Bioprexum

Perindopril arginine

HTN. Stable CAD: In patients w/ a history of MI &/or revascularisation. Heart failure (5 mg only): In CHF, as adjunct to diuretic & digitalis. Stroke (5 mg only): Reduction of stroke recurrence in combination w/ indapamide in patient w/ history of cerebrovascular disease.

HTN Starting dose: 5 mg daily, may be increased to 10 mg daily after 1 mth. Starting dose should be 2.5 mg for HTN patient w/ strongly activated RAAS. Use w/ caution for HTN patient concurrently treated w/ diuretic. Elderly Initiate treatment at 2.5 mg daily, may be increased to 5 mg daily after 1 mth & then to 10 mg depending on renal function. Stable CAD 5 mg daily for 2 wk, then increased to 10 mg daily, depending on renal function & if 5 mg is well tolerated. Elderly 2.5 mg daily for 1 wk, then 5 mg daily the next week, before increasing up to 10 mg daily depending on renal function. Heart failure Starting dose is 2.5 mg daily, may be increased to 5 mg daily after 2 wk if tolerated. In severe heart failure & other high risk patients, treatment initiated under careful supervision. Reduction of stroke recurrence Starting dose: 2.5 mg daily for 2 wk, then increased to 5 mg daily for a further 2 wk before introducing indapamide. Renal impairment CrCl ≥60 mL/min 5 mg daily, CrCl 30-60 mL/min 2.5 mg daily, CrCl 15-30 mL/min 2.5 mg every other day, Haemodialysed patients CrCl <15 mL/min 2.5 mg on the day of dialysis. Hepatic impairment No dosage adjustment.

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

Hypersensitivity to perindopril arginine, or to any other ACE inhibitor. History of angioedema associated w/ previous ACE inhibitor therapy, hereditary or idiopathic angioedema. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²); sacubitril/valsartan therapy. 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. 2nd & 3rd trimesters of pregnancy.

Stable CAD: If unstable angina pectoris during 1st month, appraisal of benefit/risk before treatment continuation. Hypotension: Close monitoring at initiation of therapy & dose adjustment in patients at increased risk of symptomatic hypotension (vol depleted, w/ severe renin-dependent HTN or w/ symptomatic or CHF) or w/ ischaemic heart or cerebrovascular disease. A transient hypotensive response is not a contraindication to further doses once the BP has increased after vol expansion. Aortic & mitral valve stenosis/hypertrophic cardiomyopathy: use w/ caution. Anaphylactoid reactions in patients dialysed w/ high flux membranes: Use different type of membrane or different class of antihypertensive agent. Increased renovascular HTN. Hypersensitivity/angioedema/intestinal angioedema: stop treatment & monitor until complete resolution of symptoms. Angioedema associated w/ laryngeal oedema may be fatal. Increased risk of angioedema w/ sacubitril/valsartan; must not be started until 36 hr after the last dose of perindopril. Perindopril therapy must not be started until 36 hr after the last dose of sacubitril/valsartan. May lead to an increased risk of angioedema w/ NEP inhibitors (eg, racecadotril), mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus) & gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin). Caution should be used when starting racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus) & gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin) in a patient already taking an ACE inhibitor. Anaphylactoid reactions during low-density lipoproteins (LDL) apheresis: Temporarily w/hold treatment prior to exams. Anaphylactoid reactions during desensitisation: Temporarily w/hold treatment prior to exams. Stop treatment if jaundice or marked elevations of hepatic enzymes. Neutropenia/agranulocytosis/thrombocytopenia/anaemia: Collagen vascular disease, immunosuppressant therapy, treated w/ allopurinol or procainamide, periodic monitoring of white blood cell counts advised. In Black patients, may be less effective & cause a higher rate of angioedema than in non-Black. Non-productive cough. Stop treatment 1 day prior to surgery. Hyperkalaemia: Frequent monitoring of blood K if renal insufficiency, worsening of renal function, age (>70 yr), DM, dehydration, acute cardiac decompensation, metabolic acidosis & concomitant use of K-sparing diuretics, K supplements or K-containing salt substitutes, heparin, co-trimoxazole & especially aldosterone antagonists or angiotensin-receptor blockers. Monitor glycaemia during 1st month in diabetic patients. Concomitant use of ACE inhibitors, ARBs or aliskiren increases the risk of hypotension, hyperkalaemia & decreased renal function (including acute renal failure). Dual blockade of RAAS is not recommended. ACE inhibitors & ARBs should not be used concomitantly in patients w/ diabetic nephropathy. Not recommended in patients w/ primary hyperaldosteronism (not responding to drugs acting through inhibition of the renin-angiotensin system). Not to be taken in patients w/ galactose intolerance/glucose-galactose malabsorption/total lactase deficiency. Renal impairment: Monitor K & creatinine. In patients w/ renal artery stenosis or renovascular HTN, start treatment w/ low dose, careful titration & close medical supervision. Diuretics may be a contributory factor. Loss of renal function may occur (minor changes in serum creatinine) even in patients w/ unilateral renal artery stenosis. No experience in kidney transplantation. Risk of hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Stop treatment during pregnancy. Not recommended in childn & adolescents.

Dizziness, headache, paraesthesia, vertigo, visual disturbances, tinnitus, hypotension, cough, dyspnoea, abdominal pain, constipation, diarrhoea, dysgeusia, dyspepsia, nausea, vomiting, pruritus, rash, muscle cramps, asthenia. Eosinophilia, hypoglycaemia, hyperkalaemia, hyponatraemia, depression, mood disturbances, sleep disorder, somnolence, syncope, palpitations, tachycardia, vasculitis, bronchospasm, dry mouth, urticaria, angioedema of face, extremities, lips, mucous membranes, tongue, glottis &/or larynx, photosensitivity reactions, pemphigoid, hyperhydrosis, arthralgia, myalgia, renal insufficiency, erectile dysfunction, chest pain, malaise, peripheral oedema, pyrexia, increased blood urea & creatinine, fall. Acute renal failure, anuria/oliguria, flushing, SIADH, psoriasis aggravation, increased blood bilirubin & hepatic enzyme. Agranulocytosis or pancytopenia, decreased Hb & haematocrit, leucopenia/neutropenia, haemolytic anaemia in patients w/ a congenital deficiency of G6PD, thrombocytopenia, confusion, angina pectoris, arrhythmia, MI, stroke, eosinophilic pneumonia, rhinitis, pancreatitis, hepatitis either cytolytic or cholestatic, erythema multiforme. Raynaud’s phenomenon.

Drugs inducing hyperkalaemia: Aliskiren, K salts, K-sparing diuretics, ACE inhibitors, angiotensin-II receptors antagonists, NSAIDs, heparins, immunosuppressant agents eg, ciclosporin or tacrolimus, trimethoprim. Contraindicated: Aliskiren (in diabetic or impaired renal patients), extracorporeal treatments, sacubitril/valsartan. Not recommended: Aliskiren (in other patients), ARB, estramustine, co-trimoxazole, K-sparing diuretics (triamterene, amiloride), K salts, lithium. Special care: Antidiabetic agents (insulins, oral hypoglycaemic agents), baclofen, non-K sparing diuretics, K-sparing diuretics (eplerenone, spironolactone), NSAIDs including acetylsalicylic ≥3 g daily, racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus). Some care: Antihypertensive agents, vasodilators, gliptins (linagliptin, saxagliptin, sitagliptin, vildagliptin), TCAs/antipsychotics/anesth, sympathomimetics, gold.

ACE Inhibitors/Direct Renin Inhibitors

C09AA04 - perindopril ; Belongs to the class of ACE inhibitors. Used in the treatment of cardiovascular disease.

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