TRYZAN

What it is

Tryzan contains ramipril . It is available in tablet strengths of 1.25 mg, 2.5 mg and 5 mg, and in capsules of 10 mg .

Approved indications

— Treatment of hypertension . — Post-myocardial infarction heart failure . — Prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g per day . — Reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of coronary artery disease, stroke, or peripheral vascular disease . — Reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 90 mmHg (or on antihypertensive treatment); total cholesterol greater than 5.2 mmol per litre or HDL cholesterol less than 0.9 mmol per litre; current smoker; known microalbuminuria; any evidence of previous vascular disease .

Dosing overview

For hypertension, the recommended initial dose is 2.5 mg once daily, which may be increased at intervals of two to three weeks first to 5 mg and then to a maximum of 10 mg once daily . Patients already taking diuretics should start at 1.25 mg once daily . For post-myocardial infarction heart failure, the recommended initial dose is 5 mg daily in two divided doses of 2.5 mg each; if not tolerated, 1.25 mg twice daily for two days is recommended, after which the dose may be increased by doubling at intervals of one to three days, to a maximum permitted daily dose of 10 mg in divided doses . For patients at increased cardiovascular risk, the recommended initial dose is 2.5 mg once daily, which should be doubled after one week and increased to 10 mg after three weeks, with usual maintenance at 10 mg daily . For progressive renal failure with persistent proteinuria exceeding 1 g per day, the recommended initial dose is 1.25 mg once daily, doubled at intervals of two to three weeks depending on tolerance . For elderly patients, the recommended starting dose is 1.25 mg once daily, which can be increased according to individual blood pressure response .

Key safety warnings

Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with ACE inhibitors; if angioedema occurs, the product should be promptly discontinued and the patient carefully observed until the swelling disappears . Laryngeal oedema can be fatal; where angioedema involves swelling of the tongue, glottis or larynx likely to cause airway obstruction, subcutaneous adrenaline solution 1:1,000 (0.3 to 0.5 mL) should be promptly administered . Hypotension may occur in patients commencing treatment with ACE inhibitors; excessive hypotension is rarely seen in uncomplicated hypertensive patients but is a possible consequence in severely salt or volume depleted persons, including those with renovascular hypertension, those treated vigorously with diuretics, or those undergoing dialysis . It is recommended that dehydration, hypovolaemia or salt depletion be corrected before initiating treatment . A persistent dry, non-productive, irritating cough has been reported with most ACE inhibitors; the incidence varies between 2% to 15% depending upon the drug, dosage and duration of use . Because ACE inhibitors decrease the formation of angiotensin II, which results in decreased aldosterone production, increase in serum potassium levels greater than 5.5 mEq per litre are not unexpected; hyperkalaemia is more likely in patients with renal impairment, those treated with potassium-sparing diuretics or potassium supplements, and those taking other medicines associated with increases in serum potassium .

Contraindications

Tryzan is contraindicated in patients with hypersensitivity to ramipril, to any other ACE inhibitor, or to any of the excipients, and in those with a history of hereditary and/or idiopathic angioedema or angioedema associated with previous treatment with an ACE inhibitor . Tryzan is contraindicated in patients with haemodynamically relevant renal artery stenosis either bilateral or unilateral in the single kidney . As with all vasodilators, ACE inhibitors should not be used in patients with haemodynamically relevant left ventricular inflow or outflow impediment, such as stenosis of the aortic or mitral valve . Hypotensive or haemodynamically unstable patients must not receive this medicine . Tryzan is contraindicated in pregnancy and lactation, and in renal failure . Ramipril must not be used with aliskiren-containing medicines in patients with diabetes or with moderate to severe renal impairment (creatinine clearance less than 60 mL per minute) . Ramipril must not be used with angiotensin II receptor antagonists in patients with diabetic nephropathy . Ramipril must not be used concomitantly with sacubitril/valsartan therapy .

PBS listing

Tryzan capsules are listed on the PBS in strengths of 1.25 mg, 2.5 mg and 5 mg, with each strength having two PBS items and an ex-manufacturer price of A$2.50 .

Regulatory history

Tryzan capsules were first listed on the ARTG on 28 June 2007, with the 1.25 mg, 2.5 mg, 5 mg and 10 mg capsule strengths registered under licence category RE . Tryzan tablets in strengths of 1.25 mg, 2.5 mg, 5 mg and 10 mg were first listed on the ARTG on 7 August 2007 .