Coversyl Plus

Coversyl Plus

perindopril + indapamide

Manufacturer:

Servier

Distributor:

Zuellig Pharma
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: Essential HTN in adult & patients whose BP is inadequately controlled on perindopril alone. 10 mg/2.5 mg: 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: Preferably taken in the morning before a meal.
Contraindications
Hypersensitivity to perindopril, indapamide, other ACE inhibitors or sulfonamides. History of angioedema (Quincke's oedema) associated w/ previous ACE inhibitor therapy; hereditary/idiopathic angioedema; hypokalaemia; untreated decompensated heart failure. Significant bilateral renal artery stenosis or artery stenosis to single functioning kidney. Extracorporeal treatments leading to blood contact w/ -ve charged surfaces. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2); sacubitril/valsartan. Dialysis patients; hepatic encephalopathy; severe hepatic, moderate & severe renal impairment. 2nd & 3rd trimesters of pregnancy.
Special Precautions
Hypersensitivity/angioedema; anaphylactoid reactions during desensitisation & LDL apheresis. Discontinue use if jaundice or marked hepatic enzymes elevation occur. Not to be used concomitantly in patients w/ diabetic nephropathy. Not recommended in bilateral renal artery stenosis or stenosis of artery to single functioning kidney; primary aldosteronism; dual blockade renin-angiotensin-aldosterone system. Collagen vascular disease, immunosuppressant therapy; renal artery stenosis, CHF or cirrhosis w/ oedema & ascites; ischaemic heart disease or cerebral circulatory insufficiency; renovascular HTN; grade IV severe cardiac insufficiency; diabetes; left ventricular outflow tract obstruction; hyperkalaemia; dehydration; undiagnosed hyperparathyroidism, hypomagnesaemia; hyperuricaemia; acute cardiac decompensation, metabolic acidosis; long QT interval; hypotension; Na, K, water & electrolyte depletion; choroidal effusion, transient myopia & acute angle-closure glaucoma; dry cough; photosensitivity. Positive result in doping test. Black patients. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Discontinue use 1 day prior to surgery. Not to initiate sacubitril/valsartan until 36 hr after last dose. Not recommended in combination w/ lithium, ARBs or aliskiren; K-sparing drugs, K supplements or K-containing salt substitutes. Concomitant use w/ allopurinol or procainamide; mTOR inhibitors eg, sirolimus, everolimus, temsirolimus; NEP inhibitors eg, racecadotril; gliptins eg, linagliptin, saxagliptin, sitagliptin, vildagliptin; drugs increasing serum K eg, heparin, co-trimoxazole. May affect ability to drive & use machines. Preexisting renal impairment; haemodialysis. Hepatic encephalopathy & failure. Not recommended during 1st trimester of pregnancy & lactation. Not to be used in childn & adolescents. Elderly.
Adverse Reactions
Perindopril: Dizziness, headache, paraesthesia, dysgeusia; visual impairment; vertigo, tinnitus; hypotension; cough, dyspnoea; abdominal pain, constipation, diarrhoea, dyspepsia, nausea, vomiting; pruritus, rash; muscle spasms; asthenia. Indapamide: Hypokalaemia; hypersensitivity reactions; maculopapular rash.
Drug Interactions
Reversible increased serum conc & toxicity of lithium. Increased antihypertensive effect w/ baclofen. Attenuated antihypertensive effect w/ NSAIDs ie, ASA, COX-2 inhibitors, nonselective NSAIDs. Increased antihypertensive effect & risk of orthostatic hypotension w/ TCAs, neuroleptics. Increased risk of hyperkalaemia w/ aliskiren, K salts, K-sparing diuretics, ACE inhibitors, AIIAs, NSAIDs, heparins, immunosuppressants eg, ciclosporin or tacrolimus, trimethoprim, co-trimoxazole. Increased risk of hyperkalaemia, worsened renal function, CV morbidity & mortality w/ aliskiren. Increased risk of severe anaphylactoid reactions w/ extracorporeal treatments. Increased risk of angioneurotic oedema w/ estramustine. Additive hyperkalaemic effects w/ K-sparing diuretics (eg, triamterene, amiloride, eplerenone, spironolactone), K salts. Increased blood-glucose lowering effect w/ antidiabetics eg, insulins, oral hypoglycemics. Excessive BP reduction w/ non-K-sparing diuretics. Increased risk of angioedema w/ racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus), gliptins (eg, linagliptin, saxagliptin, sitagliptin, vildagliptin); sacubitril/valsartan. Increased hypotensive effects by antihypertensives & vasodilators. Reduced BP w/ nitroglycerin & other nitrates or other vasodilators. Increased risk of leucopenia w/ allopurinol, cytostatic or immunosuppressive agents, systemic corticosteroids or procainamide. Enhanced hypotensive effects w/ anaesth drugs. Reduced antihypertensive effects w/ sympathomimetics, corticosteroids & systemic tetracosactide. Nitritoid reactions w/ injectable gold (Na aurothiomalate). Risk of hypokalemia w/ Torsade de pointes-inducing drugs eg, class IA & III antiarrhythmic agents, phenothiazines, benzamides, butyrophenones, other antipsychotics; bepridil, cisapride, diphemanil, IV erythromycin, halofantrine, mizolastine, moxifloxacin, pentamidine, sparfloxacin, IV vincamine, methadone, astemizole, terfenadine. Increased risk of low K levels by IV amphotericin B, glucocorticoids, systemic mineralocorticoids, tetracosactide, stimulant laxatives. Increased hypersensitivity reactions to allopurinol. Hypokalaemia &/or hypomagnesaemia predisposed to toxic effects of digitalis. Lactic acidosis due to metformin. Increased risk of acute renal insufficiency w/ high-dose iodinated contrast media. Reduced urine Ca elimination. 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
Coversyl Plus 10 mg/2.5 mg FC tab
Packing/Price
30's
Form
Coversyl Plus 5 mg/1.25 mg FC tab
Packing/Price
30's
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