Triplixam

Triplixam

Manufacturer:

Servier

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
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
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.
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. Concomitant use w/ 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. 10 mg/2.5 mg/5 mg & 10 mg/2.5 mg/10 mg: Moderate renal impairment (CrCl <60 mL/min).
Special Precautions
Hypersensitivity/angioedema; anaphylactoid reactions during desensitization & LDL apheresis. 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), 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. Dry cough. Black patients. Haemodialysis patients. Photosensitivity. Regular monitoring of plasma electrolytes & K levels. 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. May affect ability to drive & use machines. Mild to moderate hepatic impairment. Preexisting renal impairment; hepatic encephalopathy. Not recommended during 1st trimester of pregnancy. Not to be used during lactation. Childn & adolescents. Elderly.
Adverse Reactions
Dizziness, headache, paraesthesia, somnolence, dysgeusia; visual impairment, diplopia; tinnitus, vertigo; palpitations; flushing, hypotension; cough, dyspnoea; GI disorders; pruritus, rash, maculopapular rash; muscle spasms, ankle swelling; asthenia, oedema, fatigue.
Drug Interactions
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, 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 antihypertensive effects w/ baclofen. Attenuated antihypertensive effects w/ NSAIDs eg, acetylsalicylic acid, 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/ angiotensin-receptor blocker. 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. Significant increased amlodipine exposure w/ CYP3A4 inhibitors eg, PIs, azole, antifungals, macrolides (eg, erythromycin or clarithromycin, verapamil, diltiazem). Increased risk of hypotension w/ clarithromycin. Varied amlodipine conc w/ strong CYP3A4 inducers eg, rifampicin, Hypericum perforatum. Risk of hypokalaemia w/ Torsade de pointes-inducing drugs. Favoured toxic effects of cardiac glucosides. 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.
MIMS Class
ACE Inhibitors/Direct Renin Inhibitors / Calcium Antagonists / Diuretics
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 10 mg/2.5 mg/10 mg FC tab
Packing/Price
30's
Form
Triplixam 10 mg/2.5 mg/5 mg FC tab
Packing/Price
30's
Form
Triplixam 5 mg/1.25 mg/10 mg FC tab
Packing/Price
30's
Form
Triplixam 5 mg/1.25 mg/5 mg FC tab
Packing/Price
30's
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