Triplixam

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

1 tab daily as single dose.

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

Hypersensitivity to perindopril, indapamide, amlodipine, other sulfonamides, dihydropyridine derivatives, any other ACE inhibitor. Patients w/ untreated decompensated heart failure; history of angioedema (Quincke's oedema) associated w/ previous ACE inhibitor therapy; hereditary/idiopathic angioedema; hypokalaemia; severe hypotension; shock including cardiogenic shock; left ventricle outflow tract obstruction eg, high grade aortic stenosis; haemodynamically unstable heart failure after acute MI. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²); sacubitril/valsartan; extracorporeal treatments. Significant bilateral renal artery stenosis or artery stenosis to single functioning kidney. Dialysis patients; hepatic encephalopathy. Moderate (CrCl <60 mL/min) & severe (CrCl <30 mL/min) renal impairment. Severe hepatic impairment. 2nd & 3rd trimester pregnancy. Lactation.

Hypersensitivity/angioedema; anaphylactoid reactions during desensitization & LDL apheresis. Angioedema associated w/ laryngeal oedema; history of angioedema; intestinal angioedema. Discontinue use if photosensitivity, hepatic encephalopathy occur; if jaundice develops or in marked elevations of hepatic enzymes. Not suitable for initial therapy. Not recommended in primary aldosteronism; bilateral renal artery stenosis or single functioning kidney. Patient w/ severe heart failure (NYHA class III & IV), severe cardiac insufficiency (grade IV); left ventricle outflow tract obstruction; collagen vascular disease, immunosuppressant therapy; CHF or cirrhosis w/ oedema & ascites; ischaemic heart disease or cerebral circulatory insufficiency; hypertensive crisis; aortic or mitral valve stenosis/hypertrophic cardiomyopathy; DM; renovascular HTN; undiagnosed hyperparathyroidism, hyperuricaemic patients; hypovolaemia; dry cough. Black patients. Monitor plasma electrolytes & K levels, blood glucose regularly. Discontinue use 1 day prior to surgery. Not to be initiated w/ sacubitril/valsartan until 36 hr after taking last dose of perindopril therapy. Not recommended in combination w/ lithium, K-sparing diuretics, K supplements or K-containing salt substitutes. Concomitant use w/ ACE ihibitors, ARBs, aliskerin; immunosuppresant therapy; allopurinol or procainamide; mTOR inhibitors eg, sirolimus, everolimus, temsirolimus; other NEP inhibitors eg, racecadotril. May affect ability to drive & use machines. Mild to moderate hepatic impairment. Pre-existing renal impairment; haemodialysis patients. Not recommended during 1st trimester of pregnancy & lactation. Childn & adolescents. Elderly.

Oedema. Dizziness, headache, paraesthesia, somnolence, dysgeusia; visual impairment, diplopia; tinnitus, vertigo; palpitations; flushing, hypotension; cough, dyspnoea; abdominal pain, constipation, diarrhoea, dyspepsia, nausea, vomiting, change of bowel habits; pruritus, rash, maculopapular rash; muscle spasms, ankle swelling; asthenia, fatigue.

Increased risk of hyperkalaemia w/ aliskiren, K-salts, K-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs, heparins, immunosuppressants, trimethoprim, co-trimoxazole. Increased risk of worsened renal function & CV morbidity & mortality w/ aliskiren. Increased risk of severe anaphylactoid reactions w/ extracorporeal treatments. Increased risk of angioedema w/ sacubitril/valsartan, estramustine, racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus), gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin). Reversible increased lithium serum conc & toxicity. Higher frequency of hypotension, syncope, hyperkalaemia & worsened renal function w/ ACE inhibitor & angiotensin-receptor blocker. Lethal ventricular fibrillation & CV collapse w/ verapamil & dantrolene IV. Increased bioavailability w/ grapefruit or grapefruit juice. Increased antihypertensive effect w/ baclofen. Attenuated antihypertensive effects, increased risk of worsening of renal function & increased serum K w/ NSAIDs eg, ASA, COX-2 inhibitors & non-selective NSAIDs. Increased blood-glucose lowering effects w/ antidiabetics eg, insulin, oral hypoglycemics. Hypotensive effects w/ non-K-sparing diuretics. Risk of hypokalaemia w/ Torsade de pointes-inducing drugs. Additive effect w/ IV amphotericin B, systemic gluco- & mineralocorticoids, tetracosactide, stimulant laxatives. Favoured toxic effects of cardiac glucosides w/ low K levels. Increased hypersensitivity reactions to allopurinol. Significant increased amlodipine exposure w/ CYP3A4 inhibitors eg, PIs, azole antifungals, macrolides eg, erythromycin or clarithromycin, verapamil, diltiazem. Increased risk of hypotension w/ clarithromycin. Increased antihypertensive effect & risk of orthostatic hypotension w/ imipramine-like antidepressants eg, TCAs, neuroleptics. Additive BP-lowering effect w/ other antihypertensives. Reduced antihypertensive effect w/ corticosteroids, tetracosactide; sympathomimetics. Reduced BP w/ nitroglycerin & other nitrates or vasodilators. Increased risk of leucopenia w/ allopurinol, cytostatic or immunosuppressive agents, systemic corticosteroids or procainamide. Enhanced hypotensive effects of anaesth. Vol depletion & risk of hypotension w/ thiazide or loop diuretics. Nitritoid reactions w/ injectable gold (Na aurothiomalate). Lactic acidosis w/ metformin. Increased risk of acute renal insufficiency w/ high-dose iodinated contrast media. Increased levels of Ca. Increased creatinine level w/ ciclosporine. Increased tacrolimus blood levels. Increased exposure of mTOR inhibitors. Increased exposure to simvastatin.

ACE Inhibitors/Direct Renin Inhibitors

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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