Betaxolol PMCS 20 mg
Betaxololi hydrochloridum 20 mg in 1 tablet
Beta-blocker, selective (ATC code: C07AB05)
Hypertension; ischemic heart disease (stable angina pectoris).
Betaxolol is a highly cardioselective beta-blocker of adrenergic receptors without intrinsic sympathomimetic activity (ISA). It has antihypertensive, negative inotropic and negative chronotropic effects. Betaxolol is well absorbed after oral administration with bioavailability approximately 85 %. 85–90 % is metabolised in the liver, 10–15 % is excreted in unchanged form. Betaxolol is excreted mostly through the kidneys, partly through the bile. Biological half-life is 16–20 hours.
Posology and method of administration
Treatment is initiated with 10 mg of betaxolol administered in one daily dose, ideally in the morning. If effects are insufficient, the dose may be increased up to 20 mg daily. Daily dose can be increased even up to 40 mg in specific cases for treatment of stable angina pectoris. In patients with severe renal impairment (creatinine clearance under 20 ml/min) and in patients receiving dialysis the daily dose of 10 mg should not be exceeded. Betaxolol is taken in the morning on empty stomach or with a meal and is washed down with a sufficient amount of liquid.
Hypersensitivity to betaxolol or any excipient, decompensated heart failure, cardiogenic shock, 2nd or 3rd degree AV block, sick sinus syndrome, severe sinoatrial block, bradycardia, hypotension, severe bronchial asthma or chronic obstruction pulmonary diseases (COPD), severe form of lower limb ischemia or severe Rynaud’s syndrome, pheochromocytoma (apart from the previous therapy by alpha receptor blockers), metabolic acidosis, anaphylactic reaction in anamnesis, combination with floctafenin, sultopride or MAO inhibitors (except for MAO-B inhibitors). The medicinal product should not be administered during pregnancy and lactation.
Combination with calcium antagonists of the verapamil type or some antiarrhythmics may induce bradycardia and decreased contractility. Concomitant use with centrally acting antihypertensive drugs (clonidine, methyldopa, moxonidine, rilmenidine) may result in decreased heart rate and cardiac output. Combination with calcium antagonists of the dihydropyridin type (e.g., nifedipine, amlodipine) may result in hypotension. Digitalis glycosides may lead to a delayed transmission of cardiac excitation resulting in slower heart rate.
Vertigo, headaches, feelings of cold or insensitive limbs, hypotension, bradycardia, diarrhoea, nausea, abdominal pain, depression, sleeping disorders, impotence, asthenia, hair loss, skin allergy reaction.
Special warnings and precautions for use
Betaxolol may cover symptoms of hypoglycemia (tachycardia, palpitation, sweating) in diabetics. Prior to surgical intervention in general anaesthesia it is necessary to inform anesthesiologist of betaxolol treatment. Betaxolol treatment must be terminated by downtitrating the dose.
For more detailed product information, see the Summary of Product Characteristics
Contents of container
10, 20, 30, 50, 60, 90 or 100 tablets of 20 mg each