Active substanceTimololTimolol
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  • Dosage form: & nbspeye drops
    Composition:
    In 1 ml of the drug contains:
    Timolol 0.25%
    Active substance: timolol maleate 3.4 mg (corresponding to 2.5 mg timolol) Timolol 0.5%
    Active ingredient: timolol maleate 6.8 mg (corresponding to 5.0 mg timolol)
    Excipients: disodium phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, disodium edetate dihydrate, sodium chloride, benzalkonium chloride, sodium hydroxide, purified water.

    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 local adaptation lowers the intraocular pressure, by reducing the formation of watery moisture a small 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.
    Pharmacokinetics:
    Timolol maleate quickly penetrates through the cornea into the tissues of the eye. In an insignificant amount enters the systemic bloodstream by absorption through the conjunctiva, the mucous membranes of the nose and the lacrimal tract. 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 miotics).

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

    Carefully:
    chronic obstructive pulmonary disease of severe course, sinoatrial block, arterial hypotension, childhood, especially the period of neonatal (contains benzalkonium chloride), cerebrovascular insufficiency, chronic cardiac insufficiency, diabetes mellitus,
    hypoglycaemia, thyrotoxicosis, myasthenia gravis, simultaneous administration of other beta-blockers.

    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:

    Newborns and children under 10 years old instilled in 1 drop of 0.25% solution 2 times a day.

    Adults and children over 10 years of age Bury in the conjunctival a bag of 1 drop of 0.25% solution 2 times a day, with insufficient efficiency - 1 drop of 0.5% solution 2 times a day. When normalization of intraocular pressure maintenance dose - 1 drop of 0.25% solution once a day.

    Side effects:
    Local reactions: hyperemia of the skin of the eyelids. burning and itching in the eyes, conjunctival hyperemia, lacrimation or a decrease in tearing, photophobia, corneal epithelial edema, W / 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: paresthesia, rhinitis, nasal congestion, epistaxis, lowering of arterial pressure, bradycardia, bradyarrhythmia. AV blockade, heart failure, cardiac arrest; decreased myocardial contractility, chest pain, dizziness, headache, drowsiness, hallucinations, muscle weakness,violation of sexual functions, decreased potency, transient impairment of cerebral circulation, collapse, depression; shortness of breath, bronchospasm, pulmonary insufficiency; nausea, vomiting, diarrhea, allergic reactions (including urticaria), ringing in the ears, * slowing the speed of psychomotor reactions ..


    Overdose:
    When topical application in the recommended dose, the symptoms of an overdose were not noted. At casual intake it is possible development of following signs: a nausea, vomiting, a giddiness, a headache, depression of arterial pressure, a bronchospasm, a 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.

    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 AV 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). When using local anesthetics, one should take into account the possibility of increasing the risk of their unwillingness to influence the cardiovascular system. With caution appoint simultaneously
    hypotensive drugs, glucocorticosteroids, psychoactive drugs (LS). During treatment it is not recommended to take ethanol (possibly a sharp drop in blood pressure). It can not be used simultaneously with tranquilizers.

    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, the function of lacrimation, the integrity of the cornea, and the field of vision should be monitored.
    During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration of attention, rapidity of psychomotor reactions and good vision (within 0.5 hours after instillation into the eye).
    The composition of the drug is benzalkonium chloride (preservative), which can be deposited on the surface of soft contact lenses. In this regard, during the period of treatment is not recommended to use soft contact lenses.
    Rigid 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 canceled.

    Form release / dosage:
    Eye drops 0.25% and 0.5%.
    To 5 ml in a plastic bottle with a stopper-dropper and a screw-on protective cap provided with a safety ring.
    1 bottle with instructions for use in a cardboard box.

    Packaging:
    Eye drops 0.25% and 0.5%.
    To 5 ml in a plastic bottle with a stopper-dropper and a screw-on protective cap provided with a safety ring.
    1 bottle with instructions for use in a cardboard box.

    Storage conditions:
    In a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:
    In closed original packaging: 3 years
    After opening the bottle: 4 weeks
    Do not use after the expiration date printed on the package. from
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-000022
    Date of registration:28.03.2007
    The owner of the registration certificate:K.O. Ромфарм Компани С.Р.Л.K.O. Ромфарм Компани С.Р.Л. Romania
    Manufacturer: & nbsp
    Representation: & nbspРомфарма ОООРомфарма ООО
    Information update date: & nbsp31.08.2015
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