国: カナダ
言語: 英語
ソース: Health Canada
WARFARIN SODIUM
BRISTOL-MYERS SQUIBB CANADA
B01AA03
WARFARIN
6MG
TABLET
WARFARIN SODIUM 6MG
ORAL
100
Prescription
COUMARIN DERIVATIVES
Active ingredient group (AIG) number: 0104597008; AHFS:
CANCELLED POST MARKET
2020-06-25
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR COUMADIN ® WARFARIN SODIUM TABLETS, BRISTOL-MYERS SQUIBB STD., (CRYSTALLINE) 1, 2, 2.5, 3, 4, 5, 6 AND 10 MG ANTICOAGULANT Bristol-Myers Squibb Canada Date of Revision: Montreal, Canada. September 4, 2018 Registered Trademark of Bristol-Myers Squibb Pharma Company used under licence by Bristol-Myers Squibb Canada Control No.: 217553 2 PRODUCT MONOGRAPH PR COUMADIN ® Warfarin Sodium Tablets, Bristol-Myers Squibb Std., (crystalline) 1, 2, 2.5, 3, 4, 5, 6 and 10 mg THERAPEUTIC CLASSIFICATION Anticoagulant ACTION AND CLINICAL PHARMACOLOGY COUMADIN (warfarin sodium) and other coumarin anticoagulants act by inhibiting the synthesis of Vitamin K dependent clotting factors, which include Factors II, VII, IX and X, and the anticoagulant proteins C and S. Half-lives of these clotting factors are as follows: Factor II - 60 hours, VII - 4-6 hours, IX - 24 hours, and X - 48-72 hours. The half-lives of proteins C and S are approximately 8 hours and 30 hours, respectively. The resultant _in vivo_ effect is a sequential depression of Factors VII, IX, X and II. Vitamin K is an essential cofactor for the post ribosomal synthesis of the vitamin K dependent clotting factors. The vitamin promotes the biosynthesis of g-carboxyglutamic acid residues in the proteins which are essential for biological activity. Warfarin is thought to interfere with clotting factor synthesis by inhibition of the regeneration of vitamin K 1 epoxide. The degree of depression is dependent upon the dosage administered. Therapeutic doses of warfarin decrease the total amount of the active form of each vitamin K dependent clotting factor made by the liver by approximately 30% to 50%. An anticoagulation effect generally occurs within 24 hours after drug administration. However, peak anticoagulant effect may be delayed 72 to 96 hours. The duration of action of a single dose of racemic warfarin is 2 to 5 days. The effects of COUMADIN may become more pronounced as effects of daily maintenance doses ove 完全なドキュメントを読む