NU-WARFARIN TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

WARFARIN SODIUM

Saadav alates:

NU-PHARM INC

ATC kood:

B01AA03

INN (Rahvusvaheline Nimetus):

WARFARIN

Annus:

2.5MG

Ravimvorm:

TABLET

Koostis:

WARFARIN SODIUM 2.5MG

Manustamisviis:

ORAL

Ühikuid pakis:

100

Retsepti tüüp:

Prescription

Terapeutiline ala:

COUMARIN DERIVATIVES

Toote kokkuvõte:

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

Volitamisolek:

CANCELLED (UNRETURNED ANNUAL)

Loa andmise kuupäev:

2018-03-28

Toote omadused

PRODUCT
MONOGRAPH
NU-WARFARIN
WARFARIN SODIUM TABLETS USP (CRYSTALLINE)
1, 2, 2.5, 3, 4, 5 AND 10 MG
ANTICOAGULANT
NU-PHARM INC.
DATE OF PREPARATION:
50 MURAL ST., UNITS 1 & 2
October 7, 2009
RICHMOND HILL, ONTARIO
L4B 1E4
CONTROL#: 133141
1
PRODUCT
MONOGRAPH
NU-WARFARIN
Warfarin Sodium Tablets USP (crystalline)
1, 2, 2.5, 3, 4, 5 and 10 mg
THERAPEUTIC
CLASSIFICATION
Anticoagulant
ACTION
AND
CLINICAL
PHARMACOLOGY
Warfarin 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
B
6 hours, IX:
24 hours, and X: 48
B
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
B
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 may become
more pronounced as
effects of daily maintenance doses overlap. Anticoagulants have no
direct effect on an
2
established thrombus, nor do they reverse ischemic tissue damage.
However, once a thrombus
has occurred, the goal of anticoagulant treatment is to preven