Active substanceNaphazolineNaphazoline
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  • Dosage form: & nbspnasal spray
    Composition:

    1 bottle (10 ml) contains:

    active substance: naphazoline nitrate 0.01 g;

    Excipients:

    ethylene diamine q.s. (about 0.4 mg), boric acid 0.170 g, methyl parahydroxybenzoate 0.010 g, water up to 10 ml.

    Description:

    Transparent, colorless liquid, without visible particles, odorless.

    Pharmacotherapeutic group:The anticongestive agent is alpha-adrenomimetic.
    ATX: & nbsp

    A.01.A.A.08   Naphazoline

    Pharmacodynamics:

    Nafazoline refers to alfa-adrenomimetics with a direct stimulating effect on the alpha-adrenoreceptors of the sympathetic nervous system. When intranasal administration has a rapid, pronounced and prolonged vasoconstrictive action against the vessels of the mucous membranes of the nasal cavity, the nasopharynx and the paranasal sinuses of the nasal cavity - reduces swelling and hyperemia, which improves the nasal passages and facilitates nasal breathing. Along with this, the patency of eustachian tubes is restored.The therapeutic effect occurs, as a rule, within 5 minutes after the administration of the drug and persists for 4-6 hours. With long-term use, the vasoconstrictor effect gradually decreases, and in this connection, after 5-7 days of treatment, a break should be made for several days.

    Pharmacokinetics:

    There are no data on the distribution, metabolism and elimination of naphazoline in humans.

    Indications:

    - acute rhinitis of various etiologies;

    - otitis media - as an additional remedy for reducing the swelling of the nasopharyngeal mucosa;

    - sinusitis;

    - eustachiitis; - laryngitis;

    - to reduce the edema of the mucous membranes of the nasal cavity, nasopharynx and paranasal sinuses of the nasal cavity in diagnostic and therapeutic procedures;

    - if necessary stopping nasal bleeding.

    Contraindications:

    - hypersensitivity to the components of the drug;

    - chronic rhinitis;

    - atrophic rhinitis;

    - angle-closure glaucoma;

    - severe eye diseases;

    - arterial hypertension;

    - severe atherosclerosis;

    - tachycardia;

    - hyperthyroidism;

    - diabetes;

    - simultaneous administration of monoamine oxidase inhibitors and a period of up to 14 days after the end of their use.

    Sanorin 0.1% solution is contraindicated in children under 15 years of age.

    Carefully:

    Pregnancy, lactation, ischemic heart disease (angina pectoris), prostatic hyperplasia, pheochromocytoma.

    Pregnancy and lactation:

    There is no data on the penetration of naphazoline through the placental barrier, as well as in breast milk. In connection with this, when prescribing the drug, it is necessary to correlate the possible risk to the child and the fetus and the expected therapeutic effect for the mother.

    Dosing and Administration:

    Intranasally. For 1-3 doses of the drug in each nasal passage 3-4 times a day.

    When using the spray for the first time, it is recommended that you press the dosing device several times until a compact aerosol cloud appears.

    Before direct use, remove the protective cap, keep the bottle in a vertical position, insert the end of the dosing device into the nasal passage, then quickly and sharply push the applicator. Immediately after injection, it is recommended to breathe lightly. After applying the preparation, cover the applicator with a protective cap.

    Apply for a short time, not more than 1 week in adults and not more than 3 days in children.

    If nasal breathing is facilitated, Sanorin can be used sooner. Repeated use of the drug is possible in a few days.

    Side effects:

    In recommended doses, the drug is usually well tolerated.

    People with special sensitivity may experience burning and dryness in the nasal cavity.

    In rare cases, after termination of the drug, reactive hyperemia and swelling of the mucous membrane of the nasal cavity develop.

    As a result of irritation of the sympathetic nervous system and general effects on the body, nausea, tachycardia, headache, irritability, excessive sweating, allergic reactions, rash, increased blood pressure, Prolonged and frequent use (more than 1 week) of Sanorin can lead to chronic disruption of nasal passages and atrophy of the mucous membrane of the nasal cavity.
    Overdose:

    When an overdose of the drug as a result of systemic effects on the body can develop such phenomena as nervousness, excessive sweating, headache, tremor, tachycardia, a feeling of palpitations, increased blood pressure.

    Also possible signs of an overdose include nausea, cyanosis, respiratory and mental disorders.

    In the case of central nervous system depression, bradycardia, weakness, drowsiness, decreased body temperature, increased sweating, collapse, it is extremely rare for coma to develop.

    Treatment: symptomatic.

    Interaction:

    With the simultaneous use of the drug with monoamine oxidase inhibitors or tricyclic antidepressants (and within 14 days after the end of their use), an increase in blood pressure is possible, which is due to the release of deposited catecholamines under the action of nafazoline. Therefore, simultaneous administration of the drug Sanorin with MAO inhibitors (and within 14 days after their cancellation) is contraindicated.

    Nafazoline slows the absorption of local anesthetics (prolongs their effect).

    Special instructions:

    Combined use with monoamine oxidase inhibitors enhances the hypertensive effect. Care should be taken when conducting general anesthesia with the use of anesthetics that increase the sensitivity of the myocardium to sympathomimetics (halothane), especially in patients with bronchial asthma.

    Avoid prolonged use of the drug.

    In view of the possible development of side effects from the cardiovascular and nervous systems, do not exceed the dosage of Sanorin recommended for use.

    Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions, taking into account the profile of side effects.
    Form release / dosage:

    Nasal Spray 0.1%

    10 ml of the drug in a frosted, translucent plastic bottle, equipped with a screw-on mechanical dispensing applicator with a protective cap and a plastic protective half ring to protect against accidental depression.

    Each vial with instructions for use is placed in a cardboard box.

    Packaging:10) - a plastic bottle (1) / 10 ml of the drug in a frosted translucent plastic bottle, equipped with a screw-on mechanical dispensing applicator with a protective cap and a plastic protective half ring to protect against accidental depression.Each vial with instructions for use is placed in a cardboard box. / - cardboard pack
    Storage conditions:

    Store at a temperature of 10 ° C to 25 ° C in a dark place.

    Keep out of the reach of children.

    Shelf life:

    4 years

    Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N011463 / 02
    Date of registration:07.07.2010
    The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp31.07.2015
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