Bioprexum Plus

Perindopril arginine 5 mg, indapamide 1.25 mg

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

1 tab daily preferably in the morning.

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

Hypersensitivity to perindopril & indapamide, any other ACE inhibitor, any other sulphonamides. History of angioedema (Quincke’s edema) 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). Concomitant use w/ 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. Severe renal impairment. Hepatic encephalopathy. Severe hepatic impairment. Hypokalemia. Combination w/ non-antiarrhythmic agents causing TDP. Due to the lack of sufficient therapeutic experience, should not be used in dialysis patients & patients w/ untreated decompensated heart failure. 2nd & 3rd trimesters of pregnancy. Lactation.

Lithium, K-sparing diuretics, K supplements & K-containing salt substitutes; dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE-inhibitors, ARB or Aliskiren: Not recommended due to increased risk of hypotension, hyperkalaemia & decreased renal function (including acute renal failure). Not to be used in patients w/ diabetic nephropathy when associated w/ ARB. Patients w/ collagen vascular disease, immunosuppressant therapy, treated w/ allopurinol or procainamide. Periodic monitoring of white blood cell counts advised. Increased risk of hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Diuretics may be a contributory factor. Loss of renal function may occur in patients w/ unilateral renal artery stenosis. Stop treatment & monitor until complete resolution of symptoms in case of hypersensitivity/angioedema, intestinal angioedema. Angioedema associated w/ laryngeal oedema may be fatal. Combination w/ sacubitril/valsartan (contraindicated due to the increased risk of angioedema). Sacubitril/valsartan must not be initiated until 36 hr after taking the last dose of perindopril therapy. Perindopril therapy must not be started until 36 hr after the last dose of sacubitril/valsartan. Concomitant use of ACE inhibitors w/ NEP inhibitors (eg, racecadotril), mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus) & gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin) may lead to an increased risk of angioedema. Caution when starting racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus) & gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin) in a patient already taking an ACE inhibitor. Isolated life-threatening anaphylactoid reactions during desensitisation treatment w/ hymenoptera (eg, bees, wasps) venom. Allergic patients treated w/ desensitisation & avoid in those undergoing venom immunotherapy. Temporarily w/draw ACE inhibitor for at least 24 hr before desensitisation. Temporarily w/hold treatment prior to each apheresis. Consider use of a different type of membrane or a different class of antihypertensive agent during dialysis w/ high-flux membranes. Not recommended in patients w/ primary hyperaldosteronism (not responding to drugs acting through inhibition of the renin-angiotensin system). Stop treatment in case of hepatic encephalopathy which can progress to hepatic coma; photosensitivity. Concomitant use w/ sultopride. Stop treatment in case of functional renal insufficiency w/o pre-existing apparent renal lesions & possibly restart at a low dose or w/ 1 constituent only. Monitor K & creatinine, after 2 wk of treatment & then every 2 mth during therapeutic stability period. Not recommended for bilateral renal artery stenosis or a single functioning kidney. Sudden hypotension if pre-existing Na depletion (in particular if renal artery stenosis): re-establish blood vol & pressure, restart treatment at a reduced dose or w/ only 1 of the constituents. Regularly monitor K levels. Not to be administerd in patients w/ hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Dry cough. Risk of arterial hypotension, &/or renal insufficiency in the case of water & electrolyte depletions in patients w/ low BP, renal artery stenosis, CHF or cirrhosis w/ edema & ascites. Start treatment at low dose in patients w/ ischemic heart disease or cerebral circulatory insufficiency. Start treatment at hospital; monitor renal function & K in patients w/ renovascular HTN. Reduce initial dose in patients w/ severe cardiac insufficiency (grade IV). Anaemia. Monitor blood glucose in case of hypokalemia in diabetic patients. In Black patients, have higher incidence of angioedema & less effective in lowering BP than in non-Blacks. Stop treatment 1 day before surgery. Use w/ caution if obstruction in the outflow tract of the left ventricle. Stop treatment if jaundice or marked elevations of hepatic enzymes. Frequent monitoring of blood K if renal insufficiency; worsening of renal function, age (>70 yr). Treatment should be started under medical supervision w/ a reduced initial dose in DM. Dehydration; acute cardiac decompensation; metabolic acidosis; & concomitant use of K-sparing diuretics, K supplements, K-containing salt substitutes & especially aldosterone antagonists or angiotensin-receptor blockers. Can cause serious, sometimes fatal arrhythmias. Test Na level before treatment; more frequent monitoring in elderly & cirrhotic patients, hyponatraemia w/ hypovolaemia may be responsible of dehydration & orthostatic hypotension. Concomitant loss of Cl ions may lead to secondary compensatory metabolic alkalosis. High risk of hypokalemia for elderly &/or malnourished subjects, cirrhotic patients w/ edema & ascites, coronary & heart failure patients, long QT interval; more frequent monitoring necessary in all cases; may cause muscle disorders & rhabdomyolysis; may favor the onset of Torsades de pointes, which may be fatal. Stop treatment in case of hypercalcemia before investigating parathyroid function. Increased tendency to gout attacks. Functional renal insufficiency: Treatment should be stopped & possibly restarted at a low dose or w/ 1 constituent only; frequent monitoring of potassium & creatinine. May cause positive doping test in athletes. Discontinue drug intake as rapidly as possible in case of choroidal effusion, acute myopia & secondary angle-closure glaucoma. Prompt medical or surgical treatments may need to be considered if IOP remains uncontrolled. Stop treatment during pregnancy. Childn & adolescents. Elderly.

Hypersensitivity reactions, dizziness, headache, paraesthesia, dysgeusia, visual impairment, vertigo, tinnitus, hypotension, cough, dypnoea, abdominal pain, constipation, diarrhoea, dyspepsia, nausea, vomiting, pruritus, rash, rash maculo-papular, muscle spasms, asthenia. Eosinophilia, hypoglycaemia, hyperkalaemia, hyponatremia, altered mood, sleep disorder, somnolence, syncope, palpitations, tachycardia, vasculitis, bronchospasm, dry mouth, urticaria, angioedema, purpura, hyperhidrosis, photosensitivity reaction, pemphigoid, arthralgia, myalgia, renal insufficiency, erectile dysfunction, chest pain, malaise, peripheral oedema, pyrexia, increased blood urea & creatinine, fall. Psoriasis aggravation, fatigue, increased blood bilirubin & hepatic enzyme. Rhinitis, agranulocytosis, aplastic anaemia, pancytopenia, leukopenia, neutropenia, haemolytic anaemia, thrombocytopenia, hypercalcaemia, confusion, stroke possibly secondary to excessive hypotension in high-risk patients, arrhythmia (including bradycardia, ventricular tachycardia, atrial fibrillation), angina pectoris & MI (secondary to hypotension in high-risk patients), eosinophilic pneumonia, pancreatitis, hepatitis, abnormal hepatic function, erythema multiforme, TEN, SJS, acute renal failure, decreased Hb & haematocrit. K depletion w/ hypokalemia particularly serious in certain high-risk populations, hepatic encephalopathy (in the case of hepatic insufficiency), myopia, blurred vision, Torsades de pointes (potentially fatal), possible worsening of pre-existing acute disseminated lupus erythematosus, increased blood glucose & blood uric acid, prolonged ECG QT, Raynaud’s phenomenon. Syndrome of inappropriate antidiuretic hormone secretion (SIADH) can be considered as a very rare complication associated w/ ACE inhibitor therapy.

Contraindicated: Aliskiren (in diabetic or impaired renal patients), extracorporeal treatments, sacubitril/valsartan. Not recommended: Aliskiren (in other patients), lithium, K-sparing diuretics, concomitant therapy w/ ACE inhibitor & ARB, estramustine, co-trimoxazole, K salts, sultopride. Special care: Baclofen, NSAID (including ASA ≥3 g daily), antidiabetic agents, Torsades de pointes−inducing drugs, K-lowering drugs, non-K-sparing diuretics, K-sparing diuretics, digitalis prep, racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus), allopurinol. Some care: Imipramine-like antidepressants (tricyclics), neuroleptics, antihypertensive agents & vasodilatators, heparins, allopurinol, cytostatic or immunosuppressive agents, systemic corticosteroids or procainamide, anesth drugs, gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin), sympathomimetics, gold, K-sparing diuretics, metformin, iodinated contrast media, Ca (salts), ciclosporin, tacrolimus, tetracosactide.

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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