RENITEC

What it is

RENITEC is enalapril maleate, available as tablets containing 5 mg, 10 mg or 20 mg enalapril maleate. Enalapril maleate is a pro-drug which when administered orally is hydrolysed to release the active converting enzyme inhibitor enalaprilat, with the liver appearing to be the main site for this conversion.

Approved indications

— All grades of essential hypertension — Renovascular hypertension — All degrees of symptomatic heart failure — All degrees of left ventricular dysfunction where the left ventricular ejection fraction is less than 35%, irrespective of the presence or severity of obvious symptoms of heart failure

Dosing overview

The recommended initial dose in patients not on diuretics for hypertension is 5 mg once a day, with a usual dosage range of 10 to 40 mg per day administered in a single dose or two divided doses. For elderly patients over 65 years, the starting dose should be 2.5 mg. For congestive heart failure, the initial dose should be lower (2.5 mg or less) administered under close medical supervision, and should be gradually increased to the usual maintenance dose of 10–20 mg given in a single or divided dose. In left ventricular dysfunction without symptoms of overt heart failure, the initial dose was 2.5 mg twice daily titrated to the usual maintenance dose of 20 mg in two divided doses.

Key safety warnings

Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with RENITEC and may occur at any time during treatment. In such cases RENITEC should be promptly discontinued and the patient carefully observed until the swelling disappears. Very rarely, fatalities have been reported due to angioedema associated with laryngeal oedema or tongue oedema, and patients with involvement of the tongue, glottis or larynx are likely to experience airway obstruction, especially those with a history of airway surgery. Black patients receiving ACE inhibitors have been reported to have higher incidence of angioedema compared to non-blacks. Excessive hypotension was rarely seen in uncomplicated hypertensive patients but is a possible consequence of enalapril use in severely salt/volume depleted persons. In patients with heart failure, excessive hypotension has been observed and may be associated with oliguria and progressive azotaemia, and rarely with acute renal failure and/or death. Elevated serum potassium (greater than 5.7 mmol/L) was observed in approximately one percent of hypertensive patients in clinical trials, with hyperkalaemia being a cause of discontinuation of therapy in 0.28 percent of hypertensive patients. Hyperkalaemia can cause serious, sometimes fatal, arrhythmias. A persistent non-productive, ticklish cough has been reported in some patients undergoing treatment with enalapril, the cough is often worse when lying down, and is commoner in women (who account for about two thirds of reported cases).

Contraindications

RENITEC is contraindicated in patients with history of previous hypersensitivity to RENITEC or to any component of the formulation and in patients with a history of angioneurotic oedema relating to previous treatment with an angiotensin-converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema. RENITEC is contraindicated in pregnancy. RENITEC should not be administered with aliskiren in patients with diabetes. RENITEC is contraindicated in combination with a neprilysin inhibitor (for example, sacubitril), and should not be administered within 36 hours of switching to or from sacubitril/valsartan.

PBS listing

No PBS listing information is provided in the source documents.

Regulatory history

RENITEC 5 mg, 10 mg and 20 mg tablet formulations were first listed on the ARTG on 22 July 1991. The medicine was first approved on 10 May 1996.