TABLETS: 28. Dosage:
Adult males (including the elderly): 1 tablet 1 x daily, to be started at the same time as treatment with an LHRH analog or surgical castration. Renal impairment: No dosage adjustment is necessary. Mild hepatic impairment: No dosage adjustment is necessary. Moderate-severe hepatic impairment: Use with caution as increased accumulation may occur. Prescribing Restrictions:
Advanced prostate cancer in combination with LHRH analog therapy or surgical castration. Contra-Indications:
Hypersensitivity, women and children, co-administration of terfenadine, astemizole or cisapride. Special Precautions:
See prescribing information for full details. Side Effects:
See prescribing information for full details. Drug Interactions:
Cimetidine, ketoconazole, oral anticoagulants.