Generic Name and Formulations:
Warfarin sodium 1mg, 2mg, 2½mg, 3mg, 4mg, 5mg, 6mg, 7½mg, 10mg (dye-free); scored tabs.
Indications for COUMADIN:
Venous thrombosis. Pulmonary embolism. Thromboembolic complications from atrial fibrillation and/or cardiac valve replacement. Reduce risk of death, recurrent MIs, and thromboembolic events (eg, stroke, systemic embolization) post-MI.
Individualize. ≥18yrs: Initially 2–5mg once daily. Usual maintenance: 2–10mg once daily. Variations in CYP2C9 or VKORC1 enzymes, elderly, debilitated, Asians: use lower initial and maintenance doses. Closely monitor INR; adjust dose based on response and clinical condition. Conversion from heparin or other anticoagulants: see full labeling.
<18yrs: see full labeling.
Hemorrhagic tendencies. Blood dyscrasias. Recent CNS, ophthalmic, or traumatic surgery. Bleeding tendencies associated with certain conditions. Threatened abortion, eclampsia, and preeclampsia. Unsupervised patients with potential high levels of non-compliance. Major regional or lumbar block anesthesia. Spinal puncture and other procedures with potential uncontrollable bleeding. Malignant hypertension. Pregnancy in women without mechanical heart valves.
Risk of major or fatal bleeding. Monitor INR frequently. History of GI bleed. Hypertension. Cerebrovascular disease. Anemia. Malignancy. Trauma. Discontinue if tissue necrosis, calciphylaxis, systemic atheroemboli or cholesterol microemboli occurs; consider alternative therapy if needed. Heparin-induced thrombocytopenia with or without thrombosis syndrome; do not use as initial therapy. Hepatic or renal impairment; monitor INR/bleeding more frequently. Infection. Disturbances of intestinal flora. Indwelling catheter. Protein C and S deficiency. Polycythemia vera. Vasculitis. Diabetes. Diarrhea. Poor nutritional status. Steatorrhea. Vitamin K deficiency or intake. Hereditary warfarin resistance. Eye surgery. Dental procedures. Elderly; monitor more frequently. Asian. Debilitated. Anticoagulation may persist 2–5 days after discontinuation. Write ℞ using fractions rather than decimals. Pregnancy in women with mechanical heart valves. Females of reproductive potential should use effective contraception during therapy and for at least 1 month after final dose. Nursing mothers.
See full labeling. Potentiated by CYP2C9, 1A2 and/or 3A4 inhibitors. Antagonized by CYP2C9, 1A2 and/or 3A4 inducers. Caution with drugs that can increase risk of bleeding (eg, anticoagulants, antiplatelets, NSAIDs, SSRIs) or herbal products (eg, garlic, ginkgo biloba, co-enzyme Q10, St. John's wort, ginseng, echinacea, grapefruit juice, goldenseal). Closely monitor INR when starting or stopping any antibiotic or antifungal agent. Cholestatic hepatitis with concomitant ticlopidine.
Tissue or organ hemorrhage, hypersensitivity reactions, hepatic disorders, GI disorders, skin disorders, tracheal or tracheobronchial calcification, chills; skin or tissue necrosis, calciphylaxis, systemic atheroemboli and cholesterol microemboli (eg, purple toes syndrome), acute kidney injury.
Tabs 1mg, 2mg, 2½mg, 5mg—100, 1000; 3mg, 4mg, 6mg, 7½mg, 10mg—100