Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
CARBAMAZEPINE (UNII: 33CM23913M) (CARBAMAZEPINE - UNII:33CM23913M)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
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 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 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
Carbamazepine extended-release capsules are supplied in three dosage strengths. 100 mg-Two-piece hard gelatin capsule (bluish green opaque body and cap) printed with S433 and 100 mg in white ink. Supplied in bottles of 120 NDC 66993-407-32 200 mg-Two-piece hard gelatin capsule (light gray opaque body with bluish green opaque cap) printed with S433 and 200 mg in white ink. Supplied in bottles of 120 NDC 66993-408-32 300 mg-Two-piece hard gelatin capsule (black opaque body with bluish green opaque cap) printed with S433 and 300 mg in white ink. Supplied in bottles of 120 NDC 66993-409-32 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature]. PROTECT FROM LIGHT AND MOISTURE.
New Drug Application Authorized Generic
CARBAMAZEPINE- CARBAMAZEPINE CAPSULE, EXTENDED RELEASE REMEDYREPACK INC. ---------- MEDICATION GUIDE CARBAMAZEPINE EXTENDED-RELEASE CAPSULES Read this Medication Guide before you start taking carbamazepine 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? Do not stop taking carbamazepine without first talking to your healthcare provider. Stopping carbamazepine suddenly can cause serious problems. Carbamazepine can cause serious side effects, including: 1. Carbamazepine 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 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 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 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 muscle pain that does not go away • swelling of your face, eyes, lips, or tongue • swollen glands that do not go away • yellowing of your skin or the whites of your eyes • loss of appetite (anorexia) that does not go away • nausea or vomitin Przeczytaj cały dokument
CARBAMAZEPINE- CARBAMAZEPINE CAPSULE, EXTENDED RELEASE REMEDYREPACK 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. 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 5-8 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 Przeczytaj cały dokument