Active substanceTimololTimolol
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  • Dosage form: & nbspeye drops
    Composition:
    1 ml of the solution contains:
    Active substance:
    Timolola maleate, 2.5 mg or 5.0 mg
    in terms of basis
    Excipients:
    Sodium hydrogen phosphate dodecahydrate 8.35 mg
    Sodium dihydrogen phosphate dihydrate 1.56 mg
    Sodium chloride' 3.75 mg
    Disodium edetat (TrilonB) 0.2 mg
    Benzalkonium chloride 0.1 mg
    Water for injections Up to 1 ml

    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 blocker of beta-adrenergic receptors without SMA. With topical application lowers the intraocular pressure by reducing the formation of watery moisture and a small increase in its outflow. Reducing intraocular pressure, does not affect the accommodation and the size of the pupil, so there is no deterioration in visual acuity; does not reduce the quality of night vision. The effect manifests itself 20 minutes after instillation. The maximum effect is observed after 1-2 hours. Duration 24 hours.

    Pharmacokinetics:Timolol maleate quickly penetrates the cornea into the tissues of the eye; In an insignificant amount gets into the systemic bloodstream by absorption, through conjunctiva, mucous nasal and tear duct. Excretion of metabolites by the kidneys.In newborns and young children, the concentration of the active substance is significantly higher than its Cmax in adult plasma.
    Indications:
    Open angle glaucoma, secondary glaucoma (uveal, aphakic, posttraumatic), acute ophthalmotonus, closed-angle glaucoma (in combination with mystics); congenital glaucoma (with ineffectiveness of other therapeutic measures).

    Contraindications:
    Bronchial asthma, sinus bradycardia, AV blockade of II-III st., Acute and chronic heart failure, cardiogenic shock, dystrophic diseases of the cornea,
    rhinitis;
    hypersensitivity to the components of the drug.

    Carefully:, COPD severe, course, arterial hypotension, Ch cerebrovascular insufficiency, chronic heart failure, diabetes mellitus, hypoglycemia, thyrotoxicosis, myasthenia gravis, concomitant administration of other beta-. adrenoblockers, lactation period, children under 18 years of age (due to the lack of data on the efficacy and safety of the drug in children and adolescents under 18 years), peripheral circulation disorders (including Raynaud's syndrome), pheochromocytoma, pregnancy
    Pregnancy and lactation:
    According to the doctor's prescription, timolol can be used during pregnancy and during breastfeeding, unless the expected therapeutic effect for the mother justifies the potential risk to the fetus and the baby.

    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 efficiency - 1 drop of 0.5%

    Side effects:
    Local reactions: hyperemia of the skin of the eyelids, burning and itching in the eyes, hyperemia of the conjunctiva, lacrimation or a decrease in teardrop, photophobia, edema of the epithelium of the cornea, short-term disturbance of 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, ptosis is possible, occasionally diplopia.
    Systemic reactions: paresthesia, rhinitis, nasal congestion, epistaxis, bronchospasm, pulmonary insufficiency; nausea, vomiting, diarrhea, allergic reactions (including urticaria).

    Overdose:
    When. local »application of the recommended dose of overdose symptoms were not noted.With accidental ingestion, the following symptoms may develop: nausea, vomiting, dizziness, headache, lowering of arterial pressure, bronchospasm, bradycardia. In case of symptoms of overdose, treatment is symptomatic. Isoprenaline can be administered intravenously to eliminate severe bradycardia or bronchospasm, dobutamine for the treatment of arterial hypotension.
    Treatment: immediately flush eyes with water or 0.9% solution of sodium chloride.

    Interaction:
    Epinephrine, pilocarpine; systemic beta-blockers increase the effect.
    -When applied with reserpine, it is possible to develop severe bradycardia or hypotension (this combination requires careful medical supervision); with calcium channel blockers or, cardiac (glycosides - possibly a violation of AV conduction, acute, left ventricular failure or arterial hypotension.
    Strengthens the effect of muscle relaxants (timolol should be canceled for '48' h to
    the proposed conduct of general anesthesia using peripheral muscle relaxants).

    Special instructions:
    Control of effectiveness should be done approximately, 3-4 weeks after the start of therapy.During the treatment period, at least once every 6 months, the function of lacrimation, the integrity of the cornea, and the field of vision should be monitored. At least once a month, measure intraocular pressure.
    Contact lenses should be removed before instillation and wear not earlier than
    15 minutes after it.
    Do not bother with 2 beta-blockers at the same time.
    With prolonged use of timolol, the effect may be weakened. ' ,
    When transferring patients to treatment with timolol, correction of refraction may be necessary.
    Before the forthcoming surgical intervention with the application of general anesthesia within 48 hours, the drug should be discontinued.
    Effect on the ability to drive transp. cf. and fur:Take care when driving a car '1 and taking other potentially dangerous activities that require increased concentration of attention, speed of psychomotor reactions (within 30 minutes after instillation into the eye).
    Form release / dosage:
    Eye drops 0.25% and 0.5%.
    5 ml or 10 ml in bottles of neutral glass or imported I or II hydrolytic class, hermetically sealed with rubber stoppers, crimped with aluminum caps.By 5 ml or 10 ml in the bottles-droppers made of polymer materials.
    1 glass bottle or a dropper with instructions for use are placed in a pack of cardboard. 1 glass bottle with instruction for use complete with a lid-dropper polyethylene placed in a pack of cardboard.

    70 glass bottles or flasks-droppers with an equal number of instructions for use are placed in a box (for hospitals).


    Packaging:
    5 ml or 10 ml in bottles of neutral glass or imported I or II hydrolytic class, hermetically sealed with rubber stoppers, crimped with aluminum caps. By 5 ml or 10 ml in the bottles-droppers made of polymer materials.
    1 glass bottle or a dropper with instructions for use are placed in a pack of cardboard. 1 glass bottle with instructions> for use complete with a lid-dropper polyethylene placed in a pack of cardboard.

    70 glass bottles or flasks-droppers with an equal number of instructions for use are placed in a box (for hospitals).


    Storage conditions:

    At a temperature not exceeding 30 ° C in a place inaccessible to children.

    Shelf life:
    3 years. 'Do not use after the expiration date printed on the package. Shelf life after opening the bottle is 30 days.

    Terms of leave from pharmacies:On prescription
    Registration number:P N000229 / 01
    Date of registration:22.11.2011
    The owner of the registration certificate:LENS-PHARM, LLC LENS-PHARM, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp31.08.2015
    Illustrated instructions
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