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Bisoprolol

Bisoprolol
Film-coated tablets:
2,5 mg;
5 mg;
10 mg;

ATC C07A B07

Prescription-only medicine

POSOLOGY AND METHOD OF ADMINISTRATION


Adults

Hypertension and angina pectoris: The dosage should be individually adjusted, according to the heart frequentation and the therapeutical effect. The recommended dose is 1 film-coated tablet of 5 mg once daily. If necessary the dose can be increased to 10 mg daily with a maximum recommended dose of 20 mg per day. The whole film-coated tablet should be swallowed with a little liquid. It’s recommended to be taken in the morning during or before breakfast.

In patients with coronary heart disease (angina pectoris) treatment should not be stopped abruptly. The dosage should be diminished slowly during 1-2 weeks. No dosage adjustment is required in patients with kidney and liver impairment.

Only in patients with severe renal impairment (terminal renal insufficiency; creatinine clearance < 20 ml/min) and patients with a severe liver impairment the dose should not exceed 10 mg once dally.

Stable, chronic, moderate to severe heart failure: The following dosage scheme is recommended: – 1,25 mg bisoprolol once daily for 7 days. – When this dose is well tolerated it should be increased to 2,5 mg once daily for 7 days. In some patients, this dose may be enough as well as a sustainment dose. – The next dosage increase is up to 3,75 mg bisoprolol, once daily for 7 days. – When the previous dose is well tolerated than it’s increased to 5 mg bisoprolol, once daily for 4 weeks. – When this dose is well tolerated, the next increase is to 7,5 mg bisoprolol, once daily for 4 weeks. – The maximal sustainment dose is 10 mg bisoprolol once daily. At the beginning of the treatment with 1,25 mg bisoprolol, the patient should be monitored during the first 4 hours (blood pressure, heart frequency, a disorder of the heart conductivity as well as symptoms of heart deficiency). Earlier after a 12-week progressive increase of the dose the recommended maximal sustainment dose is achieved. The recommended maximal maintaining dose of 10 mg bisoprolol is achieved earliest after 12 weeks of progressive increase of the dose. The dose can be decreased or the treatment stopped if needed, and later it can be continued.

At patients with hepatic and renal impairment, titration of the dose should be with particular precaution. In the case of the ceasing of the therapy, the dose should be gradually decreased. The dosage should be diminished slowly by a weekly halving of the dose. Abruptly cessation of the therapy might cause temporary deterioration of heart failure.

Elderly

No dosage adjustment is required.

Pediatric Usage

It is not recommended the usage of bisoprolol at children’s age.


Medicine’s information on this web page is only a short description of its characteristics. Do not take them as recommendations for self-treatment of your health condition.

You must inform your physician and pharmacist and follow their recommendations before you use the medicine for treatment. Always read carefully the patient information leaflet.

COMPOSITION

Each film-coated tablet contains bisoprolol fumarate 2,5 mg.
Each film-coated tablet contains bisoprolol fumarate 5 mg.
Each film-coated tablet contains bisoprolol fumarate 10 mg.

THERAPEUTIC INDICATIONS

– Hypertension;
– Coronary heart disease (angina pectoris);
– treatment of chronic, stable, moderate to severe heart failure (myocardial insufficiency) with disordered systolic ventricular function (ejection fraction ≤ 35% obtained by echocardiographic determination), in combination with ACE inhibitors, diuretics, and/or cardiotonic.

CONTRAINDICATIONS

– acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy;
– cardiogenic shock;
– AV bloc of second or third degree (without a pacemaker);
– sick sinus syndrome;
– sinoatrial block ( block in conductivity between the sinoatrial node and the atrium);
– bradycardia with less than 60 beats/min before the start of the therapy;
– hypotension ( systolic blood pressure less than 100 mm Hg);
– severe bronchial asthma or severe chronic obstructive pulmonary disease;
– late stages of peripheral arterial occlusive disease and Raynaud’s syndrome;
– untreated phaeochromocytoma;
– metabolic acidosis;
– hypersensitivity to bisoprolol or to any of the excipients of the medicine

PACKAGING

Box of 30 film-coated tablets of 2,5 mg
Box of 30 film-coated tablets of 5 mg
Box of 30 film-coated tablets of 10 mg