Coveram

Substitution therapy of essential HTN &/or stable CAD in patients already controlled w/ perindopril & amlodipine given concurrently at the same dose level.

1 tab daily as single dose. If change of posology is required, dose modification or titration w/ individual components.

Should be taken on an empty stomach: Preferably taken in the morning before a meal.

Hypersensitivity to perindopril arginine, amlodipine, other ACE inhibitor & dihydropyridines derivatives. History of angioedema associated w/ previous ACE inhibitor therapy, hereditary or idiopathic angioedema; severe hypotension; shock, including cardiogenic shock; left ventricle outflow tract obstruction eg, high grade aortic stenosis; haemodynamically unstable heart failure after acute MI. Extracorporeal treatments leading to contact of blood w/ -ve charged surfaces. Significant bilateral renal artery stenosis or artery stenosis to single functioning kidney. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²); sacubitril/valsartan therapy. 2nd & 3rd trimesters of pregnancy.

Hypersensitivity/angioedema; anaphylactoid reactions during LDL apheresis & desensitisation. Discontinue use if jaundice or marked hepatic enzymes elevation occur. Not suitable for initial therapy. Not to be used concomitantly w/ ARBs in patients w/ diabetic nephropathy. Not recommended in dual blockade of the renin-angiotensin-aldosterone system; primary hyperaldosteronism. Symptomatic hypotension in vol-depleted patients eg, diuretic therapy, dietary salt restriction, dialysis, diarrhoea, vomiting, severe renin-dependent HTN; 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 eg, aortic stenosis or hypertrophic cardiomyopathy; renovascular HTN; DM, intercurrent events, dehydration, acute cardiac decompensation, metabolic acidosis; hypertensive crisis; hyperkalaemia; cough. Bilateral renal artery stenosis or artery stenosis to single functioning kidney. Close monitoring of renal function, electrolytes & BP; periodically monitor WBC counts during therapy. Black patients; diabetic patients. Discontinue use 1 day prior to surgery. Not to initiate sacubitril/valsartan until 36 hr after last dose. Not recommended in concomitant use w/ lithium; K-sparing drugs or K-supplements, dantrolene. Concomitant use w/ allopurinol or procainamide; NEP inhibitors (eg, racecadotril); mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus); gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin); drugs increasing serum K (eg, heparin, co-trimoxazole). Not to be taken by patients w/ galactose intolerance, glucose-galactose malabsorption or total lactase deficiency. Minor or moderate influence on the ability to drive & use machines. Not suitable in patients w/ CrCl <60 mL/min. Preexisting renal impairment. Renal & hepatic impairment & failure. Not recommended during 1st trimester of pregnancy & lactation. Not to be used in childn & adolescents <18 yr. Elderly.

Dizziness, headache; visual impairment; dyspnea; abdominal pain, nausea, dyspepsia, diarrhea, constipation; muscle spasms; asthenia. Perindopril: Dysgeusia, paresthesia; tinnitus, vertigo; hypotension; cough; vomiting; pruritus, rash, exanthema. Amlodipine: Oedema. Somnolence; diplopia; palpitations; flushing; change of bowel habit; joint swelling (ankle swelling); fatigue.

Increased antihypertensive effect w/ baclofen. May increase hypotensive effects w/ antihypertensive agents (eg, β-blockers) & vasodilators. May further reduce BP w/ nitroglycerine & other nitrates or vasodilators. Reduced antihypertensive effects w/ corticosteroids, tetracosactide. Increased antihypertensive effect & risk of orthostatic hypotension w/ α-blockers (prazosin, alfuzosin, doxazosin, tamsulosin, terazosin); TCAs, antipsychotics, anesth. May potentiate antihypertensive effect w/ amifostine. Perindopril: Higher frequency of adverse events w/ ACE inhibitor & ARBs. Increased risk of angioedema w/ sacubitril/valsartan; racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus) & gliptins (eg, linagliptin, saxagliptin, sitagliptin, vidagliptin). Increased risk of hyperkalaemia w/ aliskiren, K salts, K-sparing diuretics (eg, spirinolactone, triamterene or amiloride), ACE inhibitors, AIIA, NSAIDs, heparins, immunosuppressant agents (eg, ciclosporin or tacrolimus, trimethoprim & cotrimoxazole. Increased risk of hyperkalaemia, worsened renal function, CV morbidity & mortality w/ aliskiren. Increased risk of severe anaphylactoid reactions w/ extracorporeal treatments eg, dialysis or hemofiltrations w/ certain high-flux membranes (eg, polyacrylonitrile membranes) & LDL apheresis w/ dextran sulphate. Increased risk of angioneurotic edema w/ estramustine. Reversible increases in serum lithium conc & toxicity (severe neurotoxicity). Increased blood-glucose lowering effect w/ risk of hypoglycaemia w/ antidiabetic medicines (insulins, oral hypoglycemic agents). Excessive reduction in BP w/ non-K-sparing diuretics. Attenuated antihypertensive effect w/ NSAIDs (ie, ASA ≥3 g/day, COX-2 inhibitors & non-selective NSAIDs). Increased risk of worsening of renal function, including possible acute renal failure, & increase in serum K w/ NSAIDs especially in patients w/ poor preexisting renal function. May reduce antihypertensive effects w/ sympathomimetics. Nitritoid reactions w/ inj gold (Na aurothiomalate). Amlodipine: Hyperkalemia w/ dantrolene IV. Plasma conc may vary w/ strong CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). Increased exposure w/ strong or moderate CYP3A4 inhibitors [PIs, azole antifungals, macrolides (eg, erythromycin or clarithromycin), verapamil or diltiazem]. Increased risk of hypotension w/ clarithromycin. Additive BP-lowering effects of other medicinal products w/ antihypertensive properties. Risk of increased tacrolimus blood levels. May increase exposure of mTOR inhibitors (eg, sirolimus, temsirolimus, & everolimus). Increased variable trough conc of ciclosporin. Increased exposure to simvastatin. May increase bioavailability w/ grapefruit or grapefruit juice.

Calcium Antagonists / ACE Inhibitors/Direct Renin Inhibitors

C09BB04 - perindopril and amlodipine ; Belongs to the class of ACE inhibitors and calcium channel blockers. Used in the treatment of cardiovascular diseases.

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