Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CAPTOPRIL
Rowex Ltd
6.25 mg Milligram
Tablets
1999-04-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Captor 6.25 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 6.25 mg Captopril. For list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets White, round, biconvex tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERTENSION: Captor is indicated for the treatment of hypertension. HEART FAILURE: Captor is indicated for the treatment of chronic heart failure with reduction of systolic ventricular function, in combination with diuretics and when appropriate, digitalis and beta-blockers. MYOCARDIAL INFARCTION: -S_hort -term (4 weeks) treatment: _Captor is indicated in any clinically stable patients within the first 24 hours of an infarction. -_Long term prevention of symptomatic heart failure: _Captor is indicated in clinically stable patients with asymptomatic left ventricular dysfunction (ejection fraction < 40%). TYPE I DIABETIC NEPHROPATHY: Captor is indicated for the treatment of macroproteinuric diabetic nephropathy in patients with type I diabetes. (_See_ _section 5.1, Pharmacodynamic Properties_). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dose should be individualised according to patient’s profile (_see section 4.4, Special warnings and precautions for use_) and blood pressure response. The recommended maximum daily dose is 150 mg. Captor may be taken before, during and after meals. HYPERTENSION: The recommended starting dose is 25-50 mg daily in two divided doses. The dose may be increased incrementally, with intervals of at least 2 weeks, to 100-150 mg/day in two divided doses as needed to reach target blood pressure. Captopril may be used alone or with other antihypertensive agents, especially thiazide diuretics. A once-daily dosing regimen may be appropriate Read the complete document