Indication

Betacor 2.5:

  • Treatment of stable chronic heart failure
Betacor 5:
  • Treatment of high blood pressure (hypertension)
  • Treatment of coronary heart disease (angina pectoris)
  • Treatment of stable chronic heart failure


Dosage & Administration

Treatment of stable chronic heart failure
Class-I antiarrhythmic medicines (e.g. quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone) may increase the depressant effect of Betacor on atrio-ventricular impulse conduction and the contractility of the heart.
All indications

Calcium antagonists of the verapamil type and to a lesser extent of the diftiazem type may lead to reduced contractility of the heart muscle and delayed atrio-ventricular impulse conduction when used concomitantly with Betacor. Especially intravenous administration of verapamil in patients on ß-blocker treatment may lead to profound hypotension and atrioventricular block. Centrally acting blood pressure-lowering medicines (such as clonidine, methyldopa, moxonodine, rilmenidine) may lead to a reduction of heart rate and cardiac output, as well as to vasodilation due to a decrease in the central sympathetic tonus. Abrupt withdrawal, particularly if prior to beta-blocker discontinuation, may increase risk of “rebound hypertension”.
 
Combinations to be used with caution

Treatment of hypertension or coronary heart disease (angina pectoris)
Class-I antiarrhythmic medicines (e.g. quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone) may increase the depressant effect of Betacor on atrio-ventricular impulse conduction and the contractility of the heart.
All indications
Calcium antagonists of the dihydropyridine type (e.g. nifedipine, felodipine, amlodipine) may increase the risk of hypotension when used concomitantly with Betacor. An increased risk of a further deterioration of the ventricular pump function in patients with heart failure cannot be excluded.

Class-III antiarrhythmic medicines (e.g. amiodarone) may increase the inhibitory effect of Betacor on atrio-ventricular impulse conduction. Topical ß-blockers (e.g. eye drops for glaucoma treatment) may add to the systemic effects of Betacor. Parasympathomimetic medicines may increase the inhibitory effect on atrio-ventricular impulse conduction and the risk of bradycardia when used concomitantly with Betacor. The blood sugar lowering effect of insulin or oral antidiabetic medicines may be increased. Warning signs of reduced blood glucose (hypoglycaemia) - especially accelerated heart rate (tachycardia)- may be masked or suppressed. Such  interactions are considered to be more likely with nonselective ß-blockers. Anaesthetic agents may increase the risk of cardiodepressive actions of Betacor, leading to hypotension (for further information on general anaesthesia see also section special warnings and precautions) Cardiac glycosides (digitalis) may lead to an increase in impulse conduction time and thus reduction in heart rate when used concomitantly with Betacor. Non-steroidal anti-inflammatory medicines (NSAIDs) may reduce the blood pressurelowering effect of Betacor. ß-Sympathomimetics (e.g. isoprenaline, dobutamine) used in combination with Betacor may lead to a reduced effect of both agents. A combination of Betacor with sympathomimetics that activate both ß- and a-adrenoceptors (e.g. noradrenaline, adrenaline) may intensify the a-adrenoceptormediated vasoconstrictor effects of these agents leading to blood pressure increase. Such interactions are considered to be more likely with nonselective ß-blockers. Antihypertensive agents as well as other medicines with blood pressure lowering potential (e.g. tricyclic antidepressants, barbiturates, phenothiazines) may increase the blood pressure lowering effect of Betacor. Combinations to be considered Mefloquine may increase the risk of decelerating the heart rate (bradycardia), if used in combination with Betacor.  Monoamine oxidase inhibitors (except MAO-B inhibitors) may enhance the hypotensive effect of the beta-blockers. Concomitant use may also be a risk for hypertensive crisis. Dosage and Administration Treatment of hypertension or angina pectoris In all cases the dose regimen is adjusted individually by your doctor, in particular according to the pulse rate and therapeutic success.

The usual initial dose is 5 mg bisoprolol fumarate (1 tablet of Betacor 5) once daily. If necessary, the dose may be increased to 10 mg bisoprolol fumarate (2 tablets of Betacor 5) once daily.

The maximum recommended dose is 20 mg bisoprolol fumarate once daily.

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

Treatment of 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-blocker, diuretics, and when appropriate cardiac glycosides. The initiation of treatment of stable chronic heart failure with Betacor necessitates a special titration phase.

Precondition for treatment with bisoprolol is stable chronic heart failure without acute failure.
It is recommended that the treating physician be experienced in the management of
chronic heart failure.

The recommended starting dose is 1.25 mg bisoprolol fumarate once daily (Half a tablet of Betacor 2.5). Depending on individual tolerance the dose is stepwise increased to 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, and 10 mg bisoprolol fumarate once daily in intervals of two weeks or longer.

If a dose increase is not well tolerated treatment may be maintained at a lower dose. The maximum recommended dose is 10 mg bisoprolol fumarate once daily.

Close monitoring of vital signs (blood pressure, heart rate) and symptoms of worsening heart failure is recommended during the titration phase.

Treatment modification
If during the titration phase or thereafter, transient worsening of heart failure, hypotension or bradycardia occurs, reconsideration of the dosage of 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 for all indications
Treatment with Betacor is generally a long-term therapy. Do not stop treatment abruptly or change the recommended dose without talking to your doctor first since this might lead to a transitory worsening of heart condition. Especially in patients with ischaemic heart disease, treatment must not be discontinued suddenly. If discontinuation is necessary, the daily dose is gradually decreased.

Special populations
Renal or hepatic impairment:
• Treatment of hypertension or angina pectoris: 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 hepatic impairment a daily dose of 10 mg bisoprolol fumarate must not be exceeded.
• Treatment of stable chronic heart failure: There is no information regarding pharmacokinetics of bisoprolol in patients with chronic heart failure and concomitant hepatic or renal impairment. Titration of the dose in these populations must therefore be made with particular caution.
Elderly:
No dosage adjustment is required.
Administration
Betacor tablets are taken in the morning with or without food. They are swallowed
with some liquid and not to be chewed.


Precautions

The following section describes when Betacor must be used with special caution:
• diabetes mellitus with extremely fluctuating blood glucose levels: symptoms of
markedly reduced blood glucose (hypoglycaemia) such as tachycardia, palpitations or sweating can be masked,
• strict fasting,
• ongoing desensitisation therapy,
• mild disturbances of atrioventricular conduction (first degree AV block),
• disturbed blood flow in the coronary vessels due to vasospasms (Prinzmetal’s angina),
• peripheral arterial occlusive disease (aggravation of symptoms may occur especially when starting therapy),

• patients with psoriasis or with a personal history of psoriasis.

Respiratory system: In bronchial asthma or other symptomatic chronic obstructive pulmonary diseases concomitant bronchodilator therapy is indicated. An increase in airway resistance may occasionally occur in patients with asthma, requiring a higher dose of beta2-sympathomimetics.

Allergic reactions: Beta-blockers, including Betacor, may increase the sensitivity to allergens and the severity of anaphylactic reactions because the adrenergic counterregulation under beta-blockade may be alleviated. Treatment with adrenaline may not always yield the expected therapeutic effect.

General anaesthesia: In patients undergoing general anaesthesia the anaesthetist must be aware of beta-blockade. If it is thought necessary to withdraw Betacor before surgery, this should be done gradually and completed about 48 hours prior to anaesthesia.

Phaeochromocytoma: In patients with a tumour of the adrenal gland (phaeochromocytoma) Betacor may only be administered after previous alpha-receptor blockade.

Thyrotoxicosis: Under treatment with Betacor the symptoms of a thyroid hyperfunction (thyrotoxicosis) may be masked.
Special populations
So far no sufficient therapeutic experience is available for Betacor in patients with heart failure and concomitant insulin dependent type I diabetes mellitus, severely impaired kidney function, severely impaired hepatic function, restrictive cardiomyopathy, congenital heart diseases or haemodynamically relevant organic valvular heart disease. No sufficient therapeutic experience is available either in patients with heart failure and myocardial infarction within the last 3 months.

There is insufficient experience with bisoprolol in children, therefore the use of Betacor cannot be recommended for children.

Effects on the ability to drive and use machines
In a study with patients suffering from coronary heart disease bisoprolol did not affect the driving performance of the patients. However, depending on the individual patients response to treatment an effect on the ability to drive a vehicle or to use machines may be impaired. This needs to be considered particularly at the start of treatment, upon change of medication, or in conjunction with alcohol.

Pregnancy and lactation: During pregnancy Betacor is only recommended following careful assessment of benefit-to-risk ratio by the doctor. In general, beta-blockers reduce placental blood flow and may affect the development of the unborn child. Placental and uterine blood flow as well as the growth of the unborn child must be monitored and, in case of harmful effects on pregnancy or the foetus, alternative therapeutic measures considered.

The newborn infant must be monitored closely after delivery. Symptoms of reduced blood glucose and slowed pulse rate generally may occur within the first 3 days of life.

There are no data on the excretion of bisoprolol in human breast milk or the safety of bisoprolol exposure in infants. Therefore administration of Betacor is not recommended during breastfeeding.


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