Vasoten

Vasoten Dosage/Direction for Use

bisoprolol

Manufacturer:

Synmosa

Distributor:

Apex
Full Prescribing Info
Dosage/Direction for Use
Treatment of hypertension or angina pectoris: In all cases the dose regimen is adjusted individually by the doctor in particular according to the pulse rate and therapeutic success.
The usual initial dose is 5 mg bisoprolol (1 tablet of Vasoten 5 mg) once daily. If necessary, the dose may be increased to 10 mg bisoprolol (2tablets of Vasoten 5 mg) once daily.
The maximum recommended dose is 20 mg bisoprolol once daily.
Treatment of stable chronic heart failure: The initiation of treatment of stable chronic heart failure with Vasoten necessitates a special titration phase and requires regular monitoring by the doctor.
Preconditions for treatment with bisoprolol are stable chronic heart failure without acute failure during the past six weeks, mainly unchanged basic therapy during the past two weeks, treatment at optimal dose with an ACE inhibitor (or other vasodilator in case of intolerance to ACE inhibitors) and a diuretic, and optionally cardiac glycosides.
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 adaption 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 once daily.
*2nd week: 2.5 mg bisoprolol (½ tablet Vasoten 5 mg) once daily.
3rd week: 3.75 mg bisoprolol once daily.
*4th - 7th week: 5 mg bisoprolol (1 tablet Vasoten 5 mg) once daily.
8th - 11th week: 7.5 mg bisoprolol (1½ tablets Vasoten 5 mg) once daily.
12th week and beyond: 10 mg bisoprolol (2 tablets Vasoten 5 mg) once daily as maintenance treatment.
*Vasoten 5 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 once daily. Patients should be titrated to and maintained at this dose unless prevented by adverse effects.
After initiation of treatment with 1.25 mg bisoprolol, the patient should be observed over a period of approximately 4 hours (especially as regards blood pressure, heart rate, conduction disturbances, signs of worsening of heart failure).
During the titration phase or thereafter, transient worsening of heart failure, fluid retention, hypotension or bradycardia may occur. In this case it is recommended first to reduce the dose of bisoprolol. Bisoprolol should be discontinued only if clearly necessary, but its reintroduction and/or uptitration should always be considered when the patient becomes stable again.
Duration of treatment for all indications: Treatment with Vasoten 5 mg is generally a long-term therapy.
The treatment may be interrupted if necessary and reintroduced as appropriate.
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 ischaemic heart disease, treatment must not be discontinued suddenly. If discontinuation is necessary, the 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 10mg bisoprolol 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.
Administration: Vasoten 5 mg tablets are taken in the morning with or without food. They are swallowed with some liquid and not to be chewed.
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