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Pharmacology/Description

Pharmacodynamics Bisoprolol, the active ingredient of Betacor, is a beta1-selective-adrenoceptor blocking agent, lacking intrinsic stimulating and relevant membrane stabilising activity. It only shows very low affinity to the beta2-receptor of the smooth muscles of bronchi and vessels as well as to the beta2-receptors concerned with metabolic regulation. Therefore, bisoprolol is generally not to be expected to influence the airway resistance and beta2- mediated metabolic effects. Its beta1-selectivity extends beyond the therapeutic dose range. Pharmacokinetics Absorption. Bisoprolol is almost completely (>90%) absorbed from the gastrointestinal tract and, because of its small first pass metabolism of approximately 10%, has an bioavailability of approximately 90% after oral administration. The bioavailability is not affected by food intake. Bisoprolol shows linear kinetics and the plasma concentrations are proportional to the administered dose over the dose range 5 to 20 mg. Peak plasma concentrations occur within 2 3 hours. Distribution Bisoprolol is extensively distributed. The volume of distribution is 3.5 I/kg. Binding to plasma proteins is approximately 30%. Metabolism Bisoprolol is metabolised via oxidative pathways with no subsequent conjugation. All metabolites, being very polar, are renally eliminated. The major metabolites in human plasma and urine were found to be without pharmacological activity. In vitro data from studies in human liver microsomes show that bisoprolol is primarily metabolised via CYP3A4 (95%) with CYP2D6 having only a minor role. Elimination The clearance of bisoprolol is balanced between renal elimination of the unchanged molecule (50%) and hepatic metabolism (50%) to metabolites which are also renally excreted. The total clearance of bisoprolol is approximately 15 l/h. Bisoprolol has an elimination half life of 10-12 hours.

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 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 BetacorTM 5) once daily. If necessary, the dose may be increased to 10 mg bisoprolol fumarate (2 tablets of BetacorTM 5) once daily. The maximum recommended dose is 20 mg bisoprolol fumarate once daily. BetacorTM 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 BetacorTM 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 BetacorTM 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.
Side Effects

The adverse effects described below are sorted according to system organ classes. Frequencies are classified as follows: Very common (affects more than 1 person in 10) Common (affects less than 1 person in 10) Uncommon (affects less than 1 person in 100) Rare (affects less than 1 person in 1,000) Very rare (affects less than 1 person in 10,000) • Investigations Rare: increased triglycerides, increased liver enzymes (ALAT, ASAT)

  • 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; bradycardia (in patients with hypertension or angina pectoris); worsening of pre-existing heart failure (in patients with hypertension or angina pectoris)
    • Nervous system disorders
    Common: dizziness, headache
    • Eye disorders
    Rare: reduced tear flow (to be considered if the patient uses contact lenses) Very rare: conjunctivitis
    • Ear and labyrinth disorders
    Rare: hearing disorders
    • 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 as nausea, vomiting, diarrhoea, constipation Skin and subcutaneous tissue disorders Rare: hypersensitivity reactions such as itching, flush, rash Very rare: alopecia. Beta-blockers may provoke or worsen psoriasis or induce psoriasis- like rash.
    • Musculoskeletal and connective tissue disorders
    Uncommon: muscle weakness, muscle cramps
    • Vascular disorders
    Common: feeling of coldness or numbness in the extremities, hypotension especially in patients with heart failure
    • General disorders
    Common: asthenia (in patients with chronic heart failure), fatigue Uncommon: asthenia (in patients with hypertension or angina pectoris)
    • Hepatobilary disorders
    Rare: hepatitis
    • Reproductive system and breast disorders
    Rare: potency disorders
    • Psychiatric disorders
    Uncommon: depression, sleep disorders Rare: nightmares, hallucinations Applies only to patients with 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. Tell your doctor if you notice any of the side effects listed above or any other unwanted or unexpected effects. To prevent serious reactions, speak to a doctor immediately if a side effect is severe, occurred suddenly, or gets worse rapidly.
Contraindications

BetacorTM must not be used in patients with:

  • acute heart failure or during episodes of heart failure decompensation requiring intravenous therapy with substances increasing the contractility of the heart,
  • shock induced by disorders of cardiac function (cardiogenic shock),
  • severe disturbances of atrioventricular conduction (second or third degree AV block) without a pacemaker,
  • sick sinus syndrome,
  • sinoatrial block,
  • slowed heart rate, causing symptoms (symptomatic bradycardia),
  • decreased blood pressure, causing symptoms (symptomatic hypotension),
  • severe bronchial asthma or severe chronic obstructive pulmonary disease,
  • severe forms of peripheral arterial occlusive disease or Raynaud's syndrome,
  • untreated tumours of the adrenal gland (phaeochromocytoma),
  • metabolic acidosis,
  • hypersensitivity to bisoprolol or to any of the excipients (see Composition).
Drug Interactions

The effect and tolerability of medicines can be influenced by simultaneous intake of other medication. Such interactions can also occur if a short time has elapsed since the use of the other medication. Tell your doctor if you are taking any other medicine - even those not prescribed to you by a doctor.

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. 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. Use in children: There is insufficient experience with bisoprolol in children, therefore the use of Betacor cannot be recommended for children. Use in Pregnancy: 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. Use in lactation: 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.
Over Dosage

The most frequent signs of Betacor overdose include slow heart rate (bradycardia), marked drop in blood pressure, acute heart failure, hypoglycaemia and bronchospasm. In the case of suspected Betacor overdose please inform your doctor immediately. The effect of overdose may vary from one person to the next and patients with heart failure are probably very sensitive. Depending on the degree of overdose your doctor can then decide which measures to take. In general, if overdose occurs, bisoprolol treatment is stopped and supportive and symptomatic treatment is provided. Limited data suggest that bisoprolol is hardly dialysable.

Pharmaceutical Precautions

Betacor 5: Do not store above 30o C. Betacor 2.5: Do not store above 25o C. Keep medicines out of the reach of children.

Commercial Pack

Betacor 2.5: Each box contains 3X10 tablets in Alu-PVDC blister pack. Betacor 5: Each box contains 3X10 tablets in Alu-PVDC blister pack.


Source: http://www.popular-pharma.com/product_details.php?gid=61&type=pharma


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