Triplixam

Per 5 mg/1.25 mg/5 mg FC tab Perindopril arginine 5 mg, indapamide 1.25 mg, amlodipine 5 mg. Per 5 mg/1.25 mg/10 mg FC tab Perindopril arginine 5 mg, indapamide 1.25 mg, amlodipine 10 mg. Per 10 mg/2.5 mg/5 mg FC tab Perindopril arginine 10 mg, indapamide 2.5 mg, amlodipine 5 mg. Per 10 mg/2.5 mg/10 mg FC tab Perindopril arginine 10 mg, indapamide 2.5 mg, amlodipine 10 mg

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 a 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; cardiogenic shock; left ventricle outflow tract obstruction eg, high grade aortic stenosis; haemodynamically unstable heart failure after acute MI. Significant bilateral renal artery stenosis or artery stenosis to single functioning kidney. Extracorporeal treatments leading to blood contact w/ -ve charged surfaces. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m²); sacubitril/valsartan. Dialysis patients; hepatic encephalopathy. Severe renal (CrCl <30 mL/min) & hepatic impairment. 2nd & 3rd trimesters of pregnancy. 10 mg/2.5 mg/5 mg & 10 mg/2.5 mg/10 mg: Moderate renal impairment (CrCl 30-60 mL/min).

Hypersensitivity/angioedema; anaphylactoid reactions during desensitization & LDL apheresis. History of sulfonamide or penicillin allergy. Discontinue use if hepatic encephalopathy, jaundice or marked elevations of hepatic enzymes; photosensitivity reactions; choroidal effusion w/ visual field defect, transient myopia, acute angle-closure glaucoma occur. Not suitable for initial therapy. Not recommended in dual blockade of renin-angiotensin-aldosterone system; primary aldosteronism; bilateral renal artery stenosis or artery stenosis to single functioning kidney. Not to be used concomitantly in patients w/ diabetic nephropathy. Severe heart failure (NYHA class III & IV) & cardiac insufficiency (grade IV); left ventricular 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; hyperuricaemic patients; hypovolaemia; dry cough. Black patients. Positive reaction in doping tests. Monitor water & electrolytes (plasma Na, K, Ca, Mg) balance, blood glucose regularly; periodically monitor WBC counts during therapy. Discontinue use 1 day prior to surgery. Not to be initiated until 36 hr after sacubitril/valsartan last dose. Not recommended in combination w/ lithium, K-sparing diuretics, K supplements or K-containing salt substitutes. Concomitant use w/ allopurinol or procainamide; mTOR inhibitors eg, sirolimus, everolimus, temsirolimus; other NEP inhibitors eg, racecadotril; gliptins eg, linagliptin, saxagliptin, sitagliptin, vildagliptin. May affect ability to drive & use machines. Mild to moderate hepatic impairment. Preexisting renal impairment; haemodialysis patients. Not recommended during 1st trimester of pregnancy & lactation. Childn & adolescents. Elderly.

Hypokalaemia; dizziness, headache, paraesthesia, somnolence, dysgeusia; visual impairment, diplopia; tinnitus, vertigo; palpitations; flushing, hypotension; cough, dyspnoea; GI disorders eg, abdominal pain, constipation, diarrhoea, dyspepsia, nausea, vomiting, change of bowel habit; pruritus, rash, maculopapular rash; muscle spasms, ankle swelling; asthenia, oedema, fatigue.

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

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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