COUMADIN (crystalline warfarin sodium) is an anticoagulant which acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-( -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 empirical formula is C 19 H 15 NaO 4 , 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 sol-uble in water; freely soluble in alcohol; very slightly soluble in chloroform and in ether.
COUMADIN Tablets for oral use also contain:
All strengths: Lactose, starch and magnesium stearate 1 mg: D& C Red No. 6 Barium Lake 2 mg: FD& C Blue No. 2 Aluminum Lake and FD& C Red No. 40 Aluminum Lake 2-1/ 2 mg: D& C Yellow No. 10 Aluminum Lake and FD& C Blue No. 1 Aluminum Lake 3 mg: FD& C Yellow No. 6 Aluminum Lake, FD& C Blue No. 2 Aluminum Lake and FD& C Red No. 40 Aluminum Lake
4 mg: FD& C Blue No. 1 Aluminum Lake 5 mg: FD& C Yellow No. 6 Aluminum Lake 6 mg: FD& C Yellow No. 6 Aluminum Lake and FD& C Blue No. 1 Aluminum Lake 7-1/ 2 mg: D& C Yellow No. 10 Aluminum Lake and FD& C Yellow No. 6 Aluminum Lake
10 mg: Dye Free
COUMADIN for Injection is supplied as a sterile, lyophilized powder, which, after reconstitution with 2.7 mL sterile Water for Injection, contains:
Warfarin Sodium 2 mg/ mL Sodium Phosphate, Dibasic, Heptahydrate 4.98 mg/ mL
Sodium Phosphate, Monobasic, Monohydrate 0.194 mg/ mL Sodium Chloride 0.1 mg/ mL
Mannitol 38.0 mg/ mL Sodium Hydroxide, as needed for pH adjustment to 8.1 to 8.3