Bisoprolol STELLA 10 mg

Rx

Indications

• Management of hypertension and angina pectoris.
• It is also used as an adjunct to standard therapy in patients with stable chronic heart failure.

Dosage

Hypertension or angina pectoris

• Adults
  The dosage should be individually adjusted, in particular according to the pulse rate and therapeutic success.
  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 once daily.
• Elderly
  Start with the lowest possible dose.
• Renal or hepatic impairment
  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 liver function disorders it is recommended that a daily dose of 10 mg is not exceeded.
  Experience with the use of bisoprolol in renal dialysis patients is limited. However, there is no evidence that the dosage regime needs to be altered.
  Discontinuation of treatment: Treatment must not be stopped abruptly. The dosage should be diminished slowly by a weekly halving of the dose.

Stable chronic heart failure

• 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.
• 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.
  Transient worsening of heart failure, hypotension, or bradycardia may occur during the titration period and thereafter.
  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.
• Duration of treatment:
  Treatment of stable chronic heart failure with bisoprolol is generally a long-term treatment.
  The treatment with bisoprolol must not be stopped abruptly since this might lead to a transitory worsening of condition.
  Especially in patients with ischaemic heart disease, treatment must not be discontinued suddenly. Gradual reduction of the daily dose is recommended.
• Special population:
  Renal or hepatic impairment: There is no information regarding pharmacokinetics of bisoprolol in patients with chronic heart failure and with impaired liver or renal function. Uptitration of the dose in these populations should therefore be made with additional caution.
  Elderly: No dosage adjustment is required.
  Paediatric population: There is no experience with bisoprolol in children and adolescents, therefore its use cannot be recommended for children.

Usage

• Bisoprolol STELLA 10 mg is only administered orally.
• Bisoprolol should be taken in the morning and can be taken with food.
• They should be swallowed with liquid and should not be chewed.

• Hypersensitivity to bisoprolol or to any of the excipients.
• Acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy.
• Cardiogenic shock.
• AV block of second or third degree (without a pacemaker).
• Sick sinus syndrome.
• Sinoatrial block.
• Bradycardia with less than 60 beats/min before the start of therapy.
• Hypotension (systolic blood pressure less than 100 mmHg).
• Severe bronchial asthma or severe chronic obstructive pulmonary disease.
• Late stages of peripheral arterial occlusive disease and Raynaud’s syndrome.
• Untreated phaeochromocytoma.
• Metabolic acidosis.

Very common

• Bradycardia in patients with chronic heart failure.

Common

• Dizziness, headache (these symptoms especially occur at the beginning of the therapy in patients with hypertension or angina pectoris. They are generally mild and usually disappear within 1 – 2 weeks).
• Worsening of pre-existing heart failure in patients with chronic heart failure.
• Feeling of coldness or numbness in the extremities, hypotension (especially in patients with heart failure).
• Gastrointestinal complaints such as nausea, vomiting, diarrhoea, constipation.
• Fatigue (these symptoms especially occur at the beginning of the therapy in patients with hypertension or angina pectoris. They are generally mild and usually disappear within 1 – 2 weeks), asthenia (patients with chronic heart failure).

• 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.
• Bisoprolol must be used with caution in patients with hypertension or angina pectoris and accompanying heart failure.
• The initiation and cessation of treatment of stable chronic heart failure 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 liver function.
  + Restrictive cardiomyopathy.
  + Congenital heart disease.
  + Haemodynamically significant organic valvular disease.
  + Myocardial infarction within 3 months.
• There is a risk of myocardial infarction and sudden death if the treatment is suddenly discontinued in patients with coronary heart disease.

Bisoprolol must be used with caution in:

• Bronchospasm (bronchial asthma, chronic obstructive pulmonary disease (COPD)): Although cardioselective (beta 1) beta-blockers may have less effect on lung function than non-selective beta-blockers, as with all beta-blockers, these should be avoided in patients with obstructive airways diseases, unless there are compelling clinical reasons for their use. Where such reasons exist, this medicinal product may be used with caution. In patients with obstructive airways diseases, the treatment with bisoprolol should be started at the lowest possible dose and patients should be carefully monitored for new symptoms (e.g. dyspnoea, exercise intolerance, cough). In bronchial asthma or other chronic obstructive lung diseases, which may cause symptoms, bronchodilating therapy should be given concomitantly. Occasionally an increase of the airway resistance may occur in patients with asthma, therefore the dose of beta 2-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. Epinephrine treatment may not always yield the expected therapeutic effect.
• AV block of first degree.
• 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 ischaemia during induction and intubation, and the post-operative period. It is currently recommended that maintenance of beta-blockade should be continued peri-operatively. The anaesthetist must be aware of beta-blockade because of the potential for interactions with other medicinal products, 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-blocking agent 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-blocking agents (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 thyrotoxicosis may be masked.
• Combination of bisoprolol with calcium antagonists of the verapamil or diltiazem type, with Class I antiarrhythmic medicinal products and with centrally acting antihypertensive medicinal products is generally not recommended.
• Bisoprolol is not recommended during pregnancy unless clearly necessary. If treatment with bisoprolol is considered necessary, monitoring of the uteroplacental blood flow and the foetal growth is recommended. In case of harmful effects on pregnancy or the foetus consideration of alternative treatment is recommended. The newborn infant must be closely monitored. Symptoms of hypoglycaemia and bradycardia are generally to be expected within the first 3 days.
• Breastfeeding is not recommended during administration of bisoprolol.
• Patients should be aware of how they react to drug before driving or operating machinery.