Treatment of hypertension or angina pectoris: In all cases the dose regimen is adjusted individually by the patient's doctor, in particular according to the pulse rate and therapeutic success. The usual initial dose 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 bisoprolol fumarate once daily. Bisoprolol must be used with caution in patients with hypertension or angina pectoris and accompanying heart failure.
Treatment of stable chronic heart failure: 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. The initiation of treatment of stable chronic heart failure with bisoprolol necessitates a special titration phase. Precondition for treatment with bisoprolol is stable chronic heart failure without acute failure. It is recommended that the treating physician be experienced in the management of chronic heart failure. The treatment of stable chronic heart failure with bisoprolol is initiated according to the following titration scheme, individual adaptation may be necessary depending on how well the patient tolerates each dose, i.e. the dose is to be increased only, if the previous dose is well tolerated. 1st week: 1.25 mg bisoprolol fumarate once daily*; 2nd week: 2.5 mg bisoprolol fumarate once daily; 3rd week: 3.75 mg bisoprolol fumarate once daily*; 4th week: 5 mg bisoprolol fumarate once daily; 8th week: 7.5 mg bisoprolol fumarate once daily; 12th week and beyond: 10 mg bisoprolol fumarate once daily as maintained treatment.
*Bisoprolol 5 mg and 10 mg is not suitable for initial treatment of stable chronic heart failure. Lower strengths are available for this purpose. The maximum recommended dose is 10 mg bisoprolol fumarate once daily. Close monitoring of vital signs (blood pressure, heart rate) and symptoms of worsening heart failure is recommended during the titration phase. Symptoms may already occur within the first day after initiating therapy.
Treatment modification: If during the titration phase or thereafter, transient worsening of heart failure, hypotension or bradycardia occurs, reconsideration of the dosage of 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 treatment: Treatment with Bisoprolol is generally a long-term therapy.
Do not stop treatment abruptly or change the recommended dose without talking to your doctor first since this might lead to a transitory worsening of heart condition. Especially in patients with ischemic heart disease, treatment must not be discontinued suddenly. If discontinuation is necessary, the daily dose is gradually decreased.
Special populations: Renal or hepatic impairment - Treatment of hypertension or angina pectoris: In patients with liver or kidney function disorders of mild to moderate severity no dosage adjustment is normally required. In patients with severe renal impairment (creatinine clearance < 20 mL/min) and in patients with severe hepatic impairment a daily dose of 10 mg Bisoprolol hemifumarate must not be exceeded.
Treatment of stable chronic heart failure: There is no information regarding pharmacokinetics of Bisoprolol in patients with chronic heart failure and concomitant hepatic or renal impairment. Titration of the dose in these populations must therefore be made with particular caution.
Elderly - No dosage adjustment is required.
Children - There is no pediatric experience with Bisoprolol, therefore its use cannot be recommended for children.