Coversyl Plus

Coversyl Plus

perindopril + indapamide

Manufacturer:

Servier

Distributor:

Zuellig
Concise Prescribing Info
Contents
Per 5 mg/1.25 mg tab Perindopril arginine 5 mg, indapamide 1.25 mg. Per 10 mg/2.5 mg tab Perindopril arginine 10 mg, indapamide 2.5 mg
Indications/Uses
5 mg/1.25 mg Essential HTN in adult & patients whose BP is not adequately controlled on perindopril alone. 10 mg/2.5 mg Substitution therapy for the treatment of 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.

Contraindications
Hypersensitivity. Dialysis patients; patients w/ untreated decompensated heart failure. Perindopril: History of angioedema associated w/ previous ACE inhibitor therapy. Hereditary or idiopathic angioedema. 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 of the artery to a single functioning kidney. Pregnancy (2nd & 3rd trimesters). Indapamide: Severe & moderate renal impairment (CrCl <60 mL/min), hepatic encephalopathy, severe hepatic impairment, hypokalemia, in combination w/ non antiarrhythmic agents causing torsades de pointes, Lactation.
Special Precautions
Concomitant use w/ lithium. Risk of sudden hypotension in the presence of preexisting Na depletion in individuals w/ renal artery stenosis. Regularly monitor plasma electrolytes & K levels. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to drive or operate machinery. Renal impairment. Pregnancy & lactation. Childn & adolescents. Perindopril: Dual blockade of renin-angiotensin-aldosterone system. Concomitant use w/ K-sparing drugs, K supplements or K-containing salts; mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus). Neutropenia/agranulocytosis/thrombocytopenia/anemia. Patients w/ collagen vascular disease, immunosuppressant therapy, treatment w/ allopurinol or procainamide, or in combination of these complicating factors, especially if there is preexisting impaired renal function. Periodic monitoring of WBC count. Hypersensitivity/angioedema. Sacubitril/valsartan must not be initiated until 36 hr after taking the last dose of perindopril therapy. Concomitant use of other NEP inhibitors (eg, racecadotril) & ACEIs may increase the risk of angioedema. Anaphylactoid reactions during desensitization & LDL apheresis. Avoid in allergic patients undergoing venom immunotherapy. Hemodialysis. Primary aldosteronism. Cough. Risk of arterial hypotension &/or renal insufficiency. Atherosclerosis. Renovascular HTN. Cardiac failure/severe cardiac insufficiency (grade IV). Diabetics. Possibility of higher prevalence of low-renin states in Black hypertensive patients than in non-Black patients. Discontinue use 1 day prior to surgery. Aortic or mitral valve stenosis/hypertrophic cardiomyopathy. Discontinue if jaundice or marked elevations of hepatic enzymes develops. Hyperkalemia. Elderly. Indapamide: Photosensitivity. Hyponatremia w/ hypovolemia. K depletion w/ hypokalemia. May reduce urinary excretion of Ca & cause a mild & transient increase in plasma Ca levels. Monitor blood glucose in diabetic patients. Increased tendency to gout attacks in hyperuricemic patients. May cause +ve reaction in doping tests. Acute myopia & secondary angle-closure glaucoma.
Adverse Reactions
Perindopril: Dizziness, headache, paresthesia, dysgeusia; visual impairment; vertigo, tinnitus; hypotension & related effects; cough, dyspnea; abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting; pruritus, rash; muscle cramps; asthenia. Indapamide: Hypersensitivity (mainly dermatological); maculopapular rash.
Drug Interactions
Reversible increase in serum lithium conc & toxicity. Increased antihypertensive effect w/ baclofen. Increased worsening of renal function w/ NSAIDs. Increased antihypertensive effect & orthostatic hypotension w/ imipramine-like antidepressants (tricyclics) & neuroleptics. Perindopril: Higher frequency of adverse events w/ angiotensin II receptor blockers, aliskiren & estramustine. Increased risk of hyperkalemia w/ aliskiren, K salts, K-sparing diuretics, ACEIs, AIIAs, NSAIDs, heparins, immunosuppressant agents eg, ciclosporin or tacrolimus, trimethoprim. Extracorporeal treatments. Increased risk of angioedema w/ racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus), sacubitril/valsartan, gliptins (linagliptin, saxagliptin, sitagliptin, vildagliptin. Increased blood-glucose lowering effect w/ antidiabetic agents (insulin, oral hypoglycemic agents). May increase hypotensive effects w/ antihypertensive agents, vasodilators, anesth. Increased risk for leucopenia w/ allopurinol, cytostatic or immunosuppressive agents, systemic corticosteroids or procainamide. Reduced antihypertensive effects w/ ACEIs. Nitritoid reactions w/ gold. Indapamide: Induce Torsades de pointes w/ class IA antiarrhythmic agents (quinidine, hydroquinidine, disopyramide), class III antiarrhythmic agents (amiodarone, dofetilide, ibutilide, bretylium, sotalol), some neuroleptics (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine), benzamides (amisulpride, sulpiride, sultopride, tiapride), butyrophenones (droperidol, haloperidol), other neuroleptics (pimozide), other substances such as bepridil, cisapride, diphemanil, IV erythromycin, halofantrine, mizolastine, moxifloxacin, pentamidine, sparfloxacin, IV vincamine, methadone, astemizole, terfenadine. Increased risk of low K levels w/ amphotericin B (IV route), glucocorticoids, mineralocorticoids (systemic route), tetracosactide, stimulant laxatives, digitalis prep. Increased incidence of hypersensitivity reactions to allopurinol. Lactic acidosis w/ metformin. Increased risk of acute renal insufficiency w/ iodinated contrast media. Increased levels w/ Ca salts. Increased creatinine levels w/ ciclosporin & tacrolimus. Reduced antihypertensive effect w/ corticosteroids, tetracosactide (systemic route).
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 (P631.2/box)
Form
Coversyl Plus 5 mg/1.25 mg FC tab
Packing/Price
30's (P1,019.22/box)
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