Coveram

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

Substitution therapy of essential HTN &/or stable CAD in patients already controlled w/ perindopril & amlodipine given concurrently at 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 arginine, amlodipine, 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 eg, high grade aortic stenosis; haemodynamically unstable heart failure after acute MI. Significant bilateral renal artery stenosis or artery stenosis to single functioning kidney. Extracorporeal treatments leading to blood contact w/ -ve charged surfaces. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²); sacubitril/valsartan. 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, dehydration, acute cardiac decompensation, metabolic acidosis; hypertensive crisis; hyperkalaemia; cough. Bilateral renal artery stenosis or artery stenosis to single functioning kidney. 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 diuretics, K-supplements, K-containing salt substitutes; dantrolene. Concomitant use w/ allopurinol or procainamide; mTOR inhibitors eg, sirolimus, everolimus, temsirolimus; NEP inhibitors eg, racecadotril; 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. May affect ability to drive & use machines. Not suitable in patients w/ 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.

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.

Increased antihypertensive effect w/ baclofen. Increased hypotensive effects w/ antihypertensive agents (eg, β-blockers), vasodilators. 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, AIIAs, NSAIDs, heparins, immunosuppressants (eg, ciclosporin, tacrolimus), trimethoprim, co-trimoxazole. Increased risk of hyperkalaemia, 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, ASA, COX-2 inhibitors, non-selective NSAIDs. Reduced antihypertensive effects w/ sympathomimetics, corticosteroids, tetracosactide. Nitritoid reactions w/ injectable gold (Na aurothiomalate). Risk of hyperkalaemia w/ dantrolene infusion. Varied conc w/ strong CYP3A4 inducers eg, rifampicin, Hypericum perforatum. Increased amlodipine exposure 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 effects to other antihypertensives. Increased tacrolimus blood levels. Increased exposure of mTOR inhibitors. Increased exposure to simvastatin. Increased bioavailability 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.

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