Active substanceXylometazolineXylometazoline
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  • Dosage form: & nbspfromnasal
    Composition:

    Active substance: xylometazoline hydrochloride 1.0 mg.

    Excipients: sodium dihydrogenphosphate dihydrate 2.0 mg, sodium hydrogen phosphate dodecahydrate 2.8 mg, sodium chloride 5.0 mg, benzalkonium chloride 0.05 mg, sorbitol (70% solution) 14.0 mg, disodium edetate dihydrate 0.5 mg, levomenthol (menthol) 0.3 mg, cineole (eucalyptol) 0.2 mg, macrogol glyceryl hydroxy stearate (cremophor RH 40) 2.5 mg, purified water to 1.0 ml.

    Description:

    Colorless, clear liquid with a smell of menthol and eucalyptus.

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

    R.01.A.A.07   Xylometazoline

    Pharmacodynamics:

    Alpha-adrenomimetic. causes narrowing of the blood vessels of the mucous membrane of the nasal cavity, eliminating the edema and hyperemia of the mucous membrane of the nasopharynx. Relieves nasal breathing in rhinitis.

    Xylenium is well tolerated by patients with a sensitive mucosa of the nasal cavity, since the drug has a balanced pH, characteristic of the nasal cavity.

    The menthol and eucalyptol contained in the preparation have a cooling effect on the mucosa of the nasal cavity, giving a feeling of freshness.

    In therapeutic concentrations, it does not irritate the mucous membrane of the nasal cavity, does not cause hyperemia.

    Pharmacological action occurs in a few minutes and lasts for several hours.

    Pharmacokinetics:

    With topical application is practically not absorbed, the concentrations in the blood plasma 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,

    - eustachyte,

    - otitis media (to reduce edema of the nasopharyngeal mucosa),

    - Preparation of the patient for diagnostic manipulations in the nasal passages.

    Contraindications:

    Hypersensitivity to the drug components, arterial hypertension, tachycardia, severe atherosclerosis, glaucoma, atrophic rhinitis, fructose intolerance, surgical interventions on the meninges (in the anamnesis), condition after transsphenoidal hypophysectomy, pregnancy, children under 6 years.

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

    Carefully:Diabetes mellitus, prostatic hyperplasia, hyperthyroidism, porphyria, the period of breastfeeding, diseases of the cardiovascular system, including coronary heart disease, pheochromocytoma, patients with hypersensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, pressure.
    Pregnancy and lactation:

    During pregnancy, the use of the drug is contraindicated.

    During the period of breastfeeding, the drug should be used only after a thorough assessment of the risk-benefit ratio for the mother and infant, it is not allowed to exceed the recommended dosage.

    Dosing and Administration:

    Intranasally.

    Adults and children over 6 years of age: 1 injection in each nasal passage 3 times a day; Do not use more than 3 times a day.

    Duration of treatment - no more than 7 days without consulting a doctor.

    During the introduction of the drug, the bottle should be kept up by the sprayer, and after injection it is recommended to breathe lightly.

    Side effects:

    Classification of incidence of adverse reactions: very often (≥1 / 10), often (≥1 / 100 - <1/10), infrequently (≥1 / 1000 - <1/100), rarely (≥1 / 10000 - <1 / 1000), very rarely (<1/10000), including individual messages.

    From the immune system: very rarely - a hypersensitivity reaction (angioedema, rash, itching).

    From the nervous system: often - headache; rarely - insomnia, depression (with prolonged use in high doses); very rarely - anxiety, fatigue, hallucinations and convulsions (mainly in children).

    From the sense organs: very rarely - a violation of the clarity of visual perception.

    From the side of the cardiovascular system: rarely - a feeling of palpitation, increased blood pressure; very rarely - tachycardia, arrhythmia.

    From the respiratory system: often - irritation and / or dryness of the mucous membrane of the nasopharynx, burning, tingling, sneezing, hypersecretion of the mucous membrane of the nasopharynx; rarely - edema of the mucous membrane of the nasal cavity, bleeding from the nose.

    From the digestive system: often - nausea; rarely vomiting.

    Local Reactions: often - burning in the place of application. Benzalkonium chloride, which is part of the drug, can cause irritation of the mucous membrane of the nasal cavity.
    Overdose:

    In case of an overdose or accidental ingestion of the drug, the following symptoms: dizziness, increased sweating, a sharp decrease in body temperature, headache, bradycardia, increased blood pressure, respiratory depression, coma and convulsions. Following the increase in blood pressure, there may be a sharp decrease in blood pressure.

    Treatment: symptomatic. Observe the patient for several hours.In case of severe poisoning with cardiac arrest, resuscitation should last at least 1 hour.

    Interaction:Incompatible with monoamine oxidase inhibitors and tricyclic antidepressants.
    Special instructions:

    It is not recommended to apply in continuous mode for more than 7 days, as with a prolonged use, the development of symptoms of nasal congestion is possible.

    Prolonged use or excess of recommended doses can lead to reactive hyperemia of the nasal mucosa, difficulty in nasal breathing and drug-induced rhinitis and / or atrophy of the mucous membrane of the nasal cavity.

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

    The drug does not affect the ability to drive vehicles or equipment.

    With prolonged use with excess of recommended doses, it is impossible to exclude the possibility of its systemic action. In such cases, care should be taken when driving vehicles or working with equipment.

    Form release / dosage:

    Nasal spray, 0,1%.

    Packaging:

    For 10 g in high-density polyethylene polymer bottles for nasal spray with a spray device and with a screwedProtective cover with control of the first opening.

    1 bottle with instructions for use in a pack of cardboard.
    Storage conditions:

    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 expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-003492
    Date of registration:09.03.2016 / 20.12.2017
    Expiration Date:09.03.2021
    The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia
    Manufacturer: & nbsp
    Information update date: & nbsp05.02.2018
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