Active substanceOxymetazolineOxymetazoline
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  • Dosage form: & nbspnasal spray
    Composition:

    1 ml of the preparation contains:

    active substance: oxymetazoline hydrochloride 0.5 mg;

    Excipients: disodium edetate dihydrate 0.3 mg, sodium hydrophosphate 0.975 mg, sodium dihydrogen phosphate monohydrate 5.525 mg, povidone-K29-32 30 mg, benzalkonium chloride solution 17% 1.471 mg, macrogol-1450 50 mg, benzyl alcohol 2.5 mg, microcrystalline cellulose and carmellose sodium (avicel RC-591) 30 mg, lemon flavor 1.5 mg, purified water q.s. up to 1 ml.

    Description:

    White or almost white gel-like suspension with a characteristic citrus smell.

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

    S.01.G.A.04   Oxymetazoline

    Pharmacodynamics:

    Alpha-adrenostimulating agent for topical application. Has vasoconstrictive effect. Oxymetazoline causes narrowing of the vessels of the mucous membranes of the nose, paranasal sinus and Eustachian tube, which leads to a decrease in their edema and the release of nasal breathing in allergic and / or infectious inflammatory rhinitis (runny nose).

    Due to the presence of auxiliary substances (microcrystalline cellulose and carmellose sodium and povidone-K29-32) in the drug composition, Afrin nasal spray does not flow from the nose and does not drain into the throat, since after administration in the drug nasal passages of the spray become more viscous and retained on the mucous membranes of the nose more effectively than the standard aqueous solution.

    According to clinical studies, the drug begins to act for 1 minute and the effect lasts up to 12 hours.

    Pharmacokinetics:

    When applied as a nasal spray oxymetazoline practically not detected in the blood plasma.

    Indications:

    Symptomatic therapy of rhinitis (rhinitis) of allergic and / or infectious inflammatory etiology, sinusitis, eustachiitis, hay fever.

    Contraindications:

    Hypersensitivity, atrophic rhinitis, simultaneous use of monoamine oxidase inhibitors (including the period of 14 days after their cancellation), children under 6 years of age.

    Carefully:

    Coronary artery disease, arrhythmias, chronic heart failure, severe atherosclerosis, arterial hypertension, hyperthyroidism, thyrotoxicosis, diabetes mellitus, chronic renal failure, angle-closure glaucoma, prostatic hyperplasia with clinical symptoms, pregnancy, lactation.

    Pregnancy and lactation:

    Safety of the drug in pregnant women and during lactation is not established, so the drug should be given to pregnant or breast-feeding only if the expected benefit of using the drug for the mother exceeds the potential risk to the fetus or baby.

    Dosing and Administration:

    Intranasally.

    Before each use, vigorously shake the spray bottle.

    Before the first application of the nasal spray, it is necessary to "calibrate" it by pressing the spray head several times.

    Adults and children over 6 years of age - 2-3 injections in each nasal passage with an interval of 10-12 hours. Multiplicity of application can be increased up to 3 times a day in adults. Do not exceed the specified dose.

    Side effects:

    Transient dryness and burning of the mucous membrane of the nasal cavity, dry mouth and throat, sneezing; increased blood pressure, increased anxiety, nausea, dizziness, headache, insomnia, palpitations, sleep disturbances. With prolonged use - tachyphylaxis, reactive hyperemia and atrophy of the mucous membrane of the nasal cavity. Benzalkonium chloride, which is part of the drug, can cause irritation of the mucous membranes of the nasal cavity.

    Overdose:

    With a significant overdose or accidental ingestion possible: 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; with accidental ingestion - gastric lavage, Activated carbon.

    Interaction:

    Slows the absorption of local anesthetic drugs, lengthens their action.

    Joint use with other vasoconstrictive drugs increases the risk of side effects.

    With the simultaneous use of monoamine oxidase inhibitors (including the period of 14 days after their withdrawal) and tricyclic antidepressants - increased blood pressure.

    Special instructions:

    With prolonged use (more than one week), it is possible to resume symptoms of nasal congestion. If you need to continue treatment for more than 5 days, you need to consult a doctor.Avoid contact with the eye. The drug, if used correctly and at recommended doses, does not affect the driving of vehicles and work with mechanisms, however, if such side effects, such as dizziness, occur, one should refrain from these activities.

    Form release / dosage:Spray nasal, 0,05%.
    Packaging:

    For 15 ml in a hermetically sealed plastic opaque bottle with a capacity of 23 ml with a metering device of fine atomization and a protective cap, covered with shrink film to control the first opening with the logo of the company.

    1 bottle per cardboard pack together with instructions for use.

    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 expiry date.
    Terms of leave from pharmacies:Without recipe
    Registration number:LP-001819
    Date of registration:30.08.2012 / 10.07.2017
    Expiration Date:30.08.2017
    The owner of the registration certificate:MSD Consumer Kare, Inc.MSD Consumer Kare, Inc. USA
    Manufacturer: & nbsp
    Representation: & nbspMSD Pharmaceuticals Ltd.MSD Pharmaceuticals Ltd.
    Information update date: & nbsp04.10.2017
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