CARBAMAZEPINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, LLC dba Vangard Labs

INN (International Name):

CARBAMAZEPINE

Composition:

CARBAMAZEPINE 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carbamazepine tablets USP and carbamazepine tablets USP (chewable) are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine tablets USP and carbamazepine tablets USP (chewable) as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2. Generalized tonic-clonic seizures (grand mal). 3. 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 tablets USP and carbamazepine tablets USP (chewable) (see PRECAUTIONS , General ). Carbamazepine tablets USP and carbamazepine tablets USP (chewable) are indicated in the treatment of the pain associated with true trigeminal neuralgia. Beneficial results have also been reported in glossophar

Product summary:

Carbamazepine Tablets USP, 200 mg are available as a round, white, single-scored tablet, debossed "109" above the score line and "TEVA" on the unscored side of the tablet. Supplied in blistercards of 30 (NDC 0615-3505-39). Carbamazepine Tablets USP (chewable), 100 mg are available as round, single-scored tablets, pink with red specks, debossed “93” - “93”/“778”. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Store in a dry place. Dispense in a tight container, preferably glass, as defined in the USP. Dispense in a container labeled: Store in a dry place. Protect from moisture. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc. Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. AR 9/2015

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CARBAMAZEPINE- CARBAMAZEPINE TABLET
NCS HealthCare of KY, LLC dba Vangard Labs
----------
MEDICATION GUIDE
Carbamazepine (kar-bah-MAZ-eh-peen)Tablets USP and Carbamazepine
(kar-bah-MAZ-eh-peen)
Tablets, USP (Chewable)
Rx only
Read this Medication Guide before you start taking carbamazepine
tablets or carbamazepine tablets
(chewable) 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 carbamazepine
tablets (chewable)?
Do not stop taking carbamazepine tablets or carbamazepine tablets
(chewable) without first talking to
your healthcare provider.
Stopping carbamazepine tablets or carbamazepine tablets (chewable)
suddenly can cause serious
problems.
Carbamazepine tablets or carbamazepine tablets (chewable) can cause
serious side effects, including:
1. Carbamazepine tablets or carbamazepine tablets (chewable) 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 carbamazepine tablets (chewable) 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 carbamazepine tablets (chewable) 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 carbamazepine tablets (chewable) 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 ot

Summary of Product characteristics

CARBAMAZEPINE- CARBAMAZEPINE TABLET
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
----------
CARBAMAZEPINE TABLETS USP, 200 MG / CARBAMAZEPINE TABLETS USP
(CHEWABLE), 100 MG
0109
0778
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 ESTIMATE ACCURATELY
THEIR INCIDENCE OR OUTCOME