Acertil Plus雅施達加利

Acertil Plus

perindopril + indapamide

Manufacturer:

Servier

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Per 5/1.25 mg Perindopril arginine 5 mg, indapamide 1.25 mg. Per 2.5/0.625 mg Perindopril arginine 2.5 mg, indapamide 0.625 mg
Indications/Uses
Essential HTN in patient not adequately controlled on perindopril alone or in patient already controlled w/ perindopril & indapamide given concurrently 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, any other ACE inhibitors, or to other sulphonamides. Should not be used in dialysis patients; patients w/ untreated decompensated heart failure. Severe renal (CrCl <30 mL/min) impairment. Perindopril: History of angioedema (Quincke's oedema) associated w/ previous ACE inhibitor therapy; hereditary/idiopathic angioedema. 2nd or 3rd trimesters of pregnancy. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Concomitant use w/ 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. Indapamide: Hepatic encephalopathy; hypokalaemia. Combination w/ non-antiarrhythmic agents causing Torsades de pointes. Severe hepatic impairment. Lactation.
Special Precautions
Concomitant use w/ lithium is not recommended. Risk of sudden hypotension in the presence of pre-existing Na depletion. Regularly monitor serum K. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to drive or operate machinery. Patients w/ renal impairment. Not recommended during the 1st trimester of pregnancy. Perindopril: Dual blockade of the renin-angiotensin-aldosterone system through combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren. Not recommended w/ concomitant use of K-sparing drugs, K supplements or K-containing salt substitutes. Reports of neutropenia/agranulocytosis, thrombocytopenia & anaemia; hypersensitivity/angioedema; dry cough. Increased risk of hypotension & renal insufficiency in patient w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. May be less effective in lowering BP in Black patients. Higher incidence of angioedema in Black patients. Anaphylactoid reactions during dialysis w/ high-flux membranes, LDL apheresis w/ dextran sulphate or desensitisation. Not recommended in primary aldosteronism. Risk of arterial hypotension &/or renal insufficiency in cases of cardiac insufficiency, water & electrolyte depletion, initially low BP, renal artery stenosis, CHF or cirrhosis w/ oedema & ascites. Risk of hyperkalaemia. Use w/ caution in patients w/ ischaemic heart disease or cerebral circulatory insufficiency; cardiac failure/severe cardiac insufficiency; obstruction in the outflow tract of the left ventricle. Stop treatment 1 day prior to surgery. Monitor glycaemic control during the 1st mth of treatment in diabetic patients treated w/ oral antidiabetics or insulin. Discontinue treatment if jaundice or marked elevations of hepatic enzymes develops. Childn & adolescents. Elderly. Indapamide: Risk of hepatic encephalopathy when liver function is impaired; hyponatraemia, hypokalaemia, mild & transient increase in plasma Ca levels; idiosyncratic reaction resulting in transient myopia & acute angle-closure glaucoma. Cases of photosensitivity reactions. Monitor blood glucose in diabetic patients. Tendency to gout attacks may be increased in hyperuricaemic patients. May cause positive reaction in doping tests.
Adverse Reactions
Paraesthesia, headache, dizziness, vertigo; visual disturbance; tinnitus; hypotension; dry cough; constipation, dry mouth, nausea, vomiting, abdominal pain, dysgeusia, dyspepsia, diarrhoea; rash, pruritus, maculopapular eruptions; muscle cramps; asthenia.
Drug Interactions
Increased serum lithium conc & toxicity. Increased antihypertensive effect w/ baclofen, TCAs, neuroleptics, other antihypertensive agents. Attenuation of antihypertensive effect w/ NSAIDs including aspirin ≥3 g/day. Reduced antihypertensive effects w/ corticosteroids, tetracosactide. Perindopril: Higher frequency of adverse events w/ other ACE inhibitors, angiotensin II receptor blockers or aliskiren. Increased occurrence of hyperkalaemia w/ K salts, K-sparing diuretics, other ACE inhibitors, angiotensin II receptor antagonists, NSAIDs, heparin, immunosuppressants; co-trimoxazole. Risk of hyperkalaemia, worsening of renal function & CV morbidity & mortality increase w/ aliskiren in diabetic or impaired renal patients. Increased risk of angioedema w/ sacubitril/valsartan; estramustine; racecadotril; mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus); gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin). Increased blood-glucose lowering effect of antidiabetic medicines. Increased hypotensive effect w/ non-K-sparing diuretics; nitroglycerin & other nitrates or other vasodilators. Increased risk for leucopenia w/ allopurinol, cystostatic or immunosuppressive agents, systemic corticosteroids or procainamide. Enhanced hypotensive effects of certain anaesthetic drugs. Reduced antihypertensive effect w/ sympathomimetics. Nitritoid reactions w/ inj gold. Indapamide: Exercise caution when administered w/ Torsades de pointes-inducing drugs. Increased risk of hypokalaemia w/ K-lowering drugs (eg, amphotericin B (IV), glucocorticoids & mineralocorticoids (systemic route), tetracosactide, stimulant laxatives). Risk of toxic effects of cardiac glycoside. Increased incidence of hypersensitivity reactions to allopurinol. Caution w/ concomitant use of K-sparing diuretics. Lactic acidosis due to metformin caused by possible functional renal insufficiency linked to diuretics. Increased risk of acute renal insufficiency w/ iodinated contrast media (in cases of dehydration caused by diuretics). Risk of increased levels of Ca. Risk of increased creatinine levels w/ ciclosporin, tacrolimus.
MIMS Class
ACE Inhibitors/Direct Renin Inhibitors / Diuretics
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
Acertil Plus 2.5/0.625 mg FC tab
Packing/Price
30's
Form
Acertil Plus 5/1.25 mg FC tab
Packing/Price
30's
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