CARBAMAZEPINE capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Carbamazepine (UNII: 33CM23913M) (Carbamazepine - UNII:33CM23913M)

Available from:

Taro Pharmaceuticals U.S.A., Inc.

INN (International Name):

Carbamazepine

Composition:

Carbamazepine 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

hard gelatin capsules, size 3, green opaque body/green opaque cap imprinted with black ink "TARO" on 1st line and "CZ ER 100" on the 2nd line on both cap and body. Contain white to off white granules. hard gelatin capsules, size 1, white opaque body/green opaque cap imprinted with black ink "TARO" on the 1st line and "CZ ER 200" on the 2nd line on both the cap and body. Contain white to off white granules. hard gelatin capsule, size 0, white-opaque body/white-opaque cap imprinted with black ink "TARO" on 1st line and "CZ ER 300" on the 2nd line on both cap and body. Contain white to off white granules. Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT AND MOISTURE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CARBAMAZEPINE- CARBAMAZEPINE CAPSULE, EXTENDED RELEASE
Taro Pharmaceuticals U.S.A., Inc.
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MEDICATION GUIDE
Carbamazepine Extended-Release Capsules
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 capsule 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 can also cause other types
of allergic reactions or serious
problems that may affect organs and other parts of your body such as
your liver or blood cells. You may
or may not have a rash when you get these types of reactions. Call
your healthcare provider right away if
you have any of these symptoms:
•
frequent fevers or fevers that do not go away
•
frequent infections or an infection that does not go away
•
unusual bruising or bleeding
•
red or purple spots on your body
•
severe fatigue or weakness
•
unexpected mu

Summary of Product characteristics

CARBAMAZEPINE- CARBAMAZEPINE CAPSULE, EXTENDED RELEASE
TARO PHARMACEUTICALS U.S.A., INC.
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CARBAMAZEPINE
EXTENDED-RELEAS E
CAPSULES, 100 MG,
200 MG AND 300 MG
RX ONLY
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 5-8 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 O