CARBAMAZEPINE tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Bryant Ranch Prepack

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Carbamazepine tablets and carbamazepine tablets (chewable) are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine tablets and carbamazepine tablets (chewable) 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 tablets and carbamazepine tablets (chewable) (see PRECAUTIONS , General ). Carbamazepine tablets and carbamazepine tablets (chewable) are 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

Vörulýsing:

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 bottles of 1000 (NDC: 63629-8753-1). 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. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

CARBAMAZEPINE- CARBAMAZEPINE TABLET
Bryant Ranch Prepack
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MEDICATION GUIDE
Carbamazepine (kar′′ ba maz′ e peen) Tablets and Carbamazepine
(kar′′ ba maz′ e peen) Tablets
(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. Carbamazepine tablets

Vara einkenni

CARBAMAZEPINE- CARBAMAZEPINE TABLET
BRYANT RANCH PREPACK
----------
CARBAMAZEPINE TABLETS USP, 200 MG
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 ESTIMATE ACCURATELY
THEIR INCIDENCE OR OUTCOME. HOWEVER, THE VAST MAJORITY OF TH