Active substanceXylometazolineXylometazoline
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  • Dosage form: & nbspnasal drops
    Composition:

    Composition per ml: ......................................0,05 % ......0,1 %

    Active substance:

    Xylometazoline hydrochloride ............0.5 mg .......1.0 mg

    Excipients:

    Benzalkonium chloride .......................................0.1 mg ......0.1 mg

    Sodium chloride........................................5.0 mg ......5.0 mg

    Disodium edetate .....................................0.5 mg .....0.5 mg

    (ethylenediaminetetraacetic
    acid disodium salt
    [Trilon B])

    Sodium dihydrogen phosphate ........................6.0 mg ....6.0 mg

    dihydrate (sodium phosphate
    monosubstituted two-water)

    Sodium hydrophosphate ............................3.5 mg .. 3.5 mg

    dodecahydrate (sodium phosphate
    disubstituted twelve-water)

    Eucalyptus of a rod-shaped ...0.85 mg..0.85 mg
    leaves oil (eucalyptus oil)

    Water for injections........................................up to 1 ml

    Description:

    Transparent colorless or slightly yellowish liquid.

    Pharmacotherapeutic group:anticonvulsant - alpha-adrenomimetic.
    ATX: & nbsp

    R.01.A.A.07   Xylometazoline

    Pharmacodynamics:

    Vasoconstrictive drug for topical application in ENT practice. Xylometazoline is an alpha-adrenomimetic, causes narrowing blood vessels of the mucous membrane of the nasal cavity, eliminating its edema and hyperemia, restores the patency of nasal passages, quickly facilitates nasal breathing.

    The effect of the drug comes in a few minutes after its application and lasts up to 10 hours.
    Pharmacokinetics:

    With topical application, the drug is practically not absorbed, therefore its concentration in the blood plasma is very small (it is not determined by modern analytical methods).

    Indications:

    - acute rhinitis (including on the background of acute respiratory diseases and allergic rhinitis);

    - sinusitis;

    - otitis media (as part of combination therapy to reduce edema of the nasopharynx mucosa);

    - preparation of a patient for a rhinoscopy.

    Contraindications:

    - arterial hypertension;

    - tachycardia;

    - severe atherosclerosis;

    - glaucoma;

    - atrophic rhinitis;

    -hyperthyroidism;

    - surgical interventions on the meninges (in the anamnesis);

    - pregnancy;

    - children under 6 years old (for 0.1% solution);

    - children under 2 years old (for 0.05% solution);

    - increased sensitivity to xylometazoline.

    Do not use with monoamine oxidase (MAO) inhibitors and tricyclic antidepressants.

    Carefully:

    Carefully should prescribe the drug for diabetes, coronary heart disease, angina III-IV functional class, prostatic hyperplasia, during lactation.

    Pregnancy and lactation:

    The drug is contraindicated for use in pregnancy.

    During the period of breastfeeding, the drug should be used with caution.
    Dosing and Administration:

    Nasal drops 0.05%, 0.1%.

    Adults and children over 6 years of age are instilled with 2-3 drops of 0.1% solution in each nasal passage 3-4 times a day.

    Children from 2 to 6 years instilled a 0.05% solution of 1-2 drops in each nasal passage - 1-2 times a day. Do not use more than 3 times a day.

    Duration of treatment - no more than 3-5 days (without interruption).

    Before using the drug, unscrew the lid of the bottle and bury it in the nose by lightly pressing the bottom of the vial.

    Side effects:

    Local Reactions: with frequent and / or prolonged use - irritation and / or dryness of the mucous membrane of the nasopharynx, burning, paresthesia, sneezing, hypersecretion; rarely - swelling of the nasal mucosa.

    Systemic reactions: Vomiting, headache, palpitations, increased arterial pressure, insomnia, visual impairment, depression (with prolonged use of high doses).

    Overdose:

    Symptoms: increased dose-related side effects.

    Treatment: conduct symptomatic therapy.

    Interaction:

    It is possible to enhance the systemic effect while using monoamine oxidase inhibitors and tricyclic antidepressants.

    Special instructions:

    Before application, it is necessary to clean the nasal passages.

    Do not use more than 7 days.

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

    The drug should be used with caution in the management of vehicles and other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Nasal drops 0.05%, 0.1%.

    5 ml or 10 ml in bottles with a nozzle-dispenser and a cap screwed from plastic or in bottles-dropper polymer with a cap screwed and stopper dropper.

    Each vial with instructions for use is placed in a pack of cardboard.

    Packaging:bottle-droppers polyethylene (1) -tacks, cardboard
    vials with dispenser (1) -tacks, cardboard
    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:3 years. Do not use after the expiration date.
    Terms of leave from pharmacies:Without recipe
    Registration number:LS-002408
    Date of registration:01.12.2010
    The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp26.06.2013
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