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Bistapro

Bistapro Dosage/Direction for Use

bisoprolol

Manufacturer:

Lek S.A

Distributor:

Stada
Full Prescribing Info
Dosage/Direction for Use
Treatment of hypertension or angina pectoris: Adults: For both indications the dosage is 5 mg bisoprolol fumarate once daily. If necessary, the dose may be increased to 10 mg bisoprolol fumarate once daily. The maximum recommended dose is 20 mg once daily.
In all cases the dose is adjusted individually, in particular according to the pulse rate and therapeutic success.
Treatment of stable chronic heart failure: Patients should be stable (without acute failure) when bisoprolol treatment is initiated.
It is recommended that the treating physician should be experienced in the management of chronic heart failure.
Titration phase: The treatment of stable chronic heart failure with bisoprolol requires a titration phase.
The recommended starting dose is 1.25 mg bisoprolol fumarate once daily. Depending on individual tolerance the dose is increased to 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, and 10 mg once daily in intervals of two weeks or longer.
If a dose increase is not well tolerated treatment may be maintained at a lower dose.
The maximum recommended dose is 10 mg once daily.
Close monitoring of vital signs (heart rate, blood pressure) and symptoms of worsening heart failure is recommended during the titration phase.
Treatment modification: If the maximum recommended dose is not well tolerated, gradual dose reduction may be considered.
In case of transient worsening of heart failure, hypotension, or bradycardia reconsideration of the dosage of the concomitant medication is recommended.
It may also be necessary to temporarily lower the dose of bisoprolol or to consider discontinuation.
The reintroduction and/or uptitration of bisoprolol should always be considered when the patient becomes stable again.
Duration of therapy for all indications: Treatment with bisoprolol is generally a long-term therapy.
The treatment with bisoprolol must not be stopped abruptly since this might lead to a transitory worsening of condition. Especially in patients with ischaemic heart disease, treatment must not be discontinued suddenly. Gradual reduction of the daily dose is recommended.
Special populations: Renal or hepatic impairment: Applies only to hypertension or angina pectoris: In patients with hepatic or renal impairment of mild to moderate severity, no dose adjustment is normally required. In patients with severe renal impairment (creatinine clearance <20 mL/min) and in patients with severe hepatic impairment it is recommended that a daily dose of 10 mg bisoprolol is not exceeded. Experience with the use of bisoprolol in renal dialysis patients is limited; however, there is no evidence that the dose regimen needs to be altered.
Applies only to CHF: There is no information regarding pharmacokinetics of bisoprolol in patients with chronic heart failure and with impaired liver or renal function. Titration of the dose in these populations should therefore, be made with particular caution.
Elderly: No dosage adjustment is required.
Children: There is no experience with bisoprolol in children, therefore its use cannot be recommended for children.
Administration: Bisoprolol should be taken in the morning with or without food. The tablets should be swallowed with some liquid and should not be chewed.
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