Active substanceXylometazolineXylometazoline
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  • Dosage form: & nbspnasal spray
    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 hydrogen phosphate 3.5 mg 3.5 mg

    dodecahydrate (sodium phosphate
    disubstituted twelve-water)

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

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

    Description:

    Transparent colorless or slightly yellowish tinge liquid.

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

    R.01.A.A.07   Xylometazoline

    Pharmacodynamics:

    Vasoconstrictive drug for topical application in ENT practice (decongestant).

    Xylometazoline (an imidazoline derivative) is an alpha-adrenomimetic. Causes constriction of the blood vessels of the nasal mucosa. Restores the patency of the nasal passages, quickly facilitates nasal breathing and improves the flow of discharge from the nose in rhinitis (colds) of various origins.

    The effect of the drug comes in 5-10 minutes after its application and lasts up to 10 hours.
    Pharmacokinetics:

    With topical application xylometazoline almost not absorbed, so its concentration in the blood plasma is very small (modern analytical methods are not determined).

    Indications:

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

    - sinusitis;

    - eustachiitis;

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

    - to facilitate the conduct of a rhinoscopy;

    preparation of patients for diagnostic manipulation in the nasal passages.
    Contraindications:

    - arterial hypertension;

    - tachycardia;

    - severe atherosclerosis;

    - glaucoma (closed-angle);

    - atrophic rhinitis;

    - hyperthyroidism;

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

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

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

    - increased sensitivity to xylometazoline;

    - hypersensitivity to the components of the drug (including eucalyptus oil).

    Do not use with monoamine oxidase (MAO) inhibitors and tricyclic antidepressants, as well as with other drugs that increase blood pressure.
    Carefully:

    With caution should prescribe the drug for diabetes, coronary heart disease, angina III-IV functional class, hyperplasia of the prostate, pheochromocytoma, with pregnancy and during lactation.

    Pregnancy and lactation:

    In pregnancy and lactation, the drug should be used only after a thorough assessment of the relationship between benefit to the mother and the risk to the fetus and the baby, with caution, do not exceed the recommended dosage.

    Dosing and Administration:

    Spray nasal 0.05%, 0.1%.

    Adults and children over 6 years of age - 1 (one) injection of 0.1% spray into each nostril (nasal passage) 3 times a day;

    If necessary, you can repeat the injection (no more than two injections at the same time).

    Children from 2 to 6 years - 1 (one) injection of 0.05% spray in each nostril (nasal passage) 1-2 times a day.

    Do not use the drug more than 3 times a day.

    Duration of treatment - no more than 5-7 days (without interruption).

    After completion of therapy, the drug can be re-administered only after a few days.

    The duration of the drug in children is determined by the doctor.

    Application rules:

    Remove the protective cap from the bottle. Before the first use, press the spray nozzle several times until a jet with a "cloud of fog" appears. The bottle is ready for use. When spraying, press the spray nozzle 1 time. The drug is inhaled through the nose.If possible, keep the spray bottle upright. Do not spray the spray horizontally or downward. After use, the spray bottle must be covered with a protective cap.

    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; edema of the nasal mucosa.

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

    Symptoms: decreased body temperature, bradycardia, increased blood pressure.

    Treatment: conduct symptomatic therapy.

    Interaction:

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

    Special instructions:

    Do not exceed recommended doses and apply for long time.

    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:

    In doses that exceed the recommended levels, it can affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, which requires caution.

    Form release / dosage:

    Spray nasal 0.05%, 0.1%.

    10 ml or 20 ml in plastic bottles with a spray nozzle and cap cover.
    Each vial with instructions for use is placed in a pack of cardboard.

    Packaging:plastic bottles with a sprayer (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:2 years. Do not use after the expiration date.
    Terms of leave from pharmacies:Without recipe
    Registration number:LP-000159
    Date of registration:13.01.2011
    The owner of the registration certificate:SYNTHESIS, OJSC SYNTHESIS, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp25.09.2013
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