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:

Physicians Total Care, 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 marrow depr

Product summary:

Carbamazepine tablets USP, 200 mg are available as round, white, single-scored tablets, debossed “T” - “109”. Supplied in Carbamazepine tablets, USP (chewable), 100 mg are available as round, single-scored tablets, pink with red specks, debossed “93” - “93”/“778”. Supplied in 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. Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. AF 12/2009 Relabeling and Repackaging by: Physicians Total Care, Inc.  Tulsa, OK    74146

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CARBAMAZEPINE - CARBAMAZEPINE TABLET
CARBAMAZEPINE - CARBAMAZEPINE TABLET, CHEWABLE
Physicians Total Care, Inc.
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MEDICATION GUIDE
Carbamazepine Tablets USP and Carbamazepine 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 other antiep

Summary of Product characteristics

CARBAMAZEPINE - CARBAMAZEPINE TABLET
CARBAMAZEPINE - CARBAMAZEPINE TABLET, CHEWABLE
PHYSICIANS TOTAL CARE, INC.
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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
T ES TS ).
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 MAJORITY
OF THE CASES OF LEUKOPENIA HAVE NOT PROGRESSED TO THE MORE