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Film Coated Tablets
30 X 5 mg
Film Coated Tablets
30 X 10 mg
Treatment should principally be initiated gradually with low doses, which are then increased slowly. In all cases the dosage should be adjusted individually, in particular according to the pulse rate and therapeutic success.
Hypertension: The recommended dosage is 5 mg bisoprolol fumarate once daily. In milder forms of hypertension (diastolic blood pressure up to 105 mmHg) therapy with 2.5 mg once daily may be adequate. If necessary, the dosage may be increased to 10 mg once daily. Any further increase of dosage is justified only in exceptional cases. The maximum recommended dosage is 20 mg once daily.
Coronary heart disease (angina pectoris): The recommended dosage is 5 mg bisoprolol fumarate once daily. If necessary, the dosage may be increased to 10 mg once daily. Any further increase of dosage is justified only in exceptional cases. The maximum recommended dosage is 20 mg once daily.
Dosage in hepatic and/or renal insufficiency: In patients with liver or kidney function disorders of mild to moderate severity no dosage adjustment is normally required. In patients with severe kidney function disorders (creatinine clearance < 20 ml/min) and in patients with severely impaired liver function a daily dose of 10 mg bisoprolol fumarate should not be exceeded. There is only limited experience with the use of bisoprolol in dialysis patients. There are no indications of the necessity to alter the dose regimen.
Elderly people: No dose adjustment is required in elderly patients.
Children: There is no therapeutic experience with bisoprolol in children. Therefore, its use cannot be recommended for children.
The film-coated tablets are to be swallowed whole with some liquid in the morning before, during or after breakfast. Do not chew tablets.
The duration of treatment is not limited. It depends upon the nature and severity of the disease. Concor therapy should not be stopped abruptly, particularly not in patients with coronary heart disease, as this may lead to acute deterioration of the patient’s condition. If discontinuation of therapy becomes necessary, the dose should be gradually reduced (e.g. halving of the dose at weekly intervals).
For full details see prescribing information.
Hypertension, angina pectoris.
Concor must not be used in 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 dysfunction. Late stages of peripheral arterial occlusive disease or Raynaud’s syndrome. Untreated phaeochromocytoma. Metabolic acidosis. Known hypersensitivity to bisoprolol or to any of the excipients.
Concor therapy should not be stopped abruptly, particularly not in patients with coronary heart disease, as this may lead to transitory deterioration of the patient’s condition.
Concor must be used with caution in patients with hypertension or angina pectoris and accompanying heart failure.
Concor may be used only with special caution in: Diabetes mellitus with large fluctuations in blood glucose levels; 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 to allergens and the severity of anaphylactic reactions. Adrenaline does not always produce the desired therapeutic effect in these cases. First degree AV block. Prinzmetal’s angina. Peripheral arterial occlusive disease (intensification of complaints may occur especially when starting therapy). In bronchial asthma or other chronic obstructive pulmonary dysfunction that may cause symptoms, concomitant bronchodilating therapy is indicated. An increase in airway resistance may occasionally occur in asthma patients, requiring a higher dose of beta2– sympathomimetics.
General anaesthesia In patients undergoing general anaesthesia, beta-blockers reduce the incidence of arrythmia and myocardial ischemia during induction, intubation and the postoperative period. It is currently recommended that ongoing beta-blocker therapy should not be interrupted in case of surgery. The anaesthetist must be informed that the patient is being treated with betablockers as this may lead to potential interactions with other pharmaceuticals resulting in bradyarrhythmia, attenuation of reflex tachycardia, and reduced reflex reactions to compensate for blood loss. If discontinuation of beta-blocker therapy prior to surgery is necessary, treatment should be tapered gradually and be discontinued altogether about 48 hours prior to anaesthesia.
In patients with psoriasis or with a history of psoriasis, beta-blockers (e.g. bisoprolol) should only be prescribed if the risk-to-benefit ratio has been carefully weighed. In patients with phaeochromocytoma bisoprolol must not be administered until after alpha-receptor blockade. Under treatment with bisoprolol the symptoms of thyrotoxicosis may be masked. Use of Concor may give positive results in doping tests.
Cold extremities, CNS and sleep disturbances (particularly with the more lipophilic drugs), bradycardia (less with carvedilol, pindolol), exertional tiredness, bronchospasm, heart failure, hypotension, GI upset, alopecia, thrombocytopenia. Withdraw gradually in unexplained dry eyes or skin rash.
Verapamil, diltiazem, class I antiarrhythmics, amiodarone, cardiac depressant anesthetics, cardiac glycosides. Oral hypoglycemics, insulin, reserpine, ergot alkaloids. Cimetidien (with labetalol and propranolol only), indomethacin (possibly other NSAIDs), clonidine. Thyroxine, liver enzyme inducers (e.g. rifampicin, barbiturates), direct and indirect sympathomimetic amines, fluvoxamine, phenothiazines, propafenone.
Pregnancy and Lactation
Pregnancy: Bisoprolol has pharmacological effects that may cause harmful effects on pregnancy and/or the foetus/new-born infant.
In general, beta-blockers reduce placental perfusion which has been associated with intrauterine growth retardation, intra-uterine death, abortion or early labour. Adverse effects (e.g. hypoglycaemia and bradycardia) may occur in the foetus and the new-born infant. If treatment with a beta-blocker is necessary, beta1-selective beta-blockers are preferable. Bisoprolol is not recommended during pregnancy unless clearly necessary. If treatment with bisoprolol is considered necessary, utero-placental blood flow and foetal growth must be monitored. In the case of harmful effects on pregnancy or the foetus, alternative therapeutic measures should be considered. The new-born infant must be monitored closely. Symptoms of hypoglycaemia and bradycardia are generally to be expected within the first 3 days of life.
Breast-feeding: It is not known whether bisoprolol is excreted in human breast milk. Therefore, breastfeeding is not recommended during bisoprolol therapy.
Symptoms of intoxication :The most common signs of overdose with a beta-blocker are bradycardia, hypotension, bronchospasm, acute heart failure and hypoglycaemia. To date a few cases of overdose (maximum 2,000 mg) with bisoprolol have been reported in patients with hypertension and/or coronary heart disease. These patients exhibited bradycardia and hypotension. All patients recovered.
The sensitivity to high single doses of bisoprolol varies greatly between individuals. It is to be considered that patients with heart failure are probably very sensitive.
Therapy of intoxication: In general, if overdose occurs, biosoprolol treatment should be stopped and supportive and symptomatic treatment should be initiated. Limited data suggest that bisoprolol is hardly dialysable. Based on the expected pharmacological actions and recommendations for other beta-blockers, the following general measures should be carried out if clinically required. Bradycardia: Intravenous administration of atropine. If the response is inadequate, orciprenaline or another agent with positive chronotropic properties may be given cautiously. Under certain circumstances, transvenous pacemaker insertion may become necessary. Hypotension: Intravenous administration of fluids and vasopressors. Intravenous glucagon may also be useful. AV block (second or third degree): Patients should be monitored carefully and treated with orciprenaline infusions. Temporary pacemaker insertion may be necessary. Acute worsening of heart failure: Intravenous administration of diuretics, positive inotropic agents, as well as vasodilators.
Bronchospasm: Administration of bronchodilators such as orciprenaline, beta2sympathomimetics and/or aminophylline. Hypoglycaemia: Intravenous administration of glucose.