MALEAN

What it is

Malean contains enalapril maleate. Enalapril maleate is a pro-drug which when administered orally is hydrolysed to release the active converting enzyme inhibitor enalaprilat. Malean is available in 5 mg, 10 mg and 20 mg tablet strengths.

Approved indications

— Essential hypertension, all grades. — Renovascular hypertension. — Congestive heart failure, all degrees of symptomatic heart failure. — 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

For renal impairment: patients with creatinine clearance >30 mL/min receive the usual dose; those with creatinine clearance <30 mL/min receive 2.5 mg once daily initially, titrated up to a maximum of 40 mg daily.

Key safety warnings

Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with enalapril. This may occur at any time during treatment. In such cases enalapril 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. 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 such as those treated vigorously with diuretics or patients on dialysis. In patients with heart failure, excessive hypotension has been observed and may be associated with oliguria and/or progressive azotaemia, and rarely with acute renal failure and/or death. Because of the potential fall in blood pressure in these patients, therapy should be started under very close medical supervision. Such patients should be followed closely for the first two weeks of treatment and whenever the dose of enalapril and/or diuretic is increased. A persistent non-productive, ticklish cough has been reported in some patients undergoing treatment with enalapril. The cough is often worse when lying down. The cough is commoner in women (who account for about two thirds of reported cases). Elevated serum potassium (greater than 5.7 mmol/L) was observed in approximately one percent of hypertensive patients in clinical trials. In most cases these were isolated values which resolved despite continued therapy. Hyperkalaemia was a cause of discontinuation of therapy in 0.28 percent of hypertensive patients.

Contraindications

Malean is contraindicated in patients with history of previous hypersensitivity to enalapril or 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. Malean is contraindicated in pregnancy. Malean should not be administered with aliskiren in patients with diabetes. Malean is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril).

Regulatory history

Malean enalapril maleate 5 mg, 10 mg and 20 mg tablets were first listed on the ARTG on 28 May 2013.