Bisoprolol (Concore) tablets are taken in the morning with or without food. They are swallowed with some liquid and are not to be chewed.
Treatment of hypertension or angina pectoris: In all cases, the dosage is adjusted individually, in particular according to the pulse rate and therapeutic success.
The usual initial dose is 5 mg bisoprolol fumarate (1 tablet of Concore 5 mg) once daily. If necessary, the dose may be increased to 10 mg bisoprolol fumarate (1 tablet of Concore 10 mg) once daily.
The maximum recommended dose is 20 mg bisoprolol fumarate once daily.
Bisoprolol (Concore) 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. Patients should be stable (without acute failure) when bisoprolol (Concore) treatment is initiated.
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 (Concore) has to be initiated with a special 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 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.
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 (Concore) or to consider discontinuation.
The reintroduction and/or uptitration of bisoprolol (Concore) should always be considered when the patient becomes stable again.
Duration of treatment for all indications: Treatment with bisoprolol (Concore) is generally a long-term therapy.
Especially in patients with ischemic heart disease, treatment must not be discontinued suddenly, unless clearly indicated because this might lead to a transitory worsening of heart condition. 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 fumarate must not be exceeded.
Experience with the use of bisoprolol (Concore) in renal dialysis patients is limited; however, there is no evidence that the dosage regimen needs to be altered.
Treatment of stable chronic heart failure: There is no information regarding pharmacokinetics of bisoprolol (Concore) in patients with chronic heart failure and concomitant hepatic or renal impairment. 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 (Concore) in children, therefore its use cannot be recommended for children.
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