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; hyperuricaemia; acute cardiac decompensation, metabolic acidosis; long QT interval; hypotension; Na, 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: 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. Favoured 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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