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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan Ranbaxy 50 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg of losartan potassium equivalent to 45.76 mg of losartan.
Excipient with known effect:
Each 50 mg film-coated tablet contains 30.98 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, circular, biconvex, film-coated tablets, debossed with “L3” in one side and plain in the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
o Treatment of essential hypertension in adults and in children and adolescents 6-18 years of age.
o Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus with proteinuria
0.5 g/day as
part of an antihypertensive treatment.
o Treatment of chronic heart failure in adult patients when treatment with Angiotensin Converting Enzyme (ACE)
inhibitors is not considered suitable due to incompatibility, _especially cough_, or contraindication. Patients with heart
failure who have been stabilised with an ACE inhibitor should not be switched to losartan potassium. The patients
should have a left ventricular ejection fraction
40% and should be clinically stable and on an established treatment
regimen for chronic heart failure.
o Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG (see
section 5.1 LIFE study, Race)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Losartan Ranbaxy tablets should be swallowed with a glass of water.
Losartan tablets may be administered with or without food.
Hypertension
The usual starting and maintenance dose is 50 mg once daily for most patients. The maximal antihypertensive e
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