Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
CARBAMAZEPINE (UNII: 33CM23913M) (CARBAMAZEPINE - UNII:33CM23913M)
Preferred Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
Carbamazepine tablets 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: 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). Carbamazepine 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.
Carbamazepine tablets, USP 200 mg are white to off-white, round, scored tablets, imprinted “APO” over “200” on one side and plain faced with a full bisect on the other side. They are supplied as follows: Bottles of 20 NDC 68788-7210 Bottles of 28 NDC 68788-7210 Bottles of 30 NDC 68788-7210 Bottles of 60 NDC 68788-7210 Bottles of 90 NDC 68788-7210 Bottles of 100 NDC 68788-7210 Do not store above 30˚C (86˚F). Protect from moisture. Dispense in tight container (USP). Dispense with Medication Guide available at https://www.apotex.com/products/us/mg.asp All registered trademarks in this document are the property of their respective owners. APOTEX INC. CARBAMAZEPINE TABLETS, USP 200 mg Manufactured by Manufactured for Apotex Inc. Apotex Corp. Toronto, Ontario Weston, Florida Canada M9L 1T9 USA, 33326 Rev. 17 Repackaged By: Preferred Pharmaceuticals Inc.
Abbreviated New Drug Application
CARBAMAZEPINE- CARBAMAZEPINE TABLET Preferred Pharmaceuticals Inc. ---------- MEDICATION GUIDE Carbamazepine Tablets, USP (kar" ba maz’ e peen) Medication Guide available at https://www.apotex.com/products/us/mg.asp 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 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 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 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 • Lestu allt skjalið
CARBAMAZEPINE- CARBAMAZEPINE TABLET PREFERRED PHARMACEUTICALS 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 PROG Lestu allt skjalið