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Glopril ® Angiotensin-Converting Enzyme Inhibitor Composition: Glopril Tablets 10 mg: Each tablet contains lisinopril dihydrate USP equivalent to lisinopril 10 mg. Glopril Tablets 5 mg: Each tablet contains lisinopril dihydrate USP equivalent to lisinopril 5 mg. Properties: lisinopril is a peptidyl dipeptidase inhibitor. It inhibits the angiotensin converting enzyme (ACE) that catalyses the conversion of angiotensin I to the vasoconstrictor peptide, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE results in decreased concentrations of angiotensin II which results in decreased vasopressor activity and reduced aldosterone secretion. The latter decrease may result in an increase in serum potassium concentration. While the mechanism through which lisinopril lowers blood pressure is believed to be primarily suppression of the renin-angiotensin-aldosterone system, lisinopril is antihypertensive even in patients with low-renin hypertension. Pharmacokinetics: Following oral administration, peak lisinopril serum concentrations occur within about 6-8 hours, and small delay in time to peak serum concentrations occur in patients with acute myocardial infarction. On chronic administration, lisinopril has an elimination half-life of 11-12 hours. lisinopril does not appear to bind to serum proteins. As lisinopril mainly excreted unchanged in urine, impaired renal function decreases elimination of the drug from the body. This decrease becomes clinically important only in patients with creatinine clearance below 30 ml/min. Elderly patients have higher serum concentrations than younger patients. Indications: Hypertension: All grades of essential hypertension and renovascular hypertension. Glopril may be used alone or with other antihypertensive agents. Heart Failure: In heart failure, Glopril is indicated as an adjunctive therapy with non-potassium-sparing diuretics and, where appropriate, digitalis. Severe Heart Failure: Treatment with Glopril should always be initiated in hospital under close medical supervision. Mild to Moderate Heart Failure: Treatment with Glopril should always be initiated under close medical supervision. Acute Myocardial Infarction: Glopril is indicated for the treatment of haemodynamically stable patients, defined as patients not in cardiogenic shock and who have a systolic blood pressure greater than 100 mmHg Glopril may be initiated within 24 hours of acute myocardial infarction to prevent the subsequent development of left ventricular dysfunction or heart failure and to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blocker. Dosage and Administration: Route of administration: oral The absorption of Glopril is not affected by food Glopril should be administered in a single daily dose. As with all single daily dose medications Glopril should be taken at approximately the same time each day. Hypertension: The need for dosage titration should be determined by measurement of the blood pressure just before the next dose. Essential and renovascular hypertension: Treatment should be started with 2.5 mg once daily, and titrated upwards to achieve optimal blood pressure control. For essential hypertension, 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. A 2.5 mg dose seldom achieves a therapeutic response. The usual effective dose range is 10-20 mg once daily.

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The maximum recommended dose is 40 mg daily. Diuretic-treated patients: Symptomatic hypotension can occur following the initial dose of Glopril; this is more likely when Glopril is added to previous diuretic therapy. Caution is recommended, therefore, since these patients may be volume or salt depleted. If possible, the diuretic should be discontinued, or the dose reduced, two to three days before beginning therapy with Glopril (see Warnings and Precautions) and may be resumed later if required. Glopril reduces the development of thiazide-induced hypokalaemia and hyperuricaemia. Use in the elderly: Age alone does not appear to affect the efficacy or safety profile of Glopril. Thus, elderly patients should start treatment with Glopril as directed above. Congestive heart failure: Glopril may be used as adjunctive therapy with non-potassium-sparing diuretics with or without digitalis. Initial dosage: Therapy with Glopril should be initiated under close medical supervision (in hospital for severe heart failure) with a recommended starting dose of 2.5 mg once daily. If possible, the dose of diuretic should be reduced before beginning treatment. Blood pressure and renal function should be monitored closely both before and during treatment because severe hypotension and, more rarely, consequent renal failure have been reported with angiotensinconverting enzyme (ACE) inhibitors (see Warnings and Precautions). The appearance of hypotension after the initial dose of Glopril does not preclude subsequent careful dose adjustment with the drug, following effective treatment of the hypotension. Some patients, other than those with severe heart failure, are considered to be at higher risk when started on an ACE inhibitor and are recommended for initiation of therapy in hospital. Research data have shown such patients to be: those on multiple or high-dose diuretics (e.g.>80 mg frusemide); patients with hypovolaemia; hyponatraemia (serum sodium