CARBAMAZEPINE tablet CARBAMAZEPINE tablet, chewable

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Teva Pharmaceuticals USA, Inc.

INN（国際名）:

CARBAMAZEPINE

構図:

CARBAMAZEPINE 200 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 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, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc. Likewise, on theoretical grounds its use with monoamine oxidase (MAO) inhibitors is not recommended. Before administration of carbamazepine, MAO inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits. Coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Coadministration of carbamazepine with nefazodone is contraindicated. No evidence of abuse potential has been associated with carbamazepine, nor is there evidence of psychological or physical dependence in humans.

製品概要:

Carbamazepine Tablets, USP 200 mg are available as a round, white to off-white, single-scored tablet, debossed "109" above the score line and "TEVA" on the unscored side of the tablet. Supplied in bottles of 100 (NDC 0093-0109-01) and 1000 (NDC 0093-0109-10). Carbamazepine Tablets, USP (chewable) 100 mg are available as round, single-scored tablets, pink with red specks, debossed “93” above the score line, “93” below the score line and “778” on the unscored side of the tablet. Supplied in bottles of 100 (NDC 0093-0778-01). 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. Brands listed are the trademarks of their respective owners. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured In Israel By: Teva Pharmaceutical Ind. Ltd. Kfar Saba, 4410202, Israel Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. AV 1/2024

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

CARBAMAZEPINE- CARBAMAZEPINE TABLET
CARBAMAZEPINE- CARBAMAZEPINE TABLET, CHEWABLE
Teva Pharmaceuticals USA, Inc.
----------
MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
Carbamazepine (kar′′ ba maz′ e peen) Tablets
and Carbamazepine (kar′′ ba maz′ e peen) Tablets (Chewable)
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

製品の特徴

CARBAMAZEPINE- CARBAMAZEPINE TABLET
CARBAMAZEPINE- CARBAMAZEPINE TABLET, CHEWABLE
TEVA PHARMACEUTICALS USA, INC.
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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 THEI