02 Oct 2012

Bisoprolol 2.5mg/5mg/10mg (bisoprolol fumarate) - United Kingdom

Updated: 02 Oct 2012

Bisoprolol 2.5mg/5mg/10mg film coated tablet

Treatment of Hypertension

Treatment of stable chronic angina

Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides

Bisoprolol 2.5mg/5mg/10mg Description, Presentation and Dosage

Bisoprolol 2.5mg/5mg/10mg Description

Bisoprolol 2.5mg/5mg/10mg Drug Class Description

Beta blocking agents, selective - ATC code: C07AB07

Bisoprolol 2.5mg/5mg/10mg Drug Description

For 2.5mg:

Each film-coated tablet contains 2.5 mg Bisoprolol fumarate.

For 5mg:

Each film-coated tablet contains 5 mg Bisoprolol fumarate

For 10mg:

Each film-coated tablet contains 10 mg Bisoprolol fumarate

Bisoprolol 2.5mg/5mg/10mg Generic Name

bisoprolol fumarate

Bisoprolol 2.5mg/5mg/10mg Presentation

Bisoprolol 2.5mg/5mg/10mg Presentation

Film-coated tablet For 2.5mg: White to off white, round, biconvex, film coated tablets, debossed 'b1' on one side and break line on other side For 5mg: White to off white, round, biconvex, film coated tablets, debossed 'b2' on one side and break line on other side For 10mg: White to off white, round, biconvex, film coated tablets, debossed 'b3' on one side and break line on other side The tablet can be divided into equal halves.

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Bisoprolol 2.5mg/5mg/10mg Dosage

Bisoprolol 2.5mg/5mg/10mg Adult Dosage

Administration:

For oral use.

Bisoprolol fumarate tablet should be taken in morning and can be taken with food in morning. They should be swallowed in liquid and should not be chewed.

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-blocker, 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 uptitration 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.

Close monitoring of vital signs (heart rate, blood pressure) and symptoms of worsening heart failure is recommended during the titration phase. Symptoms may already occur within the first day after initiating the therapy.

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 or to consider discontinuation.

The reintroduction and/or uptitration of bisoprolol should always be considered when the patient becomes stable again.

If discontinuation is considered, gradual dose decrease is recommended, since abrupt withdrawal may lead to acute deterioration of the patients condition.

Treatment of stable chronic heart failure with bisoprolol is generally a long-term treatment.

Special population

Renal or hepatic impairment

There is no information regarding pharmacokinetics of bisoprolol in patients with chronic heart failure and with impaired hepatic or renal function. Uptitration of the dose in these populations should therefore be made with additional caution.

Elderly

No dosage adjustment is normally required.

Children`

There is no paediatric experience with bisoprolol, therefore its use cannot be recommended for children.

Bisoprolol 2.5mg/5mg/10mg Child Dosage

There is no experience with bisoprolol in children, therefore its use cannot be recommended for children.

Bisoprolol 2.5mg/5mg/10mg Elderly Dosage

No dosage adjustment is required.

Bisoprolol 2.5mg/5mg/10mg Precautions, Reactions and Contraindications

Bisoprolol 2.5mg/5mg/10mg Special Precautions

Bisoprolol 2.5mg/5mg/10mg Special Precautions

Special warnings:

Applies only to chronic heart failure:

The treatment of stable chronic heart failure with bisoprolol has to be initiated with special titration phase.

Applies to all indications:

Especially in patients with ischemic heart disease the cessation of therapy with bisoprolol must not be done abruptly unless clearly indicated, because this may lad to transition worsening of heart condition.

Precautions:

Applies only to hypertension or angina pectoris:

Bisoprolol must be used with caution in patients with hypertension or angina pectoris and accompanying heart failure.

Applies only to chronic heart failure:

The initiation of treatment with bisoprolol necessitates regular monitoring. For posology and method of administration please.

There is no therapeutic experience of bisoprolol treatment of heart failure in patients with the following diseases and conditions:

- insulin dependent diabetes mellitus (type I)

- severely impaired renal function

- severely impaired hepatic function

- restrictive cardiomyopathy

- congenital heart disease

- haemodynamically significant organic valvular disease

- myocardial infarction within 3 months

Applies to all indications:

Bisoprolol must be used with caution in:

- bronchospasm (bronchial asthma, obstructive airways diseases).

In bronchial asthma or other chronic obstructive lung diseases, which may cause symptoms, bronchodilating therapy is recommended to be given concomitantly. Occasionally an increase of the airway resistance may occur in patients with asthma, therefore the dose of beta2-stimulants may have to be increased.

- diabetes mellitus with large fluctuations in blood glucose values; symptoms of hypoglycaemia (e.g. tachycardia, palpitations or sweating) can be masked.

- strict fasting

- ongoing desensitisation therapy

As with other beta-blockers, bisoprolol may increase both the sensitivity towards allergens and the severity of anaphylactic reactions. Adrenaline treatment does not always give the expected therapeutic effect.

- first degree AV block

- Prinzmetal's angina

- peripheral arterial occlusive disease (intensification of complaints might happen especially during the start of therapy)

- general anaesthesia

In patients undergoing general anaesthesia beta-blockade reduces the incidence of arrhythmias and myocardial ischemia during induction and intubation, and the post-operative period. It is currently recommended that maintenance beta-blockade be continued peri-operatively. The anaesthesist must be aware of beta-blockade because of the potential for interactions with other drugs, resulting in bradyarrhythmias, attenuation of the reflex tachycardia and the decreased reflex ability to compensate for blood loss. If it is thought necessary to withdraw beta-blocker therapy before surgery, this should be done gradually and completed about 48 hours before anaesthesia.

Patients with psoriasis or with a history of psoriasis should only be given beta-blockers (e.g. bisoprolol) after carefully balancing the benefits against the risks.

In patients with phaeochromocytoma bisoprolol must not be administered until after alpha-receptor blockade.

Under treatment with bisoprolol the symptoms of a thyreotoxicosis may be masked.

Bisoprolol 2.5mg/5mg/10mg Adverse Reactions

Bisoprolol 2.5mg/5mg/10mg Adverse Reactions

The following definitions apply to the frequency terminology used hereafter:

Very common (> 1/10)

Common (> 1/100, < 1/10)

Uncommon (> 1/1,000, < 1/100)

Rare (> 1/10,000, < 1/1,000)

Very rare (< 1/10,000)

Psychiatric disorders:

Uncommon: sleep disorders, depression.

Rare: nightmares, hallucinations.

Nervous system disorders:

Common: dizziness*, headache*

Rare: syncope

Eye disorders:

Rare: reduced tear flow (to be considered if the patient uses lenses).

Very rare: conjunctivitis.

Ear and labyrinth disorders:

Rare: hearing disorders.

Cardiac disorders:

Very common: bradycardia (in patients with chronic heart failure).

Common: worsening of pre-existing heart failure (in patients with chronic heart failure).

Uncommon: AV-conduction disturbances, worsening of pre-existing heart failure (in patients with hypertension or angina pectoris); bradycardia (in patients with hypertension or angina pectoris).

Vascular disorders:

Common: feeling of coldness or numbness in the extremities, hypotension especially in patient with heart failure.

Respiratory, thoracic and mediastinal disorders:

Uncommon: bronchospasm in patients with bronchial asthma or a history of obstructive airways disease.

Rare: allergic rhinitis.

Gastrointestinal disorders:

Common: gastrointestinal complaints such as nausea, vomiting, diarrhoea, constipation.

Hepatobiliary disorders:

Rare: hepatitis.

Skin and subcutaneous tissue disorders:

Rare: hypersensitivity reactions (such as itching, flush, rash).

Very rare: beta-blockers may provoke or worsen psoriasis or induce psoriasis-like rash, alopecia.

Musculoskeletal and connective tissue disorders:

Uncommon: muscular weakness and cramps.

Reproductive system and breast disorders:

Rare: potency disorders

General disorders:

Common: asthenia (in patients with chronic heart failure), fatigue*.

Uncommon: asthenia (in patients with hypertension or angina pectoris)

Investigations:

Rare: increased triglycerides, increased liver enzymes (ALAT, ASAT).

Applies only to hypertension or angina pectoris:

*These symptoms especially occur at the beginning of the therapy. They are generally mild and usually disappear within 1 - 2 weeks.

Bisoprolol 2.5mg/5mg/10mg Contraindications

Bisoprolol 2.5mg/5mg/10mg Contraindications

Bisoprolol is contraindicated in chronic heart failure patients with:

- 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

- late stages of peripheral arterial occlusive disease and Raynaud's syndrome

- untreated phaeochromocytoma

- metabolic acidosis

- hypersensitivity to bisoprolol or to any of the excipients

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