Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
IRBESARTAN
Ranbaxy Ireland Limited
150 Milligram
Film Coated Tablet
2009-02-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Irbesartan Ranbaxy 150mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150mg irbesartan. Each tablet also contains 51.74mg lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off white, film-coated oval shaped, biconvex tablet debossed with 'I4' on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension. Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive drug regimen (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. Irbesartan Ranbaxy at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years. In patients insufficiently controlled with 150 mg once daily, the dose of Irbesartan Ranbaxy can be increased to 300 mg, or other anti-hypertensive agents can be added. In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Irbesartan (see section 4.5). In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease. The demonstration of renal benefit of Irbesartan Ranbaxy in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, a Belgenin tamamını okuyun