Tencard

Tencard

bisoprolol

Manufacturer:

Kimia Farma

Marketer:

Pharmasolindo
Concise Prescribing Info
Contents
Bisoprolol fumarate
Indications/Uses
Chronic moderate to severe heart failure w/ reduced systolic ventricle function (ejection fraction ≤35% based on ECG) w/ additional ACE inhibitors, diuretics & cardiac glycosides. Tab 5 mg: HTN, coronary arterial disease (angina pectoris).
Dosage/Direction for Use
Initially 5 mg once daily in the morning, may be increased to 10-20 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ chronic heart failure w/ the following conditions: acute heart failure during episodes of heart failure decompensation requiring IV inotropic therapy, heart attack, 2nd & 3rd AV block, sick sinus syndrome, SA block, bradycardia symptoms (HR <60/min before treatment), hypotension (BP <100 mmHg/min), severe bronchial asthma or severe COPD, end stage of peripheral arterial occlusion disease & Raynaud’s syndrome, untreated pheochromocytoma, metabolic acidosis.
Special Precautions
Cessation of therapy must not be done abruptly. Patients w/ HTN or angina pectoris & accompanying heart failure. Bronchospasm (bronchial asthma, obstructive airways diseases), DM w/ large fluctuations in blood glucose values; symptoms of hypoglycaemia can be masked; strict fasting; ongoing desensitisation therapy, 1st degree AV block, Prinzmetal's angina, peripheral arterial occlusive disease. May increase both the sensitivity towards allergens & the severity of anaphylactic reactions. General anaesth. Patients w/ or w/ a history of psoriasis. Phaeochromocytoma. May mask symptoms of thyrotoxicosis. May impair ability to drive a vehicle or to operate a machinery. Pregnancy, lactation. Childn.
Adverse Reactions
Bradycardia (in patients w/ chronic heart failure). Worsening of heart failure. Trembling or numbness in the extremities, hypotension especially in patients w/ heart failure. GI complaints eg, nausea, vomiting, diarrhoea, constipation. Fatigue, weakness.
Drug Interactions
Effect of AV conduction time may be potentiated & -ve inotropic effect may be increased w/ class I antiarrhythmic drugs (eg, quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone). IV administration of verapamil in patients on β-blocker may cause severe HTN & AV blockage. Concomitant use w/ centrally acting BP-lowering agents eg, clonidine, methyldopa, moxonidine, rilmenidine, may aggravate heart failure. Abrupt w/drawal may cause rebound HTN. Concomitant use w/ class I antiarrhythmic agents (eg, clonidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone) may potentiate AV conduction time & increase -ve inotropic effect. Ca antagonist of dihydropyridine eg, felodipine, amlodipine. Class III antiarrhythmic agents eg, amiodarone. Parasympathomimetic drugs. Topical β-blocker. Insulin & oral antidiabetic drugs. Anesth agents. Digitalis glycosides. NSAIDs. β-sympathomimetics eg, isoprenaline, dobutamine. α & β-sympathomimetics eg, noradrenaline, adrenaline. Non-selective β-blocker. Increased risk of hypotension w/ antihypertensive agents as well as other drugs w/ BP lowering potential (eg, TCA, barbiturate, phenothiazine). Increased risk of bradycardia w/ mefloquine. Increased hypotension effect of β-blocker & the risk of HTN crisis w/ MAOI (except MAO-B inhibitors). Exacerbation of peripheral circulation w/ ergotamine derivatives. Rifampicin may cause slight reduction of T½ bisoprolol.
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
Tencard FC tab 2.5 mg
Packing/Price
10 × 10's (Rp210,000/boks)
Form
Tencard FC tab 5 mg
Packing/Price
10 × 10's (Rp420,000/boks)
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