Coversyl

Coversyl

perindopril

Manufacturer:

Servier

Distributor:

Zuellig
Concise Prescribing Info
Contents
Perindopril arginine
Indications/Uses
Arterial HTN, CHF, prevention of stroke recurrence in combination w/ indapamide in patient w/ a history of cerebrovascular disease; stable CAD: Reduces the risk of CV events in patient w/ CAD.
Dosage/Direction for Use
HTN Starting dose: 5 mg once daily. Patient w/ a strongly activated renin-angiotensin-aldosterone system (renovascular HTN, salt &/or vol depletion, cardiac decompensation or severe HTN) Starting dose: 2.5 mg. May be increased to 10 mg once daily after 1 mth. Concomitant treatment w/ diuretics: Discontinue diuretic 2-3 days before start of Coversyl. If not possible, initiate Coversyl w/ 2.5 mg & monitor renal function & serum K, adjust subsequent dosage according to response. Elderly Initially 2.5 mg, may increase to 5 mg after 1 mth, then 10 mg if necessary depending on renal function. Stable CAD Starting dose: 5 mg once daily for 2 wk, then increase to 10 mg once daily, depending on renal function & if well tolerated. Elderly 2.5 mg once daily for 1 wk, then 5 mg once daily the next wk, before increasing up to 10 mg once daily, depending on renal function & if tolerated. Patient w/ renal impairment CrCl ≥60 5 mg/day. 30-60 CrCl 2.5 mg/day. 15-30 CrCl 2.5 mg every other day. <15 mg CrCl 2.5 mg on the day of dialysis. The dose should be taken after dialysis in hemodialysis patients. 5 mg: Symptomatic heart failure Starting dose: 2.5 mg/day. May be increased to 5 mg once daily after 2 wk if tolerated.
Administration
Should be taken on an empty stomach: Preferably taken in the morning.
Contraindications
Hypersensitivity to any ACE inhibitor. 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).
Special Precautions
Perform careful appraisal of the benefit/risk if an episode of unstable angina pectoris (major or not) may occur during the 1st mth of therapy. May cause hypotension in patients who have been vol-depleted (eg, by diuretic therapy, dietary salt restriction, dialysis, diarrhea or vomiting) or who have severe renin-dependent HTN, symptomatic heart failure w/ or w/o associated renal insufficiency, severe degrees of heart failure, ischemic heart or cerebrovascular disease. Mitral valve stenosis & obstruction in the outflow of the left ventricle eg, aortic stenosis or hypertrophic cardiomyopathy. Renal impairment (CrCl <60 mL/min), bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, preexisting renal impairment. Routine monitoring of K & creatinine. Hemodialysis. Recent kidney transplantation. Increased risk of hypotension & renal insufficiency in patient w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Angioedema. Anaphylactoid reactions during desensitization & LDL apheresis. Discontinue in patients who develop jaundice or marked elevations of hepatic enzymes. Neutropenia/agranulocytosis/thrombocytopenia/anemia. Patients w/ collagen vascular disease, immunosuppressant therapy, treatment w/ allopurinol or procainamide, or a combination of these complicating factors especially if there is preexisting impaired renal function. Renal impairment. Periodic monitoring of WBC. Higher prevalence of low-renin states in Black patients. Cough. Discontinue 1 day prior to surgery. Risk factors for hyperkalemia include renal insufficiency, worsening renal function, patients >70 yr, DM, intercurrent events particularly dehydration, acute cardiac decompensation, metabolic acidosis, concomitant use of K-sparing diuretics, K supplements or K-containing salt substitutes, taking other drugs associated w/ increases in serum K (eg, heparin). Diabetic patients. Concomitant use w/ lithium; K-sparing drugs, K supplements or K-containing salts. Dual blockade of renin-angiotensin-aldosterone system. Not recommended in patients w/ primary aldosteronism. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to drive or operate machinery. Pregnancy (1st trimester) & lactation.
Adverse Reactions
Dizziness, headache, paresthesia, vertigo; visual disturbances; tinnitus; hypotension; cough, dyspnea; abdominal pain, constipation, diarrhea, dysgeusia, dyspepsia, nausea, vomiting; pruritus, rash; muscle cramps; asthenia.
Drug Interactions
Hypotension, hyperkalemia & decreased renal function (including acute renal failure) w/ other ACE inhibitors, angiotensin II receptor blockers or aliskiren. Increased risk of severe anaphylactoid reactions w/ extracorporeal treatment. Increased risk of hyperkalemia w/ aliskiren, K salts, K-sparing diuretics (eg, triamterene, amiloride), ACE inhibitors, angiotensin-II receptors antagonists, NSAIDs, heparins, immunosuppressant agents eg, ciclosporin or tacrolimus, trimethoprim & co-trimoxazole. Increased risk of angioedema w/ estramustine, racecadotril, mTOR inhibitors (eg, sirolimus, everolimus, temsirolimus), gliptines (linagliptine, saxagliptine, sitagliptine, vildagliptine) & sacubitril/valsartan. Increased serum lithium conc & toxicity. May increase blood-glucose lowering effect of antidiabetics (insulins, oral hypoglycemic agents). Increased antihypertensive effect w/ baclofen. Reduction in BP w/ diuretics; TCAs & antipsychotics. Risk of hyperkalemia w/ K-sparing diuretics (eplerenone or spironolactone) at doses between 12.5-50 mg by day. Attenuated antihypertensive effect w/ NSAIDs. May increase hypotensive effects w/ nitroglycerin & other nitrates, or other vasodilators. May reduce antihypertensive effects of ACE inhibitors w/ sympathomimetics. Nitroid reactions (symptoms include facial flushing, nausea, vomiting & hypotension) w/ inj gold (Na aurothiomalate).
ATC Classification
C09AA04 - perindopril ; Belongs to the class of ACE inhibitors. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Coversyl FC tab 5 mg
Packing/Price
30's (P927.01/box)
Form
Coversyl FC tab 10 mg
Packing/Price
30's (P1,568.53/box)
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