Active substanceXylometazolineXylometazoline
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  • Dosage form: & nbsptoApli nasal
    Composition:In 1 ml of the drug contains:

    active substance: xylometazoline hydrochloride - 0.5 or 1.0 mg;

    Excipients: benzalkonium chloride 0.15 mg; disodium edetate 0.50 mg; potassium dihydrogen phosphate - 3.63 mg; sodium hydrogen phosphate dodecahydrate - 7.13 mg; sodium chloride - 9.00 mg; purified water - up to 1 ml.

    Description:Pcolorless or slightly yellowish liquid.
    Pharmacotherapeutic group:The anticongestive agent is a vasoconstrictor (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 nasal mucosa, thus eliminating the edema and hyperemia of the nasal mucosa, restoring the nasal passages, facilitating nasal breathing.

    The effect of the drug comes in a few minutes after its application and lasts up to 8-10 hours.

    Pharmacokinetics:

    With topical application, the preparation is practically not absorbed, therefore its concentrations in the blood plasma are very small (they are not determined by modern analytical methods).

    Indications:

    Acute respiratory diseases with the phenomena of rhinitis (rhinitis), acute allergic rhinitis, sinusitis, pollinosis, eustachitis, otitis media (as part of combination therapy to reduce edema of the nasopharyngeal mucosa), preparation of the patient for diagnostic manipulation (rhinoscopy).

    Contraindications:

    - Hypersensitivity to xylometazoline and other components of the drug;

    - children under 2 years old for applying 0.05% solution;

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

    - pregnancy;

    - arterial hypertension, tachycardia;

    - severe atherosclerosis;

    - glaucoma;

    - atrophic rhinitis;

    - thyrotoxicosis;

    - condition after transsphenoidal hypophysectomy;

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

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

    Carefully:

    This drug can be used only after careful weighing of risk factors and benefits when:

    - Cardiovascular diseases (coronary heart disease, angina pectoris III-IV functional class);

    - pheochromocytoma;

    - hyperthyroidism;

    - diabetes mellitus;

    - porphyria;

    - hyperplasia of the prostate;

    - in the period of breastfeeding;

    - with increased sensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure.

    Pregnancy and lactation:

    The use of the drug during pregnancy is contraindicated.

    The use of the drug in the period of breastfeeding is possible for the prescriber's appointment, if the expected therapeutic effect of the mother exceeds the risk of development of possible side effects in the child.

    Dosing and Administration:

    Intranasally.

    Adults and children over 6 years of age: for 1-2 drops of 0.1% xylometazoline solution in each nasal passage 2-3 times a day.

    Children aged 2 to 6 years: apply 0.05% a solution of xylometazoline 1-2 drops in each nasal passage 1-2 times a day.

    Do not use the drug more than 3 times a day. Do not apply the drug without interruption for more than 5-7 days.

    Side effects:

    When assessing the incidence of various adverse reactions, the following grades are used: very often: more than 10%; often - 1-10%; infrequently, 0.1-1%; rarely - 0,01-0,1%; very rarely - less than 0.01%; the frequency is unknown (it is not possible to determine the frequency of occurrence from the available data).

    On the part of the respiratory system, the organs of the thorax and the mediastinum

    Often: burning and dryness of the nasal mucosa, sneezing, hypersecretion.

    Infrequently: after using the drug, there may be increased edema of the nasal mucosa (reactive hyperemia), bleeding from the nose.

    From the immune system

    Infrequently: reactions of hypersensitivity (angioedema, skin rash, urticaria).

    From the side of the cardiovascular system

    Rarely: palpitation, tachycardia, increased blood pressure.

    Rarely: arrhythmia.

    From the central nervous system

    Rarely: anxiety, insomnia, fatigue (drowsiness, sedation), headache, paresthesia, hallucinations (mainly in children), depression (with prolonged use of high doses).

    From the digestive system

    Often: nausea.

    Rarely: vomiting.

    From the musculoskeletal and connective tissue

    Rarely: convulsions (mainly in children).

    From the sense organs

    Rarely: impaired vision.

    If any of the side effects listed in the instructions are aggravated or you notice other side effects (not listed in the instructions), inform the doctor about it.
    Overdose:

    In case of an overdose or accidental ingestion of the drug, the following symptomsDizziness, sweating, sudden drop in body temperature, headache, bradycardia, arrhythmia, tachycardia, 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.

    In young children, overdose often dominates the central effects with convulsions, coma and bradycardia, apnea, as well as an increase in blood pressure, which follows the hypotension.

    Interaction:

    Simultaneous reception of xylometazoline and tri- or tetracyclic antidepressants, monoamine oxidase inhibitors such as tranylcypromine, drugs that increase blood pressure, may lead to an increase in blood pressure, so simultaneous reception of these medications should be avoided.

    Special instructions:

    The drug should not be used without a break for more than 7 days. Do not exceed the recommended dosage.

    With prolonged use and overdose of xylometazoline, the therapeutic effect may be weakened, and the risk of reactive hyperemia (drug rhinitis) and atrophy of the nasal mucosa may increase.

    The preparation contains benzalkonium chloride, which can cause irritation and swelling of the nasal mucosa.

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

    In therapeutic doses does not affect the ability to drive a car and to control machinery.

    When developing unwanted reactions, it is advisable to take care when performing actions that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Nasal drops, 0.05% and 0.1%.

    Packaging:

    For 10 or 15 ml in polyethylene bottles, hermetically sealed with stoppers, droppers and caps screwed.

    Each bottle, together with the instructions for use, is placed in a pack of cardboard.

    Storage conditions:

    In the dark place at a temperature of 2 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003616
    Date of registration:12.05.2016
    Expiration Date:12.05.2021
    The owner of the registration certificate:Firm VIPS-MED, LLC Firm VIPS-MED, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp05.02.2018
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