Active substanceOxymetazolineOxymetazoline
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  • Dosage form: & nbspnasal spray
    Composition:

    active substance: oxymetazoline hydrochloride 0.5 mg;

    Spray nasal

    Excipients: microcrystalline cellulose and carmellose sodium (avicel RC-591) 30 mg, sodium hydrophosphate 0.975 mg, sodium dihydrogen phosphate monohydrate 5.525 mg, disodium edetate dihydrate 0.3 mg, macrogol-1450 50 mg, povidone-K29-32 30 mg, petrol alcohol 2.5 mg, flavoring lemon 1, 5 mg, benzalkonium chloride solution 17% 1.471 mg, glycerol 5 mg, purified water q.s. up to 1 ml.

    Spray nasal (chamomile)

    Excipients: microcrystalline cellulose and carmellose sodium (avicel RC-591) 30 mg, sodium hydrophosphate 0.975 mg, sodium dihydrogen phosphate monohydrate 5.525 mg, disodium edetate dihydrate 0.3 mg, macrogol-1450 50 mg, povidone-K29-32 30 mg, petrol alcohol 2.5 mg, chamomile flavor 0, 2 mg, benzalkonium chloride solution 17% 1.471 mg, glycerol 5 mg, purified water q.s. up to 1 ml.

    Description:

    Spray nasal: white or almost white gel-like suspension with a characteristic citrus smell.

    Spray nasal (chamomile): white or almost white gel-like suspension.

    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, the Afrin moisturizing spray nasal does not flow out of the nose and does not drain into the throat, as after injection into the nasal passages the spray becomes more viscous and retained by the mucous membranes of the nose is more effective than the standard aqueous solution.

    This medication contains moisturizers (glycerol and macrogol-1450), which promote moisture retention, which helps to ensure the hydration of dry or irritated nasal mucosa.

    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 to sympathomimetic agents, to any component of the drug, 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, 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, therefore, the drug should be given to pregnant or breast-feeding women only on the recommendation of the doctor 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:

    In general, the drug is well tolerated, and possible adverse events are usually mild and transient.

    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 local skin reactions.

    Overdose:

    With a significant overdose or accidental ingestion possible: nausea, vomiting, cyanosis, fever, tachycardia, arrhythmia, increased blood pressure, dyspnea, mental disorders, depression of the central nervous system (drowsiness,decrease in body temperature, bradycardia, lowering blood pressure, stopping breathing and coma).

    Treatment is symptomatic. At casual reception inside - gastric lavage, Activated carbon.

    Vasopressor drugs are contraindicated.

    Interaction:

    Slows the absorption of local anesthetic drugs, lengthens the time of 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), maprotiline 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, when properly applied 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%, nasal spray 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-001875
    Date of registration:11.10.2012 / 11.07.2017
    Expiration Date:11.10.2017
    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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