NIKP-Bisoprolol Dosage/Direction for Use

Treatment of stable chronic heart failure: Adults: Standard treatment of CHF consists of an ACE inhibitor (or an angiotensin receptor blocker in case of intolerance to ACE inhibitors), a beta-blocking agent, diuretics, and when appropriate cardiac glycosides. 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 treatment with bisoprolol 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.
The maximum recommended dose is 10 mg once daily.
Transient worsening of heart failure, hypotension, or bradycardia may occur during the titration period and thereafter.
Close monitoring of vital signs (heart rate, blood pressure) and symptoms of worsening heart failure is recommended during the titration phase. Symptoms may already occur within the first day after initiating the therapy.
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.
If discontinuation is considered, gradual dose decrease is recommended, since abrupt withdrawal may lead to acute deterioration of the patient's condition.
Treatment of stable chronic heart failure with bisoprolol is generally a long-term treatment.
Special populations: Hepatic or renal impairment: There is no information regarding pharmacokinetics of bisoprolol in patients with chronic heart failure and with impaired hepatic or renal function. Titration of the dose in these populations should therefore be made with particular caution.
Elderly: No dosage adjustment is normally required.
Paediatric population: There is no paediatric experience with bisoprolol, therefore its use cannot be recommended in paediatric patients.
Mode of administration: For oral use.
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.
5 mg: Posology: Treatment of hypertension and chronic stable angina pectoris: Adults: The dosage should be individually adjusted. It is recommended to start with 5 mg per day. The usual dose is 10 mg once daily with a maximum recommended dose of 20 mg per day.
Patients with renal or hepatic impairment: In patients with severe renal impairment (creatinine clearance <20 ml/min) and in patients with severe hepatic function disorders the dose should not exceed 10 mg once daily. This dosage may eventually be divided into halves.
Elderly: No dosage adjustment is normally required. It is recommended to start with the lowest possible dose.
Paediatric population: There is no experience with bisoprolol in children, therefore its use cannot be recommended for children.
Discontinuation of treatment: Treatment should not be stopped abruptly (see Precautions). The dosage should be diminished slowly by a weekly halving of the dose.