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  • Bisoprolol Fumarate
    / Inovamed


    Active Ingredient
    Bisoprolol Fumarate 2.5, 5, 10 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    30 X 2.5 mg

    not in the basket chart 71854 2577

    Film Coated Tablets

    30 X 5 mg

    not in the basket chart 71856 2578

    Film Coated Tablets

    30 X 10 mg

    not in the basket chart 71858 2579

    Related information


    Dosage

    Treatment should principally be initiated gradually with low doses, which are then increased slowly. In all cases the dosage should be adjusted individually, in particular according to the pulse rate and therapeutic success. Depending on the disease and the patient condition, the recommended dosage can vary from 2.5 mg Bisoprolol once daily to a dosage increase of up to 10 mg once daily. Any further increase of dosage is justified only in exceptional cases. The maximum recommended dosage is 20 mg once daily. The film-coated tablets are to be swallowed whole with some liquid in the morning before, during or after breakfast. Do not chew tablets. The duration of treatment is not limited. It depends upon the nature and severity of the disease. Bisoprolol therapy should not be stopped abruptly, particularly not in patients with coronary heart disease, as this may lead to acute deterioration of the patient’s condition. If discontinuation of therapy becomes necessary, the dose should be gradually reduced (e.g. halving of the dose at weekly intervals).


    Indications

    2.5 mg Tablets: Stable, chronic, moderate to severe heart failure.
    5 mg and 10 mg Tablets: Hypertension. Coronary heart disease (angina pectoris).
    Please refer to the license holder for further details.


    Contra-Indications

    2nd or 3rd degree AV block. Sinus bradycardia. Sick sinus syndrome. Severe peripheral arterial disease. Printzmetal’s angina, uncompensated cardiac failure (except carvedilol), cardiogenic shock, hypotension, right ventricular failure secondary to pulmonary hypertension, significant cardiomegaly. Untreated phaeochromocytoma, metabolic acidosis. Non-cardioselective β-blockers (nadolol, oxprenolol, penbutolol, pindolol, propranolol, timolol) are also generally contraindicated in patients with obstructive airways disease or a history of bronchospasm.


    Special Precautions

    Poor cardiac reserve should be controlled with digitalis and diuretics. History of bronchospasm (cardioselective beta-blockers, e.g. acebutolol, atenolol, betaxolol, bisoprolol, celiprolol, metoprolol, nebivolol, and the beta-blocker, labetalol, usually have a lesser effect on airways resistance than the non-selective type but their use should also be avoided in patients with wheezing or obstructive airway disease unless there are compelling clinical reasons). Diabetes. Asthenic symptoms. Cerebrovascular insufficiency. Atopy. Renal or hepatic impairment, thyrotoxic crisis. General anaesthesia; consider withdrawal before elective surgery. Pregnancy, lactation. Withdraw gradually.
    Please refer to the license holder for further details.


    Side Effects

    Cold extremities, CNS and sleep disturbances (particularly with the more lipophilic drugs), bradycardia (less with carvedilol, pindolol), exertional tiredness, bronchospasm, heart failure, hypotension, GI upset, alopecia, thrombocytopenia. Withdraw gradually in unexplained dry eyes or skin rash.
    Please refer to the license holder for further details.


    Drug interactions

    Verapamil, diltiazem, class I antiarrhythmics, amiodarone, cardiac depressant anesthetics, cardiac glycosides. Oral hypoglycemics, insulin, reserpine, ergot alkaloids. Cimetidien (with labetalol and propranolol only), indomethacin (possibly other NSAIDs), clonidine. Thyroxine, liver enzyme inducers (e.g. rifampicin, barbiturates), alpha-adrenergic agonists, direct and indirect sympathomimetic amines, fluvoxamine, phenothiazines, propafenone.
    Please refer to the license holder for further details.


    Manufacturer
    Aurobindo Pharma, India
    Licence holder
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