Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
FLUTAMIDE
TAD Pharma GmbH
250 Milligram
Tablets
2002-12-06
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flutamide 250mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 250mg flutamide. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Slightly yellow, round, biplane tablet with the imprint ‘F 250’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of advanced prostatic carcinoma in which suppression of testosterone effects is indicated: as initial treatment in combination with an LHRH agonist; as adjunctive therapy in patients already receiving LHRH agonist therapy; in surgically castrated patients; in the treatment of patients who have not responded to other forms of hormonal manipulation or in patients who cannot tolerate such treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION One 250mg tablet three times daily at 8 hour intervals. When used as initial treatment with an LHRH agonist, a greater reduction in the incidence and severity of the LHRH agonist flare reaction may be achieved if Flutamide 250mg Tablets are introduced before rather than concomitantly with the LHRH agonist. It is, therefore, recommended that treatment with Flutamide 250mg Tablets, one tablet three times daily, should be started at least three days before an LHRH agonist and continued thereafter at the same dosage. In the management of locally confined prostatic carcinoma, the recommended dosage is one 250mg tablet three times a day. Treatment with Flutamide 250mg Tablets should be started at least three days prior to initiation of the LHRH agonist. Administration of Flutomide 250mg tablets and the LHRH agonist should begin eight weeks prior to radiation therapy and continue through the course of radiation therapy (usually approximately 8 weeks), i.e. a total of approximately Baca dokumen lengkap