Active substanceNaphazolineNaphazoline
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  • Dosage form: & nbspnasal drops
    Composition:

    Composition of the preparation per 1 ml:

    Active substance:

    0,05 %

    0,1 %

    Naphazoline nitrate (naphthysine)

    0.5 mg

    1.0 mg

    Excipients:

    Boric acid

    20 mg

    Sea water

    5 mg

    0.1 M sodium hydroxide solution

    to pH 4.5 - 6.0

    Water for injections

    up to 1 ml

    Description:

    Transparent, colorless or slightly colored liquid.

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

    A.01.A.A.08   Naphazoline

    Pharmacodynamics:Alfa2-adrenomimetic, has a rapid, pronounced and prolonged vasoconstrictive action against the vessels of the nasal mucosa (reduces swelling, flushing, exudation). Relieves nasal breathing in rhinitis. After 5-7 days there is tolerance.
    Pharmacokinetics:

    With topical application, systemic absorption is low. The vasoconstrictive effect comes in a few minutes and lasts for several hours.

    Indications:

    Acute rhinitis, allergic rhinitis, sinusitis, eustachitis.

    To facilitate the conduct of a rhinoscopy.

    Contraindications:

    Hypersensitivity to the drug components, arterial hypertension, severe atherosclerosis, hyperthyroidism, chronic rhinitis, severe eye diseases, diabetes mellitus, tachycardia, concomitant use of monoamine oxidase inhibitors and up to 14 days after the end of their use, age to 2 years (for 0.05% solution), age to 15 years (for 0.1% solution).

    Carefully:

    Ischemic heart disease (angina pectoris), prostatic hyperplasia, pheochromocytoma, pregnancy, the period of breastfeeding.

    Pregnancy and lactation:

    Use for treatment of pregnant women and during breastfeeding is possible only if the expected benefit to the mother exceeds the potential risk to the fetus and the baby.

    Dosing and Administration:

    Apply intranasal (in each nasal passage).

    Adults and children over 15 years are prescribed 1-3 drops of 0.05-0.1% solution of the drug 3-4 times a day.

    Children use 0.05% solution: from 2 to 6 years - 1-2 drops, from 6 to 15 years - 2 drops 1 -3 times a day.

    For diagnostic purposes - after cleaning the nose in each nasal drip drop 3-4 drops or insert a swab soaked in a 0.05% solution and leave for 1-2 minutes.

    In rhinitis treatment should not exceed 5-7 days in adults and not more than 3 days in children.

    Side effects:

    From the central nervous system: headache.

    From the cardiovascular system: tachycardia, increased blood pressure, reactive hyperemia.

    From the digestive system: nausea.

    Local reactions: irritation, swelling of the nasal mucosa, when used for more than 1 week - swelling of the nasal mucosa, atrophic rhinitis.

    Overdose:

    Symptoms: decrease in body temperature, bradycardia, increased blood pressure.

    Treatment: symptomatic.

    Interaction:

    Do not use simultaneously with monoamine oxidase inhibitors or within 14 days after the end of their use.

    Slows the absorption of local anesthetic drugs (lengthens their action in the conduct of surface anesthesia).

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

    Special instructions:

    May have a resorptive effect.

    With prolonged use, the severity of the vasoconstrictor effect gradually decreases (the phenomenon of tachyphylaxis),in connection with which it is recommended after 5-7 days of use to take a break for several days.

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

    Not found.

    Form release / dosage:

    Nasal drops, 0.05% and 0.1%.

    Packaging:

    To 5, 10 or 15 ml in a bottle with a dropper of low-density polyethylene and a lid with a control of the first opening or in a bottle-dropper made of high-density polyethylene, complete with a cap screwed and stopper-dropper.

    For 1 bottle of 5, 10 or 15 ml or 3 bottles of 5 ml, along with instructions for use in a pack of cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    After opening the bottle - 1 month.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-003580
    Date of registration:20.04.2016 / 24.05.2017
    Expiration Date:20.04.2021
    The owner of the registration certificate:GROTEKS, LLC GROTEKS, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspGROTEKS, LLCGROTEKS, LLC
    Information update date: & nbsp17.06.2018
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