CARBAMAZEPINE tablet, extended release CARBAMAZEPIN- 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:

Upsher-Smith Laboratories, LLC

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: - 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 [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, hyp

Product summary:

Carbamazepine extended-release tablets, USP, 100 mg are available as pinkish white, round, coated tablets, imprinted "B28" and a release portal on one side. They are supplied as follows: Bottles of 100 with a child-resistant closure, NDC 0832-6022-11 Carbamazepine extended-release tablets, USP, 200 mg are available as pinkish white, round, coated tablets, imprinted "B29" and a release portal on one side. They are supplied as follows: Bottles of 100 with a child-resistant closure, NDC 0832-6023-11 Carbamazepine extended-release tablets, USP, 400 mg are available as pinkish white, round, coated tablets, imprinted "B30" and a release portal on one side. They are supplied as follows: Bottles of 100 with a child-resistant closure, NDC 0832-6024-11 Store at 25°C (77°F); excursions permitted from 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container with a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CARBAMAZEPINE- CARBAMAZEPINE TABLET, EXTENDED RELEASE
CARBAMAZEPIN- CARBAMAZEPINE TABLET, EXTENDED RELEASE
Upsher-Smith Laboratories, LLC
----------
MEDICATION GUIDE
Carbamazepine Extended-Release Tablets, USP
(karʺ ba mazʹ e peen), for oral use
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 live

Summary of Product characteristics

CARBAMAZEPINE- CARBAMAZEPINE TABLET, EXTENDED RELEASE
CARBAMAZEPIN- CARBAMAZEPINE TABLET, EXTENDED RELEASE
UPSHER-SMITH LABORATORIES, LLC
----------
CARBAMAZEPINE EXTENDED-RELEASE TABLETS, USP
100 MG, 200 MG, 400 MG
RX ONLY
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 TIMES 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