Index of drugs

Hypertension. Ischemic heart disease (angina pectoris).

1 tabl powl. contains 5 mg or 10 mg of Bisoprolol fumarate; tablets contain lactose.

Bisoprolol is a selective drug blocking β receptors₁-renergic, deprived of intrinsic sympathomimetic activity and significant cell membrane stabilizing properties. It has low affinity for β receptors₂ smooth muscle of the bronchi and vessels and to the β receptors₂ related to the regulation of metabolism. The mechanism of action in hypertension is not clear, but it is known that bisoprolol significantly reduces plasma renin activity. Used in acute conditions in patients with ischemic heart disease without chronic heart failure, it relieves cardiac function and contraction volume and, consequently, reduces ejection volume and oxygen consumption. During long-term feeding, the initially increased peripheral resistance decreases. The bioavailability of bisoprolol after oral administration is approximately 90%. Bisoprolol is approximately 30% bound to plasma proteins. In 50% it is metabolized in the liver to an inactive metabolite, which is then excreted through the kidneys; the remaining 50% of the dose is excreted unchanged by the kidneys. T_0,5 is 10-12 h and provides 24-hour efficacy when given once a day.

Hypersensitivity to bisoprolol or to any of the excipients. Acute heart failure or a period of decompensation of heart failure that requires intravenous administration of inotropic drugs. Cardiogenic shock. Atrio-ventricular block IIst. or IIIst. (without starter). Sick node syndrome. Sinus-vestibular block. Bradycardia (cardiac function before treatment <50 contractions / min). Hypotension (systolic blood pressure <90 mmHg). Severe bronchial asthma or severe chronic obstructive pulmonary disease. A severe form of obliterative peripheral artery disease or a severe form of Raynaud's syndrome. Untreated phaeochromocytoma. Metabolic acidosis.

Use with caution in patients with: hypertension or angina pectoris and concomitant myocardial insufficiency; with diabetes with significant fluctuations in blood Glucose (symptoms of hypoglycaemia may be masked, such as tachycardia, palpitations or sweating); using a strict diet; with atrioventricular block Ist; with Prinzmetal's gland; with obliterative disease of the peripheral arteries (symptoms may worsen, especially at the beginning of treatment); during desensitisation treatment (bisoprolol may increase sensitivity to allergens and increase the severity of anaphylactic reactions, and adrenaline therapy may not always produce the expected therapeutic effect); with bronchospasm, eg bronchial asthma, obstructive airway diseases (simultaneous use of bronchodilators is recommended, it may be necessary to increase the dose of β₂-adrenomimetics in patients with asthma). In patients with a history of psoriasis or psoriasis, beta-blockers can only be used after careful consideration of the benefit / risk ratio. Treatment with bisoprolol may mask the symptoms of hyperthyroidism. In patients with pheochromocytoma, bisoprolol can be used only after blocking α receptors. In accordance with current recommendations, it is recommended to keep blocking β-receptors in the perioperative period (this blockade reduces the incidence of arrhythmias and myocardial ischemia during the induction of anesthesia, intubation and in the postoperative period); inform the anesthetist that you are taking bisoprolol. If it is deemed appropriate to discontinue the treatment before the surgery, the dose should be gradually reduced and the bisoprolol should be discontinued completely 48 h before the anesthesia is planned. The use of bisoprolol in children is not recommended (lack of experience). Due to the lactose content, the drug should not be used in patients with rare inherited disorders associated with galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

Β-blockers reduce placental flow, which is associated with fetal growth retardation, intrauterine death, miscarriage or premature birth. In cases where beta blocker therapy is necessary, selective β should be used₁-adrenolityk. Bisoprolol should not be used during pregnancy unless clearly necessary; you should then monitor the blood flow through the uterus and placenta and the growth of the fetus. In case of harmful effects on pregnancy or fetus, alternative treatment should be considered. The newborn should be carefully observed for signs of hypoglycaemia and bradycardia (they usually occur within the first 3 days). It is not known whether bisoprolol is excreted in human milk. Breast-feeding is not recommended during treatment.

Common: fatigue, exhaustion, pain and dizziness, cold or limb numbness, nausea, vomiting, diarrhea, constipation. Uncommon: sleep disturbances, depression, bradycardia, atrioventricular block, worsening of cardiac output, hypotension (especially orthostatic), bronchospasm in patients with bronchial asthma or obstructive pulmonary disease, weakness or muscle spasms. Rare: increased triglycerides, nightmarish dreams, hallucinations, impaired lacrimation (important if the patient uses contact lenses), hearing impairment, allergic rhinitis, increased ALT and AST, hepatitis, hypersensitivity reactions (pruritus, temporary redness, rash) ), potency disorders. Very rare: conjunctivitis, alopecia, psoriasis or its severity, psoriasis-like rash.

Orally. Adults: individually, the starting dose is 5 mg daily (in milder forms of hypertension at diastolic pressure up to 105 mmHg 2.5 mg / day may be given). If necessary, the initial dose should be gradually increased to 10 mg daily. The maximum daily dose is 20 mg.Special groups of patients. In elderly people, patients with mild to moderate hepatic or renal dysfunction usually do not need to adjust their dosage. In patients with severely impaired hepatic function and in patients with severe renal impairment (CCr <20 ml / min), the 10 mg dose should not be exceeded once daily. There is no evidence to suggest a change in the dosage regimen in dialysis patients.Way of giving. The tablets should be taken once a day, usually at the same time each day, regardless of the meal, with a small amount of liquid. The tablets should not be chewed. The tablet can be divided into two equal doses.