美国华法林药品说明书.pdf

WARFARIN SODIUM- warfarin sodium tablet
Genpharm, .
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WARFARIN SODIUM TABLETS USP
Crystalline
1 mg, 2 mg, mg, 3 mg, 4 mg, 5 mg, 6 mg, mg, 10 mg
Rx only
WARNING
DESCRIPTION
Warfarin sodium (crystalline), is an anticoagulant which acts by inhibiting vitamin K-dependent
coagulation factors. Chemically, it is 3- α -Acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture
of the R-and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. The crystallization
of warfarin sodium virtually eliminates trace impurities present in amorphous warfarin. Its molecular
formula is C 19H 15NaO 4, its molecular weight is , and its structural formula may be represented
by the following:
Crystalline warfarin sodium occurs as a white, odorless, crystalline powder, is discolored by light and
is very soluble in water; freely soluble in alcohol; very slightly soluble in chloroform and in ether.
Warfarin sodium tablets, for oral administration contain either 1 mg, 2 mg, mg, 3 mg, 4 mg, 5 mg, 6
mg, mg or 10 mg warfarin sodium. In addition they also contain the following inactive ingredients:
corn starch, lactose monohydrate, magnesium stearate, stearic acid and,
1 mg tablets: FD&C Red # 40 Aluminum Lake
2 mg tablets: FD&C Blue # 2 Aluminum Lake and FD&C Red # 40 Aluminum Lake
mg tablets: D&C Yellow # 10 Aluminum Lake and FD&C Blue # 1 Aluminum Lake
3 mg tablets: FD&C Yellow # 6 Aluminum Lake, FD&C Blue # 2 Aluminum Lake, FD&C Red #40
Aluminum Lake
4 mg tablets: FD&C Blue # 1 Aluminum Lake
5 mg tablets: FD&C Yellow # 6 Aluminum Lake
6 mg tablets: FD&C Blue # 1 Aluminum Lake, FD&C Yellow # 6 Aluminum Lake
mg tablets: D&C Yellow # 10 Aluminum Lake and FD&C Yellow # 6 Aluminum Lake
10 mg tablets: Dye Free
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