Betaxolol PMCS 20 mg

Basic information

Composition

Betaxololi hydrochloridum 20 mg in 1 tablet

Pharmacotherapeutic group

Beta-blocker, selective (ATC code: C07AB05)

Therapeutic indications

Hypertension; ischemic heart disease (stable angina pectoris).

Pharmacological properties

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.

Pharmaceutical form

Tablets

More information

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.

Contraindications

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.

Interactions

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.

Undesirable effects

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

Availability

The product can only be obtained with a prescription. The package of 100 tablets is fully covered, and the package of 30 tablets is partly covered by health insurance.

Contents of container

10, 20, 30, 50, 60, 90 or 100 tablets of 20 mg each

Package available in the Czech Republic

30 or 100 tablets of 20 mg each;

SPC and PIL

Manufacturer and marketing authorisation holder

PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic

Date of revision of the text

16 January 2020

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