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:

Nostrum Laboratories, 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 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 and nortriptyline. Likewise, on theoretical grounds its use with monoamine oxidase 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. Coadministration of carbamazepine extended-release capsules are contraindicated with delavirdine due to the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. 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 capsules are supplied as. 100 mg - Hard gelatin capsule (dark green opaque body with dark green opaque cap) printed with the "NC" / "100" logo in black ink. Supplied in bottles of 120........................ NDC 29033-019-12 200 mg - Hard gelatin capsule (yellow opaque body with yellow opaque cap) printed with the "NC" / "200" logo in black ink. Supplied in bottles of 120........................ NDC 29033-020-12 300 mg - Hard gelatin capsule (purple opaque body with purple opaque cap) printed with the "NC" / "300" logo in black ink. Supplied in bottles of 120........................ NDC 29033-004-12 Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE. Manufactured by: Nostrum Laboratories Inc. Kansas City, MO 64120 Rev: February 2024 To report SUSPECTED ADVERSE REACTIONS, contact Nostrum Laboratories, Inc. at [e-mail] or 1-877-770-1288 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CARBAMAZEPINE- CARBAMAZEPINE CAPSULE, EXTENDED RELEASE
Nostrum Laboratories, Inc.
----------
MEDICATION GUIDE
CARBAMAZEPINE ("kar″ ba maz′ e peen") EXTENDED-RELEASE CAPSULES
(100 mg, 200 mg and 300 mg)
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 capsules 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:
•
swelling of your face, eyes, lips, or tongue
•
trouble swallowing or breathing
•
frequent fevers or fevers that do not go away
•
frequent infections or an infection that d

Summary of Product characteristics

CARBAMAZEPINE- CARBAMAZEPINE CAPSULE, EXTENDED RELEASE
NOSTRUM LABORATORIES, INC.
----------
CARBAMAZEPINE EXTENDED-RELEASE 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 OR OUTCOM