warfarin sodium 2.5 MG Oral Tablet
1. INDICATIONS AND USAGE Warfarin sodium tablets, 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 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. Warfarin sodium tablets are vitamin K antagonist indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (1) Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement (1) Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction (1) Limitation of Use Warfarin sodium tablets, have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. (1)
Exelan Pharmaceuticals Inc.
ROUND GREEN IG W 2 1 2
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16. HOW SUPPLIED/STORAGE AND HANDLING
WARFARIN sodium tablets, USP are supplied as follows: 1 mg Tablets: Light pink, round, flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘1’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-327-01) and 1000’s count (NDC 76282-327-10) 2 mg Tablets: Lavender, round, flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘2’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-328-01) and 1000’s count (NDC 76282-328-10) 2.5 mg Tablets: green, round, flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘2 1 / 2 ’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-329-01) and 1000’s count (NDC 76282-329-10) 3 mg Tablets: tan, round, flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘3’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-330-01) and 1000’s count (NDC 76282-330-10) 4 mg Tablets: blue, round, flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘4’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-331-01) and 1000’s count (NDC 76282-331-10) 5 mg Tablets: peach, round, flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘5’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-332-01) and 1000’s count (NDC 76282-332-10) 6 mg Tablets: teal, round, flat Beveled edge tablets de-bossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘6’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-333-01) and 1000’s count (NDC 76282-333-10) 7.5 mg Tablets: yellow, round, flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘7 1 / 2 ’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-334-01) 10 mg Tablets: white, round, flat Beveled edge tablets debossed ‘I’ on the left side of bisect and ‘G’ on the right side of bisect on one side and ‘W’ on the top and ‘10’ on the bottom of other side, supplied in bottles of 100’s count (NDC 76282-335-01) Storage: Store at 20° to 25°C (68° F to 77° F). [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP. Special Handling Procedures for proper handling and disposal of potentially hazardous drugs should be considered. Guidelines on this subject have been published [see References (15) ]. Pharmacy and clinical personnel who are pregnant should avoid exposure to crushed or broken tablets [see Use in Specific Populations (8.1) ] .
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