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 adult patients 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 adult patients 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.
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. Concomitant use w/ sacubitril/valsartan; extracorporeal treatments leading to blood contact w/ negatively charged surfaces. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). 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 relevant organic valvular disease, MI w/in last 3 mth. Haemodialysis. Patients w/ strict fasting. Cough. Black patients. May mask symptoms of hypoglycaemia. Avoid abrupt discontinuation. Major surgery, during anesth. Periodically monitor WBC. 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; allopurinol, procainamide. May affect ability to drive & use machines. Renal or hepatic impairment. Not recommended during 1st trimester of pregnancy & lactation. Not recommended in childn & adolescents. Elderly.
Adverse Reactions
Headache, dizziness, hypotension, nausea, vomiting, abdominal pain, diarrhoea, constipation, asthenia. Bisoprolol: Heart failure worsening, cold extremities, fatigue. Perindopril: Vertigo, paraesthesia, visual disturbance, tinnitus, cough, dyspnoea, dysgeusia, dyspepsia, rash, pruritus, muscle cramps.
Drug Interactions
Increased risk of hyperkalaemia w/ aliskiren, K salts, K-sparing diuretics, ACE inhibitors, angiotensin-II receptors antagonists, 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 & negative inotropic effect w/ class I antiarrhythmics eg, disopyramide, quinidine, 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, acetylsalicylic acid, 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
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in