ZINOPRIL

What it is

Zinopril is a tablet formulation containing lisinopril dihydrate as the active ingredient, available in 5 mg, 10 mg and 20 mg strengths. Lisinopril is a synthetic peptide derivative and oral, long acting angiotensin converting enzyme inhibitor, and is a lysine analogue of enalaprilat.

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, initiated within 24 hours of an acute myocardial infarction.

Dosing overview

Zinopril may be administered before, during or after meals and should be given in a single daily dose.

Key safety warnings

Severe life-threatening angioedema has been reported rarely with angiotensin converting enzyme inhibitors, most commonly during the first week of therapy but also after long-term therapy. Angioedema of the face, extremities, lips, tongue, glottis and/or larynx may occur at any time during treatment, and Zinopril should be discontinued promptly with appropriate monitoring to ensure complete resolution of symptoms. Angioedema associated with laryngeal oedema is potentially life-threatening, and very rarely, fatalities have been reported. Where involvement of the tongue, glottis, or larynx is likely to cause airway obstruction, appropriate emergency therapy including adrenalin and oxygen administration and/or maintenance of a patent airway should be carried out promptly. Hypotension may occur in patients commencing treatment with Zinopril. Excessive hypotension is rarely seen in uncomplicated hypertension but can develop in patients with impaired renal function, salt/volume depletion, or undergoing dialysis. In severe congestive heart failure, excessive hypotension has been observed and may be associated with syncope, neurological deficits, oliguria, progressive azotaemia, and rarely acute renal failure or death. Therapy should be started at low doses under very close supervision, and such patients should be followed closely for the first two weeks of treatment and whenever dosage is increased or diuretic therapy is commenced or increased. Because Zinopril decreases formation of angiotensin II and subsequent aldosterone production, serum potassium concentrations may exceed 5.5 mEq/L. Hyperkalaemia is more likely in patients with renal impairment, those treated with potassium-sparing diuretics or potassium supplements, and those consuming potassium-containing salt substitutes, with diabetics and elderly diabetics particularly at increased risk. A persistent dry irritating cough has been reported with angiotensin converting enzyme inhibitors, most likely due to stimulation of the pulmonary cough reflex by kinins and/or prostaglandins which accumulate because of angiotensin converting enzyme inhibition, and a change to another class of drugs may be required in severe cases.

Contraindications

Zinopril is contraindicated in patients who are hypersensitive to lisinopril or any other component of Zinopril and in patients with a history of hereditary and/or idiopathic angioedema, anaphylactic/anaphylactoid reactions or angioedema associated with previous treatment with an angiotensin converting enzyme inhibitor. Zinopril is contraindicated in pregnancy and in patients undergoing haemodialysis with polyacrylonitrile-metalylsulphonate high flux membranes. Zinopril is contraindicated in combination with aliskiren-containing medicines in patients with diabetes mellitus or with moderate to severe renal impairment (GFR <60 mL/min/1.73 m²).

PBS listing

No PBS listing information is provided in the source documents.

Regulatory history

Zinopril 5 mg, 10 mg and 20 mg tablets were first listed on the Australian Register of Therapeutic Goods (ARTG) on 30 January 2009 under licence category RE, sponsored by Alphapharm.