TABLETS: 28. Dosage:
Adult males (including the elderly): 1 tablet 1 x daily, for at least 2 years or until disease progresses.
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:
Locally advanced prostate cancer (T3-T4, any N, MO; T1-T2, N+, MO), as immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy. Management of patients with locally advanced, non-metastatic prostate cancer for whom surgical castration or other medical intervention is not considered appropriate or acceptable. 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.