Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
DISOPYRAMIDE PHOSPHATE
Hoechst Marion Roussel Irl Ltd
DISOPYRAMIDE PHOSPHATE
100mg Milligram
Capsule
Withdrawn
2007-04-16
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rythmodan 100mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100mg of Disopyramide. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Capsule Hard opaque capsules containing a white powder and consisting of an opaque yellow body and an opaque green cap, printed RL on one part and RY on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of patients with various atrial and ventricular arrhythmias, singly or in combination. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults Only: The initial dose ranges from 400-600 mg daily in divided doses every six hours. The dose may subsequently be adjusted up to 800 mg if required. In the presence of impaired renal function the following schedule is suggested with a reduction in dosage dependent directly on Creatinine Clearance. The drug’s use and effects in children have not been studied adequately for recommendations to be made for paediatric dosage. Elderly: A dose reduction due to reduced renal and hepatic function in the elderly (especially elderly non-smokers) should be considered (see section 4.4). 4.3 CONTRAINDICATIONS Use in patients with pre-existing heart block (if no pacemaker is present) shock, or untreated urinary tract obstruction. Creatinine Clearance ml/min Dosage mg Dosage interval 20-60 100 or 150 8 hour 12 hour 8-20 100 12 hour <8 150 24 hour IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 11/10/2006_ _CRN 2028762_ _page number: 1_ Use in patients with cardiomyopathy or congestive heart failure unless adequately controlled and digitalised. The drug should not be used in patients with hypersensitivity to disopyramide. 4 Baca dokumen lengkap