Triplixam

Triplixam

Manufacturer:

Servier

Distributor:

Maxxcare
Concise Prescribing Info
Contents
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. Per 10/2.5/5 mg FC tab Perindopril arginine 10 mg, indapamide 2.5 mg, amlodipine 5 mg. Per 10/2.5/10 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 the same dose level.
Dosage/Direction for Use
Administration
Should be taken on an empty stomach: Preferably taken in the morning before a 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; 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. 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. Extracorporeal treatments leading to contact of blood w/ negatively charged surfaces. Dialysis patients. Hepatic encephalopathy. Severe renal (CrCl <30 mL/min) & hepatic impairment. Moderate renal impairment (CrCl 30-60 mL/min) for 10/2.5/5 mg & 10/2.5/10 mg tab. Pregnancy (2nd & 3rd trimester) & lactation.
Special Precautions
Not suitable for initial therapy. Anaphylactoid reactions during desensitization treatment; LDL apheresis w/ dextran sulphate; haemodialysis using high-flux membranes. Discontinue in cases of hypersensitivity/angioedema/intestinal angioedema (monitor until complete resolution of symptoms); jaundice or marked elevations of hepatic enzymes. Dual blockade of renin-angiotensin-aldosterone system is not recommended. Not recommended in patients w/ primary aldosteronism; bilateral renal artery stenosis or stenosis to the artery of a single functioning kidney. Renovascular HTN; hepatic encephalopathy; photosensitivity; dry cough; increased tendency to gout attacks in hyperuricemic patients. Blood urea & creatinine levels may be increased due to reduced glomerular filtration caused by hypovolaemia secondary to loss of water & Na. Risk of sudden hypotension in presence of preexisting Na depletion. Mild & transient increase in plasma Ca levels. Patients w/ collagen vascular disease, on immunosuppressant therapy, treated w/ allopurinol or procainamide (periodically monitor WBC counts); ischaemic heart disease or cerebral circulatory insufficiency; hypertensive crisis; heart failure; obstruction in the outflow tract of the left ventricle; insulin-dependent DM. Black patients. Regular monitoring of plasma electrolytes & K levels. Discontinue use 1 day prior to surgery. Not to be initiated until 36 hr after last dose of sacubitril/valsartan. Not recommended in combination w/ lithium; K-sparing diuretics, K supplements or K-containing salt substitutes. Not to be used concomitantly w/ angiotensin II receptor-blockers in patients w/ diabetic nephropathy. Concomitant use w/ other NEP inhibitors (eg, racecadotril) & ACE inhibitors; mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus) may increase risk of angioedema. May impair ability to drive or operate machinery. Mild to moderate hepatic impairment. Hepatic & renal dysfunction; preexisting renal impairment. Not recommended during 1st trimester of pregnancy. Childn & adolescents. Elderly.
Adverse Reactions
Perindopril & amlodipine: Dizziness, headache; visual impairment; dyspnoea; abdominal pain, constipation, diarrhoea, dyspepsia, nausea; muscle spasms; asthenia. Perindopril: Paraesthesia, dysgeusia; tinnitus, vertigo; hypotension; cough; vomiting; pruritus, rash. Indapamide: Maculo-papular rash. Amlodipine: Oedema. Somnolence; diplopia; palpitations; flushing; change of bowel habit; ankle swelling; fatigue.
Drug Interactions
Higher frequency of adverse events w/ angiotensin II receptor-blockers 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 antihypertensive effect & risk of orthostatic hypotension w/ imipramine-like antidepressants (eg, tricyclics), neuroleptics. Additive BP-lowering effect w/ other antihypertensive agents. Reduced antihypertensive effect w/ corticosteroids, tetracosactide. Contraindicated: Increased risk of hyperkalaemia, worsening renal function & increased CV morbidity & mortality w/ aliskiren in diabetic or impaired renal patients. Increased risk of severe anaphylactoid reactions w/ extracorporeal treatments. May increase risk of angioedema w/ sacubitril/valsartan. Perindopril & indapamide: Increased antihypertensive effect w/ baclofen. May attenuate antihypertensive effect w/ NSAIDs (ie, acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors & non-selective NSAIDs). Not recommended: Reversible increased serum conc & toxicity of lithium. Perindopril: May increase blood glucose-lowering effect of antidiabetic agents eg, insulin, oral hypoglycaemic agents. Excessive reduction in BP w/ non-K-sparing diuretics. Risk of hyperkalaemia w/ K-sparing diuretics eg, eplerenone, spironolactone. May increase risk of angioedema w/ racecadotril; mTOR inhibitors eg, sirolimus, everolimus, temsirolimus. May further reduce BP w/ nitroglycerin & other nitrates. May increase risk of leucopenia w/ allopurinol, cytostatic or immunosuppressive agents, systemic corticosteroids or procainamide. May enhance hypotensive effects of certain anaesth. May result in vol depletion & risk of hypotension w/ high-dose thiazide or loop diuretics. Increased risk of angioedema w/ gliptins eg, linagliptine, saxagliptine, sitagliptine, vildagliptine. May reduce antihypertensive effects w/ sympathomimetics. Nitritoid reactions w/ injectable gold (Na aurothiomalate). Not recommended: Risk of increased adverse effects eg, angioneurotic oedema w/ estramustine. Hyperkalaemia w/ K-sparing drugs (eg, triamterene, amiloride), K salts. Increased risk of hyperkalaemia w/ co-trimoxazole. Indapamide: Risk of hypokalemia w/ torsades de pointes-inducing drugs eg, class IA (eg, quinidine, hydroquinidine, disopyramide) & III (eg, amiodarone, dofetilide, ibutilide, bretylium, sotalol) antiarrhythmic agents, neuroleptics (eg, chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine; pimozide), benzamides (eg, amisulpride, sulpiride, sultopride, tiapride), butyrophenones (eg, droperidol, haloperidol), others (eg, bepridil, cisapride, diphemanil, IV erythromycin, halofantrine, mizolastine, moxifloxacin, pentamidine, sparfloxacin, IV vincamine, methadone, astemizole, terfenadine). Increased risk of low K levels w/ amphotericin B (IV), glucocorticoids & mineralocorticoids (systemic), tetracosactide, stimulant laxatives. Toxic effects due to low K levels may occur w/ cardiac glycosides. May increase incidence of hypersensitivity reactions to allopurinol. May increase exposure w/ strong or moderate CYP3A4 inhibitors eg, PIs, azole antifungals, macrolides (eg, erythromycin or clarithromycin), verapamil or diltiazem. Increased risk of hypotension w/ clarithromycin. Lactic acidosis w/ metformin caused by possible functional renal insufficiency linked to loop diuretics. Increased risk of acute renal insufficiency w/ high-dose iodinated contrast media. Risk of increased Ca levels w/ Ca salts. Risk of increased creatinine levels w/ ciclosporine. Amlodipine: Plasma conc may vary w/ strong CYP3A4 inducers (eg, rifampicin, Hypericum perforatum). May increase exposure w/ strong or moderate CYP3A4 inducers (eg, PIs, azole antifungals, macrolides ie, erythromycin or clarithromycin, verapamil or diltiazem). Risk of increased tacrolimus blood levels. May increase exposure of mTOR inhibitors. Increased exposure to simvastatin. Not recommended: Lethal ventricular fibrillation & CV collapse associated w/ hyperkalemia w/ dantrolene infusion. Bioavailability may be increased w/ grapefruit or grapefruit juice.
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 FC tab 10/2.5/10 mg
Packing/Price
30's
Form
Triplixam FC tab 10/2.5/5 mg
Packing/Price
30's
Form
Triplixam FC tab 5/1.25/10 mg
Packing/Price
30's
Form
Triplixam FC tab 5/1.25/5 mg
Packing/Price
30's
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