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Coumadin

[Warfarin Sodium Tablets, USP]

Based on limited data, Asian patients may also require lower initiation and maintenance doses of COUMADIN (see CLINICAL PHARMACOLOGY). It is recommended that COUMADIN therapy be initiated with a dose of 2 to 5 mg per day with dosage adjustments based on the results of PT/ INR determinations.

Maintenance:

Most patients are satisfactorily maintained at a dose of 2 to 10 mg daily. Flexibility of dosage is provided by breaking scored tablets in half. The individual dose and interval should be gauged by the patient's pro-thrombin response.

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Duration of Therapy:

The duration of therapy in each patient should be individualized. In general, anticoagulant therapy should be continued until the danger of thrombosis and embolism has passed.

Missed Dose:

The anticoagulant effect of COUMADIN persists beyond 24 hours. If the patient forgets to take the prescribed dose of COUMADIN at the scheduled time, the dose should be taken as soon as possible on the same day. The patient should not take the missed dose by doubling the daily dose to make up for missed doses, but should refer back to his or her physician.

Intravenous Route of Administration:

COUMADIN for Injection provides an alternate administration route for patients who cannot receive oral drugs. The IV dosages would be the same as those that would be used orally if the patient could take the drug by the oral route. COUMADIN for Injection should be administered as a slow bolus injection over 1 to 2 minutes into a peripheral vein. It is not recommended for intramuscular administration. The vial should be reconstituted with 2.7 mL of sterile Water for Injection and inspected for particulate matter and discoloration immediately prior to use. Do not use if either particulate matter and/ or discoloration is noted.

After reconstitution, COUMADIN for Injection is chemically and physically stable for 4 hours at room temperature. It does not contain any antimicrobial preservative and, thus, care must be taken to assure the sterility of the prepared solu-tion. The vial is not recommended for multiple use and unused solution should be discarded.

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