Vizin® Alerji (Visine® Allergy)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceLevocabastineLevocabastine
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  • Vizin® Alerji
    drops d / eye 
    Johnson & Johnson, LLC     Russia
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    spray nazal. 
    Johnson & Johnson, LLC     Russia
    • Dosage form: & nbspeye drops
    Composition:

    Active substance: Levocabastin hydrochloride (0.54 mg / ml) in terms of levocabastine 0.5 mg / ml (0.05%);

    Excipients: propylene glycol 48.26 μl, sodium hydrophosphate 8.66 mg, sodium hydrogen phosphate monohydrate 5.38 mg, hypromellose (2910 3 mPa.s) 2.50 mg, polysorbate 80 1.00 mg, benzalkonium chloride 0.15 mg (as 50 % solution 0.03 ml), disodium edetate 0.15 mg, water for injection up to 1.0 ml.

    Description:White homogeneous suspension.
    Pharmacotherapeutic group:Anti-allergic agent-H1-histamine receptor blocker
    ATX: & nbsp

    R.01.A.C   Antiallergic drugs (excluding corticosteroids)

    R.01.A.C.02   Levocabastine

    Pharmacodynamics:

    Levokabastin is a selective blocker of H1-histamine receptors with a prolonged action. Local effect occurs within 5 minutes. Eliminates the typical symptoms of allergic conjunctivitis (itching, redness, conjunctival edema and eyelids, lachrymation). The action lasts up to 12 hours.

    Pharmacokinetics:

    After instillation in the eye at a dose of 15 μg / drop absorbed about 6 μg of levocabastine, and the maximum concentration in the blood plasma is achieved in about 6 hours. Levocabastine binds to blood plasma proteins by approximately 55%.

    The main metabolite of levocabastine, acylglucuronide, is formed in glucuronidation, which is the main pathway for the formation of metabolites.

    Levokabastin is excreted mainly by the kidneys in unchanged form (about 70 % of the absorbed amount). The half-life of levocabastine is about 39-70 hours.

    Indications:

    Allergic conjunctivitis.

    Contraindications:

    Hypersensitivity to the components of the drug, wearing contact lenses, age to 12 years, the period of breastfeeding.

    Carefully:Elderly age, impaired renal function.
    Pregnancy and lactation:

    In pre-clinical studies in animals levocabastine at systemic administration in doses up to 2500 times (in terms of mg / kg) above the recommended maximum dose for local, use in humans did not cause embryotoxic and teratogenic effects. In animals with systemic use of levocabastine in doses more than 5000 times (in terms of mg / kg) exceeding the recommended maximum dose for topical application in humans, teratogenic properties and / or increased embryo death are noted.

    There are no data on the use of levocabastine in pregnant women. Therefore, it is not recommended to apply eye drops during pregnancy, except for cases when the expected benefit for the mother exceeds the potential risk to the fetus.

    The drug penetrates into breast milk, so for the period of treatment breastfeeding should be discontinued.

    Dosing and Administration:

    Locally. For adults and children over 12 years: 1 drop in each eye twice a day (if necessary - 3-4 times a day). Treatment should continue until the symptoms disappear.

    Since the eye drops are a suspension, the vial must be shaken before each use.

    Use of a dropper bottle:

    Remove the lid from the dropper and flip the bottle.

    Do not touch the tip of the bottle before any surfaces.

    After application, screw the cap of the dropper bottle.

    Side effects:

    Undesirable effects that have been observed in patients during clinical trials.

    From the side of the organ of vision: irritation of the eyes.

    Post-marketing data

    Very often (> 1/10), often (> 1/100, <1/10) and infrequently (> 1/1000, <1/100), rarely (> 1/10000, <1/1000) and very rarely (<1/10000, including individual cases).

    From the side of the organ of vision: pain in the eye area, blurred vision (often); swelling of the eyelids (infrequently); conjunctivitis, blepharitis, eye hyperemia, burning sensation, itching, lachrymation (frequency unknown).

    Systemic reactions: angioedema, allergic reactions (the frequency is unknown); contact dermatitis, urticaria (frequency unknown), headache (often).

    Overdose:

    Symptoms

    At casual intake it is possible decrease in arterial pressure, a tachycardia, the expressed sedation.

    Treatment

    Forced diuresis.

    Interaction:

    Not studied.

    Special instructions:

    During the period of treatment, it is not recommended to use soft (hydrophilic) contact lenses - it is possible to interact with the chloride included in the preparation of benzalkonium.

    To prevent microbial contamination, avoid touching the eyelid with a pipette and close the vial tightly.

    If the medicine has become unusable or the expiration date has expired, do not dispose of it! Place the drug in a bag and put it in the trash. These measures will help protect the environment!

    Effect on the ability to drive transp. cf. and fur:

    Eye drops do not affect the speed of psychomotor reactions, can be used by patients who drive a car or work with machinery.

    Form release / dosage:

    Eye drops 0.05%.

    Packaging:

    For 4 ml of the drug in a bottle of low-density polyethylene with a drip device and a screw cap made of high-density polyethylene with control of the first opening. 1 bottle with instructions for use in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C. Eye drops should be used within one month after opening.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use the product after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N014198 / 01
    Date of registration:22.07.2011 / 10.12.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:Johnson & Johnson, LLC Johnson & Johnson, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspJohnson & Johnson LLC Johnson & Johnson LLC Russia
    Information update date: & nbsp13.02.2017
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