Active substanceOxymetazolineOxymetazoline
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  • Dosage form: & nbspnasal dosing spray
    Composition:


    100 ml contains:

    1 dose contains:

    active substance:

    oxymetazoline

    hydrochloride

    0,05 g

    0,025 mg

    Excipients:

    benzalkonium chloride

    0,02 g

    0,01 mg

    macrogol 400

    7,5 g

    3,75 mg

    povidone

    0,4 g

    0,2 mg

    propylene glycol

    7,5 g

    3,75 mg

    sodium hydrogen phosphate dihydrate

    0,006 g

    0,003 mg

    sodium dihydrogen phosphate dihydrate

    0.65 g

    0.325 mg

    disodium edetate dihydrate

    0,1 g

    0,05 g

    hydrochloric acid.

    0,003 g

    0,0015 g

    purified water

    86.571 g

    43.2855 mg

    Description:

    A clear, colorless, odorless solution.

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

    S.01.G.A.04   Oxymetazoline

    Pharmacodynamics:

    Oksimetazolin belongs to the group of alpha-adrenostimulators for topical application. Has vasoconstrictive effect. With intranasal administration reduces the swelling of the mucous membrane of the upper respiratory tract, which leads to the relief of nasal breathing and the opening of the mouth of the paranasal sinuses and Eustachian tubes. The effect of the drug manifests itself 10-15 minutes after application and lasts for 10-12 hours.

    Indications:

    To facilitate nasal breathing with "cold" diseases and viral infections of the upper respiratory tract, sinusitis, rhinitis of any etiology.

    Contraindications:

    Hypersensitivity to the drug or its components, atrophic rhinitis, zakratougolnaya glaucoma, severe atherosclerosis, conditions after transsphenoidal hypophysectomy, concurrent use of monoamine oxidase inhibitors (including the period of 14 days after their withdrawal), children under 6 years of age, pregnancy, lactation.

    Carefully:

    Patients with diseases of the cardiovascular system (arterial hypertension, coronary heart disease, chronic heart failure, tachycardia, arrhythmias), a violation of carbohydrate metabolism (diabetes mellitus), hyperthyroidism, pheochromocytoma, chronic renal failure, prostatic hyperplasia (urinary retention), with increased intraocular pressure, taking tricyclic antidepressants.

    Pregnancy and lactation:

    Application during pregnancy and breastfeeding is possible only if the intended benefit to the mother exceeds the possible risk to the fetus or baby.

    Dosing and Administration:

    Intranasally.

    1 dose contains 0.025 mg of oxymetazoline hydrochloride.

    Adults and children over 12 years of age - 2-3 doses in each nasal passage 2 times a day.

    Children from 6 to 12 years old - 1 dose in each nasal passage 2 times a day.

    Do not use the drug more than 2 times a day.

    Duration of treatment

    It is not recommended to use the drug for more than 3 days. With frequent or prolonged use of the drug, a feeling of difficulty in nasal breathing may reappear or worsen. If these symptoms appear, discontinue treatment and consult a doctor.

    When injecting, do not tilt the head back and do not spray in the "lying" position.

    Side effects:

    Burning or dryness of the mucous membrane of the nasal cavity, dryness in the oral cavity and throat, sneezing, increase in the volume of secret secretion from the nasal cavity. After the effect of using the drug, a strong sense of "stuffiness" of the nose (reactive hyperemia).

    Side effects caused by the systemic effect of the drug: increased blood pressure, headache, dizziness, palpitations, anxiety, nausea, insomnia. With prolonged use of the drug (more than 7 days) are possible: reactive hyperemia of the nasal mucosa, atrophy of the nasal mucosa, tachyphylaxis (rapid reduction of the therapeutic effect with repeated 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: nausea, vomiting, cyanosis, fever, tachycardia, arrhythmia, increased blood pressure, dyspnea, mental disorders, central nervous system depression (drowsiness, lower body temperature, bradycardia, lowering blood pressure, stopping breathing and coma).

    Treatment - symptomatic; at casual reception inside - gastric lavage, reception of the activated coal.

    Interaction:

    When used simultaneously with MAO inhibitors (including the period within 14 days after their cancellation) and tricyclic antidepressants, an increase in blood pressure may be observed. The drug slows the absorption of local anesthetic drugs, lengthens their action. Co-administration of other vasoconstrictor drugs increases the risk of side effects.

    Special instructions:

    In the recommended dosage without consulting a doctor, use no more than 3 days.

    Avoid contact with eyes.The drug has an effect on vision, possibly reducing the reaction rate.

    To avoid the spread of infection, it is necessary to use the drug individually. With prolonged use (more than one week), it is possible to update the symptoms of nasal congestion.

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

    During treatment, one should refrain from driving vehicles and practicing other potentially hazardous activities requiring increased concentration or speed of psychomotor reactions, as the drug may cause dizziness and other side effects that may affect these abilities.

    Form release / dosage:

    Spray nasal dosed, 0.025 mg / dose.

    Packaging:

    For 10 ml (150 doses) in a vial of high-density polyethylene with a dispenser, a polypropylene sprayer and a polyethylene protective cap. A label is attached to the bottle.

    The bottle, along with instructions for medical use, is placed in a cardboard box.

    Storage conditions:At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N013208 / 01
    Date of registration:13.08.2010 / 18.05.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:BAYER, AO BAYER, AO Russia
    Manufacturer: & nbsp
    Representation: & nbspBAYER, AOBAYER, AO
    Information update date: & nbsp30.05.2018
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