CARBAMAZEPINE capsule, extended release

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Avera McKennan Hospital

INN (Nama Antarabangsa):

CARBAMAZEPINE

Komposisi:

CARBAMAZEPINE 300 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 improvements 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 depressio

Ringkasan produk:

300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with S433 and 300 mg in white ink. Supplied in bottles of 120 ............................NDC 66993-409-32 NDC 69189-0410-1 single dose pack with 1 capsule as repackaged by Avera McKennan Hospital Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE. Distributed by: Prasco Laboratories Mason, OH 45040 USA Manufactured for: Shire US Inc. Wayne, PA 19087 USA © 2011 Prasco Laboratories 009726        1122v2AG        08/2011

Status kebenaran:

New Drug Application Authorized Generic

Risalah maklumat

CARBAMAZEPINE- CARBAMAZEPINE CAPSULE, EXTENDED RELEASE
Avera McKennan Hospital
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MEDICATION GUIDE
CARBAMAZEPINE
EXTENDED-RELEASE CAPSULES
Read this Medication Guide before you start taking carbamazepine 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 rashes that may lead to
death. These serious skin reactions
are more likely to happen within the first four months of
carbamazepine 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, or worry you:
•
thoughts about suicide or dying
•
attempt to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggress

Ciri produk

CARBAMAZEPINE- CARBAMAZEPINE CAPSULE, EXTENDED RELEASE
AVERA MCKENNAN HOSPITAL
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CARBAMAZEPINE EXTENDED-RELEASE CAPSULES
100 MG, 200 MG AND 300 MG
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. 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 5-8 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 NO