CARBAMAZEPINE tablet

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:

Aphena Pharma Solutions - Tennessee, LLC

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, USP 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: Carbamazepine tablets, USP 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

製品概要:

Carbamazepine tablets, USP 200 mg are white to off-white, round, scored tablets, imprinted “APO” over “200” on one side and plain with a full bisect on the other side. They are supplied as follows: Bottles of 100                          NDC 60429-032-01 Bottles of 1000                        NDC 60429-032-10 Do not store above 30˚C (86˚F). Protect from moisture. Dispense in tight container (USP). GSMS INC. CARBAMAZEPINE TABLETS, USP 200 mg September 2015 Rev. 13

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

CARBAMAZEPINE- CARBAMAZEPINE TABLET
Aphena Pharma Solutions - Tennessee, LLC
----------
MEDICATION GUIDE
Carbamazepine Tablets, USP
(kar" ba maz’ e peen)
Read this Medication Guide before you start taking carbamazepine
tablets 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?
Do not stop taking carbamazepine tablets without first talking to your
healthcare provider.
Stopping carbamazepine suddenly can cause serious problems.
Carbamazepine tablets can cause serious side effects, including:
1. Carbamazepine tablets 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:
1.
skin rash
2.
hives
3.
sores in your mouth
4.
blistering or peeling of the skin
2. Carbamazepine tablets may cause rare but serious blood problems.
Symptoms may include:
1.
fever, sore throat, or other infections that come and go or do not go
away
2.
easy bruising
3.
red or purple spots on your body
4.
bleeding gums or nose bleeds
5.
severe fatigue or weakness
3. Like other antiepileptic drugs, carbamazepine tablets 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:
1.
thoughts about suicide or dying
2.
attempts to commit suicide
3.
new or worse depression
4.
new or worse anxiety
5.
feeling agitated or restless
6.
panic attacks

製品の特徴

CARBAMAZEPINE- CARBAMAZEPINE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
CARBAMAZEPINE TABLETS, USP 200 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 THEIR INCIDENCE OR OUTCOME. HOWEVER, THE VAST MAJORITY
OF THE CASES OF LEUKOPENIA HAV