CARBAMAZEPINE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

McKesson Contract Packaging

INN (Mezinárodní Name):

CARBAMAZEPINE

Složení:

CARBAMAZEPINE 200 mg

Druh předpisu:

PRESCRIPTION DRUG

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CARBAMAZEPINE- CARBAMAZEPINE TABLET
MCKESSON CONTRACT PACKAGING
----------
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
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, TH