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Cosyrel

Cosyrel

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Concise Prescribing Info
Contents
Per 5 mg/5 mg FC tab Bisoprolol fumarate 5 mg (equiv to bisoprolol 4.24 mg), perindopril arginine 5 mg (equiv to perindopril 3.395 mg). Per 5 mg/10 mg FC tab Bisoprolol fumarate 5 mg (equiv to bisoprolol 4.24 mg), perindopril arginine 10 mg (equiv to perindopril 6.790 mg).
Indications/Uses
Substitution therapy for HTN, stable CAD (in patients w/ history of MI &/or revascularization), 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. Stabilize at the same dose level for at least 4 wk.
Administration
Should be taken on an empty stomach: Take in the morning before a meal.
Contraindications
Hypersensitivity to bisoprolol, perindopril or other ACE inhibitors. 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; 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); sacubitril/valsartan. Extracorporeal treatments leading to blood contact w/ negatively charged surfaces. Significant bilateral renal artery stenosis or artery stenosis to a single functioning kidney. Pregnancy (2nd & 3rd trimesters).
Special Precautions
Hypersensitivity/angioedema. Discontinue if angioedema occurs during therapy. May increase risk of angioedema in patients w/ history of angioedema unrelated to ACE inhibitor. Discontinue use if jaundice or marked hepatic enzyme elevations occur. Higher risk of angioedema in Black patients. Closely monitor initiation of therapy & dose adjustment in patients at increased risk of symptomatic hypotension; ischaemic heart or cerebrovascular disease. Dose reduction or gradual discontinuation of treatment using individual components may be necessary if hypotension becomes symptomatic. Cough, hyperkalaemia. Not recommended in combination w/ lithium, K-sparing drugs, K supplements or K-containing salt substitutes; Ca antagonists (verapamil or diltiazem type), class I antiarrhythmics & centrally acting antihypertensives. Dual blockade of renin-angiotensin-aldosterone system (RAAS) through combined use of ACE inhibitors, AIIA or aliskiren is not recommended. ACE inhibitors & AIIA should not be used concomitantly in patients w/ diabetic nephropathy. Avoid abrupt discontinuation of therapy w/ β-blocker. Bradycardia. Patients w/ 1st degree AV block; aortic & mitral valve stenosis/hypertrophic cardiomyopathy; Prinzmetal's angina; preexisting renal impairment; recent kidney transplantation; collagen vascular disease; bronchospasm; DM; strict fasting; psoriasis or history of psoriasis; known or suspected phaeochromocytoma; IDDM, restrictive cardiomyopathy, congenital heart disease, haemodynamically significant organic valvular disease, MI w/in last 3 mth; renovascular HTN. Anaphylactoid reactions may occur during LDL apheresis (w/ dextran sulphate) or desensitisation, & in patients dialysed w/ high flux membranes & treated concomitantly w/ ACE inhibitors. Immunosuppressant therapy, treatment w/ allopurinol or procainamide. Aggravation of peripheral arterial occlusive disease symptoms may occur when starting therapy. Discontinue 1 day prior to surgery (in patients undergoing major surgery or during anaesth). May mask thyrotoxicosis symptoms. Not recommended in patients w/ primary hyperaldosteronism. May impair ability to drive or operate machinery. Renal impairment. Not recommended during 1st trimester of pregnancy & lactation. Not recommended in childn & adolescents. Elderly.
Adverse Reactions
Headache, dizziness; hypotension & effects related to hypotension; abdominal pain, constipation, diarrhoea, nausea, vomiting; asthenia. Bisoprolol: Bradycardia. Heart failure worsening; cold or numb feeling of the extremities; fatigue. Perindopril: Vertigo, dysgeusia, paraesthesia; visual impairment; tinnitus; cough, dyspnoea; dyspepsia; rash, pruritus; muscle cramps.
Drug Interactions
Increased risk of hyperkalaemia w/ K salts, K-sparing diuretics (eg, triamterene, amiloride, eplerenone, spironolactone), NSAIDs, heparins, immunosuppressants (eg, ciclosporin, tacrolimus, trimethoprim), co-trimoxazole. Increased risk of hyperkalaemia, worsened renal function, CV morbidity & mortality w/ aliskiren. Increased frequency of hypotension, syncope, hyperkalaemia & worsened renal function w/ ACE inhibitors & AIIA. Increased risk of severe anaphylactoid reactions w/ extracorporeal treatments eg, dialysis or haemofiltration & LDL apheresis w/ dextran sulphate. 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, quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone. Negative influence on contractility & AV conduction w/ verapamil- & diltiazem-type Ca antagonists. Reversible increased lithium serum conc & toxicity. Increased blood-glucose lowering effects w/ antidiabetics eg, insulin, oral hypoglycaemics. Attenuated antihypertensive effects w/ NSAIDs eg, acetylsalicylic acid, COX-2 inhibitors & non-selective NSAIDs. Increased hypotensive effects w/ antihypertensives, vasodilators (eg, nitroglycerin, other nitrates or vasodilators) or other medications w/ BP reducing potential (eg, TCAs, barbiturates, phenothiazines). 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. Effect on AV conduction time may be potentiated w/ class III antiarrhythmics eg, amiodarone. May increase AV conduction time & risk of bradycardia w/ parasympathomimetics. Additive systemic effects w/ topical β-blockers. Reduced heart rate & increased AV conduction time w/ digitalis glycosides. Increased antihypertensive effects w/ baclofen. Risk of excessive BP reduction w/ non-K-sparing diuretics. Increased risk of bradycardia w/ mefloquine. Enhanced hypotensive effects & risk of hypertensive crisis 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 5 mg/10 mg FC tab
Packing/Price
30's (Rp444,700/boks)
Form
Cosyrel 5 mg/5 mg FC tab
Packing/Price
30's (Rp323,400/boks)
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