DESCRIPTION
Warfarin sodium tablet (crystalline warfarin sodium) is an anticoagulant which acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(á-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 C19H15NaO4, and its structural formula may be represented by the following:
INDICATIONS AND USAGE
Warfarin sodium tablets are indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, and pulmonary embolism.
Warfarin sodium tablets are indicated for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement.
Warfarin sodium tablets are indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
INDICATIONS AND USAGE
Warfarin sodium tablets are indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, and pulmonary embolism.
Warfarin sodium tablets are indicated for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement.
Warfarin sodium tablets are indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
Camber's Warfarin Sodium Tablets, USP
Demonstrate superior bioequivalence with Coumadin® through cross-over studies.
Demonstrate superior bioequivalence with Coumadin® through cross-over studies.
Below is the information of two-way, single dose studies of Camber's Warfarin Sodium Tablets, USP 10 mg in comparison to Coumadin® 10mg.
Mean Warfarin Plasma concentration (ng/mL) in Fasted Subjects after 10 mg dose
R = Coumadin® T = Warfarin Sodium Tablets, USP 10mg
Comments:
- Warfarin Sodium Tablets, USP 10 mg formulation is bioequivalent to the Coumadin® tablet 10mg.
- The 90% confidence intervals are very close in range leading to superior dose titration.
- Warfarin Sodium Tablets, USP 1, 2, 2.5, 3, 4, 5, 6, 7.5 and 10 mg exhibit similar in-vitro drug release profiles to Coumadin Tablets.
- Camber's formulation has consistent dose delivery with tight control on the process.
Comparison of Coumadin
Physical Equivalency