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Bistapro

Bistapro

bisoprolol

Manufacturer:

Lek S.A

Distributor:

Stada
Concise Prescribing Info
Contents
Bisoprolol fumarate
Indications/Uses
HTN. CHD (angina pectoris). Stable chronic heart failure w/ reduced systolic left ventricular function in addition to ACE inhibitors & diuretics, & optionally cardiac glycosides.
Dosage/Direction for Use
HTN or angina pectoris Adult 5 mg once daily, may be increased to 10 mg once daily if necessary. Max: 20 mg once daily. Stable chronic heart failure Titration phase: Initially 1.25 mg once daily, increased to 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, & 10 mg once daily in intervals of ≥2 wk depending on tolerance. Max: 10 mg once daily. Patient w/ severe renal (CrCl <20 mL/min) & hepatic impairment Max: Not to exceed 10 mg daily.
Administration
May be taken with or without food: Tab should be taken in the morning, swallowed w/ some liqd & not be chewed.
Contraindications
Hypersensitivity. Acute heart failure or during episodes of heart failure decompensation requiring IV inotropic therapy. Cardiogenic shock. 2nd or 3rd degree AV block. 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.
Special Precautions
Do not abruptly cease therapy especially in patients w/ ischaemic heart disease. Not to be administered in patients w/ phaeochromocytoma until after α-receptor blockade. Caution in bronchospasm (bronchial asthma, obstructive airways diseases); DM w/ large fluctuations in blood glucose values; strict fasting; ongoing desensitisation therapy; 1st degree AV block; Prinzmetal's angina; peripheral arterial occlusive disease; patients w/ psoriasis or history of psoriasis. May mask symptoms of thyrotoxicosis. Gradually w/draw therapy 48 hr prior to anaesth. May cause +ve reaction to anti-doping tests. Concomitant bronchodilating therapy is recommended in bronchial asthma or other COPD. May impair ability to drive a vehicle or use machines particularly at start of treatment, upon change of medication, or w/ alcohol. Not recommended during pregnancy & lactation. Not recommended in childn. CHF: No therapeutic experience in heart failure treatment in patients w/ IDDM (type 1), severe renal & hepatic impairment, restrictive cardiomyopathy, congenital heart disease, haemodynamically significant organic valvular disease, MI w/in 3 mth. Regularly monitor during initiation & cessation of treatment.
Adverse Reactions
Feeling of coldness or numbness in extremities, hypotension; GI complaints eg, nausea, vomiting, diarrhoea, constipation. HTN or angina pectoris: Dizziness, headache; fatigue. Chronic heart failure: Bradycardia. Worsening of preexisting heart failure; asthenia.
Drug Interactions
Effect on AV conduction time may be potentiated & -ve inotropic effect increased w/ class I antiarrhythmics. -ve influence on contractility & AV conduction w/ Ca antagonists of verapamil type & to a lesser extent of diltiazem type. May lead to profound hypotension & AV block w/ IV verapamil. May lead to reduction of heart rate & cardiac output & to vasodilatation w/ centrally-acting antihypertensives. May increase risk of hypotension w/ Ca antagonists of dihydropyridine type; antihypertensives & other medicinal products w/ BP lowering potential. Effect on AV conduction time may be potentiated w/ class III antiarrhythmics. May increase AV conduction time & risk of bradycardia w/ parasympathomimetics. Potential additive systemic effects w/ topical β-blockers. Increased blood sugar lowering effect w/ Insulin & oral antidiabetics. Attenuated reflex tachycardia & increased risk of hypotension w/ anaesth agents. Increased AV conduction time & reduced heart rate w/ digitalis glycosides. Hypotensive effect may be reduced by NSAIDs. Effect of both agents may be reduced w/ concomitant β-sympathomimetics. May increase BP w/ sympathomimetics that activate both β- & α-adrenoceptors. Increased risk of bradycardia w/ mefloquine. Enhanced hypotensive effect but also risk for hypertensive crisis w/ MAOIs except MAO-B inhibitors.
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
Bistapro FC tab 5 mg
Packing/Price
100's
Form
Bistapro FC tab 10 mg
Packing/Price
100's
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