Each coated-tablet contains bisoprolol fumarate 5 mg
For the full list of excipients, see section List of excipients.
Drug formTablets
ATC categoryCardiology, angiology
ATC subcategoryAdrenoblockers
Brand nameBisoprolol
Generic nameBisoprolol
Each coated-tablet contains bisoprolol fumarate 5 mg
For the full list of excipients, see section List of excipients.
Standard treatment of CHF consists of an ACE inhibitor (or an angiotensin receptor blocker in case of intolerance to ACE inhibitors), a beta-blocker, 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.
Transient worsening of heart failure, hypotension, or bradycardia may occur during the titration period and thereafter.
Posology
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:
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. 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 patients condition.
Treatment of stable chronic heart failure with bisoprolol is generally a long-term treatment.
Patients with 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. Uptitration of the dose in these populations should therefore be made with additional caution.
Older people
No dosage adjustment is required.
Paediatric population
There is no paediatric experience with bisoprolol, therefore its use cannot be recommended in paediatric patients.
Method of administration
Bisoprolol tablets should be taken in the morning and can be taken with food. They should be swallowed with liquid and should not be chewed.
Pharmacotherapeutic group: Beta blocking agents, selective
ATC Code: C07AB07
List of excipients
Tablet core:
microcrystalline cellulose,
povidone,
sodium starch glycolate,
magnesium stearate,
maize starch,
aerosol 200;
Tablet coating:
talc purified,
propylene glycol,
titanium dioxide,
hypromellose,
sunset yellow FCF (E110),
color red (E129).
For more detailed information about the drug, click: http://pharm.cals.am/pharm/data/drug_134482/1734095746965.pdf