Active substanceXylometazolineXylometazoline
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  • Dosage form: & nbspnasal drops
    Composition:

    1 ml of the preparation contains:

    Quantity for ................................0,05 % ...0,1 %

    Active substance:

    Xylometazoline hydrochloride........ 0.5 mg .... 1 mg

    Excipients:

    Disodium Edetate................................. 0.5 mg .... 0.5 mg

    Sodium hydrogen phosphate dihydrate..... .. 2 mg...... 2 mg

    Sodium dihydrogen phosphate dihydrate ... 2 mg......... 2 mg

    Sodium chloride.......................... ..... 7,4 mg.... 7.3 mg

    Benzalkonium chloride in the form

    solution of benzalkonium 10%.......... ... 0.1 mg .... 0.1 mg

    Purified water..................... ... 991.5 mg .. 991.1 mg

    Description:Transparent colorless liquid.
    Pharmacotherapeutic group:anticonvulsant - alpha-adrenomimetic
    ATX: & nbsp

    R.01.A.A.07   Xylometazoline

    Pharmacodynamics:

    Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with alpha-adrenomimetic action, causes narrowing of the blood vessels of the mucous membrane of the nasal cavity, thus eliminating the edema and hyperemia of the nasopharyngeal mucosa. Relieves nasal breathing in rhinitis.

    In therapeutic concentrations, it does not irritate the mucous membrane of the nasal cavity, does not cause its hyperemia. The action comes in a few minutes and lasts for 10-12 hours.

    Pharmacokinetics:With topical application is practically not absorbed, plasma concentrations are so small that they can not be determined by modern analytical methods.
    Indications:

    Acute respiratory diseases with phenomena of rhinitis (rhinitis), acute allergic rhinitis, pollinosis, sinusitis, eustachitis, otitis media (to reduce edema of the nasopharyngeal mucosa).

    Preparation of the patient for diagnostic manipulation in the nasal passages.

    Contraindications:

    Hypersensitivity to the drug components, arterial hypertension, tachycardia, severe atherosclerosis, glaucoma, atrophic rhinitis, thyrotoxicosis, surgical interventions on the meninges (in the anamnesis), pregnancy, children under 2 years of age (for Kzymelin 0.05%); children's age to 6 years (for Ximelin 0.1%).

    Carefully:FROM caution: diabetes mellitus, angina pectoris of III-IV functional class, prostatic hyperplasia.
    Pregnancy and lactation:During lactation the drug should only be used after a thorough evaluation of the ratio of benefit to mother and risk to the child, it is not allowed to exceed the recommended dose.
    Dosing and Administration:

    Intranasally.

    0.05% drops for children from 2 to 6 years: 1-2 drops per each nasal passage 1-2 times a day; Do not use more than 3 times a day.

    0.1% drops for adults and children over 6 years of age: 2-3 drops in each nasal passage (if necessary, repeat); Do not use more than 3 times a day.

    The drug is applied no more than 7 days.

    Side effects:

    With frequent and / or prolonged use - irritation and / or dryness of the mucous membrane of the nasopharynx, burning, paresthesia of the mucous membrane of the nasal cavity, sneezing, hypersecretion of the mucous membrane of the nasal cavity.

    Rarely - edema of the nasal mucosa, palpitations, tachycardia, arrhythmias, increased blood pressure, headache, vomiting, insomnia, impaired vision; depressionapplication of high doz).

    Overdose:

    Symptoms: increased blood pressure changing to lower blood pressure, bradycardia, lower body temperature.

    Treatment: symptomatic.

    Interaction:

    Incompatible with monoamine oxidase inhibitors and tricyclic antidepressants.

    Special instructions:

    Before applying the drug, it is necessary to clean the nasal passages.

    Do not exceed the recommended dosage alone and use the drug for more than 7 days. If after this time the symptoms persist, is necessary see a doctor.

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

    The drug in recommended doses does not affect the ability to drive a vehicle or equipment that requires an increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Nasal drops 0.05% and 0.1%.

    For 10 ml of the drug in a bottle-dropper from low-density polyethylene. The bottle is closed with a screw cap made of polypropylene.One bottle together with the instruction for use is placed in a cardboard box.

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

    At a temperature of 15-25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N015643 / 01
    Date of registration:23.03.2009
    The owner of the registration certificate:Nycomed Denmark APSNycomed Denmark APS Denmark
    Manufacturer: & nbsp
    Representation: & nbspNycomed Distribution Ltd.Nycomed Distribution Ltd.
    Information update date: & nbsp22.08.2011
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