Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
DISOPYRAMIDE PHOSPHATE
Hoechst Marion Roussel Irl Ltd
DISOPYRAMIDE PHOSPHATE
150mg Milligram
Capsule
Withdrawn
2008-07-14
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rythmodan 150mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 150mg of Disopyramide. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Capsule Hard opaque capsule containing a white powder and consisting of an opaque white body and cap. The capsule is printed in black, RY underlined on one part and 150 on the other part 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 so 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 2028766_ _page number: 1_ Use in patients with cardiomyopathy or congestive heart failure unless adequately controlled and digitalized. The drug should not be used in patients with hypers Կարդացեք ամբողջական փաստաթուղթը