CARBAMAZEPINE tablet, chewable CARBAMAZEPINE tablet CARBAMAZEPINE tablet, extended release CARBAMAZEPINE suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Carbamazepine (UNII: 33CM23913M) (Carbamazepine - UNII:33CM23913M)

Available from:

Taro Pharmaceuticals U.S.A., Inc.

INN (International Name):

Carbamazepine

Composition:

Carbamazepine 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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). 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. Carbamazepine should not be used in patients with a history of previous bone marrow depression, hype

Product summary:

Carbamazepine Tablets USP, (Chewable), 100 mg: White, flat, round tablet with pink specks, and cherry fragrance. One side scored and engraved with "TARO" above the score and "16" under the score. Other side plain. Carbamazepine Tablets USP, (Chewable), 200 mg: White, flat, oval beveled tablet, with pink specks, and cherry fragrance. One side scored and engraved with "T" above the score and "27" under the score. Other side scored. Store Carbamazepine Tablets USP, (Chewable) at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in tight, light-resistant container (USP). Meets USP Dissolution Test 1. Carbamazepine Tablets USP, 200 mg: White, round, flat beveled-edge, one side scored and engraved "TARO" above and "11" below the score, the other side plain. Store Carbamazepine Tablets USP at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP). Meets USP Dissolution Test 2. Carbamazepine Extended-Release Tablets USP, 100 mg: White to off-white, round bi-convexed tablets engraved with "T91" on one side and plain on the other side. Carbamazepine Extended-Release Tablets USP, 200 mg: White to off-white, round bi-convexed tablets engraved with "T26" on one side and plain on the other side. Carbamazepine Extended-Release Tablets USP, 400 mg: White to off-white, capsule-shaped bi-convexed tablets engraved with "T29" on one side and plain on the other side. Store Carbamazepine Extended-Release Tablets USP at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP). Carbamazepine Oral Suspension USP, 100 mg/5 mL (teaspoonful): Orange colored and orange flavored suspension. Shake well before using. Store Carbamazepine Oral Suspension USP at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing and from excessive heat. Dispense in tight, light-resistant container (USP).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CARBAMAZEPINE- CARBAMAZEPINE TABLET, CHEWABLE
CARBAMAZEPINE- CARBAMAZEPINE TABLET
CARBAMAZEPINE- CARBAMAZEPINE TABLET, EXTENDED RELEASE
CARBAMAZEPINE- CARBAMAZEPINE SUSPENSION
Taro Pharmaceuticals U.S.A., Inc.
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MEDICATION GUIDE
Carbamazepine (kar" ba maz' e peen) Tablets,
Carbamazepine (kar" ba maz' e peen) Oral Suspension,
Carbamazepine (kar" ba maz' e peen) Tablets (Chewable),
and Carbamazepine (kar" ba maz' e peen) Extended-Release Tablets
Read this Medication Guide before you start taking Carbamazepine
Tablets, Carbamazepine Oral
Suspension, Carbamazepine Tablets (Chewable), or Carbamazepine
Extended-Release 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?
Do not stop taking carbamazepine without first talking to your
healthcare provider.
Stopping carbamazepine suddenly can cause serious problems.
Carbamazepine can cause serious side effects, including:
1.
Carbamazepine 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 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 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 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.
Carbamazepine may cause allergic reactions or serious p

Summary of Product characteristics

CARBAMAZEPINE- CARBAMAZEPINE TABLET, CHEWABLE
CARBAMAZEPINE- CARBAMAZEPINE TABLET
CARBAMAZEPINE- CARBAMAZEPINE TABLET, EXTENDED RELEASE
CARBAMAZEPINE- CARBAMAZEPINE SUSPENSION
TARO PHARMACEUTICALS U.S.A., INC.
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CARBAMAZEPINE TABLETS USP, (CHEWABLE), 100 MG AND 200 MG
CARBAMAZEPINE TABLETS USP, 200 MG
CARBAMAZEPINE EXTENDED-RELEASE TABLETS USP, 100 MG, 200 MG, AND 400 MG
CARBAMAZEPINE ORAL SUSPENSION USP, 100 MG/5 ML
RX ONLY
PRESCRIBING INFORMATION
WARNINGS
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 YE