Anisindione is indicated for the prophylaxis and treatment of venous thrombosis and its extension, the treatment of atrial fibrillation with embolization, the prophylaxis and treatment of pulmonary embolism, and as an adjunct in the treatment of coronary occlusion.

Initial dosage of MIRADON Tablets is 300 mg the first day, 200 mg the second day, and 100 mg the third day. With initiation of treatment, prothrombin activity decreases rapidly to 50 percent of baseline values within 6 hours; thereafter it decreases slowly until it reaches 15 to 30 percent of baseline values in 48 to 72 hours. Maintenance dosage is established from daily prothrombin-time determinations for each patient, although with MIRADON Tablets, the uniform, predictable action of the drug makes it possible to reduce the frequency of prothrombin-time determinations in some cases. Maintenance dosage will vary between 25 to 250 mg a day and should be set to keep the prothrombin time one and one-half to two times the normal value. The dose may be repeated for many days; anisindione does not accumulate in the body.

Prothrombin activity returns to normal within 24 to 72 hours after treatment when the drug is discontinued. Some studies suggest that gradual reduction of dosage over a 2-week period may decrease the frequency of recurrence of thrombo-embolic disease by preventing a rapid rise in pro-thrombin activity.

MIRADON Tablets, 50 mg, pink, scored, compressed tablets impressed with the Schering trademark and product identification numbers 795; bottle of 100 (NDC 0085-0795-05).

Schering Corporation Kenilworth, NJ 07033 USA, Rev. 7/01 B-16099775, Copyright © 1972, 1992, 1994, Schering Corporation. All rights reserved.

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