Triplixam

Per 5/1.25/5 mg FC tab Perindopril arginine 5 mg, indapamide 1.25 mg, amlodipine 5 mg. Per 5/1.25/10 mg FC tab Perindopril arginine 5 mg, indapamide 1.25 mg, amlodipine 10 mg

Substitution therapy for treatment of essential HTN, in patients already controlled w/ perindopril/indapamide fixed dose combination & amlodipine, taken at the same dose level.

1 tab once daily.

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

Hypersensitivity to perindopril arginine, indapamide & amlodipine; other sulfonamides, dihydropyridine derivatives, or any other ACE-inhibitors. Dialysis patients. Patients w/ untreated decompensated heart failure. History of angioedema (Quincke's oedema) associated w/ previous ACE inhibitor therapy. Hereditary/idiopathic angioedema. Hepatic encephalopathy. Hypokalaemia. Severe hypotension. Shock, including cardiogenic shock. Obstruction of the outflow-tract of the left ventricle (eg, high grade aortic stenosis). Haemodynamically unstable heart failure after acute MI. 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); sacubitril/valsartan. Severe renal impairment (CrCl <30 mL/min). Severe hepatic impairment. 2nd & 3rd trimesters of pregnancy. Lactation.

Risk of sudden hypotension in the presence of pre-existing Na depletion. Perform regular monitoring of plasma electrolytes (eg, Na, K). Patients w/ ischaemic heart disease or cerebral circulatory insufficiency. Increased tendency of gout attacks in hyperuricaemic patients. Combination of lithium & combination of perindopril/indapamide is not recommended. Renal impairment. Mild to moderate hepatic impairment. Not recommended during 1st trimester of pregnancy. Paed population. Elderly. Perindopril: Dual blockade of the renin-angiotensin-aldosterone system (RAAS) though combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren. Risk of neutropenia/agranulocytosis, thrombocytopenia & anaemia; hypotension & renal insufficiency in patients w/ initially low BP, in cases of renal artery stenosis, CHF or cirrhosis w/ oedema & ascites; angioedema; dry cough. Anaphylactoid reactions during desensitization treatment w/ hymenoptera (bees, wasps) venom; LDL-apheresis w/ dextran sulphate; haemodialysis using high-flux membranes (eg, AN 69). Stop treatment 1 day before surgery. Not recommended in patients w/ primary aldosteronism. Patients w/ obstruction in the outflow tract of the left ventricle; insulin-dependent DM. Reduced efficacy in Black patients. Not recommended w/ concomitant use of K-sparing drugs, K supplements or K-containing salt substitutes. Indapamide: Hepatic encephalopathy in patients w/ liver impairment. Cases of photosensitivity reactions. Possible increase in blood urea & creatinine levels due to reduced glomerular filtration caused by hypovolaemia. May reduce urinary excretion of Ca & cause mild & transient increase in plasma Ca levels. Amlodipine: Patients w/ hypertensive crisis; cardiac failure/severe cardiac insufficiency. Minor or moderate influence on the ability to drive & use machines.

Dizziness, headache, paraesthesia, somnolence, dysgeusia; visual impairment, diplopia; tinnitus, vertigo; palpitations; flushing, hypotension (& effects related to hypotension); cough, dyspnoea; GI disorders (eg, abdominal pain, constipation, diarrhoea, dyspepsia, nausea, vomiting, change of bowel habit); pruritus, rash, rash maculo-papular; muscle spasms, ankle swelling; asthenia, oedema, fatigue.

Higher frequency of adverse events w/ combined use of ACE inhibitors, AIIA, or aliskiren. Increased risk of hyperkalaemia w/ aliskiren, K salts, K-sparing diuretics, ACE inhibitors, AIIA, NSAIDs, heparins, immunosuppressant agents eg, ciclosporine or tacrolimus, trimethoprim. Increased risk of hyperkalaemia, worsening of renal function & CV morbidity & mortality w/ aliskiren in diabetic or impaired renal patients. Increased risk of angioedema w/ sacubitril/valsartan. Increased antihypertensive effect w/ imipramine-like antidepressants, neuroleptics; other antihypertensive agents. Reduced antihypertensive effect w/ corticosteroids, tetracosactide. Perindopril/indapamide: Increased serum conc & toxicity of lithium. Increased antihypertensive effect w/ baclofen. Attenuation of antihypertensive effect w/ NSAIDs. Perindopril: Increased risk of angioedema w/ estramustine; racecadotril; mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus); gliptins. Increased risk of hyperkalaemia w/ co-trimoxazole. Increased blood-glucose lowering effect of antidiabetic agents. Further reduction in BP w/ non-K-sparing diuretics; nitroglycerin & other nitrates, other vasodilators. Increased risk of leucopenia w/ allopurinol, cytostatic or immunosuppressive agents, systemic corticosteroids or procainamide. Enhanced hypotensive effects of certain anaesthetic drugs. Vol depletion & risk of hypotension w/ prior treatment w/ high dose diuretics. Reduced antihypertensive effects w/ sympathomimetics. Nitritoid reactions w/ injectable gold (Na aurothiomalate). Indapamide: Risk of hypokalaemia w/ Torsades de pointes-inducing drugs; amphotericin B (IV), glucocorticoids & mineralocorticoids (systemic), tetracosactide, stimulant laxatives. Cardiac glycoside-toxicity due to low K levels. Increased incidence of hypersensitivity reactions to allopurinol. Lactic acidosis due to metformin caused by possible functional renal insufficiency linked to loop diuretics. Increased risk of acute renal insufficiency w/ high doses of iodinated contrast media. Risk of increased levels of Ca. Risk of increased creatinine levels w/ ciclosporine. Amlodipine: Risk of hyperkalaemia-associated lethal ventricular fibrillation & CV collapse w/ IV dantrolene. Increased bioavailability w/ grapefruit or grapefruit juice. Possible lower plasma conc w/ CYP3A4 inducers. Possible increase in exposure w/ CYP3A4 inhibitors. Increased risk of hypotension w/ clarithromycin. Risk of increased blood levels of tacrolimus. May increase exposure of mTOR inhibitors (eg, sirolimus, temsirolimus, everolimus). Increased exposure of simvastatin. Possible trough conc increases of ciclosporine in renal transplant patients.

ACE Inhibitors/Direct Renin Inhibitors / Calcium Antagonists / Diuretics

C09BX01 - perindopril, amlodipine and indapamide ; Belongs to the class of ACE inhibitors and other combinations. Used in the treatment of cardiovascular disease.

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