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If therapy with COUMADIN is discontinued, patients should be cautioned that the anticoagulant effects of COUMADIN may persist for about 2 to 5 days. Patients should be informed that all warfarin sodium, USP, products represent the same medication, and should not be taken concomitantly, as
overdosage may result. Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity and mutagenicity studies have not been performed with COUMADIN. The reproductive effects of COUMADIN have not been evaluated. Text Continues Below
Use in Pregnancy: Pregnancy Category X -See CONTRAINDICATIONS. Pediatric Use: Safety and effectiveness in pediatric patients below the age of 18 have not been established, in ran-domized, controlled clinical trials. However, the use of COUMADIN in pediatric patients is well-documented for the prevention and treatment of thromboembolic events. Difficulty achieving and maintaining therapeutic PT/ INR ranges in the pediatric patient has been reported. More frequent PT/ INR determinations are recommended because of possible changing warfarin requirements. Geriatric Use: Patients 60 years or older appear to exhibit greater than expected PT/ INR response to the anticoag-ulant effects of warfarin (see CLINICAL PHARMACOLOGY). COUMADIN is contraindicated in any unsupervised patient with senility. Caution should be observed with administration of warfarin sodium to elderly patients in any situation or physical condition where added risk of hemorrhage is present. Lower initiation and maintenance doses of COUMADIN are recommended for elderly patients (see DOSAGE AND ADMINISTRATION).
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