SINOPRIL 5MG TABS.-Egypt

Global Napi Pharmaceuticals

Clinical particulars

Therapeutic indications

Hypertension

Treatment of hypertension.

Heart Failure

Treatment of symptomatic heart failure.

Acute Myocardial Infarction

Short-term (6 weeks) treatment of haemodynamically stable patients within 24 hours of an acute myocardial infarction.

Renal Complications of Diabetes Mellitus

Treatment of renal disease in hypertensive patients with Type 2 diabetes mellitus and incipient nephropathy (see section 5.1).

Lisinopril can be used alone or in combination with other antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1).

4.2 Posology and method of administration

Lisinopril tablets should be administered orally in a single daily dose. As with all other medication taken once daily, Lisinopril tablets should be taken at approximately the same time each day. The absorption of Lisinopril tablets is not affected by food.

The dose should be individualised according to patient profile and blood pressure response (see section 4.4)

Hypertension

Lisinopril tablets can be used alone or with other antihypertensive agents (see sections 4.3, 4.4, 4.5 and 5.1).

Starting dose

In patients with hypertension the usual recommended starting dose is 10 mg. Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and /or volume depletion, cardiac decompensation, or severe hypertension) may experience an excessive blood pressure fall following the initial dose. A starting dose of 2.5-5 mg is recommended in such patients and the initiation of treatment should take place under medical supervision. A lower starting dose is required in the presence of renal impairment (see Table 1 below).

Maintenance dose

The usual effective maintenance dosage is 20 mg administered in a single daily dose. In general if the desired therapeutic effect cannot be achieved in a period of 2 to 4 weeks on a certain dose level, the dose can be further increased. The maximum dose used in long-term, controlled clinical trials was 80 mg/day.

Diuretic-Treated Patients

Symptomatic hypotension may occur following initiation of therapy with Lisinopril tablets. This is more likely in patients who are being treated currently with diuretics. Caution is recommended therefore, since these patients may be volume and/or salt depleted. If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with Lisinopril tablets. In hypertensive patients in whom the diuretic cannot be discontinued, therapy with Lisinopril tablets should be initiated with a 5 mg dose. Renal function and serum potassium should be monitored. The subsequent dosage of Lisinopril tablets should be adjusted according to blood pressure response. If required, diuretic therapy may be resumed