Active substanceTimololTimolol
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  • Dosage form: & nbspeye drops
    Composition:
    Each 5 ml of the solution contains:
    Okumol 0.25%
    Active substance: timolol maleate, equivalent to timolol 12.5 mg
    Okumol 0.5%
    Active substance: timolol maleate equivalent to timolol 25.0 mg
    Excipients: benzalkonium chloride, sodium dihydrogen phosphate; sodium hydrogen phosphate; sodium disulfite, water for injection.
    Description:
    Transparent, colorless or slightly yellowish solution.
    Pharmacotherapeutic group:Antiglaucoma means β-blocker
    ATX: & nbsp

    S.01.E.D.   Beta-blockers

    S.01.E.D.01   Timolol

    Pharmacodynamics:
    A non-selective beta-adrenergic receptor blocker without sympathomimetic activity. With topical application reduces 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 h; the duration of 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 through absorption through the conjunctiva, the mucous membranes of the nose and
    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 an 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 MI-st., Acute and chronic heart failure, cardiogenic shock, dystrophic diseases of the cornea, rhinitis, hypersensitivity to the drug, children under 1 year.
    Carefully:
    Chronic obstructive pulmonary disease of the severe course, cerebrovascular insufficiency, chronic heart failure, pulmonary insufficiency, diabetes mellitus, hypoglycemia, thyrotoxicosis, myasthenia gravis, concomitant administration of other beta adrenoblockers, arterial hypotension, sinoatrial blockade.
    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 efficiency - 1 drop of 0.5% solution 2 times a day. With the normalization of intraocular pressure, the maintenance dose is 1 drop of 0.25% 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 lacrimation, 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: paresthesia, rhinitis, nasal congestion, epistaxis, lowering of blood pressure, bradycardia, bradyarrhythmia, AV blockade, heart failure, cardiac arrest; decreased myocardial contractility, chest pain, dizziness, headache, drowsiness, hallucinations, muscle weakness, impaired sexual function, decreased potency, transient cerebral circulation, collapse, depression; dyspnea,
    bronchospasm, pulmonary insufficiency; nausea, vomiting, diarrhea, allergic reactions (including urticaria).
    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).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).
    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 treatment, you should avoid wearing soft contact lenses due to the content of benzalkonium chloride preservative in the solution. 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 - for 48 hours the drug is canceled.
    Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and practicing other potentially dangerous speciesactivities that require increased concentration of attention, rapidity of psychomotor reactions and good vision (within 0.5 hours after instillation into the eye).
    Form release / dosage:
    Eye drops 0.25% and 0.5%.
    Packaging:
    5 ml or 10 ml per bottle-dropper made of polyethylene, screwed with a plastic stopper. Each vial-dropper along with the instruction for use is placed in a cardboard box.
    Storage conditions:
    List B. Store in a dark place at a temperature of no higher than + 25 ° C. Keep out of the reach of children.
    Shelf life:
    2 years. After opening the package, the drug is usable for 1 month when stored at room temperature. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N013170 / 01
    Date of registration:22.01.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:Wave Pharmaceuticals Co., Ltd.Wave Pharmaceuticals Co., Ltd. India
    Manufacturer: & nbsp
    Information update date: & nbsp02.06.2017
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