Coveram

Coveram

perindopril + amlodipine

Manufacturer:

Servier

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 5/5 mg tab Perindopril arginine 5 mg, amlodipine besilate 5 mg. Per 5/10 mg tab Perindopril arginine 5 mg, amlodipine besilate 10 mg. Per 10/5 mg tab Perindopril arginine 10 mg, amlodipine besilate 5 mg. Per 10/10 mg tab Perindopril arginine 10 mg, amlodipine besilate 10 mg
Indications/Uses
Substitution treatment of essential HTN &/or stable CAD in patients already controlled w/ perindopril & amlodipine given concurrently at same dose level.
Dosage/Direction for Use
Administration
Should be taken on an empty stomach: Preferably taken in the morning before a meal.
Contraindications
Hypersensitivity to perindopril arginine, amlodipine besilate, other ACE inhibitors & dihydropyridines. History of angioedema associated w/ previous ACE inhibitor therapy; hereditary or idiopathic angioedema; severe hypotension; cardiogenic shock; left ventricle outflow tract obstruction; haemodynamically unstable heart failure after acute MI. Significant bilateral renal artery stenosis or artery stenosis to single functioning kidney. Concomitant use w/ sacubitril/valsartan; extracorporeal treatments. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). 2nd & 3rd trimesters of pregnancy.
Special Precautions
Hypersensitivity/angioedema; anaphylactoid reactions during LDL apheresis & desensitisation. Discontinue use if jaundice or marked hepatic enzymes elevations occur. Not suitable for initial therapy. Not recommended in dual blockade renin-angiotensin-aldosterone system; primary aldosteronism. Not to be used concomitantly in patients w/ diabetic nephropathy. Excessive BP reduction in patients w/ ischaemic heart or cerebrovascular disease. Severe heart failure (NYHA class III & IV); CHF. Collagen vascular disease, immunosuppressant therapy; mitral valve stenosis & left ventricle outflow tract obstruction; renovascular HTN; DM, dehydration, acute cardiac decompensation, metabolic acidosis; hypertensive crisis. Bilateral renal artery stenosis or artery stenosis to single functioning kidney. Cough. Black patients. Discontinue use 1 day prior to surgery. Not to initiate sacubitril/valsartan until 36 hr after last dose. Not recommended in concomitant w/ lithium, K-sparing diuretics, K-supplements, K-containing salt substitute; dantrolene. Concomitant use w/ allopurinol or procainamide; mTOR inhibitors eg, sirolimus, everolimus, temsirolimus; NEP inhibitors eg, racecadotril; drugs known to increase serum K eg, heparin, co-trimoxazole. Galactose intolerance, glucose-galactose malabsorption or total lactase deficiency. May affect ability to drive & use machines. Renal impairment (CrCl <60 mL/min). Preexisting renal impairment. Hepatic impairment & failure. Not recommended during 1st trimester of pregnancy & lactation. Not to be used in childn & adolescents. Elderly.
Adverse Reactions
Oedema; somnolence, dizziness, headache, dysgeusia, paraesthesia; visual impairment, diplopia; tinnitus, vertigo; palpitations; flushing, hypotension; dyspnoea, cough; abdominal pain, nausea, vomiting, dyspepsia, change of bowel habit, diarrhoea, constipation; pruritus, rash, exanthema; joint/ankle swelling, muscle spasms; fatigue, asthenia.
Drug Interactions
Increased antihypertensive effect w/ baclofen. Increased hypotensive effect w/ antihypertensive agents (eg, β-blockers), vasodilatators. Reduced BP w/ nitroglycerin, other nitrates or vasodilators. Increased antihypertensive effect & risk of orthostatic hypotension w/ α-blockers (eg, prazosin, alfuzosin, doxazosin, tamsulosin, terazosin), TCAs, antipsychotics, anaesth. Potentiated antihypertensive effect w/ amifostine. Increased risk of hyperkalaemia w/ aliskiren, K salts, K-sparing diuretics, ACE inhibitors, ARB, NSAIDs, heparins, immunosuppresants eg, ciclosporin, tacrolimus, trimethoprim, co-trimoxazole. Increased risk of worsened renal function, CV morbidity & mortality w/ aliskiren. Increased risk of severe anaphylactoid reactions w/ extracorporeal treatments. Increased risk of angioedema w/ sacubitril/valsartan, racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus), gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin). Increased risk of angioneurotic oedema w/ estramustine. Reversible increased serum conc & toxicity of lithium. Increased blood-glucose lowering effect of antidiabetic agents eg, insulin, oral hypoglycaemic agents. Excessive BP reduction w/ non-K-sparing diuretics. Attenuated antihypertensive effect w/ NSAIDs eg, acetylsalicylic acid, COX-2 inhibitors, nonselective NSAIDs. Reduced antihypertensive effects w/ sympathomimetics, corticosteroids, tetracosactide. Nitritoid reactions w/ injectable gold (Na aurothiomalate). Lethal ventricular fibrillation & CV collapse w/ dantrolene infusion. Increased amlodipine exposure w/ CYP3A4 inhibitors eg, PIs, azole antifungals, macrolides (eg, erythromycin or clarithromycin), verapamil, diltiazem. Increased risk of hypotension w/ clarithromycin. Increased tacrolimus blood levels. Increased mTOR inhibitors exposure. Increased exposure to simvastatin. Increased BP-lowering effects w/ grapefruit or grapefruit juice. CYP3A4 inducers eg, rifampicin, Hypericum perforatum.
ATC Classification
C09BB04 - perindopril and amlodipine ; Belongs to the class of ACE inhibitors and calcium channel blockers. Used in the treatment of cardiovascular diseases.
Presentation/Packing
Form
Coveram 5/10 mg tab
Packing/Price
30's
Form
Coveram 10/5 mg tab
Packing/Price
30's
Form
Coveram 10/10 mg tab
Packing/Price
30's
Form
Coveram 5/5 mg tab
Packing/Price
30's
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