Active substanceXylometazolineXylometazoline
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  • Dosage form: & nbspSpray nasal with the aroma of camphor and menthol
    Composition:

    Active substance: xylometazoline hydrochloride 0.100 g

    Excipients: benzyl alcohol - 0.250 g, benzalkonium chloride - 0.010 g, disodium edetate dihydrate (Trilon B) 0.015 g, racemic camphor (camphor synthetic) 0.005 g, levomenthol 0.008 g,povidone K-17 0.250 g, microcrystalline cellulose and 4,000 g of carmellose sodium, macrogol 400 21.500 g, sodium dihydrogen phosphate dihydrate 0.750 g, disodium hydrogen phosphate dodecahydrate (in terms of 100% substance) 0.150 g, purified water 100 , 0 g.

    Description:

    Opaque, white gel-like or liquid mass with a very slight smell of camphor and menthol and thixotropic properties (thickens at rest and is liquefied by shaking), which is in a vial sealed with a dispenser pump equipped with a spray nozzle with a protective cap. The drug is dispensed from the vial through the spray nozzle in the form of an aerosol cloud, which is a viscous liquid dispersed in a gaseous medium.

    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. The drug facilitates nasal breathing due to reduction of edema and hyperemia of the mucous membrane of the nasal cavity, and also improves the discharge of excreta.Relieves nasal breathing in rhinitis.

    The effect of the drug comes in a few minutes after its application. After introduction into the nasal cavity due to auxiliary substances, its viscosity increases, it lingers on the mucous membrane of the nasal cavity, not extending to the lower respiratory tract, and remains active. Due to this the drug lasts up to 24 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, sinusitis, hay fever; eustachiitis, otitis media (as part of combination therapy to reduce edema of the nasopharynx mucosa); Preparation of the patient for diagnostic manipulation in the nasal passages.

    Contraindications:

    Hypersensitivity to xylometazoline or any other component of the drug, arterial hypertension, tachycardia, severe atherosclerosis, glaucoma, atrophic rhinitis, surgical interventions on the meninges (in the anamnesis),inflammatory diseases of the skin or mucous membrane of the vestibule of the nose, hyperthyroidism, condition after transsphenoidal hypophysectomy, pregnancy, children under 6 years.

    Do not use with monoamine oxidase (MAO) inhibitors (including 14 days after their withdrawal), and tricyclic and tetracyclic antidepressants, other local vasoconstrictors (decongestants), as well as with other drugs that increase blood pressure.

    Carefully:

    Diabetes mellitus, prostatic hyperplasia, the period of breastfeeding, diseases of the cardiovascular system, including ischemic heart disease (angina pectoris), porphyria, pheochromocytoma, patients with hypersensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, blood pressure.

    Pregnancy and lactation:

    During pregnancy, the use of the drug is contraindicated.

    During the period of breastfeeding, the drug can be used only if the potential benefit to the mother exceeds the potential risk for the child.

    Dosing and Administration:

    Intranasally.

    Before each use, shake vial vigorously. Remove the protective cap. Before using the dosing device for the first time, press it several times until the aerosol cloud appears. Insert the tip into the nostril and press the dosing device, taking a deep breath with the nose, without having to tilt the head back. Then repeat the procedure by inserting the tip into the other nostril. After use, wipe off the tip clean and cover the bottle with a protective cap.

    The drug is prescribed for 1 injection in each nasal passage 1-2 times a day.

    Do not apply the drug for more than 5-7 days.

    Side effects:

    Classification of incidence of adverse reactions: very often (≥1 / 10), often (≥1 / 100 and <1/10), infrequently (≥1 / 1,000 and <1/100), rarely (≥1 / 10,000 and <1/1 000), very rarely (<1/10 000).

    From the immune system: very rarely - the reaction of hypersensitivity (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 cardiovascular system: rarely - palpitations, 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 and swelling of the mucous membrane of the nasal cavity.

    Overdose:

    Symptoms: In case of an overdose or accidental ingestion, the following symptoms may develop: nausea, vomiting, cyanosis, fever, significant decrease in body temperature, dizziness, increased sweating, headache, bradycardia, tachycardia, arrhythmia, followed by a decrease in arterial pressure pressure, dyspnea, respiratory depression, coma, convulsions.In young children, overdose often dominates the central effects with convulsions, coma and bradycardia, apnea.

    Treatment: symptomatic, the patient should be monitored for several hours. At casual reception inside - gastric lavage, reception of the activated coal.

    Interaction:

    The simultaneous use of xylometazoline with monoamine oxidase (MAO) inhibitors and tricyclic and tetracyclic antidepressants may lead to an increase in blood pressure.

    Special instructions:

    Before application, it is necessary to clean the nasal passages.

    Do not use more than 5-7 days. Prolonged use (more than 7 days) can lead to reactive hyperemia of the mucous membrane of the nasal cavity and atrophy of the nasal mucosa. Do not exceed recommended doses. Benzalkonium chloride, which is part of the drug, can cause irritation and swelling of the mucous membrane of the nasal cavity. Avoid contact with eyes.

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

    When xylometazoline is used in dosages exceeding the recommended dosage, visual impairment can not be ruled out,the possibility of systemic action on the cardiovascular system. In this case, deterioration of the ability to drive vehicles and mechanisms is possible. Care must be taken when driving vehicles and mechanisms.

    Form release / dosage:

    Spray nasal with the aroma of camphor and menthol, 0.1%.

    Packaging:

    For 10 g, 15 g or 20 g in glass bottles made of light-protective glass with a screw neck.

    Each vial is sealed with a dosing pump. Components of the dosing pump are made of polyoxymethylene, low density polyethylene, polypropylene and stainless steel. The dosing pump is equipped with a spray nozzle for nasal injection of polypropylene with a protective cap made of low density polyethylene.

    Each vial with the drug, sealed with a dosing pump, together with a spray nozzle and a protective cap, as well as instructions for medical use, are placed in a pack of cardboard.

    Storage conditions:

    At a temperature of 15 to 25 ° C. Do not chill or freeze.

    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-004832
    Date of registration:03.05.2018
    Expiration Date:03.05.2023
    The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia
    Manufacturer: & nbsp
    Information update date: & nbsp28.05.2018
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