Active substanceOxymetazolineOxymetazoline
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  • Dosage form: & nbspnasal drops
    Composition:

    1 ml of the preparation contains:

    Active substance:

    Nazivin 0,01% - Oxymetazoline hydrochloride 0.1 mg

    Nazivin 0.025% - Oxymetazoline hydrochloride 0.25 mg

    Nazivin 0.05% - Oxymetazoline hydrochloride 0.5 mg

    Excipients:

    Citric acid monohydrate 0.6093 mg

    Sodium citrate dihydrate 3.823 mg

    Glycerol (85%) 24.348 mg

    Benzalkonium chloride (50% solution) 0.100 mg

    Purified water 979.020 mg (for 0.01%); 978.870 mg (for 0.025%); 978.600 mg (for 0.05%)

    Description:
    Transparent or almost transparent, from almost colorless to slightly yellow in color solution.
    Pharmacotherapeutic group:Antitussive medication - alpha-adrenomimetic
    ATX: & nbsp

    S.01.G.A.04   Oxymetazoline

    Pharmacodynamics:

    The drug Nazivin® (oxymetazoline) has a vasoconstrictive effect. When applied locally to the inflamed mucous membrane of the nasal cavity reduces its swelling and discharge from the nose.

    Restores nasal breathing. Elimination of the edema of the mucous membrane of the nasal cavity facilitates the restoration of the aeration of the paranasal sinuses of the nasal cavity, the middle ear cavity, which prevents the development of bacterial complications (sinusitis, sinusitis, otitis media).

    With local intranasal use in therapeutic concentrations, it does not irritate and does not cause hyperemia of the mucous membrane of the nasal cavity.

    The drug starts to act quickly (within a few minutes).Duration of the drug up to 12 hours.

    The results of a double-blind, placebo-controlled study in patients with acute viral rhinitis at the age of 12-70 years showed that the use of the drug Nazivin® drops nasal 0.05% reduces the median duration of the common cold from 6 to 4 days.

    Pharmacokinetics:

    With topical intranasal application oxymetazoline does not have a systemic effect. The half-life of oxymetazoline with its intranasal administration is 35 hours. 2.1% of oxymetazoline is excreted in urine and about 1.1% with feces.

    Indications:

    - Treatment of acute respiratory diseases accompanied by a runny nose;

    - allergic rhinitis;

    - vasomotor rhinitis;

    - for restoration of drainage with inflammation of the paranasal sinuses of the nasal cavity, eustachiitis, otitis media;

    for elimination of edema before diagnostic manipulations in the nasal passages.
    Contraindications:

    - Atrophic rhinitis;

    - an angle-closure glaucoma;

    hypersensitivity to the components of the drug.

    It is recommended to adhere to recommended concentrations of the drug, intended for different age categories (see methods of use).

    Carefully:

    In patients taking monoamine oxidase inhibitors and other drugs that promote blood pressure increase up to 10 days after their use; with increased intraocular pressure, during pregnancy and lactation, with severe forms of cardiovascular diseases (hypertension, angina pectoris); with thyrotoxicosis and diabetes mellitus.

    Pregnancy and lactation:

    When used during pregnancy or breastfeeding, the recommended dosage should not be exceeded. The drug should only be used after a thorough assessment of the risk-benefit relationship for the mother and fetus.

    Dosing and Administration:

    Nasivin® 0.01%, 0.025% and 0.05% Drops are for use in the nose.

    Adults and children over 6 years of age: Use Nazivin® drops 0.05% for 1-2 drops in each nasal passage 2-3 times a day.

    Children from 1 to 6 years: Use Nazivin® drops 0.02% for 1-2 drops in each nasal passage 2-3 times a day.

    Children under 1 year old: children under 4 weeks are prescribed 1 drop of Nazivin® 0.01% in each nasal passage 2-3 times a day. From the 5th week of life and up to 1 year - 1-2 drops in each nasal passage 2-3 times a day.

    To ensure the accuracy of the dosage, the Nazivin® bottle, 0.01% drops, has a graduated dropper with the number of drops.For example, if 1 drop is prescribed, the pipette should be filled with a solution to the mark 1.

    The effectiveness of the following procedure is also proved: depending on the age of 1-2 drops 0.01% solution is applied to cotton wool and the nasal passages are wiped.

    Nasivin® 0.01%, 0.025% and 0.05% drops should be applied 3-5 days. Doses above recommended can be used only under the supervision of a doctor.

    Side effects:

    Sometimes: burning or dry nasal membranes, sneezing.

    In rare cases: after the effect of using Nazivin®, a strong sense of "stuffiness" of the nose (reactive hyperemia). Multiple overdose with local nasal use sometimes leads to such systemic sympathomimetic effects as increased heart rate (tachycardia) and increased blood pressure.

    In very rare cases anxiety, insomnia, fatigue, headaches and nausea. Prolonged continuous use of vasoconstrictive drugs can lead to tachyphylaxis, atrophy of the nasal mucosa and recurrent edema of the nasal mucosa (medicamentous rhinitis).

    Overdose:

    After a significant overdose or accidental ingestion, the following symptoms may appearsymptoms: pupillary narrowing, nausea, vomiting, cyanosis, fever, tachycardia, arrhythmia, collapse, cardiac depression, arterial hypertension, pulmonary edema, respiratory distress. In addition, mental disorders may occur, as well as depression of central nervous system functions, accompanied by drowsiness, lower body temperature, bradycardia, arterial hypotension, respiratory arrest and possible development of coma.

    In case of an overdose associated with taking the drug inside, a gastric lavage is prescribed, Activated carbon.

    Interaction:

    At simultaneous appointment of blockers MAO and tricyclic antidepressants - increase of arterial pressure.

    Co-administration of other vasoconstrictive drugs increases the risk of side effects.

    Special instructions:

    Avoid prolonged use and overdose of the drug, especially in children.

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

    After a prolonged use or intake of funds from the cold, containing oxymetazoline, in dosages exceeding the recommended, it is impossible to exclude the general effect on the cardiovascular system and the central nervous system. In these cases, the ability to drive a vehicle or equipment can be reduced.

    Form release / dosage:

    Nasal drops, 0.01%, 0.025% and 0.05%.

    Packaging:

    For Nazivin® 0.01%: 5 ml per bottle of dark glass with a lid-pipette. 1 bottle with the instruction for use is placed in a cardboard box.

    For Nazivin® 0.025% and 0.05%: 10 ml in a bottle of dark glass with a pipette cap. 1 bottle with the instruction for use is placed in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N012964 / 01
    Date of registration:21.05.2007 / 25.10.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:Merck Selbstmedikation GmbHMerck Selbstmedikation GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspDR REDDY'S LABORATORIS LTD. DR REDDY'S LABORATORIS LTD. India
    Information update date: & nbsp30.05.2018
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