Active substanceTropicamideTropicamide
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  • Dosage form: & nbspeye drops
    Composition:

    1 ml of the drug:

    Active substance: Tropicamide - 5 mg.

    Excipients: sodium nitrate 11.8 mg, nitric acid 0.48 mg, purified water 988.71 mg.

    Description:A clear, colorless solution.
    Pharmacotherapeutic group:M-holinoblokator
    ATX: & nbsp

    S.01.F.A   Holinblockers

    S.01.F.A.06   Tropicamide

    Pharmacodynamics:

    M-cholinoblocking agent. It blocks the receptors of the sphincter of the iris and ciliary muscle, causing short-term mydriasis and accommodation paralysis. Slightly increases the intraocular pressure.

    The mydriasis develops in 5-10 minutes (depending on the color of the iris and reaches a maximum after 20-45 min).

    The maximum dilatation of the pupil is 1 hour.The original diameter of the pupils is restored after 6 hours.

    Pharmacokinetics:After instillation of the drug into the conjunctival sac tropicamide is subject to insignificant systemic absorption (especially in children and the elderly).
    Indications:

    - For diagnostic purposes with ophthalmoscopy and determination of refraction after cycloplegia;

    - the dilatation of the pupil before the surgical (extraction of cataracts, operations on the retina and vitreous body) and laser operations (laser coagulation of the retina) and in cases where short-term mydriasis is required.

    Contraindications:Glaucoma (especially closed-angle), narrowing of the anterior chamber angle, increased intraocular pressure, increased sensitivity to the drug components.
    Pregnancy and lactation:The use for the treatment of pregnant and lactating mothers is only possible for the purpose of the attending physician if the expected curative effect for the mother exceeds the risk of developing possible side effects in the fetus or the baby.
    Dosing and Administration:

    To dilate the pupil, drop 1-2 drops of 0.5% solution of tropicamide 15-20 minutes before the test.

    To achieve cycloplegia, drop 6 drops of a 0.5% solution of tropicamide in 6-12 minutes.

    Side effects:

    Local: transient burning sensation in the eyes, photophobia due to dilated pupil, increased intraocular pressure. Long-term use may lead to local irritation, conjunctival hyperemia, edema and conjunctivitis.

    System: dry mouth, hyperemia and dry skin, bradycardia, followed by tachycardia and arrhythmia, dysuria, decreased tonus and motility of the gastrointestinal tract, leading to constipation; headache, vomiting, dizziness, central nervous system disorders and muscle rigidity.

    Children may develop psychotic reactions, behavioral disorders, vasomotor or cardiorespiratory collapse, the appearance of rash and bloating.

    Overdose:

    Symptoms of overdosage include dry skin (children may have a rash), blurred vision, tachycardia, arrhythmia, fever, bloating in children, convulsions, hallucinations, coordination disorders, at high doses - coma and respiratory paralysis.

    Treatment is symptomatic. In case of accidental ingestion, gastric lavage should be done.

    Interaction:

    Adrenomimetics strengthen, and m-holinomimetiki - weaken the effect of tropicamide.

    Tricyclic and tetracyclic antidepressants, phenothiazine derivatives, amantadine, quinidine, blockers of H1-histamine receptors increase the likelihood of systemic side effects of tropicamide.

    Special instructions:

    To reduce the risk of systemic side effects, it is recommended to lightly press a finger in the area of ​​the projection of the lacrimal sac at the inner corner of the eye within 1-2 minutes after instillation of the drug.

    After application of the drug, due to changes in accommodation and the width of the pupil, visual acuity can be reduced, therefore, the use of the drug is not recommended for drivers of motor vehicles and when engaging in other potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions.

    For patients using contact lenses, before using the drug, the lenses should be removed and placed back no earlier than 15 minutes after instillation of the drug.

    Form release / dosage:Eye drops 5 mg / ml.
    Packaging:

    Packing for pharmacies

    0.4 ml of preparation in a tube-dropper made of polyethylene.

    5 tubes of IVs are soldered into a block.

    1 block (No. 5), 6 blocks (No. 30) or 12 blocks (No. 60) together with instructions for use in a cardboard package.

    Packing for hospitals

    0.4 ml of preparation in a tube-dropper made of polyethylene.

    5 tubes of IVs are soldered into a block.

    12 blocks (No. 60) together with instructions for use in a pack of cardboard.

    5 packs of cardboard in a plastic bag (№ 300).

    Storage conditions:In the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:

    2 years.

    Do not use after the expiry date printed on the package. Portion packaging is intended for single use.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001093
    Date of registration:03.11.2011
    Expiration Date:03.11.2016
    The owner of the registration certificate:Pharma Stülln GmbHPharma Stülln GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspProfInform, OOOProfInform, OOORussia
    Information update date: & nbsp24.04.2018
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