as follows: (1) white cell and platelet antibodies, (2) 59 Fe-ferrokinetic studies, (3) peripheral blood cell typing, (4) cytogenetic studies on marrow and peripheral blood, (5) bone marrow culture studies for colony-forming units, (6) hemoglobin electrophoresis for A 2 and F hemoglobin, and (7) serum folic acid and B 12 levels.

A fully developed aplastic anemia will require appropriate, intensive monitoring and therapy, for which specialized consultation should be sought.

DOSAGE AND ADMINISTRATION (see table below)

Monitoring of blood levels has increased the efficacy and safety of anticonvulsants (see PRECAUTIONS, Laboratory Tests). Dosage should be adjusted to the needs of the indi vidual patient. A low initial daily dosage with a gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the mini mum effective level. Medication should be taken with meals.

Conversion of patients from oral Carbamazepine tablets to Carbamazepine suspension: Patients should be converted by administering the same number of mg per day in smaller, more frequent doses (i. e. b. i.d. tablets to t. i.d. suspension).

Epilepsy (SEE INDICATIONS AND USAGE)

Adults and children over 12 years of age-Initial: 200 mg b. i.d. Increase at weekly intervals by adding up to 200 mg/day using a t. i.d. or q. i.d. regimen until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily in children 12 to 15 years of age, and 1200 mg daily in patients above 15 years of age. Doses up to 1600 mg daily have been used in adults in rare instances. Maintenance: Adjust dosage to the minimum effective level, usually 800 to 1200 mg daily.

Children 6 to 12 years of age-Initial: 100 mg b. i.d. Increase at weekly intervals by adding up to 100 mg/day using a t. i.d. or q. i.d. regimen until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily. Maintenance: Adjust dosage to the minimum effective level, usually 400 to 800 mg daily.

Children under 6 years of age-Initial: 10 to 20 mg/kg/day b. i.d. or t. i.d. Increase weekly to achieve optimal clinical response administered t. i.d. or q. i.d. Maintenance: Ordinarily, optimal clinical response is achieved at daily doses below 35 mg/kg. If sat isfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range. No recommendation regarding the safety of Carbamazepine for use at doses above 35 mg/kg/24 hours can be made.

Combination Therapy: Carbamazepine may be used alone or with other anticonvul sants. When added to existing anticonvulsant therapy, the drug should be added gradually while the other anticonvulsants are maintained or gradually decreased, except phenytoin, which may have to be increased (see PRECAUTIONS, Drug Interactions, and Pregnancy Category D).

Trigeminal Neuralgia (see INDICATIONS AND USAGE)

Initial: On the first day, 100 mg b. i.d. for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours only as needed to achieve freedom from pain. Do not exceed 1200 mg daily. Maintenance: Control of pain can be maintained in most patients with 400 to 800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while oth ers may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug.

Dosage Information

*Tablet = Chewable or conventional tablets

How is Carbamazepine Supplied

Carbamazepine Tablets, USP (chewable), 100 mg are available in the following form: pink colored, circular, strawberry/vanilla flavored, flat beveled, uncoated tablets with "271" debossed on one side and scoreline on the other.

Bottle of 100 NDC 13668-271-01

Bottle of 500 NDC 13668-271-05

Bottle of 750 NDC 13668-271-49

Bottle of 1000 NDC 13668-271-10

Carbamazepine Tablets, USP, 100 mg are available in the following form: pink colored, capsule shaped, biconvex tablets with '539' debossed on one side and plain on the other side.

Bottle of 100 NDC 13668-267-01

Bottle of 500 NDC 13668-267-05

Bottle of 1000 NDC 13668-267-10

Carbamazepine Tablets, USP, 200 mg are available in the following form: pink colored, capsule shaped, biconvex tablets with '268' debossed on one side and scored on the other side.

Bottle of 30 NDC 13668-268-30

Bottle of 100 NDC 13668-268-01

Bottle of 500 NDC 13668-268-05

Bottle of 1000 NDC 13668-268-10

Bottle of 2500 NDC 13668-268-31

Carbamazepine Tablets, USP, 300 mg are available in the following form: pink colored, capsule shaped, biconvex tablets with '535' debossed on one side and scored on the other side.

Bottle of 100 NDC 13668-269-01

Bottle of 500 NDC 13668-269-05

Bottle of 1000 NDC 13668-269-10

Carbamazepine Tablets, USP, 400 mg are available in the following form: pink colored, capsule shaped, biconvex tablets with '536' debossed on one side and scored on the other side.

Bottle of 100 NDC 13668-270-01

Bottle of 500 NDC 13668-270-05

Bottle of 1000 NDC 13668-270-10

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP.

TORRENT PHARMACEUTICALS LTD. Indrad-382 721, Dist. Mehsana, INDIA.

TORRENT PHARMA INC. 150 Allen Road, Suite 102, Basking Ridge, NJ 07920.

8057712 Revised November 2015

Carbamazepine (kar ba MAZ e peen) Tablets, USP, 100 mg, 200 mg, 300 mg, 400 mg and Carbamazepine (kar ba MAZ e peen) Tablets, USP (Chewable), 100 mg

Read this Medication Guide before you start taking Carbamazepine tablets or chewable tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about Carbamazepine tablets or chewable tablets?

Do not stop taking Carbamazepine tablets or chewable tablets without first talking to your healthcare provider.

Stopping Carbamazepine tablets or chewable tablets suddenly can cause serious problems.

Carbamazepine tablets or chewable tablets can cause serious side effects, including:

1. Carbamazepine tablets or chewable tablets may cause rare but serious skin rashes that may lead to death. These serious skin reactions are more likely to happen when you begin taking Carbamazepine tablets or chewable tablets within the first four months of treatment but may occur at later times. These reactions can happen in anyone, but are more likely in people of Asian descent. If you are of Asian descent, you may need a genetic blood test before you take Carbamazepine tablets or chewable tablets to see if you are at a higher risk for serious skin reactions with this medicine. Symptoms may include:

skin rash

hives

sores in your mouth

blistering or peeling of the skin

2. Carbamazepine tablets or chewable tablets may cause rare but serious blood problems. Symptoms may include:

fever, sore throat or other infections that come and go or do not go away

easy bruising

red or purple spots on your body

bleeding gums or nose bleeds

severe fatigue or weakness

3. Like other antiepileptic drugs, Carbamazepine tablets or chewable tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

thoughts about suicide or dying

attempts to commit suicide

new or worse depression

new or worse anxiety

feeling agitated or restless

panic attacks

trouble sleeping (insomnia)

new or worse irritability

acting aggressive, being angry, or violent

acting on dangerous impulses

an extreme increase in activity and talking (mania)

other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.

Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop Carbamazepine tablets or chewable tablets without first talking to a healthcare provider.

Stopping Carbamazepine tablets or chewable tablets suddenly can cause serious problems. You should talk to your healthcare provider before stopping.

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

What are Carbamazepine tablets or chewable tablets?

Carbamazepine tablets or chewable tablets are a prescription medicine used to treat:

certain types of seizures (partial, tonic-clonic, mixed)

certain types of nerve pain (trigeminal and glossopharyngeal neuralgia)

Carbamazepine tablets or chewable tablets are not a regular pain medicine and should not be used for aches or pains.

Who should not take Carbamazepine tablets or chewable tablets?

Do not take Carbamazepine tablets or chewable tablets if you:

have a history of bone marrow depression.

are allergic to Carbamazepine or any of the ingredients in Carbamazepine tablets or chewable tablets. See the end of this Medication Guide for a complete list of ingredients in Carbamazepine tablets or chewable tablets.

take nefazodone.

are allergic to medicines called tricyclic antidepressants (TCAs). Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

have taken a medicine called a Monoamine Oxidase Inhibitor (MAOI) in the last 14 days. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

What should I tell my healthcare provider before taking Carbamazepine tablets or chewable tablets?

Before you take Carbamazepine tablets or chewable tablets, tell your healthcare provider if you:

have or have had suicidal thoughts or actions, depression, or mood problems

have or ever had heart problems

have or ever had blood problems

have or ever had liver problems

have or ever had kidney problems

have or ever had allergic reactions to medicines

have or ever had increased pressure in your eye

have any other medical conditions

drink grapefruit juice or eat grapefruit

use birth control. Carbamazepine tablets or chewable tablets may make your birth control less effective. Tell your healthcare provider if your menstrual bleeding changes while you take birth control and Carbamazepine tablets or chewable tablets.

are pregnant or plan to become pregnant. Carbamazepine tablets or chewable tablets may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Carbamazepine tablets or chewable tablets. You and your healthcare provider should decide if you should take Carbamazepine tablets or chewable tablets while you are pregnant.

If you become pregnant while taking Carbamazepine tablets or chewable tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

are breastfeeding or plan to breastfeed. Carbamazepine passes into breast milk. You and your healthcare provider should discuss whether you should take Carbamazepine tablets or chewable tablets or breastfeed; you should not do both.

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

Taking Carbamazepine tablets or chewable tablets with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

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

How should I take Carbamazepine tablets or chewable tablets?

Do not stop taking Carbamazepine tablets or chewable tablets without first talking to your healthcare provider. Stopping Carbamazepine tablets or chewable tablets suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus).

Take Carbamazepine tablets or chewable tablets exactly as prescribed. Your healthcare provider will tell you how many Carbamazepine tablets or chewable tablets to take.

Your healthcare provider may change your dose. Do not change your dose of Carbamazepine tablets or chewable tablets without talking to your healthcare provider.

Take Carbamazepine tablets or chewable tablets with food.

If you take too many Carbamazepine tablets or chewable tablets, call your healthcare provider or local Poison Control Center right away.

What should I avoid while taking Carbamazepine tablets or chewable ta

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Diclofenac is used to treat pain or inflammation caused by arthritis or ankylosing spondylitis. Diclofenac may also be used for purposes other than those listed in this medication guide.

Use Diclofenac as directed by your doctor.

Take Diclofenac by mouth with or without food. Ask your health care provider any questions you may have about how to use Diclofenac.

Drug Class and Mechanism

Diclofenac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Diclofenac works by reducing hormones that cause inflammation and pain in the body.

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Important : Diclofenac may cause dizziness or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Diclofenac with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Before you start any new medicine, check the label to see if it has Diclorapid or another nonsteroidal anti-inflammatory drug (NSAID) medicine in it too. If it does or if you are not sure, check with your doctor or pharmacist. Diclofenac should not be used in children; safety and effectiveness in children have not been confirmed. Pregnancy and breast-feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Diclofenac while you are pregnant. It is not known if Diclofenac is found in breast milk. Do not breast-feed while using Diclofenac.

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severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred or distorted vision; eye infection; eyelid swelling or redness; sensitivity to glare or light.

Diclofenac 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.



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Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

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Omeprazole Oral Uses, Side Effects, Interactions, Pictures, Warnings - Dosing, Oprazole

omeprazole

Uses

Omeprazole is used to treat certain stomach and esophagus problems (such as acid reflux. ulcers). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn. difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Omeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).

If you are self-treating with this medication, over-the-counter omeprazole products are used to treat frequent heartburn (occurring 2 or more days a week). Since it may take 1 to 4 days to have full effect, these products do not relieve heartburn right away.

For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar brand names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

How to use omeprazole

Read the Patient Information Leaflet if available from your pharmacist before you start taking omeprazole and each time you get a refill.

Take this medication by mouth as directed by your doctor, usually once daily, before a meal. If you are self-treating, follow all directions on the product package. Dosage and length of treatment are based on your medical condition and response to treatment. In children, the dosage is also based on weight. Do not increase your dose or take this drug more often than directed. If you have any questions, ask your doctor or pharmacist.

Do not crush, break, or chew the tablets. Swallow this medication whole with a glass of water.

If needed, antacids may be taken along with this medication. If you are also taking sucralfate, take omeprazole at least 30 minutes before sucralfate.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Continue to take this medication for the prescribed length of treatment even if you are feeling better. If you are self-treating with the over-the-counter product, do not take it for more than 14 days unless directed by your doctor.

Tell your doctor if your condition persists or worsens. If you are self-treating, tell your doctor if your heartburn persists after 14 days or if you need to use this medication more than once every 4 months. If you think you may have a serious medical problem, get medical help right away.

Side Effects

See also Precautions section.

Headache or abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this product, remember that 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: symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat. persistent muscle spasms. seizures ).

This medication may rarely cause a severe intestinal condition (Clostridium difficile - associated diarrhea ) due to a type of bacteria. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, fever, blood /mucus in your stool.

Rarely, proton pump inhibitors (such as omeprazole) have caused vitamin B-12 deficiency. The risk is increased if they are taken every day for a long time (3 years or longer). Tell your doctor right away if you develop symptoms of vitamin B-12 deficiency (such as unusual weakness. sore tongue. or numbness/tingling of the hands/feet).

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. kidney problems (such as change in the amount of urine).

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 omeprazole, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as esomeprazole. lansoprazole. pantoprazole ); 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: liver disease.

Some symptoms may actually be signs of a more serious condition. Get medical help right away if you have: heartburn with lightheadedness/sweating /dizziness, chest/jaw/arm/shoulder pain (especially with shortness of breath, unusual sweating ), unexplained weight loss .

In addition, before you self-treat with this medication, get medical help right away if you have any of these signs of a serious condition: trouble/pain swallowing food, bloody vomit, vomit that looks like coffee grounds, bloody/black stools, heartburn for over 3 months, frequent chest pain. frequent wheezing (especially with heartburn), nausea /vomiting. stomach pain.

Proton pump inhibitors (such as omeprazole) may increase your risk for bone fractures. especially with longer use, higher doses, and in older adults. Talk with your doctor or pharmacist about ways to prevent bone loss /fracture, such as by taking calcium (such as calcium citrate ) and vitamin D supplements .

Children may be more sensitive to the side effects of this drug, especially fever, cough, and infections of the nose/throat/airways.

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

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. The effects on a nursing infant are unknown. Consult your doctor before breast-feeding.

Interactions

See also How to Use section.

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: cilostazol, clopidogrel, methotrexate (especially high-dose treatment), rifampin, St John's wort.

Some products need stomach acid so that the body can absorb them properly. Omeprazole decreases stomach acid, so it may change how well these products work. Some affected products include atazanavir, erlotinib, nelfinavir, pazopanib, rilpivirine, certain azole antifungals (itraconazole, ketoconazole, posaconazole), among others.

Omeprazole is very similar to esomeprazole. Do not use any medications containing esomeprazole while using omeprazole.

This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

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: confusion, unusual sweating, blurred vision, unusually fast heartbeat.

Notes

If your doctor has prescribed this medication for you, do not share it with others.

If your doctor instructs you to use this medication regularly for a long time, laboratory and medical tests (such as a magnesium blood test, vitamin B-12 levels) may be performed periodically to monitor your progress or check for side effects. Keep all regular medical and laboratory appointments.

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.

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Loette (Levonorgestrel And Ethinyloestradiol Tablets) Drug, Loette

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NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Loette. It does not contain all the information that is known about Loette. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What Loette is used for

Loette is an oral contraceptive, commonly known as a "birth control pill" or "the Pill". Loette tablets contain two hormones (levonorgestrel and ethinyloestradiol), which prevent you from becoming pregnant if taken correctly. They are similar to the hormones that your body normally produces.

Loette prevents pregnancy in several ways:

It inhibits the egg release by stopping it maturing

It changes the cervical mucus consistency making it difficult for the sperm to reach the egg

It changes the lining of the uterus making it less suitable for implantation.

Loette is also used to treat moderate acne in women when this has not improved with acne treatments applied to the skin and who are also willing to be on a contraceptive.

Ask your doctor if you have any questions about why Loette has been prescribed for you.

Your doctor may have prescribed Loette for another reason.

This medicine is available only with a doctor's prescription.

Loette is not habit-forming.

This medicine is not expected to affect your ability to drive a car or operate machinery.

Before you take Loette

When you must not take Loette

Do not take Loette if you have an allergy to:

Any medicine containing ethinyloestradiol or levonorgestrel

Any of the ingredients listed at the end of this leaflet

Any other similar medicines (such as other oral contraceptives).

Some of the symptoms of an allergic reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue or other parts of the body

rash, itching or hives on the skin.

Do not take Loette if you have or have had any of the following medical conditions:

Blood clots in the legs (thrombophlebitis or deep vein thrombosis (DVT)), lungs (pulmonary embolism) or eyes

Heart valve or heart rhythm disorders that may be associated with the formation of blood clots

Heart attack or stroke

Chest pain (angina pectoris)

High blood pressure which is uncontrolled

Some severe types of headache or migraine, including migraine with partial paralysis

Diabetes with blood vessel damage

Breast cancer or cancer of the lining of the womb, cervix or vagina, or you think you have these conditions

Unexplained vaginal bleeding

Liver tumour or liver disease

Inflammation of the pancreas which is associated with very high blood levels of triglycerides (fatty substances)

Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of an oral contraceptive

High blood levels of cholesterol or triglycerides

Changes in vision, such as blurring.

If you are not certain whether these may apply to you, or you are worried by anything in this list, tell your doctor.

Do not take this medicine if you are pregnant or you think you are pregnant.

Pregnancy must be excluded before you start taking Loette.

Do not give this medicine to a child.

Do not take this medicine if you have already experienced menopause.

Do not take this medicine after the expiry date (EXP) printed on the pack or if the packaging is torn or shows signs of tampering.

If it is expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take Loette

You must have a thorough medical check-up, including a Pap smear, breast check, blood pressure check and urine test.

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

Tell your doctor if you smoke.

Oral contraceptives increase your risk of having a stroke or heart attack. The risk of serious side effects on the heart and blood vessels is even greater if you smoke and take oral contraceptives. The risk increases with age and with heavy smoking (15 or more cigarettes per day), especially in women older than 35 years. If you take Loette, you should not smoke.

Tell your doctor if you have any other health problems, especially:

Breast lumps, abnormal breast X-ray or mammogram

High cholesterol or blood fats

High blood pressure, a history of high blood pressure or high blood pressure during pregnancy



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AMILOFERM (MIDAMOR) INDICATIONS

Amiloferm is used for preventing development of low blood potassium or helping to restore normal blood potassium in patients with high blood pressure or heart failure. It is usually used with other medicines. Amiloferm is a potassium-sparing diuretic. It works by making the kidneys eliminate sodium (salt) and water from the body while retaining potassium.

AMILOFERM (MIDAMOR) INSTRUCTIONS

Use Amiloferm as directed by your doctor.

Take Amiloferm by mouth with food.

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

If you miss a dose of Amiloferm, 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 Amiloferm.

AMILOFERM (MIDAMOR) STORAGE

Store Amiloferm at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Amiloferm out of the reach of children and away from pets. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

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Basic Idea: It is a very common mistake to say things like 'could of', 'should of', 'might of', or 'would of'. When talking with friends this isn't so bad, but in written Engl … ish or in more formal settings, it sounds very bad. You should say 'could have', should have', might have' or 'would have'. They can be abbreviated with 've when writing dialogue or when quoting someone, as in should've. The abbreviation is probably what leads to the 'of' error. In the cases above, the word have is a helping verb; it helps to clarify the verb's tense. "If I had known that you were coming, I would have baked a cake." At that past time, I did not know that you were coming. But if I HAD known [had is the past tense of have], if I could go back and change the past, I would have baked a cake. The word 'of' is never used to help express a verb's tense. Check the link for a helpful site on helping verbs! [NOTE: NOT for the faint of heart. If the above is enough, you should go to your next question.] You might ask if it would be ok to say "If I knew you were coming, I would have baked a cake." The difference is subtle. Saying "If I knew" implies that perhaps I knew, and perhaps I did not; it is unclear to me at this time whether or not I knew. And that might be exactly what you want to say. But if you are interested in the clearest language this leads to a logical conflict, doesn't it? It is unclear to me at this time whether or not I knew you were coming, but we can use the baking of a cake as a partial proof. If no cake was baked, then certainly I did not know you were coming. Assuming for a moment there was no cake, I am saying that I'm certain I did not know, but I'm expressing it with a verb that implies uncertainty. If a cake was baked, there is still ambiguity. "If I had known" implies that I in fact did not know, but would have taken action if I had. (MORE)

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"He" is a nominative Pronoun (Subjective) and "Him" is accussative pronoun (Objective) so subject always comes before verb and object always comes after verb. Thus … He is used as the subject of the sentence and him is used as the object of the sentence. He is eating an apple. (He-Subject) An apple is eaten by him. (Him - Object) (MORE)

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Was is a simple past tense of the verb "to be" used with singular nouns as in "The boy was angry," meaning at some point in the past the male in question was angry. Were is th … e correct past tense form to use when addressing more than one subject as in "The boys were angry." Along with the noun, it helps establish whether the referent is singular or plural. (MORE)

Answer A general working rule is to remove the 'other person'. The sentence, 'You and I went to town' should make just as much sense when you remove the 'y … ou': 'I went to town'. If you had said, 'You and me went to town' then you would be left with, 'Me went to town,' which is obviously wrong! What about this: 'He brought cake for you and me' 'He brought cake for me' which is correct. 'He brought cake for you and I' 'He brought cake for I'. is incorrect. Make sense? (MORE)

You use 'an' before a vowel: - an apple, an orange - you use 'a' before a consonant: - a bridge, a spanner. You use the word 'a' if the word after it starts with a consonant ( … any letter in the alphabet except a, e, i, o and u) - for example; Johnny was playing with a ball. Johnny wanted a snack However, you use the 'an' if the word after it starts with a vowel (a, e, i, o or u) - for example; Johnny was playing with an animal. Johnny wanted an ice-cream (MORE)

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There is one B in the word about. There is one student in the class who answered all 20 questions correctly. There is is singular, agreeing with one B and one student. There … are twelve donuts in one dozen. There are many ways to make good pizza. TUse "there is" when the subject of the verb is singular and "there are" when the subject is plural. Sometimes there are grey areas. Crowd, group, class, tribe, audience. "The audience came to their feet" "The group discussed the matter among themselves". Sometimes there are grey areas. Crowd, group, class, tribe, audience. "The audience came to their feet" "The group discussed the matter among themselves". (MORE)



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European Medicines Agency - News And Events - European Medicines Agency Recommendation On The Use Of

European Medicines Agency recommendation on the use of Linoladiol N and Linoladiol HN estradiol-containing creams

Press release

European Medicines Agency recommendation on the use of Linoladiol N and Linoladiol HN estradiol-containing creams

A limit to the duration of use and other measures put in place to manage potential risk of side effects

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has updated recommendations on the use of two high-strength estradiol-containing creams, Linoladiol N and Linoladiol HN.

The Linoladiol N cream is only to be used inside the vagina for treating postmenopausal women with vaginal atrophy due to a lack of the hormone estrogen, while the Linoladiol HN cream is for postmenopausal women with mild, inflammatory skin conditions around the genital area. Treatment with both creams should be limited to a maximum duration of 4 weeks.

In addition, Linoladiol HN is no longer to be used to treat lichen sclerosus, a skin condition that commonly affects the genital area, because of a lack of evidence of benefit in this condition.

In December 2013, the CHMP had concluded a review of the benefits and risks of both creams and made recommendations on their use. Following a request by the company for a re-examination of Linoladiol N, the recommendations for this cream have now been updated, taking into account new measures to manage the potential risk of side effects.

The CHMP reiterates the need to limit treatment with both creams to 4 weeks because of their relatively high estradiol content and the potential risks of side effects from estradiol being absorbed systemically (throughout the body). Systemic absorption of estradiol may be associated with risks similar to those seen in systemic hormone replacement therapy (HRT), including blood clots, stroke and endometrial (womb) cancer. The product information of Linoladiol N and Linoladiol HN have been updated to inform patients and healthcare professionals about these potential risks.

In addition, for Linoladiol N, the cream with the higher amount of estradiol, the CHMP has required the company to limit the amount of cream available in the packs to prevent patients from using them for longer than recommended.

The CHMP’s recommendations will now be sent to the European Commission for the adoption of a final, legally binding decision to be valid throughout the EU.

Information to patients

The European Medicines Agency has updated advice on how to use Linoladiol N and Linoladiol HN creams. Patients using these creams should be aware of the following:

Linoladiol N is only to be used inside the vagina for treating postmenopausal women with vaginal atrophy due to a lack of estrogen.

Linoladiol HN should only be used for treating postmenopausal women with mild, inflammatory skin conditions affecting the external genital area.

Linoladiol HN was previously being used to treat a condition called lichen sclerosus. If you have been using Linoladiol HN for this condition, contact your doctor to discuss alternative treatments.

Both creams should not be used for more than 4 weeks. This is because the creams contain the hormone estradiol which can be absorbed into the bloodstream and may increase your risks of side effects such as blood clots and strokes if the creams are used for extended periods.

Linoladiol N should be applied into the vagina while Linoladiol HN should be applied to the external genital area.

If you have any questions about your treatment, you should contact your doctor or pharmacist.

Information to healthcare professionals

The EMA has concluded a review of Linoladiol N and Linoladiol HN estradiol-containing creams and has updated recommendations on their use. The product information for both creams will be updated with the following recommendations:

Linoladiol N is indicated for the treatment of vaginal atrophy due to estrogen deficiency in postmenopausal women.

Linoladiol HN is indicated in the short-term treatment of acute, mild inflammatory skin diseases of the external genital area in postmenopausal women.

Linoladiol HN should no longer be prescribed for lichen sclerosus.

Both Linoladiol N and Linoladiol HN should not be used beyond four weeks due to the risks associated with possible systemic exposure to estradiol.

More about the medicine

The Linoladiol N cream (0.01 %w/w) contains 100 microgram of estradiol per gram, while Linoladiol HN (0.005 %w/w, 0.4 %w/w) contains 50 microgram of estradiol and 4 mg of the corticosteroid prednisolone per gram.

Linoladiol N and Linoladiol HN are a type of local ‘hormone replacement therapy’: they contain a female hormone, estradiol, used to replace the estradiol hormone the body no longer makes after menopause. Linoladiol HN also contains low-dose prednisolone, which acts as an anti-inflammatory agent.

Both medicines have been authorised in the EU through national procedures for over 40 years. Linoladiol N is marketed in Bulgaria, Czech Republic, Estonia, Germany, Hungary, Latvia, Lithuania and Slovakia, while Linoladiol HN is marketed in Estonia, Germany, Latvia and Lithuania.

More about the procedure

The review of the topical estradiol-containing medicines Linoladiol N and Linoladiol HN was triggered on 24 May 2012 by Germany, under Article 31 of Directive 2001/83/EC. The German medicines agency asked the CHMP to carry out a full assessment of the benefit-risk balance of these medicines and to issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the European Union.

The review has been carried out by the Committee for Medicinal Products for Human Use (CHMP) responsible for questions concerning medicines for human use.

The CHMP issued an opinion in December 2013. Following a request from the company, a re-examination of the opinion for Linoladiol N was carried out and concluded in April 2014. The final CHMP opinion will now be forwarded to the European Commission, which will issue a final decision in due course.



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Common use The main component of Viagra is Sildenafil Citrate. Sildenafil Citrate affects the response to sexual stimulation. It acts by enhancing smooth muscle relaxation using nitric oxide, a chemical that is normally released in response to sexual stimulation. This smooth muscle relaxation allows increased blood flow into certain areas of the penis, which leads to an erection. Sildenafil Citrate is applied for the treatment of erectile dysfunction (impotence) in men and pulmonary arterial hypertension. Sildenafil Citrate may also be used for other purposes not listed above.

Dosage and direction Usually the recommended dose is 50 mg. It is taken approximately 0,5-1 hour before sexual activity. Do not take Viagra more then once a day. A high fat meal may delay the time of the effect of this drug. Try not to eat grapefruit or drink grapefruit juice while you are being treated with Sildenafil Citrate .

Precautions Before you start taking Sildenafil Citrate. tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Aged people may be more sensitive to the side effects of the drug.

Viagra is contraindicated in patients who take another medicine to treat impotence or using a nitrate drug for chest pain or heart problems. This medicine should not be taken by women and children as well as in patients with a known hypersensitivity to any component of the tablet.

Possible side effect The most common side effects are headache, flushing, heartburn, stomach upset, nasal stuffiness, lightheadedness, dizziness or diarrhea. A serious allergic reaction to this drug is very rare, but seek immediate medical help if it occurs. Many people who use this medicine do not have serious side effects. In case you notice any side effects not listed above, contact your doctor or pharmacist.

Drug interaction This drug should not be used with nitrates and recreational drugs called "poppers" containing amyl or butyl nitrite; alpha-blocker medications; other medications for impotence; high blood pressure medicines, etc. Consult your doctor or pharmacist for more details.

Missed dose Viagra is used as needed, so you are unlikely to be on a dosing schedule.

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

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

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.



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Flagyl ER (Varizil)

Flagyl ER is used for treating certain bacterial infections of the vagina (bacterial vaginosis). Flagyl ER is an oral antiprotozoal and antibacterial. It is thought to work by entering the bacterial cell, acting on some components of the cell, and destroying the bacteria.

Use Flagyl ER as directed by your doctor.

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

Swallow Flagyl ER whole. Do not break, crush, or chew before swallowing.

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

If you miss a dose of Flagyl ER, 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 Flagyl ER.

Store Flagyl ER at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Flagyl ER out of the reach of children and away from pets.

Active Ingredient: Metronidazole.

Do NOT use Flagyl ER if:

you are allergic to any ingredient in Flagyl ER or to another nitroimidazole (eg, tinidazole)

you are in the first trimestr of pregnancy

you are taking busulfan, an ergot alkaloid (eg, ergotamine), or you have taken disulfiram within the past 2 weeks

you are taking an HIV protease inhibitor that contains alcohol (eg, amprenavir solution); check with your pharmacist if you are unsure if the medicine contains alcohol

you drink alcohol.

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

Some medical conditions may interact with Flagyl ER. 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 nerve, brain, or blood problems; Crohn disease; or a history of liver problems or seizures.

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

Disulfiram because side effects, such as mental or mood changes, may occur

Amiodarone because the risk of irregular heartbeat may be increased

Barbiturates (eg, phenobarbital) or phenytoin because they may decrease Flagyl ER's effectiveness

Anticoagulants (eg, warfarin), busulfan, cyclosporine, ergot alkaloids (eg, ergotamine), HIV protease inhibitors containing alcohol (eg, amprenavir solution ), lithium, or macrolide immunosuppressants (eg, tacrolimus) because the risk of their side effects may be increased by Flagyl ER.

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

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

Do not drink alcohol while you are taking Flagyl ER and for at least 3 days after the last dose.

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.

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

Be sure to use Flagyl ER 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 Flagyl ER 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.

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

Lab tests, including liver function and white blood cell counts, may be performed while you use Flagyl ER. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

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

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

Pregnancy and breast-feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Flagyl ER while you are pregnant. Do not use Flagyl ER in the first 3 months of pregnancy. Flagyl ER is found in breast milk. Do not breastfeed while taking Flagyl ER.

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:

Appetite loss; constipation; diarrhea; dizziness; headache; metallic taste; nausea; stomach upset; 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); bloody stools; decreased coordination; increased or decreased urination; numbness, tingling, or burning of the arms, hands, legs, or feet; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; severe or persistent dizziness or headache; sore throat, chills, or fever; speech problems; stiff neck; stomach pain or cramps; vaginal itching, odor, or discharge; vision loss or other vision changes; 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.

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Diflucan - Anti Fungal, Cofkol

Anti Fungal - Cofkol (Brand name: diflucan)

Product Description Common use Diflucan is an anti-fungal antibiotic which is used to treat fungal infections called candidiasis. This medication is prescribed for the treatment of such type of infections as vaginal, throat and fungal infections, infections of the urinary tract, peritonitis, and pneumonia. Diflucan works by killing sensitive fungi by interfering with the formation of the fungal cell membrane.

Dosage and direction Take it orally once a day, with or without food using the measuring spoon. Take it at the same time each day with a full glass of water if you want to get the best result. Diflucan make you feel better after 24 hours. However, your symptoms will go away completely just after few days. If there is no change in your health after a few days consult your doctor immediately. The dosage for adults may vary from type of infection: 1) Genital thrush - 150mg as a single dose 2) Mucosal thrush - dose depends on where the infection is located 50mg once daily during month. 3)Fungal skin infections - 50mg once daily for 2-4 weeks ; 4) Internal fungal infections 400mg on the first day then 200-400mg once daily for 6-8 weeks or longer if needed. 5) To stop you from getting fungal infections - 50-400mg once daily while you have risk to get an infection; 6) To stop infection caused by Cryptococcus from coming back - 100-200mg once daily indefinitely The dosage for children 4 weeks to 15 years old may also vary from type of infection: 1) mucosal infections - 3mg/kg once daily; 2)internal fungal infections - 6-12mg/kg once daily; 3)prevention of fungal infections - 3-12mg/kg once daily while at risk of getting an infection. For children 2-4 weeks old it is same dose as above but given once every 2 days. A maximum dose of 12mg/kg every 2 days. For children less than 2 weeks old it is same dose as above but given once every 3 days. Do not give more then 12mg/kg every 3 days. Note: this instruction presented here is just for review. It's very necessary to consult your doctor before using. It will help you to get best results.

For vaginal yeast infections, doctors usually prescribe a single dose of Diflucan. If the yeast infection does not improve after 5 days, contact your doctor as soon as possible. Be careful with this medication if your medical history include liver disease or kidney disease. Although uncommon, this drug may make you dizzy, so be more attentive while you are driving or using machinery. Limit alcohol intake. Diflucan should not be used during pregnancy, lactation or if you plan to become pregnant without a doctor's advice. Do not use before breast-feeding without a doctor's advice.

Contraindications Diflucan is not allowed to people who have hypersensitivity to Fluconazole or other anti fungal azole preparations, eg clotrimazole, ketoconazole, itraconazole and other. Also Diflucan contraindicated in: Kidney and liver disorders; Cardiovascular diseases including heart diseases(heart rate or rhythm disturbances); Low blood levels of calcium, magnesium or potassium.

Possible side effect

They may include an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Also the most possible side effects include: nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); fever, chills, body aches, flu symptoms; severe blistering, peeling, and red skin rash; easy bruising or bleeding, unusual weakness; or seizure (convulsions). Less serious include: mild nausea, vomiting, diarrhea, or upset stomach; headache; dizziness; unusual or unpleasant taste in your mouth; or skin rash or itching. If you experience one of them stop using Diflucan and tell your doctor as soon as possible. Also consult your doctor about any side effect that seems unusual.

Drug interaction Diflucan interact with such medication as: a blood thinner such as warfarin (Coumadin) cyclosporine (Gengraf, Sandimmune, Neoral); an oral diabetes medicine such as glipizide (Glucotrol), glyburide (Diabeta, Micronase, Glynase), tolbutamide (Orinase), tolazamide (Tolinase), chlorpropamide (Diabinese), and others; rifabutin (Mycobutin) or rifampin (Rifadin, Rifater, Rifamate, Rimactane); a sedative such as diazepam (Valium), lorazepam (Ativan), alprazolam (Xanax), or midazolam (Versed); seizure medication such as phenytoin (Dilantin) or valproic acid (Depakene); tacrolimus ((Prograf); theophylline (Theo-Dur, Theolair, Theochron, Elixophyllin, Slo-Phyllin, others). Also note that interaction between two medications does not always mean that you must stop taking one of them. Usually it affects the the effect of drugs, so consult your doctor about the way these interactions are being managed or should be managed.

Missed dose If you forgot to take your dose in time, please do it as soon as you remember. But do not take if it is too late or almost time for your next dose. Do not take double or extra doses. Take your usual dose next day in the same time.

Overdose Symptoms of Diflucan overdose may include: confusion or unusual thoughts or behavior. If you experience one of them call your doctor immediately.

Storage Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture, kids and pets. Do not use after expiration term.

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

Product Description Common use Diflucan is an anti-fungal antibiotic which is used to treat fungal infections called candidiasis. This medication is prescribed for the treatment of such type of infections as vaginal, throat and fungal infections, infections of the urinary tract, peritonitis, and pneumonia. Diflucan works by killing sensitive fungi by interfering with the formation of the fungal cell membrane.

Dosage and direction Take it orally once a day, with or without food using the measuring spoon. Take it at the same time each day with a full glass of water if you want to get the best result. Diflucan make you feel better after 24 hours. However, your symptoms will go away completely just after few days. If there is no change in your health after a few days consult your doctor immediately. The dosage for adults may vary from type of infection: 1) Genital thrush - 150mg as a single dose 2) Mucosal thrush - dose depends on where the infection is located 50mg once daily during month. 3)Fungal skin infections - 50mg once daily for 2-4 weeks ; 4) Internal fungal infections 400mg on the first day then 200-400mg once daily for 6-8 weeks or longer if needed. 5) To stop you from getting fungal infections - 50-400mg once daily while you have risk to get an infection; 6) To stop infection caused by Cryptococcus from coming back - 100-200mg once daily indefinitely The dosage for children 4 weeks to 15 years old may also vary from type of infection: 1) mucosal infections - 3mg/kg once daily; 2)internal fungal infections - 6-12mg/kg once daily; 3)prevention of fungal infections - 3-12mg/kg once daily while at risk of getting an infection. For children 2-4 weeks old it is same dose as above but given once every 2 days. A maximum dose of 12mg/kg every 2 days. For children less than 2 weeks old it is same dose as above but given once every 3 days. Do not give more then 12mg/kg every 3 days. Note: this instruction presented here is just for review. It's very necessary to consult your doctor before using. It will help you to get best results.

For vaginal yeast infections, doctors usually prescribe a single dose of Diflucan. If the yeast infection does not improve after 5 days, contact your doctor as soon as possible. Be careful with this medication if your medical history include liver disease or kidney disease. Although uncommon, this drug may make you dizzy, so be more attentive while you are driving or using machinery. Limit alcohol intake. Diflucan should not be used during pregnancy, lactation or if you plan to become pregnant without a doctor's advice. Do not use before breast-feeding without a doctor's advice.

Contraindications Diflucan is not allowed to people who have hypersensitivity to Fluconazole or other anti fungal azole preparations, eg clotrimazole, ketoconazole, itraconazole and other. Also Diflucan contraindicated in: Kidney and liver disorders; Cardiovascular diseases including heart diseases(heart rate or rhythm disturbances); Low blood levels of calcium, magnesium or potassium.

Possible side effect

They may include an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Also the most possible side effects include: nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); fever, chills, body aches, flu symptoms; severe blistering, peeling, and red skin rash; easy bruising or bleeding, unusual weakness; or seizure (convulsions). Less serious include: mild nausea, vomiting, diarrhea, or upset stomach; headache; dizziness; unusual or unpleasant taste in your mouth; or skin rash or itching. If you experience one of them stop using Diflucan and tell your doctor as soon as possible. Also consult your doctor about any side effect that seems unusual.

Drug interaction Diflucan interact with such medication as: a blood thinner such as warfarin (Coumadin) cyclosporine (Gengraf, Sandimmune, Neoral); an oral diabetes medicine such as glipizide (Glucotrol), glyburide (Diabeta, Micronase, Glynase), tolbutamide (Orinase), tolazamide (Tolinase), chlorpropamide (Diabinese), and others; rifabutin (Mycobutin) or rifampin (Rifadin, Rifater, Rifamate, Rimactane); a sedative such as diazepam (Valium), lorazepam (Ativan), alprazolam (Xanax), or midazolam (Versed); seizure medication such as phenytoin (Dilantin) or valproic acid (Depakene); tacrolimus ((Prograf); theophylline (Theo-Dur, Theolair, Theochron, Elixophyllin, Slo-Phyllin, others). Also note that interaction between two medications does not always mean that you must stop taking one of them. Usually it affects the the effect of drugs, so consult your doctor about the way these interactions are being managed or should be managed.

Missed dose If you forgot to take your dose in time, please do it as soon as you remember. But do not take if it is too late or almost time for your next dose. Do not take double or extra doses. Take your usual dose next day in the same time.

Overdose Symptoms of Diflucan overdose may include: confusion or unusual thoughts or behavior. If you experience one of them call your doctor immediately.

Storage Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture, kids and pets. Do not use after expiration term.

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

Product Description Common use Diflucan is an anti-fungal antibiotic which is used to treat fungal infections called candidiasis. This medication is prescribed for the treatment of such type of infections as vaginal, throat and fungal infections, infections of the urinary tract, peritonitis, and pneumonia. Diflucan works by killing sensitive fungi by interfering with the formation of the fungal cell membrane.

Dosage and direction Take it orally once a day, with or without food using the measuring spoon. Take it at the same time each day with a full glass of water if you want to get the best result. Diflucan make you feel better after 24 hours. However, your symptoms will go away completely just after few days. If there is no change in your health after a few days consult your doctor immediately. The dosage for adults may vary from type of infection: 1) Genital thrush - 150mg as a single dose 2) Mucosal thrush - dose depends on where the infection is located 50mg once daily during month. 3)Fungal skin infections - 50mg once daily for 2-4 weeks ; 4) Internal fungal infections 400mg on the first day then 200-400mg once daily for 6-8 weeks or longer if needed. 5) To stop you from getting fungal infections - 50-400mg once daily while you have risk to get an infection; 6) To stop infection caused by Cryptococcus from coming back - 100-200mg once daily indefinitely The dosage for children 4 weeks to 15 years old may also vary from type of infection: 1) mucosal infections - 3mg/kg once daily; 2)internal fungal infections - 6-12mg/kg once daily; 3)prevention of fungal infections - 3-12mg/kg once daily while at risk of getting an infection. For children 2-4 weeks old it is same dose as above but given once every 2 days. A maximum dose of 12mg/kg every 2 days. For children less than 2 weeks old it is same dose as above but given once every 3 days. Do not give more then 12mg/kg every 3 days. Note: this instruction presented here is just for review. It's very necessary to consult your doctor before using. It will help you to get best results.

For vaginal yeast infections, doctors usually prescribe a single dose of Diflucan. If the yeast infection does not improve after 5 days, contact your doctor as soon as possible. Be careful with this medication if your medical history include liver disease or kidney disease. Although uncommon, this drug may make you dizzy, so be more attentive while you are driving or using machinery. Limit alcohol intake. Diflucan should not be used during pregnancy, lactation or if you plan to become pregnant without a doctor's advice. Do not use before breast-feeding without a doctor's advice.

Contraindications Diflucan is not allowed to people who have hypersensitivity to Fluconazole or other anti fungal azole preparations, eg clotrimazole, ketoconazole, itraconazole and other. Also Diflucan contraindicated in: Kidney and liver disorders; Cardiovascular diseases including heart diseases(heart rate or rhythm disturbances); Low blood levels of calcium, magnesium or potassium.

Possible side effect

They may include an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Also the most possible side effects include: nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); fever, chills, body aches, flu symptoms; severe blistering, peeling, and red skin rash; easy bruising or bleeding, unusual weakness; or seizure (convulsions). Less serious include: mild nausea, vomiting, diarrhea, or upset stomach; headache; dizziness; unusual or unpleasant taste in your mouth; or skin rash or itching. If you experience one of them stop using Diflucan and tell your doctor as soon as possible. Also consult your doctor about any side effect that seems unusual.

Drug interaction Diflucan interact with such medication as: a blood thinner such as warfarin (Coumadin) cyclosporine (Gengraf, Sandimmune, Neoral); an oral diabetes medicine such as glipizide (Glucotrol), glyburide (Diabeta, Micronase, Glynase), tolbutamide (Orinase), tolazamide (Tolinase), chlorpropamide (Diabinese), and others; rifabutin (Mycobutin) or rifampin (Rifadin, Rifater, Rifamate, Rimactane); a sedative such as diazepam (Valium), lorazepam (Ativan), alprazolam (Xanax), or midazolam (Versed); seizure medication such as phenytoin (Dilantin) or valproic acid (Depakene); tacrolimus ((Prograf); theophylline (Theo-Dur, Theolair, Theochron, Elixophyllin, Slo-Phyllin, others). Also note that interaction between two medications does not always mean that you must stop taking one of them. Usually it affects the the effect of drugs, so consult your doctor about the way these interactions are being managed or should be managed.

Missed dose If you forgot to take your dose in time, please do it as soon as you remember. But do not take if it is too late or almost time for your next dose. Do not take double or extra doses. Take your usual dose next day in the same time.

Overdose Symptoms of Diflucan overdose may include: confusion or unusual thoughts or behavior. If you experience one of them call your doctor immediately.

Storage Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture, kids and pets. Do not use after expiration term.

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



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Gear and Equipment

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Aproxol, Aproxol

Aproxol

Important Notice: The Drugs. com international database is in BETA release. This means it is still under development and may contain inaccuracies. It is not intended as a substitute for the expertise and judgement of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that the use of any medication in any country is safe, appropriate or effective for you. Consult with your healthcare professional before taking any medication.

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Ambroxol

Click for further information on drug naming conventions and International Nonproprietary Names .

Important Notice: The Drugs. com international database is in BETA release. This means it is still under development and may contain inaccuracies. It is not intended as a substitute for the expertise and judgement of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that the use of any medication in any country is safe, appropriate or effective for you. Consult with your healthcare professional before taking any medication.

Was this page helpful?

Diclofenac is used to treat pain or inflammation caused by arthritis or ankylosing spondylitis. Diclofenac may also be used for purposes other than those listed in this medication guide.

Use Diclofenac as directed by your doctor.

Take Diclofenac by mouth with or without food. Ask your health care provider any questions you may have about how to use Diclofenac.

Drug Class and Mechanism

Diclofenac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Diclofenac works by reducing hormones that cause inflammation and pain in the body.

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

Store Diclofenac at room temperature between 68 and 77 degrees F (20 and 25 degrees C) in a tightly closed container. Brief periods at temperatures of 59 to 86 degrees F (15 to 30 degrees C) are permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Diclofenac out of the reach of children and away from pets.

Do not use Diclofenac if:

you are allergic to any ingredient in Diclofenac; you have had a severe allergic reaction (e. g. severe rash, hives, breathing difficulties, dizziness) to another NSAID (e. g. ibuprofen, naproxen, celecoxib) or aspirin. Contact your doctor or health care provider right away if any of these apply to you.

Important : Diclofenac may cause dizziness or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Diclofenac with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Before you start any new medicine, check the label to see if it has Aproxol or another nonsteroidal anti-inflammatory drug (NSAID) medicine in it too. If it does or if you are not sure, check with your doctor or pharmacist. Diclofenac should not be used in children; safety and effectiveness in children have not been confirmed. Pregnancy and breast-feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Diclofenac while you are pregnant. It is not known if Diclofenac is found in breast milk. Do not breast-feed while using Diclofenac.

Possible Side Effects

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

burning or stinging; discharge; eye redness, irritation, or itching. Seek medical attention right away if any of these severe side effects occur:

severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred or distorted vision; eye infection; eyelid swelling or redness; sensitivity to glare or light.

Diclofenac 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.



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Velorina

Velorina is a ghost in the northern-most house in Port Phasmatys. Players must speak to her to start the Ghosts Ahoy quest, where she informs the player of the history of Port Phasmatys and Necrovarus 's imprisonment of its citizens using the Ectofuntus. and enlists their help to free them. At the end she decides to stay for the time being and, if you lose the Ectophial given to you after completing the Ghosts Ahoy quest, Velorina will give you another one for free. A Ghostspeak Amulet is required to speak to Velorina

Interestingly, Velorina does not appear green, like the other ghosts. Both her avatar and her chathead appear grey.

Trivia Edit



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