Coveram

Per 5 mg/5 mg tab Perindopril arginine 5 mg, amlodipine besilate 5 mg. Per 5 mg/10 mg tab Perindopril arginine 5 mg, amlodipine besilate 10 mg. Per 10 mg/5 mg tab Perindopril arginine 10 mg, amlodipine besilate 5 mg. Per 10 mg/10 mg tab Perindopril arginine 10 mg, amlodipine besilate 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/once daily preferably in the morning.

Should be taken on an empty stomach: Preferably taken in the morning. Avoid grapefruit & grapefruit juice.

Hypersensitivity to perindopril arginine, amlodipine besilate, other ACE inhibitors, or dihydropyridine derivatives. Perindopril: History of angioedema associated w/ previous ACE inhibitor therapy. Hereditary or idiopathic angioedema. 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). Concomitant use w/ sacubitril/valsartan therapy. Pregnancy (2nd & 3rd trimester). Amlodipine: Severe hypotension. Shock, including cardiogenic shock. Obstruction of the outflow-tract of the left ventricle (eg, high-grade aortic stenosis). Hemodynamically unstable heart failure after acute MI.

Fixed dose combination is not suitable for initial therapy. Not recommended in concomitant use w/ lithium, K-sparing drugs, K-supplements or dantrolene. Galactose intolerance, glucose-galactose malabsorption, or total lactase deficiency. Not recommended during pregnancy (1st trimester) & lactation. Not to be used in childn & adolescents. Perindopril: Hypersensitivity/angioedema. Temporarily w/hold therapy to avoid anaphylactoid reactions during LDL apheresis w/ dextran sulphate & desensitization treatment (eg, hymenoptera venom). Neutropenia, agranulocytosis, thrombocytopenia & anemia. Periodic monitoring of WBC counts & check for signs of infection (eg, sore throat, fever) in patients w/ collagen vascular disease, immunosuppressant therapy, treatment w/ allopurinol or procainamide, or combination of these complicating factors, especially if there is preexisting impaired renal function. Dual blockade of renin-angiotensin-aldosterone system through combination w/ ARBs or aliskiren is not recommended. Patients w/ bilateral renal artery or stenosis of the artery to a single functioning kidney; mitral valve stenosis & left ventricle outflow obstruction eg, aortic stenosis or hypertrophic cardiomyopathy. Not recommended in patients w/ primary aldosteronism. Discontinue if jaundice or marked elevations of hepatic enzymes develop; 1 day prior to surgery. Higher rate of angioedema in Black patients. Non-productive & persistent cough. Hyperkalemia. Closely monitor BP, renal function & serum K in patients at high risk of symptomatic hypotension & those w/ ischemic heart or cerebrovascular disease in whom an excessive fall in BP results in MI or CVA; glycemic control in diabetic patients treated w/ oral antidiabetic agents or insulin during the 1st mth of treatment. Must not be initiated until 36 hr after the last dose of sacubitril/valsartan. Concomitant use w/ NEP inhibitors (eg, racecadotril) & mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus). Amlodipine: Hypertensive crisis. Severe heart failure (NYHA class II & IV); CHF. Slow dose titration & careful monitoring in patients w/ severe hepatic impairment. Not dialyzable. Minor or moderate influence on the ability to drive & use machines. 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: Somnolence; diplopia; palpitations; flushing; change of bowel habit; joint swelling (ankle swelling); fatigue.

Increased antihypertensive effect w/ baclofen. Increased risk of angioedema w/ sacubitril/valsartan. May increase risk of angioedema w/ racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus) & gliptins (eg, linagliptin, saxagliptin, sitagliptin, vidagliptin). 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: Increased risk of hyperkalemia w/ aliskiren, K salts, K-sparing diuretics (eg, triamterene, amiloride, eplerenone, spironolactone), ACE inhibitors, AIIAs, NSAIDs, heparins, immunosuppressant agents (eg, ciclosporin or tacrolimus), trimethoprim & fixed dose combination w/ sulfamethoxazole (co-trimoxazole). 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 angioedema w/ estramustine. Reversible increases in serum lithium conc & toxicity (severe neurotoxicity). Increased blood-glucose lowering effect w/ risk of hypoglycemia w/ antidiabetic medicines (insulins, oral hypoglycemic agents). Excessive reduction in BP w/ non-K-sparing diuretics. Attenuated antihypertensive effect w/ NSAIDs (ie, aspirin ≥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/ 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

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.

Rx