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COUMADIN is a 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 COUMADIN has no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. (1)
- Most common adverse reactions to COUMADIN are fatal and nonfatal hemorrhage from any tissue or organ. (6)
Consult labeling of all concurrently used drugs for complete information about interactions with COUMADIN or increased risks for bleeding. (7)
• Inhibitors and inducers of CYP2C9, 1A2, or 3A4: May alter warfarin exposure. Monitor INR closely when any such drug is used with COUMADIN. (7.1)
• Drugs that increase bleeding risk: Closely monitor patients receiving any such drug (e.g., other anticoagulants, antiplatelet agents, nonsteroidal antiinflammatory drugs, serotonin reuptake inhibitors). (7.2)
• Antibiotics and antifungals: Closely monitor INR when initiating or stopping an antibiotic or antifungal course of therapy. (7.3)
• Botanical (herbal) products: Some may influence patient response to COUMADIN necessitating close INR monitoring. (7.4)
Tissue necrosis: Necrosis or gangrene of skin or other tissues can occur, with severe cases requiring debridement or amputation. Discontinue COUMADIN and consider alternative anticoagulants if necessary. (5.2)
• Systemic atheroemboli and cholesterol microemboli: Some cases have progressed to necrosis or death. Discontinue COUMADIN if such emboli occur. (5.3)
• Heparin-induced thrombocytopenia (HIT): Initial therapy with COUMADIN in HIT has resulted in cases of amputation and death. COUMADIN may be considered after platelet count has normalized. (5.4)
• Pregnant women with mechanical heart valves: COUMADIN may cause fetal harm; however, the benefits may outweigh the risks. (5.5)
