Triplixam

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

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.

1 FC tab as a single dose daily.

Should be taken on an empty stomach: Preferably taken in the morning & before a meal. Avoid grapefruit & grapefruit juice.

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 30-60 mL/min) for Triplixam 10 mg/2.5 mg/10 mg. Pregnancy (2nd & 3rd trimester). Lactation.

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 counts. Increased risk of hypotension & renal insufficiency in patient w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Diuretics may be a contributory factor. Loss of renal function may occur (minor changes in serum creatinine) even in patients w/ unilateral renal artery stenosis. Black patients. Allergic patients treated w/ desensitization & those undergoing venom immunotherapy. Temporary w/drawal of ACE-inhibitor at least 24 hr before desensitization. Anaphylactoid reactions during LDL apheresis. Temporarily w/holding ACE-inhibitor prior to each apheresis. Hemodialysis patients. Consideration to use dialysis membranes other than high flux or antihypertensive agents other than ACE inhibitors. 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 cough. 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, ARBs 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.

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.

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/ ARB, aliskiren, diuretics; eplerenone & spironolactone; anesth; iodinated contrast agent; bepridil; moxifloxacin, 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, ASA); 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.

ACE Inhibitors/Direct Renin Inhibitors / Calcium Antagonists / Diuretics

C09BX01 - perindopril, amlodipine and indapamide ; Belongs to the class of ACE inhibitors and other combinations. Used in the treatment of cardiovascular disease.

Rx