Cosyrel

Cosyrel

Manufacturer:

Servier

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per 5 mg/5 mg FC tab Bisoprolol fumarate 5 mg, perindopril arginine 5 mg. Per 5 mg/10 mg FC tab Bisoprolol fumarate 5 mg, perindopril arginine 10 mg. Per 10 mg/10 mg FC tab Bisoprolol fumarate 10 mg, perindopril arginine 10 mg
Indications/Uses
Substitution treatment of HTN &/or stable CAD (patients w/ history of MI &/or revascularisation) in adults adequately controlled w/ bisoprolol & perindopril given concurrently at same dose level. 5 mg/5 mg: Stable chronic heart failure w/ reduced systolic left ventricular function in adults adequately controlled w/ bisoprolol & perindopril given concurrently at same dose level.
Dosage/Direction for Use
1 tab once daily for at least 4 wk. Patient stabilized w/ bisoprolol 2.5 mg & perindopril 2.5 mg ½ tab of 5 mg/5 mg once daily. Patient stabilized w/ bisoprolol 2.5 mg & perindopril 5 mg ½ tab of 5 mg/10 mg once daily.
Administration
Should be taken on an empty stomach: Take in the morning before a meal.
Contraindications
Hypersensitivity to bisoprolol, perindopril, other ACE inhibitors. History of angioedema associated w/ previous ACE inhibitor therapy; hereditary or idiopathic angioedema; acute heart failure or during episodes of heart failure decompensation requiring IV inotropic therapy; cardiogenic shock; 2nd or 3rd degree AV block (w/o pacemaker); sick sinus syndrome; SA block; symptomatic bradycardia & hypotension; severe bronchial asthma or COPD; severe forms of peripheral arterial occlusive disease or Raynaud's syndrome; untreated phaeochromocytoma; metabolic acidosis. 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. 2nd & 3rd trimesters of pregnancy.
Special Precautions
Hypersensitivity/angioedema; anaphylactoid reactions during LDL apheresis & desensitisation. Discontinue use if jaundice or marked hepatic enzymes elevations occur. Not suitable for initial therapy. Not recommended in patients w/ primary hyperaldosteronism; dual blockade renin-angiotensin-aldosterone system. Not to be used concomitantly in patients w/ diabetic nephropathy. Aortic & mitral valve stenosis, hypertrophic cardiomyopathy; 1st degree AV block, Prinzmetal's angina; bradycardia; collagen vascular disease, immunosuppressant therapy; hypotension, hyperkalaemia; DM, renovascular HTN; bronchospasm; peripheral arterial occlusive disease; psoriasis, known or suspected phaeochromocytoma; thyreotoxicosis; recent kidney transplantation; IDDM, restrictive cardiomyopathy, congenital heart disease, haemodynamically significant organic valvular disease, MI w/in last 3 mth; cough. Patients w/ strict fasting. May mask symptoms of hypoglycaemia. Close monitoring of renal function, electrolytes & BP; periodically monitor WBC counts during therapy. Avoid abrupt discontinuation. Black patients. Discontinue use 1 day prior to major surgery or during anesth. Not to initiate sacubitril/valsartan until 36 hr after last dose. Not recommended in combination w/ lithium, K-sparing drugs, K supplements or K-containing salt substitutes; Ca antagonists, class I antiarrhythmics, centrally-acting antihypertensives. Concomitant use w/ NEP inhibitors eg, racecadotril; mTOR inhibitors eg, sirolimus, everolimus, temsirolimus; gliptins eg, linagliptin, saxagliptin, sitagliptin, vildagliptin; allopurinol, procainamide. May affect ability to drive & use machines. Haemodialysis; renal or hepatic impairment. Not recommended during 1st trimester of pregnancy & lactation. Not recommended in childn & adolescents. Elderly.
Adverse Reactions
Headache, dizziness; hypotension; abdominal pain, constipation, diarrhoea, nausea, vomiting; asthenia. Bisoprolol: Bradycardia; heart failure worsening, cold/numb extremities; fatigue. Perindopril: Vertigo, dysgeusia, paraesthesia; visual impairment; tinnitus; cough, dyspnoea; dyspepsia; rash, pruritus; muscle cramps.
Drug Interactions
Increased risk of hyperkalaemia w/ aliskiren, K salts, K-sparing diuretics, ACE inhibitors, AIIA, NSAIDs, heparins, immunosuppressant agents eg, ciclosporin, 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 eg, dialysis or haemofiltration. Increased risk of angioedema w/ sacubitril/valsartan, estramustine, racecadotril, mTOR inhibitors eg, sirolimus, everolimus, temsirolimus; gliptins eg, linagliptin, saxagliptin, sitagliptin, vildagliptin. Reduced heart rate & cardiac output & vasodilation w/ centrally-acting antihypertensives eg, clonidine, methyldopa, moxonidine, rilmenidine. Potentiated AV conduction time & -ve inotropic effect w/ class I antiarrhythmics eg, quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone. Negative influence on contractility & AV conduction w/ verapamil- & diltiazem-type Ca antagonists. Additive hyperkalaemic effects w/ K-sparing diuretics eg, triamterene, amiloride; K-salts. Reversible increased serum conc & toxicity of lithium. Increased blood-glucose lowering effects w/ antidiabetics eg, insulin, oral hypoglycemics. Attenuated antihypertensive effects w/ NSAIDs eg, ASA, COX-2 inhibitors & non-selective NSAIDs. Increased hypotensive effects w/ antihypertensive agents, vasodilators. Reduced BP w/ anaesth medicinal products, TCAs, antipsychotics. Reduced reflex tachycardia & increased risk of hypotension w/ anaesth. Reduced effects w/ β- & α-sympathomimetics. Increased risk of hypotension & ventricular pump function deterioration w/ dihydropyridine-type Ca antagonists eg, felodipine, amlodipine. Potentiated AV conduction time w/ class III antiarrhythmic drugs eg, amiodarone. Increased AV conduction time & risk of bradycardia w/ parasympathomimetic drugs. Additive systemic effects w/ topical β-blockers. Reduced heart rate & increased AV conduction time w/ digitalis glycosides. Increased antihypertensive effects w/ baclofen. Excessive BP reduction w/ non-K-sparing diuretics. Increased risk of bradycardia w/ mefloquine. Enhanced hypotensive effects w/ MAOIs (except MAO-B inhibitors). Nitritoid reactions w/ injectable gold (Na aurothiomalate).
MIMS Class
ACE Inhibitors/Direct Renin Inhibitors / Beta-Blockers
ATC Classification
C09BX02 - perindopril and bisoprolol ; Belongs to the class of ACE inhibitors and other combinations. Used in the treatment of cardiovascular disease.
Presentation/Packing
Form
Cosyrel 10 mg/10 mg FC tab
Packing/Price
30's
Form
Cosyrel 5 mg/10 mg FC tab
Packing/Price
30's
Form
Cosyrel 5 mg/5 mg FC tab
Packing/Price
30's
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