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Coumadin

[Warfarin Sodium Tablets, USP]

Post-Myocardial Infarction:

In post-myocardial infarction patients, COUMADIN therapy should be initiated early (2-4 weeks post-infarction) and dosage should be adjusted to maintain an INR of 2.5-3.5 long-term. The recommen-dation is based on the results of the WARIS study in which treatment was initiated 2 to 4 weeks after the infarction. In patients thought to be at an increased risk of bleeding complications or on aspirin therapy, maintenance of COUMADIN therapy at the lower end of this INR range is recommended.

Mechanical and Bioprosthetic Heart Valves:

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In patients with mechanical heart valve( s), long term prophylaxis with warfarin to an INR of 2.5-3.5 is recommended. In patients with bioprosthetic heart valve( s), based on limited data, the American College of Chest Physicians recommends warfarin therapy to an INR of 2.0-3.0 for 12 weeks after valve insertion. In patients with additional risk factors such as atrial fibrillation or prior thromboembolism, consid-eration should be given for longer term therapy.

Recurrent Systemic Embolism:

In cases where the risk of thromboembolism is great, such as in patients with recurrent systemic embolism, a higher INR may be required.
An INR of greater than 4.0 appears to provide no additional therapeutic benefit in most patients and is associ-ated with a higher risk of bleeding.

Initial Dosage:

The dosing of COUMADIN must be individualized according to patient's sensitivity to the drug as indicated by the PT/ INR. Use of a large loading dose may increase the incidence of hemorrhagic and other com-plications, does not offer more rapid protection against thrombi formation, and is not recommended. Lower initiation and maintenance doses are recommended for elderly and/ or debilitated patients and patients with potential to exhibit greater than expected PT/ INR response to COUMADIN (see PRECAUTIONS).

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