Bisocor

Bisocor

bisoprolol

Manufacturer:

Y.S.P. Industries

Distributor:

Yung Shin
Concise Prescribing Info
Contents
Bisoprolol fumarate
Indications/Uses
HTN. Stable chronic angina. Stable chronic heart failure w/ reduced systolic left ventricular function, in combination w/ ACE inhibitors & diuretics, & optionally cardiac glycosides.
Dosage/Direction for Use
HTN & chronic stable angina pectoris Adult Initially 5 mg daily. Usual dose: 10 mg once daily. Max: 20 mg daily. Patient w/ renal impairment Max: 10 mg once daily. Chronic stable heart failure Adult Titration phase: 1.25 mg once daily for 1 wk. If well tolerated, increase to 2.5 mg once daily for a further wk. If well tolerated, increase to 3.75 mg once daily for a further wk. If well tolerated, increase to 5 mg once daily for the 4 following wk. If well tolerated, increase to 7.5 mg once daily for the 4 following wk. If well tolerated, increase to maintenance dose of 10 mg once daily. Max: 10 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Chronic heart failure patients w/ acute heart failure or during episodes of heart failure decompensation requiring IV inotropic therapy; cardiogenic shock; 2nd or 3rd degree AV block (w/o a pacemaker); sick sinus syndrome; SA block; symptomatic bradycardia; symptomatic hypotension; severe bronchial asthma or severe COPD; late stages of peripheral arterial occlusive disease & Raynaud's syndrome; untreated phaeochromocytoma; metabolic acidosis.
Special Precautions
Do not abruptly stop treatment especially in patients w/ ischemic heart disease. Caution in bronchospasm (bronchial asthma, obstructive airways disease); DM w/ large fluctuations in blood glucose values; strict fasting; ongoing desensitisation therapy; 1st degree AV block; Prinzmetal's angina; peripheral arterial occlusive disease; general anaesth; psoriasis or history of psoriasis. Concomitant bronchodilating therapy is recommended in patients w/ bronchial asthma or other chronic obstructive lung diseases. May mask symptoms of hypoglycaemia. May increase both sensitivity towards allergens & the severity of anaphylactic reactions. Adrenaline treatment may not always give the expected therapeutic effect. May mask symptoms of thyrotoxicosis. Do not administer in patients w/ phaeochromocytoma until after α-receptor blockade. May impair ability to drive a vehicle or to operate machinery. Not recommended during pregnancy & breastfeeding. Not recommended in childn. HTN or angina pectoris: Caution in patients w/ HTN or angina pectoris & accompanying heart failure; severe renal or hepatic impairment. Chronic heart failure: Treatment w/ bisoprolol must be initiated w/ special titration phase. Patients should be stable (w/o acute failure) when bisoprolol treatment is initiated. Regularly monitor patients upon treatment initiation. No therapeutic experience of bisoprolol treatment of heart failure in patients w/ insulin dependent DM (type 1), severely impaired renal or hepatic function, restrictive cardiomyopathy, congenital heart disease, haemodynamically significant organic valvular disease, MI w/in 3 mth.
Adverse Reactions
Feeling of coldness or numbness in the extremities, hypotension especially in patients w/ heart failure; GI complaints eg, nausea, vomiting, diarrhoea, constipation. HTN or angina pectoris: Dizziness, headache; fatigue. Chronic heart failure: Bradycardia; worsening of pre-existing heart failure; asthenia.
Drug Interactions
Potentiated effect on AV conduction time & increased -ve inotropic effect w/ class I antiarrhythmics (eg, quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone). -ve influence on contractility & AV conduction w/ Ca antagonists (eg, verapamil, diltiazem). Profound hypotension & AV block w/ IV verapamil. Risk of worsened heart failure w/ centrally acting antihypertensive drugs (eg, clonidine, methyldopa, moxonidine, rilmenidine). β-blockers may exacerbate the rebound HTN which can follow the withdrawal of clonidine. Increased risk of hypotension & further deterioration of ventricular pump function in heart failure patients w/ Ca antagonists of the dihydropyridine type eg, felodipine, amlodipine. Potentiated effect on AV conduction w/ class III antiarrhythmics (eg, amiodarone). Topical β-blockers (eg, eye drops for glaucoma treatment) may add to the systemic effects of bisoprolol. Increased AV conduction time & risk of bradycardia w/ parasympathomimetic drugs. Increased blood sugar lowering effect of insulin & oral antidiabetics. Attenuated reflex tachycardia & increased risk of hypotension w/ anaesth. Reduced heart rate & increased AV conduction time w/ digitalis glycosides. Reduced hypotensive effect w/ NSAIDs. Reduced effect of both β-blocker & β-sympathomimetic agents (eg, isoprenaline, dobutamine) when concomitantly administered. May unmask α-adrenoceptor-mediated vasoconstrictor effects of sympathomimetics that activate both β- & α-adrenoceptors (eg, noradrenaline, adrenaline). Increased risk of hypotension w/ antihypertensives or other drugs w/ BP-lowering potential (eg, TCAs, barbiturates, phenothiazines). Increased risk of bradycardia w/ mefloquine. Enhanced hypotensive effect & risk for hypertensive crisis w/ MAOIs (except MAO-B inhibitors). Slight reduction of t½ w/ rifampicin. Exacerbation of peripheral circulatory disturbances w/ ergotamine derivatives.
MIMS Class
Beta-Blockers
ATC Classification
C07AB07 - bisoprolol ; Belongs to the class of selective beta-blocking agents. Used in the treatment of cardiovascular diseases.
Presentation/Packing
Form
Bisocor tab 5 mg
Packing/Price
10 × 10's
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