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:

Ajanta Pharma USA Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Epilepsy   Carbamazepine extended-release tablets are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine extended-release tablets 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 improvement 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 extended-release tablets (see PRECAUTIONS, General). Trigeminal Neuralgia Carbamazepine extended-release tablets 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 clinical situation permits. Coadministration of carbamazepine and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Coadministration of carbamazepine with nefazodone is contraindicated. No evidence of abuse potential has been associated with carbamazepine, nor is there evidence of psychological or physical dependence in humans.

Product summary:

Carbamazepine extended-release tablets, USP 100 mg - Off white to light brown colored, round, biconvex, coated tablet imprinted ‘CR1’ in black ink on one side and release portal on either side of tablet. NDC 27241-231-01 Bottles of 100 with child resistant closures   Carbamazepine extended-release tablets, USP 200 mg - Off white to light brown colored, round, biconvex, coated tablet imprinted ‘CR2’ in black ink on one side and release portal on either side of tablet NDC 27241-232-01 Bottles of 100 with child resistant closures Carbamazepine extended-release tablets, USP 400 mg - Off white to light brown colored, round, biconvex, coated tablet imprinted ‘CR3’ in black ink on one side and release portal on either side of tablet. NDC 27241-233-01 Bottles of 100 with child resistant closures Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP). # All trademarks are the properties of their respective owners. Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807.   Made in INDIA  Revised: 01/2024

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CARBAMAZEPINE - CARBAMAZEPINE TABLET, EXTENDED RELEASE
Ajanta Pharma USA Inc.
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MEDICATION GUIDE
Carbamazepine (KAR-ba-MAZ-e-peen)
Extended-Release Tablets
Read this Medication Guide before you start taking carbamazepine
extended-release 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 extended-release tablets?
Do not stop taking carbamazepine extended-release tablets without
first talking to your healthcare
provider.
Stopping carbamazepine extended-release tablets suddenly can cause
serious problems.
Carbamazepine extended-release tablets can cause serious side effects,
including:
1. Carbamazepine extended-release 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 extended-
release tablets 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
extended-release tablets 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 tablets 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. Carbamazepine extended-release tablets may cause allergic reactions
or serious problems, which may
affect organs and other parts of your body like the liver or blood
cells. You may or may not have a rash
with these types of reactions.
Ca

Summary of Product characteristics

CARBAMAZEPINE - CARBAMAZEPINE TABLET, EXTENDED RELEASE
AJANTA PHARMA USA INC.
----------
CARBAMAZEPINE EXTENDED-RELEASE TABLETS, USP
100 MG, 200 MG, 400 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 EXTENDED-
RELEASE TABLETS. 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 TABLETS.
PATIENTS TESTING POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH
CARBAMAZEPINE EXTENDED-RELEASE TABLETS 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 EXTENDED-RELEASE TABLETS.
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 CARBAMAZEPI