Triplixam

Substitution therapy for treatment of essential HTN, in patients already controlled w/ perindopril/indapamide fixed-dose combination & amlodipine, taken at the same dose level.

1 tab as 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 or 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). Not to be initiated earlier than 36 hours after last dose of sacubitril/valsartan. Severe renal (CrCl <30 mL/min) & hepatic impairment. Moderate renal impairment (CrCl <60 mL/min) for Triplixam 10 mg/2.5 mg/10 mg. Pregnancy (2nd & 3rd trimester).

Discontinue use in cases of hypersensitivity/angioedema; hepatic encephalopathy; photosensitivity reactions. Discontinue use as rapidly as possible if symptoms of choroidal effusion, acute myopia & secondary angle-closure glaucoma appear. Not suitable for initial therapy. Dual blockade of RAAS through combination w/ ARBs or aliskiren is not recommended. Not to be used concomitantly w/ ARBs in patients w/ diabetic nephropathy. Not recommended in patients w/ primary aldosteronism; in case of bilateral renal artery stenosis or a single functioning kidney. Neutropenia/agranulocytosis, thrombocytopenia & anemia; extreme caution in patients w/ collagen vascular disease, immunosuppressant therapy, treatment w/ allopurinol or procainamide, or combination of these complicating factors, especially w/ preexisting impaired renal function (periodic monitoring of WBC & report any sign 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. 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. Allergic patients treated w/ desensitization & avoid in those undergoing venom immunotherapy; temporarily w/draw ACE-inhibitor for at least 24 hr before desensitization. Anaphylactoid reactions during LDL apheresis; temporarily w/hold ACE-inhibitor prior to each apheresis. Hemodialysis patients; consider using dialysis membranes other than high flux or antihypertensive agents other than ACE inhibitors. Patients whose BP is initially low, in cases of renal artery stenosis, CHF or cirrhosis w/ edema & ascites. Risk of arterial hypotension &/or renal insufficiency. Hypovolemia. Regular monitoring of plasma electrolytes, K & Ca levels. Renovascular HTN. Dry cough. Atherosclerosis. Hypertensive crisis. Patients w/ heart failure, severe cardiac insufficiency; obstruction in outflow tract of left ventricle; insulin dependent DM. Closely monitor glycemia levels during 1st mth of treatment in diabetic patients previously treated w/ oral antidiabetics or insulin. May increase tendency to gout attacks in hyperuricemia patients. Black patients. Discontinue use 1 day prior to surgery. Not recommended in combination w/ lithium; K-sparing drugs, K supplements or K-containing salt substitutes. Concomitant use w/ racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus) & gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin). May cause +ve reaction in doping tests. Contains <1 mmol Na/tab. Mild to moderate hepatic impairment. Renal & hepatic dysfunction. Minor or moderate influence on ability to drive & use machines. Not recommended during 1st trimester of pregnancy & during lactation. Not to be given in childn & adolescents. Elderly.

Perindopril & amlodipine: Dizziness, headache; visual impairment; dyspnea; abdominal pain, constipation, diarrhea, dyspepsia, nausea; muscle spasms. Perindopril: Paresthesia; dysgeusia; tinnitus, vertigo; hypotension (& effects related to hypotension); cough; vomiting; pruritus, rash. Indapamide: Hypokalemia; maculopapular rash. Amlodipine: Somnolence; diplopia; palpitations; flushing; change of bowel habit; ankle swelling.

Higher frequency of adverse events (eg, hypotension, hyperkalaemia & decreased renal function including acute renal failure) associated w/ dual blockade of the RAAS through combination w/ ARBs or aliskiren. May increase risk of angioedema w/ racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus) & gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin). May increase occurrence of hyperkalaemia w/ aliskiren, K salts, K-sparing diuretics (eg, spironolactone, triamterene or amiloride), ACE inhibitors, AIIAs, NSAIDs, heparins, immunosuppressants (eg, ciclosporin or tacrolimus), trimethoprim & co-trimoxazole. Increased risk of hyperkalaemia, worsening of renal function & CV morbidity & mortality w/ aliskiren in diabetic or impaired renal patients. Increased risk of severe anaphylactoid reactions w/ extracorporeal treatments. Avoid use w/ lithium; K-sparing drugs (eg, triamterene, amiloride), K supplements or K-containing salt substitutes, other drugs which can increase K in the body (eg, heparin, co-trimoxazole); dantrolene (infusion); medicines most often used for diarrhea (eg, racecadotril) or to avoid rejection of transplanted organs (eg, sirolimus, everolimus, temsirolimus & other mTOR inhibitors); sacubitril/valsartan; other medicines for high BP eg, ACE inhibitor & ARBs. Caution in use w/ ARB, aliskiren, or diuretics; K-sparing diuretics for heart failure eg, eplerenone & spironolactone; anesth; iodinated contrast agent; bepridil; methadone; medicines for heart rhythm problems eg, dofetilide, ibutilide, bretylium, cisapride, diphemanil, procainamide, quinidine, hydroquinidine, disopyramide, amiodarone, sotalol; verapamil, diltiazem; digoxin or other cardiac glycosides; antibiotics for bacterial infections eg, rifampicin, erythromycin, clarithromycin, sparfloxacin, moxifloxacin; antifungals eg, itraconazole, ketoconazole, amphotericin B (inj); allopurinol; antihistamines for allergic reactions eg, hay fever (eg, mizolastine, terfenadine, astemizole); corticosteroids for severe asthma & RA, & NSAIDs (eg, ibuprofen) or high-dose salicylates (eg, ASA); immunosuppressants eg, ciclosporin, tacrolimus; tetracosactide; gold salts (especially IV); halofantrine; baclofen; medicines for diabetes eg, insulin or metformin; Ca including Ca supplements; stimulant laxatives eg, senna; medicines for cancer; vincamine; medicines for mental disorders eg, TCAs, antipsychotics, imipramine-like antidepressants, neuroleptics (eg, amisulpride, sulpride, sultopride, tiapride, haloperidol, droperidol); pentamidine; ritonavir, indinavir, nelfinavir; Hypericum perforatum; trimethoprim; medicines for low BP, shock or asthma eg, ephedrine, noradrenaline or adrenaline; nitroglycerin & other nitrates, or other vasodilators that may further reduce BP. Increased blood levels of amlodipine which can increase BP-lowering effect w/ grapefruit juice & grapefruit.

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