APO-WARFARIN TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

WARFARIN SODIUM

Beschikbaar vanaf:

APOTEX INC

ATC-code:

B01AA03

INN (Algemene Internationale Benaming):

WARFARIN

Dosering:

2.5MG

farmaceutische vorm:

TABLET

Samenstelling:

WARFARIN SODIUM 2.5MG

Toedieningsweg:

ORAL

Eenheden in pakket:

100/500

Prescription-type:

Prescription

Therapeutisch gebied:

COUMARIN DERIVATIVES

Product samenvatting:

Active ingredient group (AIG) number: 0104597005; AHFS:

Autorisatie-status:

MARKETED

Autorisatie datum:

2000-10-16

Productkenmerken

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
APO-WARFARIN
WARFARIN SODIUM TABLETS, USP
(CRYSTALLINE)
3 MG
ANTICOAGULANT
APOTEX INC.
150 SIGNET DRIVE
WESTON, ONTARIO
M9L 1T9
Control No.: 201024
DATE OF REVISION:
MAY 8, 2017
2
PRODUCT MONOGRAPH
APO-WARFARIN
Warfarin Sodium Tablets USP (crystalline)
3 mg
THERAPEUTIC CLASSIFICATION
Anticoagulant
ACTION AND CLINICAL PHARMACOLOGY
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 warfarin sodium may
become more pronounced
as effects of daily maintenance doses overlap. Anticoagulants have no
direct effect on an
established thrombus, nor do they reverse ischemic tissue damage.
However, once a thrombus
has occurred, the goal of anticoagulant treatment is to prevent
further extensi