País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
LISINOPRIL DIHYDRATE
Ergha Healthcare Ltd
2.5 Milligram
Tablets
2005-04-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ByZestra 2.5 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 2.5 mg of lisinopril (as dihydrate) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. White, oval tablets, marked ‘LSN 2.5’ on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS o Arterial hypertension It may be used alone or concomitantly with other classes of antihypertensive agents, e.g. thiazide diuretics. o Treatment of heart failure as additive therapy to non-potassium-sparing diuretics and where appropriate, digitalis. o Treatment of acute myocardial infarction, in haemodynamically stable patients (systolic blood pressure >100 mm Hg) without significant renal dysfunction (serum creatinine <177 micromol/l [2.0 mg/dl] and proteinuria <500 mg/24 hours.) Lisinopril should be given in addition to usual standard therapy in MI (thrombolytics, acetylsalicylic acid and ß blocking agents), especially together with nitrates. o Renal Complications of Diabetes Mellitus Treatment of renal disease in hypertensive patients with type 2 daibetes mellitus and incipient nephropathy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Precautionary note:_ Excessive first dose hypotension may occur in high risk patients (in patients with salt and/or fluid deficiency, e.g. after dialysis, vomiting, in concomitant diuretic therapy, in patients with heart failure, severe or renal hypertension). Initiation of therapy requires, if possible, correction in salt and/or body fluids deficiencies, discontinuation or reduction of an existing diuretic therapy for two to three days before starting ACE inhibition and starting therapy with the lowest single dose of 2.5mg lisinopril in the morning. Patients at hig Leer el documento completo