Coumadin

[Warfarin Sodium Tablets, USP]

Indications & Dosage
INDICATIONS AND USAGE

COUMADIN is indicated for the prophylaxis and/ or treatment of venous thrombosis and its extension, and pul-monary embolism.

COUMADIN is indicated for the prophylaxis and/ or treatment of the thromboembolic complications associated with atrial fibrillation and/ or cardiac valve replacement.

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COUMADIN is indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.

DOSAGE AND ADMINISTRATION

The dosage and administration of COUMADIN must be individualized for each patient according to the particular patient's PT/ INR response to the drug. The dosage should be adjusted based upon the patient's PT/ INR. (See LAB-ORATORY CONTROL below for full discussion on INR.)

Venous Thromboembolism (including pulmonary embolism):

Available clinical evidence indicates that an INR of 2.0-3.0 is sufficient for prophylaxis and treatment of venous thromboembolism and minimizes the risk of hemor-rhage associated with higher INRs. In patients with risk factors for recurrent venous thromboembolism including venous insufficiency, inherited thrombophilia, idiopathic venous thromboembolism, and a history of thrombotic events, consideration should be given to longer term therapy (Schulman et al, 1995 and Schulman et al, 1997).

Atrial Fibrillation:

Five recent clinical trials evaluated the effects of warfarin in patients with non-valvular atrial fibril-lation (AF). Meta-analysis findings of these studies revealed that the effects of warfarin in reducing thromboembolic events including stroke were similar at either moderately high INR (2.0-4.5) or low INR (1.4-3.0). There was a signif-icant reduction in minor bleeds at the low INR. Similar data from clinical studies in valvular atrial fibrillation patients are not available. The trials in non-valvular atrial fibrillation support the American College of Chest Physicians' (ACCP) recommendation that an INR of 2.0-3.0 be used for long term warfarin therapy in appropriate AF patients.

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