CARBAMAZEPINE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

State of Florida DOH Central Pharmacy

INN (International Name):

CARBAMAZEPINE

Composition:

CARBAMAZEPINE 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 improvement 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 depression, h

Product summary:

Carbamazepine Extended-Release Tablets USP, 100 mg: White to off-white, round convex tablets embossed with "T91" on one side and plain on the other side. Carbamazepine Extended-Release Tablets USP, 200 mg: White to off-white, round convex tablets embossed with "T26" on one side and plain on the other side. Carbamazepine Extended-Release Tablets USP, 400 mg: White to off-white capsule-shaped tablets embossed with "T29" on one side and plain on the other. They are supplied by State of Florida DOH Central Pharmacy as follows: Store Carbamazepine Extended-Release Tablets USP at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CARBAMAZEPINE - CARBAMAZEPINE TABLET, EXTENDED RELEASE
State of Florida DOH Central Pharmacy
----------
MEDICATION GUIDE
Carbamazepine
Tablets USP,
Carbamazepine
Oral Suspension USP,
Carbamazepine
Tablets USP (Chewable),
and Carbamazepine
Extended-Release Tablets USP
Read this Medication Guide before you start taking Carbamazepine
Tablets USP, Carbamazepine Oral
Suspension USP, Carbamazepine Tablets USP (Chewable), or Carbamazepine
Extended-Release Tablets
USP 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 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:
•
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 the

Summary of Product characteristics

CARBAMAZEPINE - CARBAMAZEPINE TABLET, EXTENDED RELEASE
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
CARBAMAZEPINE TABLETS USP, (CHEWABLE), 100 MG AND 200 MG
CARBAMAZEPINE TABLETS USP, 200 MG
CARBAMAZEPINE EXTENDED-RELEASE TABLETS USP, 100 MG, 200 MG, AND 400 MG
CARBAMAZEPINE ORAL SUSPENSION USP, 100 MG/5 ML
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