Coveram

Per 5/5 mg tab Perindopril arginine 5 mg, amlodipine 5 mg. Per 5/10 mg tab Perindopril arginine 5 mg, amlodipine 10 mg. Per 10/5 mg tab Perindopril arginine 10 mg, amlodipine 5 mg. Per 10/10 mg tab Perindopril arginine 10 mg, amlodipine 10 mg

Substitution therapy for 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.

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

Hypersensitivity to perindopril, amlodipine, any other ACE inhibitor or dihydropyridine derivatives. History of angioedema associated w/ previous ACE inhibitor therapy; hereditary or idiopathic angioedema; severe hypotension; shock, including cardiogenic shock; obstruction of the outflow tract of the left ventricle (eg, high-grade aortic stenosis); haemodynamically unstable heart failure after acute MI. Extracorporeal treatments leading to contact of blood w/ negatively charged surfaces. Significant bilateral renal artery stenosis or stenosis of the artery to a 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. Pregnancy (2nd & 3rd trimesters).

Not suitable for initial therapy. Temporarily withhold treatment prior to exams in the presence of anaphylactoid reactions during LDL apheresis w/ dextran sulphate or desensitisation treatment. Discontinue in cases of hypersensitivity/angioedema/intestinal angioedema (monitor until complete resolution of symptoms); if jaundice or marked elevations of hepatic enzymes develop. Dual blockade of the renin-angiotensin-aldosterone system is not recommended. Not recommended in patients w/ primary hyperaldosteronism. Not to be used concomitantly w/ angiotensin II receptor blockers in patients w/ diabetic nephropathy. Renovascular HTN; hypotension; non-productive, persistent cough. Patients w/ collagen vascular disease, on immunosuppressant therapy, treated w/ allopurinol or procainamide (periodically monitor WBC counts); mitral valve stenosis & obstruction in the outflow of the left ventricle eg, aortic stenosis or hypertrophic cardiomyopathy; risk factors for hyperkalemia; diabetic patients; hypertensive crisis; heart failure. Black patients. Discontinue 1 day prior to surgery. Not to initiate until 36 hr after last dose of sacubitril/valsartan. Not recommended in concomitant use w/ lithium, K-sparing drugs or K supplements, or dantrolene. Concomitant use w/ other NEP inhibitors (eg, racecadotril) & ACE inhibitors; mTOR inhibitors eg, sirolimus, everolimus, temsirolimus may increase risk of angioedema. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, glucose-galactose malabsorption or total lactase deficiency. May have minor or moderate influence on the ability to drive & use machines. Not suitable for patients w/ CrCl <60 mL/min. Mild to moderate hepatic impairment. Preexisting renal impairment. Not recommended during 1st trimester of pregnancy & lactation. Not to be used in childn & adolescents. Elderly.

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

Increased antihypertensive effect w/ baclofen. May increase hypotensive effects w/ antihypertensive agents (eg, β-blockers) & vasodilatators. May further reduce BP w/ nitroglycerine & other nitrates or vasodilatators. Reduced antihypertensive effects w/ corticosteroids, tetracosactide. Increased antihypertensive effect & risk of orthostatic hypotension w/ α-blockers (eg, prazosin, alfuzosin, doxazosin, tamsulosin); TCAs/antipsychotics/anaesth. May potentiate antihypertensive effect of amlodipine w/ amifostine. Perindopril: Higher frequency of adverse events w/ angiotensin II receptor-blockers or aliskiren. Increased risk of hyperkalaemia w/ aliskiren, K salts, K-sparing diuretics, ACE inhibitors, AIIA, NSAIDs, heparins, immunosuppressant agents (eg, ciclosporine or tacrolimus), trimethoprim, co-trimoxazole. May increase blood glucose lowering-effect of antidiabetic medicines eg, insulins, oral hypoglycaemic agents. Excessive BP reduction w/ non-K-sparing diuretics. May increase risk of angioedema w/ racecadotril; mTOR inhibitors eg, sirolimus, everolimus, temsirolimus. Antihypertensive effect may be attenuated w/ NSAIDs (eg, aspirin ≥3 g daily, COX-2 inhibitors & non-selective NSAIDs) & may be reduced w/ sympathomimetics. Increased risk of angiooedema w/ gliptines eg, linagliptine, saxagliptine, sitagliptine, vildagliptine. Nitritoid reactions w/ injectable gold (Na aurothiomalate). Contraindicated: Risk of hyperkalaemia, worsened renal function & increased CV morbidity & mortality w/ aliskiren in diabetic or impaired renal patients. Increased risk of severe anaphylactoid reactions w/ extracorporeal treatments. May increase risk of angioedema w/ sacubitril/valsartan. Not recommended: Aliskiren. Higher frequency of hypotension, syncope, hyperkalaemia, & worsened renal function w/ angiotensin receptor blocker. Risk of increased angioneurotic oedema w/ estramustine. May increase risk of hyperkalaemia w/ co-trimoxazole. Hyperkalaemia w/ K-sparing diuretics (eg, triamterene, amiloride) & K salts. Reversible increased serum conc & toxicity of lithium. Amlodipine: Plasma conc may vary w/ strong CYP3A4 inducers eg, rifampicin, Hypericum perforatum. Exposure may be increased w/ strong or moderate CYP3A4 inhibitors eg, PIs, azole antifungals, macrolides (eg, erythromycin or clarithromycin), verapamil or diltiazem. Increased risk of hypotension w/ clarithromycin. Additive BP-lowering effect w/ other medicinal products w/ antihypertensive properties. Risk of increased tacrolimus blood levels. May increase exposure of mTOR inhibitors. Increased exposure to simvastatin. Not recommended: Lethal ventricular fibrillation & CV collapse w/ dantrolene infusion. Bioavailability may be increased w/ grapefruit or grapefruit juice.

ACE Inhibitors/Direct Renin Inhibitors / Calcium Antagonists

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

POM