Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
losartan (losartan potassium)
Brupharmexport sprl
losartan (losartan potassium)
50mg
tablets film-coated
Prescription
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT BRUSARTAN 50MG BRUSARTAN 100MG 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each BRUSARTAN 50 mg film-coated tablet contains 50 mg losartan potassium. Each BRUSARTAN 100 mg film-coated tablet contains 100 mg losartan potassium. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). BRUSARTAN 50 mg: film-coated, white to off-white, oval shaped scored tablets. Tablets can be divided into equal halves. BRUSARTAN 100 mg: film-coated, white to off-white, oval shaped scored tablets. Tablets can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults and in children and adolescents 6 – 18 years of age. Treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus with proteinuria ≥0.5 g/day as part of an anti-hypertensive treatment. Treatment of chronic heart failure (in patients ≥60 years), when treatment with Angiotensin-Converting Enzyme (ACE) inhibitors is not considered suitable due to incompatibility, especially cough, or contraindication. In patients with heart failure who have been stabilized with an ACE inhibitor, a switch to losartan is not recommended. The patients should have a left ventricular ejection fraction ≤40% and should be stabilized under the treatment of the chronic heart failure. Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG (see 5.1: LIFE study, Race). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION BRUSARTAN tablets should be swallowed with a glass of water. BRUSARTAN may be administered with or without food. 2 HYPERTENSION The usual starting and maintenance dose is 50 mg once daily for most patients. The maximal anti- hypertensive effect is attained 3 - 6 weeks after initiation of therapy. Some patients may receive an additional benefit by increasing the dose to 100 mg once daily (in the morning). Losartan may be adminis Прочитать полный документ