CARBAMAZEPINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals, Inc.

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, 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 66267-268-30 Bottle of 90 NDC 66267-268-90 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., Indrad-382 721, Dist. Mehsana, INDIA. For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. 8057712 Revised November 2015

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CARBAMAZEPINE- CARBAMAZEPINE TABLET
NuCare Pharmaceuticals, Inc.
----------
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. Like other antiepileptic drugs, carbamazepine tablets or chewable
tablets may cause suicidal thoughts or
actions in a very small

Summary of Product characteristics

CARBAMAZEPINE- CARBAMAZEPINE TABLET
NUCARE PHARMACEUTICALS, INC.
----------
CARBAMAZEPINE TABLETS, USP, 100 MG, 200 MG, 300 MG, 400 MG AND
CARBAMAZEPINE TABLETS, USP (CHEWABLE), 100 MG
RX ONLY
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 ESTIMATE
ACCURATELY THEIR INCIDENCE OR OUTCOME. HOWEVER, THE VAST