CARBAMAZEPINE tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Unichem Pharmaceuticals (USA), Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Epilepsy Carbamazepine tablet 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). Trigeminal Neuralgia Carbamazepine tablet 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 pa

Resumen del producto:

Tablets 200 mg – White to off-white, capsule shaped tablets, debossed with "382" on one side of functional score and "U" on the other side of functional score and plain on other side Bottles of 100: NDC 29300-382-01 Bottles of 500: NDC 29300-382-05 Bottles of 1,000: NDC 29300-382-10 Protect from moisture. Dispense in tight container (USP). All Product/Brand names are the trademarks of their respective owners. Store at 20° to 25°C (68° to 77°F) [see USP controlled Room Temperature].   04-R-10/2023

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

CARBAMAZEPINE- CARBAMAZEPINE TABLET
Unichem Pharmaceuticals (USA), Inc.
----------
MEDICATION GUIDE
Carbamazepine (kar" ba maz' e peen)
Tablets
Read this Medication Guide before you start taking carbamazepine
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 tablets?
Do not stop taking Carbamazepine tablets without first talking to your
healthcare provider.
Stopping carbamazepine tablets suddenly can cause serious problems.
Carbamazepine tablets can cause serious side effects, including:
1. Carbamazepine 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 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 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 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 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.
Call your healthcare provider right away if you have any of the
following:
•
swelling of your face, eyes, lips, or tongue
•
a skin rash
•
painful sores in the mouth or around your eyes
•

Fitxa tècnica

CARBAMAZEPINE- CARBAMAZEPINE TABLET
UNICHEM PHARMACEUTICALS (USA), INC.
----------
CARBAMAZEPINE TABLETS, USP 200 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. 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 NOT UNCOMMON IN ASSOCIATION WITH THE
USE OF CARBAMAZEPINE, DATA ARE NOT AVAILABLE TO ESTIMATE ACCURATELY
THEIR INCIDENCE OR OUTCOME. HOWEVER, THE VAST MAJORITY OF THE CASES
OF LEUKOPENIA HAVE NOT