Bioprexum Plus

Essential HTN in adults whose BP is not adequately controlled on perindopril alone.

1 tab daily as a single dose.

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

Hypersensitivity to perindopril, indapamide, any other ACE inhibitors or sulphonamides. Should not be used in dialysis patients; patients w/ untreated decompensated heart failure. Perindopril: History of angioedema (Quincke's oedema) associated w/ previous ACE inhibitor therapy; hereditary/idiopathic angioedema. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²); sacubitril/valsartan. Extracorporeal treatments leading to contact of blood w/ -ve charged surfaces. Significant bilateral renal artery stenosis or artery stenosis to single functioning kidney. 2nd & 3rd trimesters of pregnancy. Indapamide: Hepatic encephalopathy; hypokalaemia. Severe renal impairment (CrCl <30 mL/min). Severe hepatic impairment.

Concomitant use w/ lithium is not recommended. Not recommended in case of bilateral renal artery stenosis or a single functioning kidney; monitor K & creatinine after 2 wk of treatment & then every 2 mth during therapeutic stability period. Risk of sudden hypotension in the presence of pre-existing Na depletion. Regularly monitor plasma electrolytes & serum K. Does not prevent the onset of hypokalaemia in diabetics or those w/ renal failure. Not to be administered to patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. May impair ability to drive or operate machinery. Not recommended during 1st trimester of pregnancy & lactation. Perindopril: Dual blockade of the renin-angiotensin-aldosterone system through combined use of ACE inhibitors, ARBs or aliskiren. Not recommended w/ concomitant use of K-sparing drugs, K supplements or K-containing salt substitutes. Reports of neutropenia/agranulocytosis, thrombocytopenia & anaemia; hypersensitivity/angioedema; dry cough. Patients w/ collagen vascular disease, immunosuppressant therapy, treatment w/ allopurinol or procainamide, or in combination of these complicating factors, especially if there is preexisting impaired renal function. Periodic monitoring of WBC count. Increased risk of hypotension & renal insufficiency in patient w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. May be less effective in lowering BP in Black patients. Higher incidence of angioedema in Black patients. Sacubitril/valsartan must not be initiated until 36 hr after taking the last dose of perindopril therapy. Concomitant use w/ NEP inhibitors (eg, racecadotril), mTOR inhibitors (eg, sirolimus, everolimus, temsilrolimus) & gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin). Anaphylactoid reactions during dialysis w/ high-flux membranes, LDL apheresis w/ dextran sulphate or desensitisation. Not recommended in primary aldosteronism. Risk of arterial hypotension &/or renal insufficiency in cases of cardiac insufficiency, water & electrolyte depletion, initially low BP, renal artery stenosis, CHF or cirrhosis w/ oedema & ascites. Patients w/ ischaemic heart disease or cerebral circulatory insufficiency; cardiac failure/severe cardiac insufficiency; obstruction in the outflow tract of the left ventricle. Discontinue use 1 day prior to surgery. Monitor glycaemic control during the 1st mth of treatment in diabetic patients treated w/ oral antidiabetics or insulin. Discontinue treatment if jaundice or marked elevations of hepatic enzymes develops. Risk factors for hyperkalaemia. Childn & adolescents. Elderly. Indapamide: Discontinue in cases of hepatic encephalopathy; photosensitivity reaction. Hyponatremia w/ hypovolemia. K depletion w/ hypokalemia. May reduce urinary excretion of Ca & cause a mild & transient increase in plasma Ca levels. Monitor blood glucose in diabetic patients. Increased tendency to gout attacks in hyperuricemic patients. Blood urea & creatinine levels may be increased due to reduced glomerular filtration caused by hypovolaemia secondary to loss of water & Na. May cause +ve reaction in doping tests. Choroidal effusion; acute myopia & secondary angle-closure glaucoma.

Perindopril: Dizziness, headache, paraesthesia, dysgeusia; visual impairment; vertigo, tinnitus; hypotension; cough, dyspnoea; abdominal pain, constipation, diarrhoea, dyspepsia, nausea, vomiting; pruritus, rash; muscle spasms; asthenia. Indapamide: Hypersensitivity reactions; maculopapular rash.

Reversible increased serum conc & toxicity of lithium. Increased antihypertensive effect w/ baclofen. Attenuated antihypertensive effect w/ NSAIDs ie, ASA, COX-2 inhibitors, nonselective NSAIDs. Increased antihypertensive effect & risk of orthostatic hypotension w/ imipramine-like antidepressants (tricyclics), neuroleptics. Perindopril: Higher frequency of adverse events w/ ARBs, aliskiren & estramustine. Increased risk of angioedema w/ racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus), gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin); sacubitril/valsartan. Increased risk of hyperkalaemia w/ aliskiren, K salts, K-sparing diuretics (e.g. spironolactone, triamterene or amiloride), ACE inhibitors, AIIAs, NSAIDs, heparins, immunosuppressants (eg, ciclosporin or 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 angioneurotic oedema w/ estramustine. Additive hyperkalaemic effects w/ K-sparing diuretics, K salts. Increased blood-glucose lowering effect w/ antidiabetics eg, insulins, oral hypoglycaemic agents. Excessive BP reduction w/ non-K-sparing diuretics. Increased hypotensive effects by antihypertensives & vasodilators. Reduced BP w/ nitroglycerin & other nitrates or other vasodilators. Increased risk of leucopenia w/ allopurinol, cytostatic or immunosuppressive agents, systemic corticosteroids or procainamide. Enhanced hypotensive effects of certain anaesth drugs. Reduced antihypertensive effects w/ sympathomimetics. Nitritoid reactions w/ injectable gold (Na aurothiomalate). Indapamide: Risk of hypokalaemia w/ Torsades de pointes-inducing drugs eg, class IA (eg, quinidine, hydroquinidine, disopyramide) & III (amiodarone, dofetilide, ibutilide, bretylium, sotalol) antiarrhythmic agents, phenothiazines (eg, chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine), benzamides (eg, amisulpride, sulpiride, sultopride, tiapride), butyrophenones (eg, droperidol, haloperidol), other antipsychotics (eg, pimozide), others (eg, bepridil, cisapride, diphemanil, IV erythromycin, halofantrine, mizolastine, moxifloxacin, pentamidine, sparfloxacin, IV vincamine, methadone, astemizole, terfenadine). Increased risk of low K levels w/ K-lowering drugs eg, amphotericin B (IV), glucocorticoids & mineralocorticoids (systemic), tetracosactide, stimulant laxatives. Toxic effects due to low K levels may occur w/ digitalis. Increased hypersensitivity reactions to allopurinol. Hypokalaemia or hyperkalaemia w/ K-sparing diuretics eg, amiloride, spironolactone, triamterene. Lactic acidosis due to metformin. Increased risk of acute renal insufficiency w/ high-dose iodinated contrast media. Increased Ca levels w/ Ca salts. Increased creatinine levels w/ ciclosporin, tacrolimus. Reduced antihypertensive effect w/ corticosteroids, tetracosactide (systemic route).

ACE Inhibitors/Direct Renin Inhibitors / Diuretics

C09BA04 - perindopril and diuretics ; Belongs to the class of ACE inhibitors in combination with diuretics. Used in the treatment of cardiovascular disease.

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