국가: 캐나다
언어: 영어
출처: Health Canada
CARBAMAZEPINE
PHARMASCIENCE INC
N03AF01
CARBAMAZEPINE
200MG
TABLET (EXTENDED-RELEASE)
CARBAMAZEPINE 200MG
ORAL
100
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0108674001; AHFS:
APPROVED
1997-07-02
PRODUCT MONOGRAPH Pr PMS-CARBAMAZEPINE (carbamazepine) 200 mg Tablets, Manufacturer’s Standard 100 mg & 200 mg Chewable Tablets, Manufacturer’s Standard Pr PMS-CARBAMAZEPINE-CR (carbamazepine) 200 mg & 400 mg Controlled Release Tablets, Manufacturer’s Standard ANTICONVULSANT FOR SYMPTOMATIC RELIEF OF TRIGEMINAL NEURALGIA ANTIMANIC PHARMASCIENCE INC. DATE OF REVISION: 6111 Royalmount Avenue, Suite 100 April 8, 2014 Montreal, Quebec H4P 2T4 www.pharmascience.com Submission Control No: 172786 _pms-CARBAMAZEPINE and pms-CARBAMAZEPINE-CR Product Monograph _ _Page 2 of 51_ PRODUCT MONOGRAPH Pr PMS-CARBAMAZEPINE (Carbamazepine) 200 mg Tablets, Manufacturer’s Standard 100 mg & 200 mg Chewable Tablets, Manufacturer’s Standard Pr PMS-CARBAMAZEPINE-CR (Carbamazepine) 200 mg & 400 mg Controlled Release Tablets, Manufacturer’s Standard THERAPEUTIC CLASSIFICATION Anticonvulsant For Symptomatic Relief of Trigeminal Neuralgia Antimanic ACTIONS AND CLINICAL PHARMACOLOGY pms-CARBAMAZEPINE and pms-CARBAMAZEPINE-CR (carbamazepine) has anticonvulsant properties which have been found useful in the treatment of partial seizures (simple or complex) with and without secondary generalization, and generalized tonic-clonic seizures. A mild psychotropic effect has been observed in some patients, which seems related to the effect of carbamazepine in localization-related epilepsies and syndromes. CLINICAL TRIALS Evidence supporting the 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 simple or complex symptomatology. 2. Generalized tonic-clonic seizures. 3. Mixed seizure patterns which include the above, or other partial or generalized seizures. _pms-CARBAMAZEPINE and pms-CARBAMAZEPINE-CR Product Monograph _ _Page 3 of 51_ Carbamazepine relieves or diminishes the pain associated with trigeminal neuralgia often within 24 to 48 hours. Carbamazepine given as a monotherapy or in combination with lithium or neu 전체 문서 읽기