Coumadin ®

Bristol-myers squibb

INDICATIONS:

• COUMADIN^® (Warfarin Sodium) is indicated:

o        For the prophylaxis and/or treatment of venous thrombosis and its extension, and pulmonary embolism.

o        For the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement.

o        To reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.

IMPORTANT SAFETY INFORMATION:

WARNING: BLEEDING RISK

Warfarin sodium can cause major or fatal bleeding. Bleeding is more likely to occur during the starting period and with a higher dose (resulting in a higher INR). Risk factors for bleeding include high intensity of anticoagulation (INR>4.0), age ≥65, highly variable INRs, history of gastrointestinal bleeding, hypertension, cerebrovascular disease, serious heart disease, anemia, malignancy, trauma, renal insufficiency, concomitant drugs (see PRECAUTIONS), and long duration of warfarin therapy. Regular monitoring of INR should be performed on all treated patients. Those at high risk of bleeding may benefit from more frequent INR monitoring, careful dose adjustment to desired INR, and a shorter duration of therapy. Patients should be instructed about prevention measures to minimize risk of bleeding and to report immediately to physicians signs and symptoms of bleeding (see PRECAUTIONS: Information for Patients).

• Anticoagulation is contraindicated in any localized or general physical condition or personal circumstance in which the hazard of hemorrhage might be greater than the potential clinical benefits of anticoagulation, such as:

o        patients who are or may become pregnant

o        hemorrhagic tendencies or blood dyscrasias

o        recent or contemplated surgery of the central nervous system, eye, or traumatic surgery resulting in large open surfaces

o        bleeding tendencies associated with active ulcerations or overt bleeding

o        threatened abortion, eclampsia and preeclampsia

o        inadequate laboratory facilities

o        unsupervised patients with senility, alcoholism, psychosis, or other lack of patient cooperation

o        spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding

• Caution should be observed when COUMADIN (Warfarin Sodium) is administered in any situation or in the presence of any predisposing condition where the added risk of necrosis and/or gangrene is present.
• Systemic atheroemboli and cholesterol microemboli can occur with COUMADIN therapy. COUMADIN therapy should be discontinued if vascular compromise due to embolic occlusion is present including purple toes syndrome.
• COUMADIN should be used with caution in patients with heparin-induced thrombocytopenia and deep venous thrombosis.
• The decision to breast-feed while taking COUMADIN should be undertaken only after careful consideration of available alternatives.
• COUMADIN should be used with caution in patients with severe to moderate hepatic insufficiency, indwelling catheters, known or suspected deficiency in protein C mediated anticoagulant response, polycythemia vera, vasculitis, and severe diabetes.
• Numerous factors, alone or in combination, including changes in diet, medications, botanicals, and genetic variations in the CYP2C9 and VKORC1 enzymes may influence the patient’s response to warfarin.
• Drugs may interact with COUMADIN (Warfarin Sodium) through pharmacodynamic or pharmacokinetic mechanisms. (Please see full Prescribing Information for the list of ENDOGENOUS and EXOGENOUS factors).
• Identification of risk factors for bleeding and certain genetic variations in CYP2C9 and VKORC1 in a patient may increase the need for more frequent INR monitoring and use of lower warfarin doses.
• Caution should be observed when COUMADIN is administered concomitantly with nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin.
• The most common adverse event and serious risk of oral anticoagulation therapy with COUMADIN (Warfarin Sodium) is bleeding in any tissue or organ.
• Patients should be informed that all warfarin sodium, USP, products represent the same medication and should not be taken together as overdosage may result.
• The use of warfarin during pregnancy has been associated with the development of fetal malformations in humans.