APO-RAMIPRIL

What it is

APO-RAMIPRIL is a ramipril tablet medicine available in strengths of 2.5 mg, 5 mg or 10 mg. Ramipril is a pro-drug which, after absorption from the gastrointestinal tract, is hydrolysed in the liver to form the active moiety, ramiprilat. Ramipril and ramiprilat inhibit angiotensin-converting enzyme (ACE) which is identical to KININASE II.

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 mm Hg or diastolic blood pressure greater than 90 mm Hg (or on antihypertensive treatment); total cholesterol greater than 5.2 mmol per litre; HDL cholesterol less than 0.9 mmol per litre; current smoker; known microalbuminuria; any evidence of previous vascular disease.

Dosing overview

Key safety warnings

Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported during ACE inhibitor treatment. If angioedema occurs, the product should be promptly discontinued and the patient carefully observed until the swelling disappears. Laryngeal oedema can be fatal; where there is angioedema involving swelling of the tongue, glottis or larynx likely to cause airway obstruction, subcutaneous adrenaline (epinephrine) solution 1:1000 (0.3–0.5 mL) should be promptly administered, and hospitalisation for observation for at least 12 to 24 hours is advisable. The onset of angioedema associated with use of ACE inhibitors may be delayed for weeks or months, and patients may have multiple episodes of angioedema with long symptom-free periods. Hypotension may occur in patients commencing treatment with ACE inhibitors. Excessive hypotension is rarely seen in uncomplicated hypertensive patients but is a possible consequence of use in severely salt or volume depleted persons such as patients with renovascular hypertension, those treated vigorously with diuretics, after severe diarrhoea or patients undergoing dialysis. In patients with severe congestive heart failure, with or without associated renal insufficiency, excessive hypotension has been observed with ACE inhibitors, which may be associated with syncope, neurological deficit, oliguria and/or progressive azotaemia, but rarely with acute renal failure and/or death. A persistent dry (non-productive) irritating cough has been reported with most ACE inhibitors in use. The incidence of cough varies between 2–15 per cent depending upon the drug, dosage and duration of use. The cough is often worse when lying down or at night and is more common in women (who account for two-thirds of the reported cases). Because ACE inhibitors decrease the formation of angiotensin II, which results in decreased production of aldosterone, increases in serum potassium levels (greater than 5.5 mEq per litre) are not unexpected with this class of drugs. Hyperkalaemia is more likely in patients with some degree of renal impairment, those treated with potassium-sparing diuretics or potassium supplements and/or consuming potassium-containing salt substitutes, or in patients taking other medicines associated with increases in serum potassium. Diabetics, and particularly elderly diabetics, may be at increased risk of hyperkalaemia.

Contraindications

APO-RAMIPRIL is contraindicated in patients with hypersensitivity to ramipril, any other ACE inhibitor, or any of the excipients, and in patients with a history of hereditary and/or idiopathic angioedema or angioedema associated with previous treatment with an ACE inhibitor. Haemodynamically relevant renal artery stenosis, either bilateral or unilateral in the single kidney, is a contraindication. 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 aortic or mitral valve). APO-RAMIPRIL is contraindicated in hypotensive or haemodynamically unstable patients, during pregnancy, and during lactation. 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.

PBS listing

No source documents contain information about PBS listing for APO-RAMIPRIL.

Regulatory history

APO-RAMIPRIL ramipril capsules in strengths of 1.25 mg, 2.5 mg, 5 mg and 10 mg were first listed on the ARTG on 27 September 2011. APO-RAMIPRIL ramipril tablets in strengths of 2.5 mg, 5 mg and 10 mg in blister packs (licence category RE) were first listed on the ARTG on 22 December 2014.