Active substanceOxymetazolineOxymetazoline
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  • Dosage form: & nbspnasal drops
    Composition:

    1 ml of the preparation (1008,000 mg) contains:

    active substance: oxymetazoline hydrochloride 0.100 mg;

    Excipients: citric acid monohydrate 0.609 mg, sodium citrate dihydrate 3.832 mg, glycerol (85%) 24.921 mg, purified water 978.547 mg.

    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:

    Nazivin® Sensitive (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 reduces the likelihood 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. Oxymetazoline starts to act quickly, within 15 minutes.

    The duration of the action of Nasivin® Sensitive is up to 12 hours.

    Pharmacokinetics:

    With local intranasal use, the drug 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:

    - Acute respiratory diseases with phenomena of rhinitis;

    acute allergic rhinitis;

    - exacerbation of vasomotor rhinitis;

    - to facilitate the outflow of the discharge from the paranasal sinuses, with sinusitis, eustachitis, middle otitis;

    - to eliminate edema before diagnostic manipulation in the nasal passages.

    Contraindications:
    Atrophic rhinitis; angle-closure glaucoma; surgical interventions on the dura mater (in the anamnesis), hypersensitivity to the components of the drug.
    Carefully:

    With increased intraocular pressure, chronic heart failure, arterial hypertension, angina pectoris, arrhythmia, chronic renal failure, in patients with prostatic hyperplasia with clinical symptoms (urinary retention), severe atherosclerosis, hyperthyroidism, diabetes, pheochromocytoma, tachycardia,porphyria, as well as in patients taking monoamine oxidase inhibitors (MAO) for the previous 2 weeks and within 2 weeks after their withdrawal, tricyclic antidepressants, bromocriptine.

    Pregnancy and lactation:

    When used during pregnancy or breastfeeding, the recommended dose should not be exceeded. The drug can only be used if the potential benefit to the mother exceeds the potential risk to the fetus and the baby.

    Dosing and Administration:

    Nasivin® Sensitive nasal drops 0.01% are intended for use in the nose of children under the age of one year.

    Children under 4 weeks are prescribed 1 drop of Nazivin® Sensitive in each nostril 2-3 times a day. From the 5th week of life and up to 1 year - 1-2 drops in each nostril 2-3 times a day.

    1 drop Nazivin® Sensitive 0.01% contains 2.8 μg of oxymetazoline hydrochloride.

    Before use, the vial should be turned over. The drug should be digested, threw back the child's head.

    The effectiveness of the following procedure was also proved: depending on the age 1-2 drops Nazivin® Sensitive is applied to cotton wool and rubbed on each nostril.

    In the recommended dose without consulting a doctor apply no more than 5-7 days. If the symptoms increase or the improvement does not occur within 3 days, consult a doctor.

    Doses above recommended can be used only under the supervision of a doctor.

    Side effects:

    The frequency of adverse reactions was determined in accordance with the classification of the World Health Organization:

    Very often (> 10%);

    Often (≥1% and <10%);

    Infrequently (≥0.1% and <1%);

    Rarely (≥0.01% and <0.1%);

    Very rarely (<0.01%);

    The frequency is unknown (can not be calculated based on available data).

    Immune system disorders:

    Infrequent: angioedema, itching.

    Disturbances from the nervous system:

    Rarely: headache, insomnia.

    Very rarely: fatigue, drowsiness, anxiety, hallucinations.

    Disorders from the cardiovascular system:

    Infrequent: tachycardia, increased blood pressure.

    Rarely: palpitations.

    Disturbances from the respiratory system, chest and mediastinal organs:

    Often: burning or dryness of the mucous membrane of the nasal cavity, sneezing.

    Infrequent: a sense of "stuffiness" of the nose (reactive hyperemia); nose bleed.

    Very rarely: stopping breathing (in infants).

    Disturbances from musculoskeletal and connective tissue:

    Very rarely: convulsions.

    Side effects due to the systemic effect of the drug:

    dizziness, anxiety, irritability, sleep disturbance (in children), nausea, exanthema, visual impairment (eye contact).

    Prolonged or continuous use of vasoconstrictive drugs can lead to tachyphylaxis, atrophy of the nasal mucosa and recurrent edema of the nasal mucosa (medicamentous rhinitis).

    Overdose:

    Clinical signs of intoxication with imidazole derivatives can be nonspecific and indistinct, as the phases of hyperactivity are replaced by phases of central nervous system depression, cardiovascular and respiratory systems.

    Symptomsanxiety, anxiety, hallucinations, convulsions, lowered body temperature, lethargy, drowsiness, coma, narrowing or dilating pupils, fever, sweating, pallor, cyanosis, palpitations, bradycardia, arrhythmia, cardiac arrest, increased blood pressure, lowering blood pressure, nausea, vomiting, respiratory depression, respiratory arrest.

    In children, an overdose can be the cause of the development of such symptoms from the central nervous system, such as: arousal, convulsions,coma, aetiology, respiratory arrest, and an increase in blood pressure, followed by a possible reduction in blood pressure.

    Treatment: gastric lavage, reception of activated charcoal (with accidental ingestion of the drug inside); symptomatic.

    In severe overdose, intensive care is indicated in a hospital setting. The use of vasoconstrictor is contraindicated.

    Interaction:

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

    In patients taking monoamine oxidase inhibitors (MAO) for the previous 2 weeks and within 2 weeks after their withdrawal, tricyclic antidepressants, or other drugs that increase blood pressure - increase blood pressure.

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

    Special instructions:

    Avoid contact with eyes.

    To avoid the spread of infection, it is necessary to apply the drug individually.

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

    After a prolonged use of funds from the cold, containing oxymetazoline, in doses exceeding the recommended, one can not exclude the general effect on the cardiovascular system and the central nervous system. In these cases, it is advisable to use caution when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

    Form release / dosage:

    Nasal drops, 0,01%.

    Packaging:

    5 ml per bottle of polyethylene with a dispensing device and with a protective cap made of polyethylene.

    1 bottle with the instruction for use is placed in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 30 ° C.

    Keep out of the reach of children.
    Shelf life:

    3 years.

    Do not use after the expiration date.
    Terms of leave from pharmacies:Without recipe
    Registration number:LP-001156
    Date of registration:11.11.2011 / 06.10.2017
    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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