Triplixam

Triplixam

Manufacturer:

Servier

Distributor:

DKSH
Concise Prescribing Info
Contents
Perindopril arginine 5 mg, indapamide 1.25 mg, amlodipine besilate 5 mg
Indications/Uses
Substitution therapy for essential HTN in patients already controlled w/ perindopril/indapamide fixed-dose combination & amlodipine taken at same dose level.
Dosage/Direction for Use
Administration
Should be taken on an empty stomach: Preferably taken in the morning & before meal.
Contraindications
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; high grade aortic stenosis; haemodynamically unstable heart failure after acute MI. Significant bilateral renal artery stenosis or artery stenosis to single functioning kidney. Concomitant use w/ sacubitril/valsartan; extracorporeal treatments; aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Dialysis patients; hepatic encephalopathy. Severe renal (CrCl <30 mL/min) & hepatic impairment. 2nd & 3rd trimester pregnancy. Lactation.
Special Precautions
Anaphylactoid reactions during desensitization & LDL apheresis. History of angioedema. Discontinue use if photosensitivity, hepatic encephalopathy, hypertensive patients w/o preexisting apparent renal lesions occur. Not recommended for primary hyperaldosteronism; bilateral renal artery stenosis or artery stenosis to single functioning kidney. Should not be used concomitantly in patients w/ diabetic nephropathy. 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; IDDM. Renovascular HTN; undiagnosed hyperparathyroidism, hyperuricaemic patients. Dry cough. Black patients. Haemodialysis patients. Regular monitoring of plasma electrolytes, K levels, WBC counts & glucose levels. Discontinue use 1 day prior to surgery. Not to be initiated until 36 hr after sacubitril/valsartan last dose. Concomitant use w/ ACE inhibitors, angiotensin II receptor blockers, or aliskiren; lithium, K-sparing diuretics, K supplements or K-containing salt substitutes; allopurinol or procainamide; mechanistic target of rapamycin (mTOR) inhibitors eg, sirolimus, everolimus, temsirolimus; other NEP inhibitors eg, racecadotril. May impair ability to drive or operate machinery. Mild to moderate hepatic impairment. Preexisting renal impairment. Not recommended during 1st trimester of pregnancy. Childn & adolescents. Elderly.
Adverse Reactions
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, oedema.
Drug Interactions
Increased risk of hyperkalaemia w/ aliskiren, K-salts, K-sparing diuretics (eg, eplerenone, spironolactone), ACE inhibitors, AIIA, NSAIDs, heparins, immunosuppressants eg, ciclosporine or tacrolimus, trimethoprim, co-trimoxazole. 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. Increased risk of leucopenia w/ allopurinol, cytostatic or immunosuppressive agents, systemic corticosteroids or procainamide. Increased antihypertensive effect & risk of orthostatic hypotension w/ imipramine-like antidepressants eg, TCAs, neuroleptics. Additive effect w/ IV amphotericin B, gluco- & mineralocorticoids (systemic route), tetracosactide, stimulant laxatives. Additive BP-lowering effect w/ other antihypertensives. Reduced antihypertensive effect w/ corticosteroids, tetracosactide; sympathomimetics. Reversible increased in serum conc & toxicity of lithium. Increased risk of worsened renal function & CV morbidity & mortality w/ aliskiren. Higher frequency of hypotension, syncope, hyperkalaemia & worsened renal function w/ angiotensin-receptor blocker. Additive hyperkalaemic effect w/ K-sparing drugs eg, triamterene, amiloride; K-salts. Increased antihypertensive effects w/ baclofen. Attenuated antihypertensive effects w/ NSAIDs eg, acetylsalicylic acid, COX-2 inhibitors & non-selective NSAIDs. Increased risk of acute renal failure w/ NSAIDs. Increased blood-glucose lowering effects w/ risk of hypoglycaemia w/ antidiabetics eg, insulin, oral hypoglycemics. Reduced hypotensive effects w/ non-K-sparing diuretics. Reduced BP w/ nitroglycerin & other nitrates or vasodilators. Lethal ventricular fibrillation & CV collapse w/ verapamil & dantrolene infusion. Increased bioavailability w/ grapefruit or grapefruit juice. Risk of hypokalaemia w/ Torsade de pointes-inducing drugs. Favoured toxic effects of cardiac glucosides w/ low K levels. Significant increased exposure w/ CYP3A4 inhibitors eg, PIs, azole antifungals, macrolides (eg, erythromycin or clarithromycin), verapamil, diltiazem. Increased risk of hypotension w/ clarithromycin. Enhanced hypotensive effects of anaesth. Vol depletion & risk of hypotension w/ thiazide or loop diuretics. Nitritoid reactions w/ injectable gold (Na aurothiomalate). Lactic acidosis may occur w/ metformin. Increased risk of acute renal insufficiency w/ high-dose iodinated contrast media. May increase levels of Ca. Increased creatinine level w/ ciclosporine. May increase blood levels of tacrolimus. May increase exposure of mTOR inhibitors & simvastatin.
ATC Classification
C09BX01 - perindopril, amlodipine and indapamide ; Belongs to the class of ACE inhibitors and other combinations. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Triplixam 5 mg/1.25 mg/5 mg FC tab
Packing/Price
30's
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