ENALAPRIL-WGR

What it is

Enalapril-WGR contains enalapril maleate as the active ingredient and is available in tablet strengths of 5 mg, 10 mg and 20 mg. 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. The mechanism involves inhibition of the angiotensin converting enzyme (ACE), which catalyses the conversion of angiotensin I to angiotensin II, resulting in decreased plasma angiotensin II and decreased aldosterone secretion.

Approved indications

— Hypertension, including all grades of essential hypertension and renovascular hypertension. — Congestive heart failure in all degrees of symptomatic heart failure. — Left ventricular dysfunction in all degrees where the left ventricular ejection fraction is less than 35%, irrespective of the presence or severity of obvious symptoms of heart failure.

Dosing overview

Key safety warnings

Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with enalapril and may occur at any time during treatment, requiring prompt discontinuation and careful observation until the swelling disappears. Very rarely, fatalities have been reported due to angioedema associated with laryngeal or tongue oedema, with patients experiencing involvement of the tongue, glottis or larynx requiring prompt administration of subcutaneous adrenaline solution and/or measures to ensure a patent airway. Excessive hypotension is a possible consequence of enalapril use in severely salt or volume depleted persons and in patients with heart failure, with or without associated renal insufficiency, may be associated with oliguria and/or progressive azotaemia, and rarely with acute renal failure or death. Therapy should be started under very close medical supervision and such patients should be followed closely for the first two weeks of treatment and whenever the dose of enalapril and/or diuretic is increased. 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 in 0.28 percent of hypertensive patients. Risk factors for hyperkalaemia include renal insufficiency, diabetes mellitus, and concomitant use of potassium-sparing diuretics, potassium supplements, or other drugs that increase serum potassium, which can cause serious, sometimes fatal, arrhythmias. A persistent non-productive, ticklish cough has been reported in some patients undergoing treatment with enalapril, is often worse when lying down, and is more common in women, accounting for about two-thirds of reported cases.

Contraindications

Enalapril-WGR is contraindicated in patients with a 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 ACE inhibitor, and in patients with hereditary or idiopathic angioedema. Enalapril-WGR is contraindicated in pregnancy. Enalapril should not be administered with aliskiren in patients with diabetes. Enalapril is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril) and should not be administered within 36 hours of switching to or from sacubitril/valsartan.

PBS listing

No information regarding PBS listing is available in the provided source documents.

Regulatory history

Enalapril-WGR was first registered on the Australian Register of Therapeutic Goods on 28 May 2013, with three variants listed: 5 mg tablets (ARTG 196507), 10 mg tablets (ARTG 196498), and 20 mg tablets (ARTG 196493).