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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
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FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Warfarin sodium tablets, USP are indicated for:
- Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE).
- Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement.
- Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction
Limitations of Use
Warfarin sodium tablets, USP have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae.
There is currently no drug history available for this drug.
Warfarin sodium is an anticoagulant that 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. Its molecular formula is C19H15NaO4, and its structural formula is represented by the following:
Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether.
Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each
1 mg tablet contains: D&C Red # 30 aluminum lake
2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2
2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2
3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake
4 mg tablet contains: FD&C Blue # 2
5 mg tablet contains: FD&C Yellow # 6 aluminum lake
6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2
7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake
10 mg tablet is dye free