Epitol

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 12/9/2021

What is Epitol and how is it used?

Epitol is a prescription medicine used to treat the symptoms of Epilepsy and Trigeminal Neuralgia. Epitol may be used alone or with other medications.

Epitol belongs to a class of drugs called Anticonvulsants, Other; Antimanic Agents; Bipolar Disorder Agents.

It is not known if Epitol is safe and effective in children younger than 6 years of age.

What are the possible side effects of Epitol?

Epitol may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • severe headaches,
  • continuous nausea or vomiting,
  • loss of appetite,
  • stomach pain,
  • yellowing eyes or skin (jaundice),
  • dark urine,
  • change in the amount of urine,
  • mouth sores,
  • fainting,
  • fast, slow, irregular heartbeat,
  • unusual eye movements,
  • vision changes,
  • blurred vision,
  • joint pain,
  • swelling of the ankles or feet,
  • pain, redness, or swelling of the arms or legs,
  • numbness or tingling of the hands and feet,
  • extreme drowsiness,
  • mental or mood changes,
  • confusion,
  • seizures,
  • depression,
  • suicidal thoughts or attempts,
  • unusual or sudden mood changes,
  • thoughts about self-harm,
  • rash,
  • itching, and
  • severe dizziness

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Epitol include:

  • dizziness,
  • drowsiness,
  • constipation,
  • dry mouth,
  • unsteadiness,
  • nausea, and
  • vomiting

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Epitol. For more information, ask 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.

WARNING

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 POPULATIONBASED 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.

DESCRIPTION

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 5H-dibenz[b,f]azepine-5- carboxamide, and its structural formula is:

EPITOL® (carbamazepine) Structural Formula Illustration

C15H12N2O       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.