CARBAMAZEPINE tablet CARBAMAZEPINE tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CARBAMAZEPINE (UNII: 33CM23913M) (CARBAMAZEPINE - UNII:33CM23913M)

Available from:

Torrent Pharmaceuticals Limited

INN (International Name):

CARBAMAZEPINE

Composition:

CARBAMAZEPINE 200 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 marro

Product summary:

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.    Manufactured by: TORRENT PHARMACEUTICALS LTD., INDIA. Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920 8094265                                                                                      Revised: October 2023

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CARBAMAZEPINE- CARBAMAZEPINE TABLET
CARBAMAZEPINE- CARBAMAZEPINE TABLET, CHEWABLE
Torrent Pharmaceuticals Limited
----------
MEDICATION GUIDE
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
Rx Only
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. Carbamazepine tablets or chewable tablets may cause allergic
reactions or seri

Summary of Product characteristics

CARBAMAZEPINE- CARBAMAZEPINE TABLET
CARBAMAZEPINE- CARBAMAZEPINE TABLET, CHEWABLE
TORRENT PHARMACEUTICALS LIMITED
----------
CARBAMAZEPINE TABLETS, USP, 100 MG, 200 MG, 300 MG, 400 MG AND
CARBAMAZEPINE TABLETS, USP (CHEWABLE), 100 MG
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 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 AVAILA