COVERAM

What it is

COVERAM contains perindopril arginine and amlodipine besilate. It is available in four strengths: COVERAM 5/5 (5 mg perindopril arginine and 5 mg amlodipine), COVERAM 5/10 (5 mg perindopril arginine and 10 mg amlodipine), COVERAM 10/5 (10 mg perindopril arginine and 5 mg amlodipine), and COVERAM 10/10 (10 mg perindopril arginine and 10 mg amlodipine).

Approved indications

— Treatment of hypertension in patients already controlled with separate doses of perindopril and amlodipine given concurrently at the same dose level. — Treatment of stable coronary heart disease in patients already controlled with separate doses of perindopril and amlodipine given concurrently at the same dose level.

Dosing overview

COVERAM is available as substitution therapy for patients already controlled with separate doses of perindopril (5 or 10 mg) and amlodipine (5 or 10 mg), given concurrently at the dose level as indicated by the dosing conversion table. The recommended treatment is one tablet per day as a single dose, preferably to be taken in the morning and before a meal. Treatment should not be initiated with this combination. In patients with impaired renal function and the elderly, elimination of perindoprilat is decreased, so usual medical follow-up will include frequent monitoring of creatinine and potassium. Where down-titration is required to achieve clinical stability in patients with creatinine clearance less than 60 mL/min, adjustments using amlodipine 2.5 mg or perindopril arginine 2.5 mg as separate products should be considered.

Key safety warnings

Life-threatening angioedema has been reported with most ACE inhibitors, with an overall incidence of approximately 0.1–0.2 per cent. Angioedema of the face, extremities, lips, tongue, mucous membranes, glottis and/or larynx has been reported uncommonly with perindopril and may occur at any time during treatment. In such cases treatment should be promptly discontinued and the patient carefully observed until the swelling disappears. Since ACE inhibitors reduce angiotensin II formation resulting in decreased aldosterone production, increases in serum potassium have been observed in some patients treated with perindopril, although the effect is usually not significant in patients with normal renal function. Hyperkalaemia can cause serious, sometimes fatal, arrhythmias. Risk factors for hyperkalaemia development include renal impairment, age greater than 70 years, diabetes, and combined use with potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other medicines associated with increased serum potassium such as heparin, co-trimoxazole, other ACE inhibitors, angiotensin receptor blockers, high-dose acetylsalicylic acid, COX-2 inhibitors and non-selective NSAIDs. A persistent dry, non-productive, irritating cough has been reported with most ACE inhibitors, with incidence varying between 2–15 per cent depending on the ACE inhibitor, dose and duration of use. The cough is often worse when lying down or at night and has been reported more frequently in women. Mild to moderate peripheral oedema was the most common adverse event in clinical trials, with incidence dose-dependent and ranging from 3.0 to 10.8 per cent in the 5 to 10 mg amlodipine dose range.

Contraindications

COVERAM is contraindicated in patients with a history of previous hypersensitivity to either perindopril or amlodipine, ACE inhibitors, dihydropyridines or excipient ingredients present in COVERAM. It is contraindicated during pregnancy and for lactating women. COVERAM is contraindicated in patients with bilateral or unilateral renal artery stenosis and in patients with a history of hereditary and/or idiopathic angioedema or angioedema associated with previous ACE inhibitor treatment. It is contraindicated in patients receiving extracorporeal treatments leading to contact of blood with negatively charged surfaces such as dialysis or haemofiltration with certain high-flux membranes (such as polyacrylonitrile membranes) and low density lipoprotein apheresis with dextran sulfate due to increased risk of severe anaphylactoid reactions. COVERAM must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan. COVERAM is contraindicated in severe hypotension, shock (including cardiogenic shock), obstruction of the left ventricular outflow tract (such as high-grade aortic stenosis), unstable angina pectoris (excluding Prinzmetal's angina), and heart failure after acute myocardial infarction.

PBS listing

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

Regulatory history

COVERAM was first registered on the Australian Register of Therapeutic Goods on 11 January 2010. Four strengths were registered: COVERAM 5/5, COVERAM 5/10, COVERAM 10/5, and COVERAM 10/10, all as uncoated tablets in bottles.