Active substanceTimololTimolol
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  • Dosage form: & nbspeye drops
    Composition:
    per 1.0 ml of the preparation:
    Timolol-Betalek 0.25%
    Active ingredient: timolol maleate (based on base) 25 mg Timolol-Betalec 0.5%
    Active substance: timolol maleate (in terms of base) 50 mg
    Excipients: benzalkonium chloride, disodium edetate, sodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, water for injection.

    Description:
    Clear, colorless liquid

    Pharmacotherapeutic group:Antiglaucoma means β-blocker.
    ATX: & nbsp

    S.01.E.D.   Beta-blockers

    S.01.E.D.01   Timolol

    Pharmacodynamics:
    Non-selective beta-adrenergic blocker without internal sympathomimetic activity. With topical application lowers the intraocular pressure, by reducing the formation of watery moisture and a slight increase in its outflow. The effect manifests itself 20 minutes after instillation, the maximum effect - after 1-2 hours; the duration of the action is 24 hours. It does not affect the accommodation and the size of the pupil.

    Pharmacokinetics:
    Timolol maleate quickly penetrates through the cornea into the tissues of the eye. The maximum concentration in the moisture of the anterior chamber is achieved after 1-2 hours.In an insignificant amount enters the systemic bloodstream by absorption through the conjunctiva, the mucous membranes of the nose and the lacrimal tract. The maximum concentration (C max) in the blood plasma is determined in a few minutes after instillation. About 60-80% is metabolized in the blood plasma. Excretion of metabolites - mainly with urine. In newborns and young children, the concentration of the active substance is significantly higher than its C max in adult plasma.

    Indications:
    Open angle glaucoma, closed angle glaucoma (in combination with mystics), secondary glaucoma (uveal, aphakic, post traumatic), congenital glaucoma (with ineffectiveness of other therapeutic measures, in preparation for surgery), ophthalmic hypertension.

    Contraindications:
    Bronchial asthma, chronic obstructive pulmonary diseases, sinus bradycardia, atrioventricular blockade of the II-III stage, acute and chronic heart failure, cardiogenic shock, dystrophic diseases of the cornea, atrophic rhinitis, hypersensitivity to the drug components.

    Carefully:
    Emphysema of the lungs, pulmonary insufficiency,
    cerebrovascular insufficiency, chronic heart failure, diabetes mellitus, hypoglycemia, thyrotoxicosis, myasthenia gravis, simultaneous administration of other beta-blockers, Raynaud's syndrome, pheochromocytoma.


    Pregnancy and lactation:
    In pregnancy, the drug is used if the expected benefit to the mother exceeds the potential risk to the fetus. During the use of the drug, breastfeeding should be discontinued.

    Dosing and Administration:
    Adults and children older than 1 year instilled in the conjunctival sac 1 drop 0.25% solution 2 times a day, with insufficient effectiveness - 1 drop of 0.5% solution 2 times a day. The difference in the severity of the action of 2 concentrations is 10-15%.

    Side effects:
    Hyperemia of the skin of the eyelids, burning and itching in the eyes, conjunctival hyperemia, lacrimation or reduction of teardrop, photophobia, corneal epithelial edema, short-term visual acuity; blepharitis, conjunctivitis, with prolonged use, it is possible to develop a surface point keratopathy (decrease the transparency of the cornea) and decrease the sensitivity of the cornea, it is possible ptosis, rarely - diplopia.
    Systemic reactions:
    From the cardiovascular system: lowering blood pressure, bradycardia,
    bradyarrhythmia, cardiac conduction abnormalities, heart failure, cardiac arrest; decreased myocardial contractility, chest pain, transient cerebral circulation disorders
    On the part of the respiratory system: dyspnea, bronchospasm, pulmonary insufficiency;
    From the side of the central nervous system: Paresthesia, dizziness, headache, drowsiness, hallucinations, muscle weakness;
    From the gastrointestinal tract: nausea, vomiting, diarrhea;
    Allergic reactions: urticaria, eczema, exacerbation of psoriasis;
    Other: rhinitis, nasal congestion, epistaxis, decreased potency, alopecia.
    Overdose:
    Overdose
    When topical application in the recommended dose, the symptoms of an overdose were not noted. With the occasional ingestion, the following symptoms may develop: nausea, vomiting,
    dizziness, headache, lowering blood pressure, bronchospasm, bradycardia. In case of symptoms of overdose, treatment is symptomatic. To eliminate severe bradycardia or bronchospasm, it is possible to inject isoprenaline 1-4 g IV for 10 minutes, to treat arterial hypotension - dobutamine 200-400 mcg iv. For cupping bronchospasm apply atropine.

    Interaction:
    Epinephrine, pilocarpine, systemic beta-blockers increase the effect. When used with reserpine - it is possible to develop severe bradycardia or hypotension (this combination requires careful medical supervision); with calcium channel blockers or cardiac glycosides - there may be a violation of atrioventricular conduction, acute
    left ventricular failure or arterial hypotension. Strengthens the effect of muscle relaxants (timolol should be discontinued 48 hours before the proposed general anesthesia using peripheral muscle relaxants). It can not be used simultaneously with antipsychotic drugs (neuroleptics) and anxiolytic drugs (tranquilizers). During treatment it is not recommended to take ethanol (possibly a sharp drop in blood pressure.
    Beneficial combinations (strengthening of the hypotensive effect):
    Sympathomimetics, myotics, prostaglandin analogues F2a, inhibitors of carbonic anhydrase
    Special instructions:
    Control of efficacy should be performed approximately 3-4 weeks after the start of therapy.During the treatment period, at least once every 6 months, one should control the production of tears, the state of the corneal epithelium, the field of vision.
    Immediately after instillation, visual acuity may decrease and the speed of mental reactions slow down, so you should be careful when driving at night. Contact lenses should be removed before instillation and put on not earlier than 15 minutes after it.
    Do not bother with two beta-blockers at the same time.
    With prolonged use of timolol, tachyphylaxis may develop.
    When transferring patients to treatment with timolol, correction of refraction may be necessary.
    Before the forthcoming surgery with the use of general anesthesia, the drug is canceled within 48 hours.

    Form release / dosage:
    Eye drops 0.25% and 0.5%.
    For 10 ml in a bottle-dropper polymer with a screw cap polymer coating with the control of the first autopsy. 1 bottle-dropper per pack of cardboard.

    Packaging:
    Eye drops 0.25% and 0.5%.
    For 10 ml in a bottle-dropper polymer with a screw cap polymer coating with the control of the first autopsy. 1 bottle-dropper per pack of cardboard.

    Storage conditions:
    List B.
    In a dry place, protected from light, out of reach of children, at a temperature not exceeding 25 ° C.
    Shelf life:
    2 years. Shelf life after opening the bottle is 14 days. Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-002282/07
    Date of registration:17.08.2007
    The owner of the registration certificate:BETA-LEK, LLC BETA-LEK, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp31.08.2015
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