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Epibloc

Epibloc

bisoprolol

Manufacturer:

ACME Formulation

Distributor:

Oxpharm

Marketer:

SRS Life Sciences
Concise Prescribing Info
Contents
Bisoprolol fumarate
Indications/Uses
HTN. 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 Initially 5 mg once daily, may be increased to usual dose of 10 mg once daily. Max: 20 mg once daily. Elderly Start w/ the lowest possible dose. Patient w/ severe renal (CrCl <20 mL/min) & hepatic impairment Max: 10 mg daily. Stable chronic heart failure Initially 1.25 mg once daily for 1 wk, if well tolerated gradually uptitrate to max recommended dose of 10 mg once daily.
Administration
May be taken with or without food: Take in the morning. Swallow whole w/ liqd, do not chew.
Contraindications
Hypersensitivity. Acute heart failure or during episodes of heart failure decompensation requiring IV inotropic therapy. Cardiogenic shock, AV block of 2nd & 3rd degree, sick sinus syndrome, SA block, symptomatic bradycardia, symptomatic hypotension, severe bronchial asthma or severe COPD, severe forms of peripheral arterial occlusive disease or severe forms of Raynaud's syndrome, untreated pheochromocytoma, metabolic acidosis.
Special Precautions
Not recommended during pregnancy unless clearly necessary. If treatment is considered necessary, monitor uteroplacental blood flow & fetal growth. Breastfeeding is not recommended. Not recommended in childn & adolescents. HTN or angina pectoris: Caution in patients w/ accompanying heart failure. Chronic heart failure: Caution in bronchospasm; DM w/ large fluctuations in blood glucose values; strict fasting; ongoing desensitization therapy; 1st-degree AV block; Prinzmetal's angina; peripheral arterial occlusive disease; general anaesth. Initiation & cessation of treatment necessitates regular monitoring. Risk of transitory worsening condition w/ abrupt discontinuation of treatment. May increase both sensitivity towards allergens & severity of anaphylactic reactions.
Adverse Reactions
Bradycardia in patients w/ chronic heart failure; GI complaints eg, nausea, vomiting, diarrhea, constipation; β-blocking agents may provoke or worsen psoriasis or induce psoriasis eg, rash & alopecia. Dizziness, headache; worsening of pre-existing heart failure in patients w/ chronic heart failure; feeling of coldness or numbness in the extremities, hypotension; fatigue, asthenia.
Drug Interactions
Effect on AV conduction time may be potentiated & -ve inotropic effect increased w/ class I antiarrhythmics (eg, quinidine, disopyramide; lidocaine, phenytoin; flecainide, propafenone). Effect on AV conduction time may be potentiated w/ class III antiarrhythmics (eg, amiodarone). Risk of profound hypotension & AV block w/ IV verapamil. Risk of worsened heart failure w/ centrally-acting antihypertensives (eg, clonidine, methyldopa, moxonodine, rilmenidine). Abrupt w/drawal of centrally-acting antihypertensives, particularly if prior to β-blocking agent discontinuation, may increase risk of rebound HTN. Increased risk of hypotension w/ Ca antagonists of the dihydropyridine type eg, felodipine & amlodipine; other antihypertensive agents & other medicinal products w/ BP-lowering potential (eg, TCAs, barbiturates, phenothiazines). Topical β-blocking agents (eg, eye drops for glaucoma treatment) may add to the systemic effects of bisoprolol. Increased AV conduction time & risk of bradycardia w/ parasympathomimetics. 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. Combination w/ β-sympathomimetic agents (eg, isoprenaline, dobutamine) may reduce effect of both bisoprolol & the co-administered drug. May unmask the α-adrenoceptor-mediated vasoconstrictor effects of sympathomimetics that activate both β- & α-adrenoceptors (eg, noradrenaline, adrenaline). Increased risk of bradycardia w/ mefloquine. Enhanced hypotensive effect & risk for hypertensive crisis w/ MAOIs (except MAO-B inhibitors). Slight t1/2 reduction 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
Epibloc FC tab 5 mg
Packing/Price
30's (P435/box, P14.5/film-coated tab)
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