Active substanceXylometazolineXylometazoline
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  • Dosage form: & nbsp

    Spray nasal dosed [with menthol and eucalyptus].

    Composition:

    1 ml of the drug contains

    Active substance: xylometazoline hydrochloride 1 mg.

    Excipients: sodium dihydrogenphosphate dihydrate 2 mg, sodium hydrophosphate dodecahydrate 2,8 mg, sodium chloride 5 mg, benzalkonium chloride, 50% solution 0.1 mg (in Conversion to benzalkonium chloride 0.05 mg), sorbitol 70% 14 mg, disodium edegate 0.5 mg, levomenthol (menthol) 0.3 mg, cineole (eucalyptol) 0.2 mg, macrogol glycerol hydroxy stearate 2.5 mg, water purified to 1 ml.

    It is not recommended to use in continuous mode for more than 10 days. Notshould exceed the recommended dose, especially in children and the elderly. Long (more than 10 days) or excessive use of the drug can cause the effect of a "ricochet" (drug rhinitis).

    Description:

    White opalescent liquid with a smell of menthol and eucalyptus.

    Pharmacotherapeutic group:anticonvulsant - alpha-adrenomimetic.
    ATX: & nbsp

    R.01.A.A.07   Xylometazoline

    Pharmacodynamics:

    Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with a- adrenomimeticheskim action, causes narrowing of the blood vessels of the nasal mucosa, eliminating the edema and hyperemia of the mucous membrane of the nasopharynx. Relieves nasal breathing in rhinitis. Otrivin® is well tolerated by patients with sensitive mucous membranes, its effect does not prevent the separation of mucus. Otrivin® has a balanced pH value, characteristic of the nasal cavity. The menthol and eucalyptol contained in the preparation have a cooling effect on the nasal mucosa, giving a feeling of freshness.

    In therapeutic concentrations, the drug does not irritate the mucous membrane, it does not cause hyperemia.

    Pharmacological action occurs through several minutes and continues for 12 hours.

    Pharmacokinetics:

    With topical application practically not absorbed, concentrations in the plasma is below the detection limit.

    Indications:

    Acute respiratory diseases with 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 xylometazoline and other components drug, arterial hypertension, tachycardia, severe atherosclerosis, glaucoma, atrophic rhinitis, hyperthyroidism, condition after transsphenoidal hypophysectomy, surgical interventions on brain shells (in the anamnesis). Children's age-up 12 years.

    Carefully:

    Carefully: diabetes; diseases of the cardiovascular system; hyperplasia of the prostate; at hypersensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure. With topical application practically not absorbed, concentrations in the plasma is below the detection limit.

    Pregnancy and lactation:

    The drug should not be used during the period pregnancy. During lactation the drug should be applied only after careful assess the risk-benefit ratio for the mother and infant, under the supervision of the doctor. Do not exceed the recommended dosage.

    Dosing and Administration:

    Intranasally.

    Adults and children over 12 years of age: 1 injection in each nasal passage 3 times a day.

    Do not use more than 3 times a day.
    Side effects:

    Classification of incidence of adverse reactions:

    very often (> = 10); often (> = 1/100, <1/10); infrequently (> = 1/1000, <1/100); rarely (> = 1/10000, <1/1000); very rarely (<1/10000).

    From the immune system:

    Very rarely: hypersensitivity reactions (angioedema, rash, itching);

    From the nervous system:

    Often: headache;

    Rarely: insomnia, depression (with prolonged use in high doses).

    From the sense organs:

    Very rarely: 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.

    From the side of the digestive system: Often: nausea.
    Rarely: vomiting.

    Local reactions:

    Often: burning in the place of application.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:

    Symptoms: increased side effects, inIn particular, the increase in heart rate, increase blood pressure, sometimes can confusion is observed.

    Treatment is symptomatic, under the supervision of a doctor.

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

    It is not recommended to use incontinuous mode for more than 10 days. Not should exceed the recommended dose, especially in children and the elderly.Long (more than 10 days) or excessive use of the drug can cause the effect of a "ricochet" (drug rhinitis).

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

    Xylometazoline does not affect the ability to drive vehicles or equipment.

    Form release / dosage:

    Spray nasal dosed [with menthol and eucalyptus] 0.1%.

    Packaging:For 10 ml of the drug in a vial of high-density polyethylene, equipped with a pump dosing device with a tip and a protective cap made of polyethylene. The bottle together with the instruction for use is placed in a cardboard box.
    Storage conditions:

    At a temperature not higher than 25 ° C, out of the reach of children.

    Shelf life:

    2.5 years. Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N011649 / 05
    Date of registration:11.09.2008
    The owner of the registration certificate:Новартис Консьюмер Хелс САНовартис Консьюмер Хелс СА Switzerland
    Manufacturer: & nbsp
    Representation: & nbspNOVARTIS CONSUMER HELS S.A. (part of Novartis groups) NOVARTIS CONSUMER HELS S.A. (part of Novartis groups) Switzerland
    Information update date: & nbsp10.10.2013
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