Preterax

Preterax

perindopril + indapamide

Manufacturer:

Servier

Distributor:

Maxxcare
Concise Prescribing Info
Contents
Per 2.5 mg/0.625 mg FC tab Perindopril arginine 2.5 mg, indapamide 0.625 mg. Per 5 mg/1.25 mg FC tab Perindopril arginine 5 mg, indapamide 1.25 mg. Per 10 mg/2.5 mg FC tab Perindopril arginine 10 mg, indapamide 2.5 mg
Dosage/Direction for Use
Adult 2.5 mg/0.625 mg tab daily as a single dose; increase to 5 mg/1.25 tab mg daily as single dose, if not adequately controlled after 1 mth; may be increased to 10 mg/2.5 mg tab daily as a single dose. Elderly Same as adult dose, 1 tab daily. Renal impairment: CrCl ≥30 mL/min & <60 mL/min Initially 2.5 mg/0.625 mg tab daily as a single dose.
Administration
Should be taken on an empty stomach: Preferably taken in the morning.
Contraindications
Hypersensitivity to perindopril, indapamide, or other ACE inhibitors & sulphonamides. 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, significant bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Not recommended in combination w/ non-antiarrhythmic drugs producing Torsade de pointes. Perindopril: Previous history of angioneurotic oedema (Quincke's oedema) linked to treatment w/ an ACE inhibitor; hyperkalemia; pregnancy; lactation. 2.5 mg/0.625 mg or 5 mg/1.25 mg: Not recommended in combinations w/ K-sparing diuretics, K salts, lithium; increased K levels. 2.5 mg/0.625 mg: Hereditary or idiopathic angioneurotic oedema. Must not be used in dialysis patients & those w/ untreated decompensated cardiac insufficiency. Indapamide: Severe renal failure (CrCl <30 mL/min), hepatic encephalopathy, severe hepatic impairment; hypokalaemia.
Special Precautions
Discontinue treatment & restart w/ a low dose or single constituent only in hypersensitive patients w/o preexisting apparent renal lesion & w/ functional renal insufficiency; periodically control K & creatinine after 2 wk of treatment & then every 2 mth during therapeutic stability period. Risk of sudden hypotension in patients w/ preexisting Na depletion (particularly in those w/ renal artery stenosis). Does not prevent the onset of hypokalaemia in diabetics or those w/ renal failure. May impair ability to drive or operate machinery. 2.5 mg/0.625 mg: Risk of renal insufficiency in patients w/ severe cardiac insufficiency or renal insufficiency w/ renal artery stenosis. Do not use in congenital galactosemia, glucose & galactose malabsorption or lactase deficiency syndrome. 5 mg/1.25 mg: Include periodic testing of K & creatinine levels in renal insufficiency (CrCl <60 mL/min) & those suffering from glomerular nephropathy. Perindopril: Increased risk of hypotension & renal insufficiency (in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney); angioedema (in concomitant use w/ mTOR, NEP & ACE inhibitors; sacubitril/valsartan). Loss of renal function may occur even in patients w/ unilateral renal artery stenosis. Monitor angioneurotic oedema (Quincke's oedema); dry cough; anaemia (in kidney transplant patients or those undergoing dialysis). Risk of arterial hypotension &/or renal insufficiency (in cases of cardiac insufficiency, salt & water depletion). Patients w/ ischaemic heart disease or cerebral circulatory insufficiency; severe cardiac insufficiency (grade IV) or IDDM. Renovascular HTN. Discontinue 2 days before surgery. 2.5 mg/0.625 mg: Risk of neutropenia in patients w/ renal insufficiency associated w/ collagen vascular disease eg, SLE or scleroderma & those on immunosuppressant therapy. Allergic patients undergoing desensitization. Avoid in patients following venom immunotherapy; those receiving dialysis w/ high permeability membranes or LDL apheresis by adsorption on dextran sulphate. Patients w/ left ventricular obstruction. 5 mg/1.25 mg: Risk of agranulocytosis &/or bone marrow depression when administered at high doses & to renal insufficiency patients associated w/ systemic auto-immune diseases, receiving treatment w/ immunosuppressants or that causing leucopenia. Avoid during haemodialysis w/ high-permeability membranes. Childn. Indapamide: Hepatic impairment. Not recommended in patients w/ primary hyperaldosteronism. Check Na (before, during & at regular intervals of treatment especially in the elderly & cirrhotic patients), K (especially in elderly &/or malnourished patients; cirrhotic patients w/ oedema & ascites; coronary patients & those w/ heart failure) & Ca levels. Monitor blood glucose (in diabetics particularly when K levels are low); uric acid; worsening of preexisting renal insufficiency. May cause positive reaction in doping tests.
Adverse Reactions
Perindopril: Constipation, dry mouth, nausea, epigastric pain, anorexia, abdominal pain, taste disturbance; dry cough.
Drug Interactions
Aliskiren, extracorporeal treatments, sacubitril/valsartan; ACE inhibitor & angiotensin-receptor blocker, estramustine, co-trimoxazole (trimethoprim/sulfamethoxazole); antidiabetic agents, K-lowering drugs, non-K-sparing diuretics; racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus); vasodilators, gliptins, sympathomimetics, gold, ciclosporin, tacrolimus. Increased lithium levels may produce signs of overdose, as occurs w/ Na-free diet. May increase hypoglycaemic effect in diabetics treated w/ insulin or hypoglycaemic sulphonamides. Potentiated antihypertensive effect w/ baclofen. Possible reduced antihypertensive effect & acute renal insufficiency in dehydrated patients w/ NSAID (systemic route), high-dose salicylates. Increased antihypertensive effect & risk of orthostatic hypotension (additive effect) w/ TCAs, neuroleptics. Reduced antihypertensive effect w/ corticosteroids (salt & water retention) & tetracosactide. Perindopril: Increased K levels (potentially lethal), particularly in cases of renal insufficiency (additive K-sparing effects) w/ spironolactone, triamterene (alone or in combination), K salts. 2.5 mg/0.625 mg: May enhance hypotensive effects of certain anaesths. May lead to increased risk for leucopenia w/ allopurinol, cytostatic or immunosuppressant agents, corticosteroids (systemic route) or procainamide. Increased hypotensive effect w/ other antihypertensive agents. Indapamide: Torsade de pointes (low K levels is a risk, as are bradycardia & preexisting long QT interval) w/ non-antiarrhythmic drugs prolonging QT interval or cause Torsade de pointes (astemizole, bepridil, erythromycin IV, halofantrine, pentamidine, sultopride, terfenadine, vincamine). Increased risk of low K levels (additive effect) w/ amphotericin B (IV route), glucocorticoids & mineralocorticoids (systemic route), tetracosactide, stimulant laxatives. Favoured cardiac glycoside toxic effects w/ low K levels. K-sparing diuretics (amiloride, spironolactone, triamterene) particularly in patients w/ renal insufficiency or diabetes. Torsade de pointes-producing antiarrhythmic drugs ie, class IA antiarrhythmic agents (quinidine, hydroquinone, disopyramide), amiodarone, bretylium, sotalol. Lactic acidosis possibly caused by renal insufficiency w/ metformin. Increased risk of acute renal insufficiency in case of dehydration caused by diuretics in high doses of iodinated contrast media. Increased Ca levels w/ Ca salts. Special care requiring: Allopurinol.
ATC Classification
C09BA04 - perindopril and diuretics ; Belongs to the class of ACE inhibitors in combination with diuretics. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Preterax FC tab 5 mg/1.25 mg
Packing/Price
30's
Form
Preterax FC tab 10 mg/2.5 mg
Packing/Price
30's
Form
Preterax FC tab 2.5 mg/0.625 mg
Packing/Price
30's
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