Inforamation about Bisoheart
Composition:
Each Film Coated Tablet Contains: 2.5 mg, 5mg or 10mg Bisoprolol Fumarate.
Indications:
Treatment of Hypertension and chronic stable angina.
Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides.
Posology and method of administration:
Treatment of hypertension and chronic stable angina pectoris:
Adults:
The dosage should be individually adjusted. It is recommended to start with 5 mg per day. The usual dose is 10 mg once daily with a maximum recommended dose of 20 mg per day.
Patients with renal impairment:
In patients with severe renal impairment (creatinine clearance < 20 ml/min) the dose should not exceed 10 mg once daily. This dosage may eventually be divided into halves.
Patients with severe liver impairment:
No dosage adjustment is required, however careful monitoring is advised.
Elderly:
No dosage adjustment is normally required. It is recommended to start with the lowest possible dose.
Children:
There is no experience with bisoprolol in children, therefore its use cannot be recommended for children.
Discontinuation of treatment:
Treatment should not be stopped abruptly. The dosage should be diminished slowly by a weekly halving of the dose.
Treatment of stable chronic heart failure:
Adults:
Standard treatment of CHF consists of an ACE inhibitor (or an angiotensin receptor blocker in case of intolerance to ACE inhibitors), a beta-blocking agent, 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.
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 up titration according to the following steps:
1.25 mg once daily for 1 week, if well tolerated increase to 2.5 mg once daily for a further week, if well tolerated increase to 3.75 mg once daily for a further week, if well tolerated increase to 5 mg once daily for the 4 following weeks, if well tolerated increase to
7.5 mg once daily for the 4 following weeks, if well tolerated increase to 10 mg once daily for the maintenance therapy.
The maximum recommended dose is 10 mg once daily.
Contraindications:
Bisoprolol is contra-indicated in patients with:
Hypersensitivity to the active substance or to any of the excipients.
Acute heart failure or during episodes of heart failure decompensation requiring
i.v. inotropic therapy.
Cardiogenic shock.
Second- or third-degree AV block (without a pacemaker).
Sick sinus syndrome.
Sinoatrial block.
Symptomatic bradycardia.
Symptomatic hypotension.
Severe bronchial asthma or severe chronic obstructive pulmonary disease.
Severe forms of peripheral arterial occlusive disease or severe forms of Raynaud's syndrome.
Untreated phaeochromocytoma.
Metabolic acidosis.
Pregnancy:
Bisoprolol has pharmacological effects that may cause harmful effects on pregnancy and/or the fetus/newborn
Lactation:
There are no data on the excretion of bisoprolol in human breast milk or the safety of bisoprolol exposure in infants. Therefore, breastfeeding is not recommended during administration of bisoprolol.
Storage conditions:
Store below 30°C.
Packaging:
Carton pack contains 30 F.C Tablets for all strengths.