Triplixam

Triplixam

Manufacturer:

Servier

Distributor:

Maxxcare
Concise Prescribing Info
Contents
Per 5/1.25/5 mg FC tab Perindopril 3.395 mg (equiv to perindopril arginine 5 mg), indapamide 1.25 mg, amlodipine besilate 6.935 mg (equiv to amlodipine 5 mg). Per 5/1.25/10 mg FC tab Perindopril 3.395 (equiv to perindopril arginine 5 mg), indapamide 1.25 mg, amlodipine besilate 13.87 mg (equiv to amlodipine 10 mg). Per 10/2.5/5 mg FC tab Perindopril 6.79 mg (equiv to perindopril arginine 10 mg), indapamide 2.5 mg, amlodipine besilate 6.935 mg (equiv to amlodipine 5 mg). Per 10/2.5/10 mg FC tab Perindopril 6.79 mg (equiv to perindopril arginine 10 mg, indapamide 2.5 mg, amlodipine besilate 13.87 mg (equiv to amlodipine 10 mg)
Indications/Uses
Substitution therapy for treatment of 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.
Contraindications
Hypersensitivity to perindopril, indapamide, amlodipine, other sulphonamides, dihydropyridine derivatives, any other ACE inhibitor. Dialysis patients & those w/ untreated decompensated heart failure. History of angioedema (Quincke's oedema) associated w/ previous ACE inhibitor. Hereditary/idiopathic angioedema. Hepatic encephalopathy; 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 leading to contact of blood with negatively charged surfaces, significant bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. 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. Childn.
Special Precautions
Do not concomitantly use w/ angiotensin II receptor blockers in patients w/ diabetic nephropathy. Collagen vascular disease, immunosuppressant therapy, treatment w/ allopurinol or procainamide, or combination of these complicating factors, especially if there is preexisting impaired renal function. Monitor WBC counts. Increased risk of hypotension & renal insufficiency in patient w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Loss of renal function may occur even in patients w/ unilateral renal artery stenosis. Risk of hypersensitivity/angioedema/intestinal angioedema (discontinue & monitor until complete resolution of symptoms). Increased risk of angioedema w/ mTOR (eg, sirolimus, everolimus, temsirolimus), NEP (eg, racecadotril) & ACE inhibitors; sacubitril/valsartan. Allergic patients treated w/ desensitization. Avoid on venom immunotherapy. Temporarily w/draw at least 24 hr before desensitization or prior to each apheresis. Haemodialysis patients; those w/ primary hyperaldosteronism. Photosensitivity (discontinue). Discontinue treatment & restart w/ a low dose or single constituent only in hypertensive patients w/o preexisting apparent renal lesions & w/ renal insufficiency; monitor K & creatinine after 2 wk of treatment & then every 2 mth during therapeutic stability period. Risk of arterial hypotension &/or renal insufficiency (in cases of cardiac insufficiency, water & electrolyte depletion, in patients w/ low BP, renal artery stenosis, CHF or cirrhosis w/ oedema & ascites). Risk of sudden hypotension in the presence of preexisting Na depletion (particularly if renal artery stenosis). Monitor Na (especially in elderly & cirrhotic patients) & K (in renal insufficiency, worsening of renal function, age >70 yr, DM, intercurrent events, in particular dehydration, acute cardiac decompensation, metabolic acidosis & concomitant use w/ K-sparing diuretics, K supplements or K salts, or other drugs associated w/ increases in serum K) & Ca levels. Risk of hypokalaemia, renovascular HTN, dry cough, atherosclerosis, hypertensive crisis. Cardiac failure/severe cardiac insufficiency; aortic or mitral valve stenosis/hypertrophic cardiomyopathy. Diabetics; Black patients. Discontinue 1 day before surgery. Increased tendency to gout attacks. May impair ability to drive or operate machinery. Mild to moderate hepatic impairment. Pregnancy (1st trimester). Elderly.
Adverse Reactions
Oedema. Dizziness, headache, paraesthesia, vertigo, somnolence, dysgeusia, visual impairment, diplopia, tinnitus, palpitations, flushing, hypotension (& hypotension-related effects), cough, dyspnoea, abdominal pain, constipation, diarrhoea, dyspepsia, nausea, vomiting, change of bowel habit, pruritus, rash, maculopapular rash, muscle spasms, ankle swelling, asthenia, fatigue.
Drug Interactions
Contraindicated: Aliskiren (in diabetic or impaired renal patients), extracorporeal treatments, sacubitril/valsartan. Not recommended: Lithium, aliskiren (in patients other than diabetic or impaired renal patients), concomitant therapy w/ ACE inhibitors & angiotensin-receptor blocker, estramustine, K-sparing drugs (eg, triamterene, amiloride), K salts, co-trimoxazole (trimethoprim/sulfamethoxazole), dantrolene (infusion), grapefruit or grapefruit juice. Special care: Baclofen, NSAIDs (including acetylsalicylic acid at high doses), antidiabetic agents (insulin, hypoglycaemic agents), non-K-sparing & K-sparing (eplerenone, spironolactone) diuretics, racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus), Torsades de pointes-inducing drugs, amphotericin B (IV route), glucocorticoids & mineralocorticoids (systemic route), tetracosactide, stimulant laxatives, cardiac glycosides, allopurinol, CYP3A4 inhibitors. To be taken into consideration: Imipramine-like antidepressants (tricyclics), neuroleptics, other antihypertensives & vasodilatators, tetracosactide, allopurinol, cytostatic or immunosuppressives, systemic corticosteroids or procainamide, anaesth, diuretics (thiazide or loop diuretics), gliptines (linagliptine, saxagliptine, sitagliptine, vildagliptine), sympathomimetics, gold, metformin, iodinated contrast media, Ca (salts), ciclosporine, atorvastatin, digoxin, warfarin, tacrolimus, 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 10/2.5/10 mg FC tab
Packing/Price
30's
Form
Triplixam 5/1.25/10 mg FC tab
Packing/Price
30's
Form
Triplixam 10/2.5/5 mg FC tab
Packing/Price
30's
Form
Triplixam 5/1.25/5 mg FC tab
Packing/Price
30's
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