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BISOPROLOL FUMARATE is a brand name for Bisoprolol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides (for additional information see section 5.1).
Verbatim from this product's MHRA label. Tap a section to expand.
Standard treatment of CHF consists of an ACE inhibitor (or an angiotensin receptor 2 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. Posology Titration phase The treatment of stable chronic heart failure with bisoprolol requires a titration phase.
5ml) once daily for the 4 following weeks, if well tolerated increase to • 10 (10ml) mg once daily for the maintenance therapy. The maximum recommended dose is 10 mg (10ml) 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 patient’s condition.
Treatment of stable chronic heart failure with bisoprolol is generally a long-term treatment. Patients with hepatic or renal impairment There is no information regarding pharmacokinetics of bisoprolol in patients with 3 chronic heart failure and with impaired hepatic or renal function.
Uptitration of the dose in these populations should therefore be made with additional caution. Older people No dosage adjustment is required. Paediatric population There is no paediatric experience with bisoprolol, therefore its use cannot be recommended in paediatric patients.
Method of administration Bisoprolol fumarate oral solution is for oral use only. Bisoprolol fumarate oral solution should be taken in the morning and can be taken with food. Instructions for use • Open the bottle: press the cap and turn it anticlockwise (figure 1) • Separate the adaptor from the syringe (figure 2).
The following definitions apply to the frequency terminology used:
Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Frequency not known (cannot be estimated from available data).
Cardiac disorders:
Very common: bradycardia. Common: worsening of heart failure.
Uncommon:
AV-conduction disturbances.
Investigations:
Rare: increased triglycerides, increased liver enzymes (ALAT, ASAT).
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 Respiratory, thoracic and mediastinal disorders: 10 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.
Skin and subcutaneous tissue disorders:
Rare: hypersensitivity reactions (pruritus, flush, rash and angioedema). Very rare: alopecia beta-blockers may provoke or worsen psoriasis or induce psoriasis-like rash Musculoskeletal and connective tissue disorders: Uncommon: muscular weakness and cramps.
The treatment of stable chronic heart failure with bisoprolol has to be initiated with a special titration phase. Especially in patients with ischaemic heart disease the cessation of therapy with bisoprolol must not be done abruptly unless clearly indicated, because this may lead to transitional worsening of heart condition.
The initiation and cessation of treatment with bisoprolol necessitates regular monitoring. 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 6 • myocardial infarction within 3 months Bisoprolol must be used with caution in: • bronchospasm (bronchial asthma, obstructive airways diseases) • diabetes mellitus with large fluctuations in blood glucose values; Symptoms of hypoglycaemia 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. Epinephrine treatment does not always yield the expected therapeutic effect. • first degree AV block • Prinzmetal’s angina: Cases of coronary vasospasm have been observed.
Despite its high beta1-selectivity, angina attacks cannot be completely excluded when bisoprolol is administered to patients with Prinzmetal’s angina. • peripheral arterial occlusive disease. Aggravation of symptoms may occur especially when starting 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.
v. 1
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Insert the adaptor into the bottle neck (figure 3). Ensure it is well fixed. • Take the syringe and put it in the adaptor opening (figure 4). Turn the bottle upside down (figure 5). 4 • Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upward in order to remove any possible bubble (figure 5B).
Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5C). • Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B). • Close the bottle with the plastic screw cap.
• Empty the contents of the syringe into your mouth. • After dosing, wash the syringe with water only (figure 7). 5
Vascular disorders:
Common: feeling of coldness or numbness in the extremities, hypotension. Uncommon: orthostatic hypotension.
General disorders:
Common: asthenia, fatigue.
Hepatobiliary disorders:
Rare: hepatitis.
Reproductive system and breast disorders:
Rare: erectile dysfunction.
Psychiatric disorders:
Uncommon: sleep disorder, depression. Rare: nightmare, hallucination. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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The anaesthetist 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. Combination of bisoprolol with calcium antagonists of the verapamil or diltiazem type, with Class I antiarrhythmic drugs and with centrally acting antihypertensive drugs is generally not recommended, for details please refer to section