CARBAMAZEPINE - carbamazepine capsule, extended release

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:

Nostrum Laboratories, Inc.

INN（国際名）:

CARBAMAZEPINE

構図:

CARBAMAZEPINE 300 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Carbamazepine Extended-Release Capsules are 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 improvements 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 Extended-Release Capsules 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

製品概要:

Carbamazepine Extended-Release Capsules are supplied as: 300 mg - Hard gelatin capsule (purple opaque body with purple opaque cap) printed with the "NC" / "300" logo in black ink. Supplied in bottles of 30.......................... NDC 29033-004-30 Supplied in bottles of 120........................ NDC 29033-004-12 Store at 20°-25°C (68°-77°F); excursions permitted to 15-30°C (59-86°F) [See USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE. Manufactured by: Nostrum Laboratories, Inc. 1800 N Topping Ave Kansas City, MO 64120 Rev: April, 2011

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

CARBAMAZEPINE - CARBAMAZEPINE CAPSULE, EXTENDED RELEASE
Nostrum Laboratories, Inc.
----------
MEDICATION GUIDE
CARBAMAZEPINE EXTENDED-RELEASE CAPSULES
(300 MG)
Read this Medication Guide before you start taking Carbamazepine
Extended-Release Capsules 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 Extended-Release
Capsules?
Do not stop taking Carbamazepine Extended-Release Capsules without
first talking to your healthcare
provider.
Stopping Carbamazepine Extended-Release Capsules suddenly can cause
serious problems.
Carbamazepine Extended-Release Capsules can cause serious side
effects, including:
1. Carbamazepine Extended-Release Capsules may cause rare but serious
rashes that may lead to death.
These serious skin reactions are more likely to happen within the
first four months of Carbamazepine
Extended-Release Capsules 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 Extended-Release Capsules 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 Extended-Release Capsules 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 Extended-Release
Capsules 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

製品の特徴

CARBAMAZEPINE - CARBAMAZEPINE CAPSULE, EXTENDED RELEASE
NOSTRUM LABORATORIES, INC.
----------
WARNING
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 EXTENDED-RELEASE CAPSULES. PATIENTS TESTING
POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH
CARBAMAZEPINE EXTENDED-RELEASE CAPSULES 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 THE CASES OF LEUKOPENIA HAVE NOT PROGR