CARBAMAZEPINE tablet, chewable

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

Carbamazepine (UNII: 33CM23913M) (Carbamazepine - UNII:33CM23913M)

Dostupné z:

Preferred Pharmaceuticals, Inc

INN (Medzinárodný Name):

Carbamazepine

Zloženie:

Carbamazepine 200 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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: 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 (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 depression, h

Prehľad produktov:

Carbamazepine Tablets USP, (Chewable), 200 mg: White, flat, oval beveled tablet, with pink specks, and cherry fragrance. One side scored and engraved with "T" above the score and "27" under the score. Other side scored. Bottle of 20 – 68788-9812-2 Bottle of 30 – 68788-9812-3 Bottle of 60 – 68788-9812-6 Bottle of 90 – 68788-9812-9 Bottle of 100 – 68788-9812-1 Store Carbamazepine Tablets USP, (Chewable) at 20°C-25°C (68°F-77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in tight, lightresistant container (USP). Meets USP Dissolution Test 1. Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 26110 Distributed by: Taro Pharmaceuticals U.S.A., Inc. , Hawthorne, NY 10532 Revised: April 2013 70725-0413-6 Repackaged by Preferred Pharmaceuticals, Inc.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

CARBAMAZEPINE- CARBAMAZEPINE TABLET, CHEWABLE
Preferred Pharmaceuticals, Inc
----------
MEDICATION GUIDE
Carbamazepine
Tablets USP,
Carbamazepine
Oral Suspension USP,
Carbamazepine
Tablets USP (Chewable),
and Carbamazepine
Extended-Release Tablets USP
Read this Medication Guide before you start taking Carbamazepine
Tablets USP, Carbamazepine Oral
Suspension USP, Carbamazepine Tablets USP (Chewable), or Carbamazepine
Extended-Release Tablets
USP 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?
Do not stop taking carbamazepine without first talking to your
healthcare provider.
Stopping carbamazepine suddenly can cause serious problems.
Carbamazepine can cause serious side effects, including:
1. Carbamazepine 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 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 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 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 may cause suicidal
thoughts or actions in a very small
number of people, about 1 in 500.
Call your healthcare provider right away if you have any of these
symptoms, especially if they are new,
worse,

Súhrn charakteristických

CARBAMAZEPINE- CARBAMAZEPINE TABLET, CHEWABLE
PREFERRED PHARMACEUTICALS, INC
----------
CARBAMAZEPINE TABLETS USP,
(CHEWABLE), 100 MG AND 200 MG
CARBAMAZEPINE TABLETS USP, 200 MG
CARBAMAZEPINE EXTENDED-RELEASE
TABLETS USP, 100 MG, 200 MG, AND 400 MG
CARBAMAZEPINE ORAL SUSPENSION USP,
100 MG/5 ML
RX ONLY
PRESCRIBING INFORMATION
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 ASSOCIAT