LISINOPRIL-WGR

What it is

LISINOPRIL-WGR contains lisinopril dihydrate as the active ingredient, available in tablets of 2.5 mg, 5 mg, 10 mg or 20 mg strength. Lisinopril is a peptidyl dipeptidase inhibitor that inhibits the angiotensin converting enzyme (ACE), which catalyses the conversion of angiotensin I to angiotensin II.

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. Dosing varies by indication.

For hypertensive patients receiving concomitant diuretics in whom the diuretic cannot be discontinued, the initial dose should be 2.5 mg, followed then by 5 mg.

Key safety warnings

Severe life-threatening angioedema has been reported rarely with most ACE inhibitors. Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with ACE inhibitors and may occur at any time during treatment. In such cases LISINOPRIL-WGR should be discontinued promptly and appropriate monitoring instituted to ensure complete resolution of symptoms prior to the patient being dismissed. ACE inhibitors cause a higher rate of angioedema in Afro-Caribbean black patients than in non-Afro-Caribbean black patients. 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 or volume depleted, and in patients undergoing dialysis. Because of the potential fall in blood pressure, 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 the dosage is increased, or diuretic therapy is commenced or increased. Because ACE inhibitors decrease the formation of angiotensin II and the 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. It is recommended that patients taking an ACE inhibitor should have serum electrolytes (including potassium, sodium, and urea) measured from time to time, which is more important in patients taking diuretics. A persistent dry (non-productive) irritating cough has been reported with ACE inhibitors, which is most likely due to stimulation of the pulmonary cough reflex by kinins (bradykinin) and/or prostaglandins which accumulate because of ACE inhibition.

Contraindications

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. Lisinopril is contraindicated in pregnancy. Lisinopril is contraindicated in patients undergoing haemodialysis with polyacrylonitrile-metalylsulphonate high flux membranes, due to risk of anaphylactoid reaction. This combination needs to be avoided, either by using other medical products to control high blood pressure or cardiac insufficiency or by using other membranes during dialysis. 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).

PBS listing

Information regarding PBS listing details is not contained in the provided source documents.

Regulatory history

LISINOPRIL-WGR was first listed on the ARTG on 2 August 2013 across four strengths (2.5 mg, 5 mg, 10 mg and 20 mg as lisinopril dihydrate tablets) under licence category RE.