ZESTRIL

What it is

Zestril (lisinopril dihydrate) is a synthetic peptide derivative and oral long-acting angiotensin converting enzyme (ACE) inhibitor, and is a lysine analogue of enalaprilat. Zestril is available as tablets containing 5 mg, 10 mg, or 20 mg of lisinopril.

Approved indications

— Treatment of hypertension. — Treatment of heart failure. — Treatment of acute myocardial infarction in haemodynamically stable patients, defined as patients who are not in cardiogenic shock and who have a systolic blood pressure greater than 100 mmHg.

Dosing overview

Zestril should be administered in a single daily dose. Since there is no clinically significant effect of food on the absorption of lisinopril, the tablets may be administered before, during or after meals.

Key safety warnings

Severe life-threatening angioedema has been reported rarely with ACE inhibitors, and angioedema associated with laryngeal oedema is potentially life threatening, with very rare fatalities reported due to angioedema associated with laryngeal or tongue oedema. If angioedema occurs, the product should be discontinued promptly and appropriate monitoring instituted to ensure complete resolution of symptoms prior to the patient being dismissed. Hypotension may occur in patients commencing treatment with ACE inhibitors, and excessive hypotension is rarely seen in patients with uncomplicated hypertension but can develop in patients with impaired renal function, those who are salt or volume depleted, patients undergoing dialysis, and in patients with severe congestive heart failure, potentially associated with syncope, neurological deficits, oliguria, progressive azotaemia, and rarely acute renal failure or death, so therapy should be started at low doses under very close supervision. Because ACE inhibitors decrease the formation of angiotensin II and subsequent production of aldosterone, serum potassium concentrations exceeding 5.5 mEq/L may occur, particularly in patients with renal impairment, those treated with potassium-sparing diuretics or potassium supplements, elderly diabetic patients, and hyperkalaemia can cause serious, sometimes fatal, arrhythmias. A persistent dry irritating cough has been reported with ACE inhibitors, most likely due to stimulation of the pulmonary cough reflex by kinins and prostaglandins which accumulate because of ACE inhibition, and a change to another class of medicines may be required in severe cases.

Contraindications

Lisinopril is contraindicated in patients who are hypersensitive to lisinopril or any other component of Zestril, patients with a history of hereditary and/or idiopathic angioedema, anaphylactic/anaphylactoid reactions or angioedema associated with previous treatment with an ACE inhibitor, patients with hereditary or idiopathic angioedema, pregnancy, and patients undergoing haemodialysis with polyacrylonitrile-metalylsulfonate high flux membranes.

PBS listing

Zestril 5 mg tablets are listed on the PBS with 2 items at an ex-manufacturer price of A$7.01, with one item restricted and one unrestricted. Zestril 10 mg tablets are listed on the PBS with 2 items at an ex-manufacturer price of A$8.00, with one item restricted and one unrestricted. Zestril 20 mg tablets are listed on the PBS with 2 items at an ex-manufacturer price of A$8.29, with one item unrestricted and one restricted.

Regulatory history

Zestril 5 mg, 10 mg, and 20 mg tablets were first registered on the ARTG on 16 November 1999.