Active substanceBetaxololBetaxolol
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  • Dosage form: & nbspeye drops
    Composition:

    1 ml of the solution contains:

    active substance: betaxolol hydrochloride 5.6 mg (corresponding to 5 mg betaxolol);

    auxiliary substances: sodium chloride, disodium edetate, benzalkonium chloride, sodium hydroxide, purified water.

    Description:Clear solution, colorless or slightly yellowish.
    Pharmacotherapeutic group:Anti-glaucoma - beta-blocker
    ATX: & nbsp

    S.01.E.D.02   Betaxolol

    Pharmacodynamics:

    Selective beta1-adrenoceptor without its own sympathomimetic activity. Reduces intraocular pressure, resorptive effect is expressed minimally; does not cause miosis, spasm of accommodation due to lowering the production of watery moisture, hemeralopia, the effect of "swaddling" in front of the eyes (in contrast to myotics).

    Usually the time for the onset of the effect is observed within 30 minutes (the maximum effect develops in 2 hours), the duration is 24 hours.

    Pharmacokinetics:

    Can be systemically absorbed. Connection with plasma proteins - 50%. The half-life (T1/2) - 14-22 h. It is excreted by the kidneys (15% unchanged). Permeability through the blood-brain barrier and placental barrier - low, secretion with breast milk - insignificant.

    Indications:

    Open angle glaucoma, condition after laser trabeculoplasty, increased intraocular pressure.

    Contraindications:

    Hypersensitivity, sinus bradycardia, atrioventricular block II-III degree, cardiogenic shock, decompensated chronic heart failure (also in anamnesis); children under 18 years of age (efficacy and safety not defined).

    Carefully:

    The drug should be used with caution when taking oral beta-blockers, as well as with Raynaud's syndrome, pheochromocytoma, diabetes, thyrotoxicosis.

    Pregnancy and lactation:

    In pregnancy and lactation apply in cases where the benefit exceeds the risk of side effects.

    Dosing and Administration:

    Locally. Bury in the conjunctival sac 1 drop 2 times a day; During the first month, treatment is carried out under the control of intraocular pressure.

    Side effects:

    Local Reactions: allergic reactions, temporary discomfort in the eyes (tingling and burning in the eye, lacrimation), short blurred vision, foreign body sensation, itching, skin hyperemia, conjunctiva, keratitis, anisocoria, photophobia, decreased corneal sensitivity, dry eye syndrome.

    Systemic reactions: insomnia, depressive neurosis, headache, urticaria, toxic epidermal necrolysis, bradycardia, hypotension, asthma, dyspnea.

    Overdose:

    In case of an overdose, wash eyes with warm running water.

    Interaction:

    With the simultaneous use of eye drops and beta-adrenoblockers inside - the risk of developing additive effects as from the side of intraocular pressure,and manifestations of systemic action of beta-blockers.

    Drugs that inhibit the deposition of catecholamines (reserpine), increase the risk of hypotension and / or bradycardia.

    Special instructions:

    During the period of application of the drug, contact lenses should not be worn.

    It does not affect the size of the pupil, with closed-angle glaucoma used only in combination with miotics. When transferring the patient to betaxolol After treatment with several antiglaucoma drugs, the latter are gradually phased out. With insufficient reduction of intraocular pressure simultaneously with betaxolol, you can use pilocarpine or other myotics and / or epinephrine, and / or carbanhydrase inhibitors. With prolonged use there is a decrease in sensitivity to betaxolol.

    After instillation, the bottle must be closed immediately.

    The cardiovascular system

    Special care is required in the treatment of patients who have a history of conduction disorders or heart failure.

    Diabetes

    It is necessary with special caution to prescribe beta-blockers to patients with spontaneous hypoglycemia or patients with diabetes mellitus,who receive insulin or oral hypoglycemic drugs, since beta-blockers may mask signs of acute hypoglycemia.

    Hyperthyroidism

    Beta-adrenoblockers can mask symptoms of hyperthyroidism (tachycardia), therefore, one should not abruptly cancel them if there is a suspicion of hyperthyroidism - a thyrotoxic crisis may develop.

    Respiratory system

    In patients with pulmonary disease, asthma attacks and other pulmonary complications are possible with treatment with betaxolol.

    Surgery

    Prior to the application of general anesthesia, beta-blockers should be gradually withdrawn, as they reduce the ability of the heart to respond to signals of a sympathetic nature.

    Muscle weakness

    Beta-adrenoblockers can increase the signs of muscle weakness, which are similar to the symptoms of a malignant myasthenia gravis (diplopia, ptosis, general weakness).

    Probability of allergic reactions

    Patients who have a history of atopy or acute anaphylactic reaction to various allergens may be more sensitive to repeated, accidental, diagnostic or therapeutic administration of the relevant allergens during administration of beta-adrenergic blockers and not respond to conventional doses of epinephrine,used to eliminate allergic reaction.

    Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
    Immediately after instillation of the drug, a short-term loss of vision is possible, therefore it is recommended that transport control and work with the mechanisms be performed no earlier than 15 minutes after the application of eye drops.
    Form release / dosage:Eye drops, 0,5%.
    Packaging:

    5 ml or 10 ml in a plastic bottle with a plug-in drip from polyethylene and a screwed plastic stopper, which has a ring of control of the first opening.

    Each vial with the instruction for use is placed in a cardboard box.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C, do not refrigerate, do not freeze.

    The drug should be stored in places inaccessible to children.

    Shelf life:

    2 years.

    The drug should not be used after the expiry date stated on the package.

    After opening the package, the drug is usable for 28 days.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-006484/08
    Date of registration:13.08.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:Unimed Pharma s.r.o.Unimed Pharma s.r.o. The Slovak Republic
    Manufacturer: & nbsp
    UNIMED PHARMA, s.r.o. The Slovak Republic
    Representation: & nbspUNIMED PHARMA SROUNIMED PHARMA SRORussia
    Information update date: & nbsp24.01.2017
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