COUMADIN TAB 10MG TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

WARFARIN SODIUM

Available from:

BRISTOL-MYERS SQUIBB CANADA

ATC code:

B01AA03

INN (International Name):

WARFARIN

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

WARFARIN SODIUM 10MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

COUMARIN DERIVATIVES

Product summary:

Active ingredient group (AIG) number: 0104597004; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2020-06-22

Summary of Product characteristics

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