Triplixam

Triplixam

Manufacturer:

Servier

Distributor:

Zuellig
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. 5 mg/1.25 mg/10 mg FC tab Perindopril arginine 5 mg, indapamide 1.25 mg, amlodipine 10 mg. 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 the 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 & before a meal. Avoid grapefruit & grapefruit juice.
Contraindications
Hypersensitivity to perindopril, indapamide, amlodipine, other sulfonamides, dihydropyridine derivatives, any other ACE inhibitor. Dialysis patients. Patients w/ untreated decompensated heart failure. History of angioedema (Quincke's edema) associated w/ previous ACE inhibitor therapy. Hereditary/idiopathic angioedema. Hepatic encephalopathy. Hypokalemia. Severe hypotension. Shock including cardiogenic shock. Obstruction of the outflow-tract of the left ventricle (eg, high grade aortic stenosis). Hemodynamically unstable heart failure after acute MI. Extracorporeal treatments leading to contact of blood w/ negatively charged surfaces. 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. Severe renal (CrCl <30 mL/min) & hepatic impairment. Moderate renal impairment (CrCl <60 mL/min) containing 10 mg/2.5 mg of perindopril/indapamide combination. Pregnancy (2nd & 3rd trimester). Lactation.
Special Precautions
Patients w/ collagen vascular disease, immunosuppressant therapy, treatment w/ allopurinol or procainamide, or a combination of complicating factors, especially if there is preexisting impaired renal function. Periodical monitoring of WBC & check for signs of infection (eg, sore throat, fever). Increased risk of hypotension & renal insufficiency in patient w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Black patients. Allergic patients treated w/ desensitization & those undergoing venom immunotherapy. Anaphylactoid reactions during LDL apheresis. Hemodialysis patients. Primary aldosteronism. Photosensitivity reactions. Not recommended in case of bilateral renal artery stenosis or a single functioning kidney, CHF or cirrhosis w/ edema & ascites. Risk of arterial hypotension &/or renal insufficiency. Hypovolemia. Regular monitoring of plasma electrolytes, K & Ca levels. Renovascular HTN, atherosclerosis. Patients w/ heart failure/severe cardiac insufficiency, aortic or mitral valve stenosis/hypertrophic cardiomyopathy, DM, intercurrent events (eg, dehydration, acute cardiac decompensation, metabolic acidosis). Dry mouth. Ischemic heart disease or cerebral circulatory insufficiency, hypertensive crisis, left ventricular outflow tract obstruction, surgery/anesth. Hyperuricemia. Not recommended in combination w/ lithium; ACE inhibitors, angiotensin II receptor blockers or aliskiren; K-sparing drugs, K-supplements or K-containing salt substitutes is not recommended. Hepatic impairment. May affect ability to drive or operate machinery. Not recommended during the 1st trimester of pregnancy. Do not use in childn & adolescents. Elderly.
Adverse Reactions
Dizziness, headache, paresthesia, somnolence, dysgeusia, visual impairment, diplopia, tinnitus, vertigo, palpitations, flushing, hypotension (& effects related to hypotension), cough, dyspnea, GI disorders (abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting, change of bowel habit), pruritus, rash, maculopapular rash, muscle spasms, ankle swelling, asthenia, edema & fatigue.
Drug Interactions
Do not use aliskiren in patients w/ DM & kidney problems. Avoid w/ lithium, K-sparing drugs (eg, triamterene, amiloride), K supplements or K-containing salt substitutes, drugs w/ increase K in the body (heparin, co-trimoxazole), dantrolene (infusion), estramustine, racecadotril or avoid rejection of transplanted organs (eg, sirolimus, everolimus, temsirolimus & other drugs belonging to mTOR inhibitors), sacubitril/valsartan; ACE inhibitor, angiotensin receptor blockers. Caution w/ angiotensin II receptor blocker, aliskiren, diuretics; eplerenone & spironolactone at doses between 12.5-50 mg/day; anesth; iodinated contrast agent; bepridil; moxifloxin, sparfloxacin; methadone; dofetilide, ibutilide, bretylium, cisapride, diphemanil, procainamide, quinidine, hydroquinidine, disopyramide, amiodarone, sotalol; verapamil, diltiazem; digoxin or other cardiac glycosides; rifampicin, erythromycin, clarithromycin; itraconazole, ketoconazole, amphotericin B (inj); allopurinol; mizolastine, terfenadine or astemizole; corticosteroids & NSAIDs (eg, ibuprofen) or high dose salicylates (eg, acetylsalicylic acid); immunosuppressants (eg, ciclosporin, tacrolimus); tetracosactide, gold salts (IV admin); halofantrine; baclofen; insulin or metformin; Ca including Ca supplements; stimulant laxatives (eg, senna); medicines for cancer; vincamine; medicines to treat mental disorders (eg, TCAs, antipsychotics, imipramine-like antidepressants, neuroleptics); pentamidine; ritonavir, indinavir, nelfinavir; H. perforatum; trimethoprim; ephedrine, noradrenaline or adrenaline; nitroglycerin & other nitrates or other vasodilators. Increased BP lowering effect w/ grapefruit or grapefruit juice.
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 (P1,068.6/box)
Form
Triplixam 10 mg/2.5 mg/10 mg FC tab
Packing/Price
30's (P1,072.5/box)
Form
Triplixam 5 mg/1.25 mg/10 mg FC tab
Packing/Price
30's (P1,133.4/box)
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