Coversyl Plus

Coversyl Plus

perindopril + indapamide

Manufacturer:

Servier

Distributor:

Maxxcare
Concise Prescribing Info
Contents
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
Indications/Uses
5 mg/1.25 mg tab: Essential HTN in adults, in patients whose BP is not adequately controlled on perindopril alone. 10 mg/2.5 mg tab: Substitution therapy for essential HTN, in patients already controlled w/ perindopril & indapamide given concurrently at the same dose level.
Dosage/Direction for Use
Administration
Should be taken on an empty stomach: Take preferably in the morning & before a meal.
Contraindications
Hypersensitivity to perindropril, indapamide, any other ACE inhibitor or sulphonamides. Dialysis patients; patients w/ untreated decompensated heart failure. Perindopril: History of angioedema (Quincke's oedema) associated w/ previous ACE inhibitor therapy; hereditary/idiopathic angioedema. 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. Pregnancy (2nd & 3rd trimesters). Indapamide: Hepatic encephalopathy; hypokalaemia. Inadvisable to combine w/ non-antiarrhythmic agents causing torsades de pointes. Severe hepatic impairment. Lactation. 5 mg/1.25 mg tab: Severe renal impairment (CrCl <30 mL/min). 10 mg/2.5 mg tab: Severe & moderate renal impairment (CrCl <60 mL/min).
Special Precautions
Not recommended in case of bilateral renal artery stenosis or a single functioning kidney. Risk of sudden hypotension in the presence of preexisting Na depletion (in particular in individuals w/ renal artery stenosis). Regular monitoring of plasma electrolytes & K levels. Not recommended in combination w/ lithium. Not to be administered to patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. May impair ability to drive or operate machinery. Not recommended during 1st first trimester of pregnancy. Not to be used in childn & adolescents. Perindopril: Anaphylactoid reactions during haemodialysis using high-flux membranes. Temporarily withhold treatment prior to exams in the presence of anaphylactoid reactions during desensitisation treatment or LDL apheresis w/ dextran sulphate. Discontinue in cases of hypersensitivity/angioedema/intestinal angioedema (monitor until complete resolution of symptoms); if jaundice or marked elevations of hepatic enzymes develop. Dual blockade of the renin-angiotensin-aldosterone system is not recommended. Not to be used concomitantly w/ angiotensin II receptor blockers should not be used concomitantly in patients w/ diabetic nephropathy. Not recommended in patients w/ primary hyperaldosteronism. Renovascular HTN; persistent dry cough; risk of arterial hypotension &/or renal insufficiency (in cases of cardiac insufficiency, water & electrolyte depletion). Patients w/ collagen vascular disease, on immunosuppressant therapy, treated w/ allopurinol or procainamide (periodically monitor WBC counts); ischaemic heart disease or cerebral circulatory insufficiency; severe cardiac insufficiency (grade IV); diabetic patients; obstruction in the outflow tract of the left ventricle; risk factors for hyperkalaemia. Black patients. Discontinue 1 day prior to surgery. Not recommended in combination w/ K-sparing drugs, K supplements or K-containing salt substitutes. Not to initiate until 36 hr after last dose of sacubitril/valsartan. Concomitant use w/ other NEP inhibitors (eg, racecadotril) & ACE inhibitors; mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus) may increase risk of angioedema. Elderly. Indapamide: Discontinue in cases of hepatic encephalopathy; photosensitivity reaction; acute myopia & secondary angle-closure glaucoma. Mild & transient increase in plasma Ca levels. Blood urea & creatinine levels may be increased due to reduced glomerular filtration caused by hypovolaemia secondary to loss of water & Na. May increase tendency to gout attacks. Test for Na levels prior to treatment then at regular intervals; plasma K levels during 1st week following start of treatment. May cause positive reaction in doping tests.
Adverse Reactions
Perindopril: Dizziness, headache, paraesthesia, dysgeusia; visual impairment; vertigo, tinnitus; hypotension; cough, dyspnoea; abdominal pain, constipation, diarrhoea, dyspepsia, nausea, vomiting; pruritus, rash; muscle cramps; asthenia. Indapamide: Hypersensitivity; maculopapular rash.
Drug Interactions
Increased antihypertensive effect w/ baclofen. Antihypertensive effect may be attenuated w/ NSAIDs eg, aspirin ≥3 g daily, COX-2 inhibitors & non-selective NSAIDs. Increased antihypertensive effect & risk of orthostatic hypotension w/ imipramine-like antidepressants (tricyclics), neuroleptics. Not recommended: Reversible increase in serum conc & toxicity of lithium. Perindopril: Higher frequency of adverse events w/ angiotensin II receptor-blockers or aliskiren. Increased risk of hyperkalaemia w/ aliskiren, K salts, K-sparing diuretics, ACE inhibitors, AIIA, NSAIDs, heparins, immunosuppressant agents (eg, ciclosporin or tacrolimus), trimethoprim. May increase blood-glucose lowering effect of antidiabetic agents eg, insulins, oral hypoglycaemic agents. Excessive BP reduction w/ non-K-sparing diuretics. Risk of hyperkalaemia w/ K-sparing diuretics eg, eplerenone, spironolactone. May increase risk of angioedema w/ racecadotril; mTOR inhibitors eg, sirolimus, everolimus, temsirolimus. May increase hypotensive effects w/ antihypertensive agents & vasodilators. May further reduce BP w/ nitroglycerin & other nitrates, or other vasodilatators. May increase risk of leucopenia w/ allopurinol, cytostatic or immunosuppressive agents, systemic corticosteroids or procainamide. May enhance hypotensive effects of certain anaesth drugs. Increased risk of angioedema w/ gliptins eg, linagliptin, saxagliptin, sitagliptin, vildagliptin. Antihypertensive effects may be reduced w/ sympathomimetics. Nitritoid reactions w/ injectable gold (Na aurothiomalate). Contraindicated: Risk of hyperkalaemia, worsening of renal function & increased CV morbidity & mortality w/ aliskiren in diabetic or impaired renal patients. Increased risk of severe anaphylactoid reactions w/ extracorporeal treatments. May increase risk of angioedema w/ sacubitril/valsartan. Not recommended: Risk of hyperkalaemia, worsening of renal function & increased CV morbidity & mortality w/ aliskiren in patients other than diabetic or impaired renal patients. Higher frequency of hypotension, syncope, hyperkalaemia, & worsening renal function w/ angiotensin-receptor blocker. Risk of increased angioneurotic oedema w/ estramustine. May increase risk of hyperkalaemia w/ co-trimoxazole. Hyperkalaemia w/ K-sparing diuretics (eg, triamterene, amiloride) & K salts. Indapamide: Risk of hypokalaemia w/ torsades de pointes-inducing drugs eg, class IA (eg, quinidine, hydroquinidine, disopyramide) & III (amiodarone, dofetilide, ibutilide, bretylium, sotalol) antiarrhythmic agents, neuroleptics (eg, chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine), benzamides (eg, amisulpride, sulpiride, sultopride, tiapride), butyrophenones (eg, droperidol, haloperidol), other neuroleptics (eg, pimozide), others (eg, bepridil, cisapride, diphemanil, IV erythromycin, halofantrine, mizolastine, moxifloxacin, pentamidine, sparfloxacin, IV vincamine, methadone, astemizole, terfenadine). Increased risk of low K levels w/ K-lowering drugs eg, amphotericin B (IV), glucocorticoids & mineralocorticoids (systemic), tetracosactide, stimulant laxatives. Toxic effects due to low K levels may occur w/ digitalis. May increase incidence of hypersensitivity reactions to allopurinol. Hypokalaemia or hyperkalaemia w/ K-sparing diuretics eg, amiloride, spironolactone, triamterene. Lactic acidosis w/ metformin caused by possible functional renal insufficiency linked to loop diuretics. Increased risk of acute renal insufficiency w/ high-dose iodinated contrast media. Risk of increased Ca levels w/ Ca salts. Risk of increased creatinine levels w/ ciclosporin, tacrolimus. Reduced antihypertensive effect w/ corticosteroids, tetracosactide (systemic route).
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
Coversyl Plus FC tab 10 mg/2.5 mg
Packing/Price
30's
Form
Coversyl Plus FC tab 5 mg/1.25 mg
Packing/Price
30's
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