Active substanceXylometazolineXylometazoline
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  • Dosage form: & nbspnasal drops
    Composition:

    In 1 ml of solution contains:

    Active substance:

    Xylometazoline hydrochloride

    0.5 mg or 1.0 mg

    Excipients:

    Benzalkonium chloride

    0.15 mg

    in terms of anhydrous

    Disodium edetate dihydrate (Trilon B)

    0.47 mg

    Potassium dihydrogen phosphate

    3.63 mg

    Sodium hydrophosphate dodecahydrate

    7.13 mg

    Sodium chloride

    9.0 mg

    Purified water

    up to 1.0 ml

    Description:

    Colorless or slightly colored transparent liquid.

    Pharmacotherapeutic group:Antitussive medication - alpha-adrenomimetic
    ATX: & nbsp

    R.01.A.A.07   Xylometazoline

    Pharmacodynamics:

    Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with alpha-adrenomimetic activity, causes narrowing of the blood vessels of the mucosa shell of the nose, thus eliminating the edema and hyperemia of the nasal mucosa, restoring the patency of the nasal passages, 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 absorbed, so its concentration, in the blood plasma, is very small (modern analytical methods are not determined).

    Indications:Applied in acute respiratory diseases with the phenomena of rhinitis (rhinitis), acute allergic rhinitis, sinusitis, with average otitis (as part of combination therapy to reduce the edema of the nasopharyngeal mucosa), to facilitate the conduct of a rhinoscopy.
    Contraindications:

    Hypersensitivity to xylometazoline, arterial hypertension, tachycardia, severe atherosclerosis, glaucoma, atrophic rhinitis, hyperthyroidism, surgical interventions on the meninges (in the anamnesis), children's age (up to 6 years - for 0.1% solution (0.001 g / ml) and up to 2 years - for 0.05% solution (0.0005 g / ml) ).

    Carefully:Pregnancy, lactation, diabetes, coronary heart disease (angina pectoris), hyperplasia, prostate, simultaneous administration of monoamine oxidase (MAO) inhibitors and tricyclic antidepressants.
    Pregnancy and lactation:In pregnancy, the drug should be used only after assessing the risk ratio for the fetus and benefit to the mother. It is not allowed to use xylometazoline during lactation without taking into account the risk for the baby and the mother's benefit.
    Dosing and Administration:

    Adults and children over 6 years of age are given 1-2 drops or 1-2 injections of 0.1% xylometazoline solution in each nasal passage 2-3 times a day: Children from 2 to 6 years of age use a 0.05% solution of 1-2 drops or 1-2 injections in each nasal passage 1-2 times a day. Do not use the drug more than 3 times a day and not more than 3-5 days.

    Side effects:

    With frequent and / or prolonged use - irritation and / or dryness, mucous membranes nasopharynx, burning, tingling, sneezing, hypersecretion; rarely - edema nasal mucosa, vomiting, headache, palpitation, increased arterial pressure, insomnia, impaired vision, depression.

    Overdose:

    Symptoms: increased side effects (dose-dependent).

    Treatment: symptomatic under the supervision of a doctor.

    Interaction:

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

    Special instructions:Do not use for a long time, for example, with chronic rhinitis.
    Effect on the ability to drive transp. cf. and fur:Xylometazoline, in dosages higher than recommended, may affect the ability to drive a vehicle or equipment. That can lead to a deterioration in the ability of driving a car and activities that require concentration and speed of psychomotor reactions.
    Form release / dosage:

    Nasal drops 0.05% and 0.1%.

    Packaging:

    10, 15, 20 or 30 ml into flasks of colorless or light-protective glass, corked with rubber stoppers under running-in with aluminum caps, or polymer stoppers with a built-in pipette, or in polymer droppers.

    Each bottle together with the instruction for use is placed in a pack of cardboard box. It is allowed to attach a pipette or a dropper cap to the pack.

    Storage conditions:At a temperature of no higher than 25 ° C. In a place inaccessible to children.
    Shelf life:3 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:LS-001334
    Date of registration:10.08.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:PHARMACY 36.6, CJSC PHARMACY 36.6, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp05.02.2018
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