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Bisoprolol Fumarate 5 mg

Bisoprolol Fumarate

Short Description

Bisoprolol Fumarate film coated tablet 5 mg contains Bisoprolol fumarate 5 mg.

Indications

  • Bisoprolol Fumarate film coated tablet 2.5 mg and 5 mg : Treatment of stable chronic moderate to severe heart failure with reduced systolic ventricular function (ejection fraction <=35%, based on echocardiography) in addition to ACE inhibitors and diuretics and optionally cardiac glycosides.

  • Bisoprolol Fumarate film coated tablet 5 mg : Treatment of hypertension and coronary heart disease (angina pectoris).

Specification

  • Treatment of hypertension or angina pectoris : 1 tablet Bisoprolol Fumarate 5 mg daily in the morning before or after breakfast. In milder form of diseases Bisoprolol Fumarate 5 mg daily may be sufficient, most patients will be controlled by 10 mg daily, ony a few cases a dosage of 20 mg daily is required.

  • Treatment of stable chronic heart failure : The patients should have stable chronic heart failure without acute failure during the past six weeks and a mainly unchanged basic therapy during the past two weeks. They should be treated at optimal dose with an ACE inhibitor (or other vasodilator in case of intolerance to ACE inhibitors) and optionally cardiac glycosides, prior to the administration of Bisoprolol fumarate.

  • It is recommended that the treating physician should be experienced in the managemnet of chronic heart failure.

  • Warning : The treatment of stable chronic heart failure with Bisoprolol fumarate has to be initiated with a titration phase as given in the description below.

  • The treatment with Bisoprolol fumarate is to be started with a gradual uptitration according to the following steps :

  • 1.25 mg once daily for 1 week, if well tolerated increase to

  • 2.5 mg once daily for a further week, if well tolerated increase to

  • 3.75 mg once daily for a further week, if well tolerated increase to

  • 5 mg once daily for the 4 following weeks, if well tolerated increase to

  • 7.5 mg once daily for the 4 following weeks, if well tolerated increase to

  • 10 mg once daily for the maintenance therapy

  • After initation of the treatment with 1.25 mg, the patients should be observed over a period of approximately 4 hours (especially as regards blood pressure, heart rate, conduction distrubances, sign of worsening of heart failure).

  • The maximum recommended dose is 10 mg once daily.

  • Occurence of adverse events may prevent all patients being treated with the maximum recommended dose. If necessary, the dose reached can also be decreased step by step. The treatment may be interrupted if necessary and reintroduced as approriate. During the titration phase, in case of worsening of the heart failure or intolerance, it is recommended first to reduce the dose of Bisoprolol fumarate, or to stop immediately if necessary (in case of severe hypotension, worsening of heart failure with acute pulmonary oedema, cardiogenic shock, symptomatic bradycardia AV block).

  • Duration of therapy for all indication :

  • Treatment of stable chronic heart failure with Bisoprolol fumarate is generally a long-term treatment

  • The treatment with Bisoprolol fumarate is not recommended to be stopped abruptly since this might lead to a transitory worsening of heart failure. If discontinuation is necessary, the dose should be gradually decreased divided into halves weekly.

  • Bisoprolol Fumarate tablets should be taken in the morning and can be taken with food. They should be swallowed with liquid and should not be chewed.

  • Renal or liver impairment :

  • Treatment of hypertension or angina pectoris : For patients with final stages of renal impairment or severe disturbances in liver function, the maximum dosage is 10 mg daily.

  • Treatment of stable chronic heart failure : There is no information regarding pharmacokinetics of Bisoprolol fumarate in patients with chronic heart failure and with impaired liver or renal function. Uptitration of the dose in these populations should therefore be made with additional caution.

  • Elderly : No dosage adjustment is required.

  • Children : There is no pediatric experience with Bisoprolol fumarate, therefore its use cannot be recommended for children.

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