CARBAMAZEPINE tablet, chewable CARBAMAZEPINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Major Pharmaceuticals

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: 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, 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.

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. Available: Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-3854-61 Bottles of 1000 tablets, NDC 0904-3854-80 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. Available:     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., Levittown, PA 19057 8085068                                                                                       Revised November2021

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CARBAMAZEPINE- carbamazepine tablet, chewable
CARBAMAZEPINE- carbamazepine tablet
Major Pharmaceuticals
----------
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 serious problems

Summary of Product characteristics

CARBAMAZEPINE- CARBAMAZEPINE TABLET, CHEWABLE
CARBAMAZEPINE- CARBAMAZEPINE TABLET
MAJOR PHARMACEUTICALS
----------
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 AVAILABLE TO EST