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Carbamazepine (Epitol)

Trade Name : Epitol

Teva Pharmaceuticals USA, Inc.

TABLET

Strength 200 mg/1

CARBAMAZEPINE Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Carbamazepine (Epitol) which is also known as Epitol and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 200 mg/1 per ml. Read more

Carbamazepine (Epitol) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • SERIOUS DERMATOLOGIC REACTIONS AND HLA-B1502 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-B1502, AN INHERITED ALLELIC VARIANT OF THE HLA-B GENE. HLA-B1502 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-B1502 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 AND ).
  • 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.
  • Prescribing Information
  • Before prescribing Epitol, 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.
  • Epitol, carbamazepine, USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as tablets of 200 mg. Its chemical name is 5-dibenz[]azepine-5-carboxamide, and its structural formula is:
  • u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0CHNOu00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 M.W. 236.27
  • Carbamazepine, USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone.
  • Epitol (Carbamazepine Tablets USP) 200 mg contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, glycerin, lactose monohydrate, magnesium stearate, and sodium starch glycolate.
  • Epitol 200 mg tablets meet USP Dissolution Test 3.
  • 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.
  • No data
  • Epitol 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 Epitol, MAO inhibitors should be discontinued 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.
  • No data
  • No data
  • If adverse reactions are of such severity that the drug must be discontinued, the physician 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 ), 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:
  • Arrayn- Hemopoietic System:
  • Arrayn- BOXED WARNING
  • Arrayn- Cardiovascular System:
  • Some of these cardiovascular complications have resulted in fatalities. Myocardial infarction has been associated with other tricyclic compounds.
  • Arrayn- Liver:
  • Arrayn- Pancreatic:
  • Arrayn- Respiratory System:
  • Arrayn- Genitourinary System:
  • 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 incidence 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.
  • Arrayn- Nervous System:
  • There have been reports of associated paralysis and other symptoms of cerebral arterial 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 concomitant use of psychotropic drugs.
  • Arrayn- Digestive System:
  • Arrayn- WARNINGSn- General
  • Arrayn- Musculoskeletal System:
  • Arrayn- WARNINGSn- General
  • Isolated cases of a lupus erythematosus-like syndrome have been reported. There have been occasional reports of elevated levels of cholesterol, HDL cholesterol, and triglycerides 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 medications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine.
  • No evidence of abuse potential has been associated with carbamazepine, nor is there evidence of psychological or physical dependence in humans.
  • No data
  • ()
  • Monitoring of blood levels has increased the efficacy and safety of anticonvulsants (see ). Dosage should be adjusted to the needs of the individual 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 minimum effective level. Medication should be taken with meals.
  • Conversion of patients from oral Epitol tablets to carbamazepine suspension: Patients should be converted by administering the same number of mg per day in smaller, more frequent doses (i.e., twice a day tablets to three times a day suspension).
  • Epitol (Carbamazepine Tablets USP) 200 mg is available as round, white, single-scored tablets, debossed u201cEPITOLu201d/u201c93u201d - u201c93u201d.
  • Supplied in bottles of 100. NDC 0093-0090-01.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Protect from moisture. Store in a dry place.
  • Dispense in a tight container, preferably glass, as defined in the USP.
  • Dispense in a container labeled: Store in a dry place. Protect from moisture.
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Manufactured In Israel By:
  • Arrayn- Teva Pharmaceutical Ind. Ltd.
  • Jerusalem, 9777402, Israel
  • Manufactured For:
  • Arrayn- Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. AM 10/2018
  • Epitol (EP-ih-tall)
  • (carbamazepine tablets) n- (kar-bah-MAZ-eh-peen)
  • Rx only
  • Read this Medication Guide before you start taking Epitol 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 Epitol?
  • Do not stop taking Epitol without first talking to your healthcare provider.
  • Stopping Epitol suddenly can cause serious problems.
  • Epitol can cause serious side effects, including:
  • 1. Epitol 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 Epitol 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 Epitol to see if you are at a higher risk for serious skin reactions with this medicine. Symptoms may include:
  • 2. Epitol may cause rare but serious blood problems. Symptoms may include:
  • 3.u00a0n- Epitoln- may cause allergic reactions or serious problems, which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions.
  • Call your healthcare provider right away if you have any of the following:
  • 4. Like other antiepileptic drugs, Epitol 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:
  • How can I watch for early symptoms of suicidal thoughts and actions?
  • Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
  • Do not stop Epitol without first talking to a healthcare provider.
  • Stopping Epitol 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 is Epitol?
  • Epitol is a prescription medicine used to treat:
  • Epitol is not a regular pain medicine and should not be used for aches or pains.
  • Who should not take Epitol?
  • Do not take Epitol if you:
  • What should I tell my healthcare provider before taking Epitol?
  • Before you take Epitol, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take
  • Taking Epitol 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 Epitol?
  • What should I avoid while taking Epitol?
  • What are the possible side effects of Epitol?
  • See u201cu201d
  • Epitol may cause other serious side effects. These include:
  • Get medical help right away if you have any of the symptoms listed above or listed in u201cWhat is the most important information I should know about Epitolu201d.
  • The most common side effects of Epitol include:
  • These are not all the possible side effects of Epitol. For more information, ask your healthcare provider or pharmacist.
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store Epitol?
  • Keep Epitol and all medicines out of the reach of children.
  • General Information about Epitol
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Epitol for a condition for which it was not prescribed. Do not give Epitol to other people, even if they have the same symptoms that you have. It may harm them.
  • This Medication Guide summarizes the most important information about Epitol. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for the full prescribing information about Epitol that is written for health professionalsn
  • For more information, call 1-888-838-2872.
  • What are the ingredients in Epitol?
  • Active ingredient: carbamazepine
  • Inactive ingredients:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured In Israel By:
  • Arrayn- Teva Pharmaceutical Ind. Ltd.
  • Jerusalem, 9777402, Israel
  • Manufactured For:
  • Arrayn- Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. C 10/2018
  • No data

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