APO-LISINOPRIL

What it is

APO-LISINOPRIL contains lisinopril dihydrate as the active ingredient, available as tablets in strengths of 2.5 mg, 5 mg, 10 mg or 20 mg.

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 Lisinopril should be administered in a single daily dose.

Key safety warnings

Severe life threatening angioedema has been reported rarely with most ACE inhibitors. There seems to be no sex difference in the incidence of angioedema. Most commonly, angioedema occurs during the first week of therapy but it has also been reported after long-term therapy. 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 adrenaline and oxygen administration, and/or the maintenance of a patent airway, should be carried out promptly. Hypotension may occur in patients commencing treatment with ACE inhibitors. Excessive hypotension is rarely seen in patients with uncomplicated hypertension but can develop in patients with impaired renal function, in those that are salt/volume depleted because of renovascular disease, diuretic therapy, vomiting or diarrhoea, and in patients undergoing dialysis. In patients with severe congestive heart failure, with or without associated renal insufficiency, excessive hypotension has been observed, which may be associated with syncope, neurological deficits, oliguria and/or progressive azotemia, and rarely with acute renal failure and/or death. ACE inhibitors cause a higher rate of angioedema in Afro-Caribbean black patients than in non-Afro-Caribbean black patients. Because ACE inhibitors decrease the formation of Angiotensin II and subsequent production of aldosterone, serum potassium concentrations exceeding 5.5 mEq/L may occur. Hyperkalaemia is more likely in patients with some degree of renal impairment, those treated with potassium-sparing diuretics or potassium supplements, and in those consuming potassium-containing salt substitutes. A persistent dry (non-productive) irritating cough has been reported with ACE inhibitors, most likely due to stimulation of the pulmonary cough reflex by kinins (bradykinin) and/or prostaglandins which accumulate because of ACE inhibition.

Contraindications

APO-LISINOPRIL is contraindicated in patients who are hypersensitive to lisinopril or any other component of this product, and in patients with a history of hereditary and/or idiopathic angioedema, anaphylactic/anaphylactoid reactions or angioedema associated with previous treatment with an ACE inhibitor. APO-LISINOPRIL is contraindicated in pregnancy. APO-LISINOPRIL is contraindicated in patients undergoing haemodialysis with polyacrylonitrile-metalylsulphonate high flux membranes, as there is a risk of anaphylactoid reaction with the simultaneous use of an ACE inhibitor and polyacrylonitrile-metalylsulphonate high flux dialysis membranes (for example, AN69) or during low-density lipoproteins apheresis with dextran sulphate within the framework of dialysis treatment. APO-LISINOPRIL is contraindicated in combination with aliskiren-containing medicines in patients with diabetes mellitus (type I or II) or with moderate to severe renal impairment (GFR<60 mL/min/1.73 m²).

Regulatory history

APO-LISINOPRIL was first registered on the ARTG on 17 October 2013, with three strengths listed: 5 mg, 10 mg and 20 mg tablets.