1 tabl powl. contains 5 mg or 10 mg of Bisoprolol fumarate.
Action:
Cardioselective drug ß1-adrenolytic, deprived of intrinsic sympathomimetic activity and stabilizing properties of cell membranes. It has little effect on ß receptors2-renergic in bronchi and vessels and has minimal effect on Glucose and lipid metabolism. The mechanism of hypotensive action is not explained, it is known that bisoprolol significantly reduces renin activity in plasma. In patients with ischemic heart disease, bisoprolol relieves cardiac function, decreases ejection volume and oxygen requirement of myocardium. After oral administration, bisoprolol is almost completely absorbed from the gastrointestinal tract. It has a slight first-pass effect, therefore the bioavailability is around 90%. Plasma proteins are approximately 30% bound. It is metabolized in the liver and excreted in the urine, including 50% in the form of metabolites. T0,5 is 10-12 h, the effect is maintained for 24 h after a single administration.
Contraindications:
Hypersensitivity to bisoprolol or other ingredients. acute heart failure or during decompensation episodes requiring intravenous inotropic medication. Cardiogenic shock. Atrio-ventricular block IIst. or IIIst. (in patients without a pacemaker). Sick node syndrome. Sinus-vestibular block. Bradycardia. Hypotension. Severe bronchial asthma or severe chronic obstructive pulmonary disease. Late stage of atherosclerotic peripheral arteriosclerosis or Raynaud's syndrome. Untreated phaeochromocytoma. Metabolic acidosis.
Precautions:
Use with caution in patients with circulatory insufficiency, diabetes mellitus with high fluctuations in blood Glucose, atrioventricular block Ist, Prinzmetal angina, peripheral arterial occlusive disease, thyrotoxicosis, inhaled anesthetic agents, or during desensitisation therapy . In patients with a history of psoriasis or psoriasis, ß-blockers may only be used after careful consideration of the benefits in relation to the risk. In patients with pheochromocytoma, the drug can be used only after the administration of α-blockers. Patients with bronchial asthma or other diseases with bronchospasm should be given concomitant bronchodilators. No experience in the use of the preparation in children - use in this age group is not recommended.
Pregnancy and lactation:
The drug should not be used during pregnancy unless it is absolutely necessary. Bisoprolol may interfere with the normal course of pregnancy and / or cause disorder in the fetus or newborn. Beta blockers reduce placental flow, which may cause fetal growth retardation, fetal death, miscarriage or premature birth. In the fetus and newborn, bisoprolol may cause hypoglycaemia, bradycardia. The newborn should be under strict control. You should not breast-feed while using bisoprolol.
Side effects:
Common: pain and dizziness, feeling freezing or numbness in the extremities, nausea, diarrhea, vomiting, constipation, fatigue. Uncommon: depression, sleep disturbances, atrioventricular conduction disorders, worsening of heart failure, bradycardia, hypotension, bronchospasm (in patients with bronchial asthma or obstructive pulmonary disease), muscle weakness and spasms. Rare: increased blood triglycerides, nightmares, hallucinations, decreased tear secretion, impaired hearing, allergic rhinitis, hepatitis, skin hypersensitivity reactions (redness, rash, pruritus), impaired potency, increased ALT and AST. Very rare: conjunctivitis, alopecia areata, psoriasis, exacerbation of existing psoriasis, psoriasis-like rash.
Dosage:
Orally. Adults: individually, the starting dose is usually 5 mg per day. If necessary, the initial dose should be gradually increased to 10 mg daily.The maximum daily dose is 20 mg. Patients with severe renal impairment (creatinine clearance <20 ml / min) or liver should not exceed 10 mg daily. The tablets should be taken once a day, in the morning, with or without food, with a small amount of liquid. The tablets should not be chewed.
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