Active substanceXylometazolineXylometazoline
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  • Dosage form: & nbspnasal spray
    Composition:

    Composition per ml:

    Active substance: xylometazoline hydrochloride 0.50 mg or 1.00 mg; Excipients: disodium edetate (Trilon B) 0.50 mg, sodium chloride 9.00 mg, benzalkonium chloride 0.15 mg, potassium dihydrogen phosphate 3.63 mg, sodium hydrogen phosphate dodecahydrate 7.13 mg, purified water up to 1 ml.

    Description:transparent colorless or slightly colored liquid.
    Pharmacotherapeutic group:anticonvulsant - alpha-adrenomimetic
    ATX: & nbsp

    R.01.A.A.07   Xylometazoline

    Pharmacodynamics:

    Xylometazolium belongs to the group local vasoconstrictor (decongestants) with alpha-adrenomimetic activity, causes narrowing of blood vessels mucous membrane of the nasal cavity, thus eliminating the edema and hyperemia of the mucous membrane of the cavity nose, restores the patency nasal passages, facilitates nasal breath.

    The effect of the drug comes through several 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:

    Applied with acute respiratory diseases with the phenomena of rhinitis (rhinitis), acute allergic rhinitis, sinusitis, with average otitis (as part of combination therapy to reduce edema of the nasopharyngeal mucosa). Preparation of the patient for diagnostic manipulation in the nasal passages.

    Contraindications:

    Hypersensitivity to xylometazoline and other components drug, arterial hypertension, tachycardia, severe atherosclerosis, glaucoma, atrophic rhinitis, shells (in the anamnesis), conditions after transsphenoidal hypophysectomy, children's age (up to 2 years - for 0.05 % spray, up to 6 years for 0.1 % of the spray), pregnancy.

    Do not use with monoamine oxidase inhibitors and tricyclic antidepressants (including the period of 14 days after their withdrawal).

    Carefully:

    Diabetes mellitus, hyperthyroidism, pheochromocytoma, diseases of the cardiovascular system (including ischemic disease heart), hyperplasia prostate, lactation. Patients from increased sensitivity to adrenomimetics, accompanied by symptoms insomnia and dizziness.

    Pregnancy and lactation:

    During pregnancy, the use of the drug is contraindicated.

    During lactation, the drug should only be used as directed by the doctor, after a thorough assessment of the risk-benefit relationship for the mother and child. Do not exceed the recommended dosage.

    Dosing and Administration:

    Intranasally.

    Spraying is carried out after removing the protective cap from the sprayer. The atomizer is injected into the nose and, pressing on its base, is sprayed for 1 second.

    For adults and children over the age of 6 years (0.1% spray): one injection from the nebulizer into each nasal passage, usually 3-4 injections per day is usually enough; Do not use more than 3 times a day.

    For children aged 2 to 6 years (0.05% spray), one injection from the nebulizer into each nasal passage 1 or 2 times a day; Do not use more than 3 times a day.

    Do not apply the drug without interruption for more than 3-5 days.
    During the introduction of the drug, the bottle should be kept up by the spray gun!

    Side effects:With frequent and / or long-term use - irritation and / or dryness of the mucous membrane of the nasopharynx, burning and paresthesia of the nasal mucosa, sneezing, hypersecretion of the mucous membrane of the nasal cavity; edema of the nasal mucosa, vomiting, headache, palpitations, increased blood pressure, tachycardia, arrhythmia, insomnia, visual impairment, depression (with prolonged use of high doses). Benzalkonium chloride, which is part of the drug, can cause irritation of the mucous membrane of the nasal cavity.
    Overdose:

    In case of overdose or accidental admission preparation inside possible development following symptoms: nausea, vomiting, cyanosis, fever, tachycardia, arrhythmia, increased blood pressure, shortness of breath, mental disorders, depression of the central nervous system (drowsiness, lower body temperature, bradycardia, lowering blood pressure, stopping breathing and coma). Treatment: symptomatic; at casual reception inside - gastric lavage, reception of the activated coal.

    Interaction:

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

    Special instructions:

    Do not use for long time (more than 7 days), for example, with chronic rhinitis. Avoid contact with eyes (the drug has an effect on the eyesight).

    With prolonged use (more one week), renewal is possible. symptoms of nasal congestion.

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

    In case of development of systemic by-products effects (headache, sensation heartbeat, increased blood pressure pressure, visual impairment), it is necessary to refrain from managing transport means and employment of other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Spray nasal 0.05% and 0.1%.

    For 10, 15, 20 or 30 ml in plastic bottles.

    Each bottle together with the activator is supplied with a protective cap and instructions for use in a pack of cardboard.

    Packaging:plastic bottles (1) / complete with activator / -tacks cardboard
    Storage conditions:

    At a temperature of 2 to 25 ° C. Keep out of the reach of children.

    Shelf life:

    2 years. Do not use the drug after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-002214
    Date of registration:02.09.2013
    The owner of the registration certificate:PHARMSTANDART-FORESTRY, OJSC PHARMSTANDART-FORESTRY, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp14.02.2014
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