Active substanceXylometazolineXylometazoline
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  • Dosage form: & nbspnasal spray; nasal drops for children
    Composition:

    1 ml of the drug contains
    Active substance:
    Spray nasal - xylometazoline hydrochloride 1 mg.
    Nasal drops for children xylometazoline hydrochloride 0.5 mg.

    Excipients: benzalkonium chloride 0.110 mg, sodium dihydrogen phosphate dihydrate 2.8 mg, sodium hydrogen phosphate dodecahydrate 3 mg, disodium edetate 0.5 mg, sodium chloride 7 mg, distilled water up to 1 ml.

    Description:

    clear, colorless, odorless solution.

    Pharmacotherapeutic group:alpha-adrenomimetic.
    ATX: & nbsp

    R.01.A.A.07   Xylometazoline

    Pharmacodynamics:

    Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with a-adrenomimetic action.

    The alpha-adrenostimulant, xylometazoline causes narrowing of the blood vessels of the nasal mucosa, thus eliminating the edema and hyperemia of the mucous membrane of the nasopharynx. Relieves nasal breathing in rhinitis. In therapeutic concentrations, it does not irritate the mucous membrane, it does not cause hyperemia.

    The action comes in a few minutes and lasts for several

    hours.

    Pharmacokinetics:When topical application is practically not absorbed, the plasma concentrations are below the detection limit.
    Indications:Acute respiratory diseases with phenomena of rhinitis (rhinitis), acute allergic rhinitis, pollinosis, sinusitis, eustachitis, otitis media (to reduce edema of the nasopharyngeal mucosa). Preparation of the patient for diagnostic manipulation in the nasal passages.
    Contraindications:Hypersensitivity to xylometazoline and other components of the drug, hypertension, tachycardia, severe atherosclerosis, glaucoma, atrophic rhinitis, hyperthyroidism,conditions after transsphenoidal hypophysectomy, surgical interventions on the meninges (in the anamnesis), pregnancy, children under 12 years (for nasal spray 0.1%), children under 2 years (for nasal drops for children 0.05%).
    Carefully:Diabetes mellitus, diseases of the cardiovascular system, prostatic hyperplasia, with hypersensitivity to adrenergic drugs, accompanied by symptoms of insomnia, dizziness, cardiac arrhythmia, tremors, high blood pressure.
    Pregnancy and lactation:

    During pregnancy and lactation, 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:

    Intranasally.

    Nasal spray 0.1% is prescribed for adults and children over 12 years of age:

    I Injection from the nebulizer into each nasal passage should not be used more than 3 times a day.

    In order to correctly do the injection, keep the sprayer upright, so that the nozzle is pointing upwards.Then you should put the nozzle in the nasal passage, quickly and sharply compress the bottle and take out the nozzle without opening the bottle. During the injection, a little air must be inhaled through the nose, which contributes to the optimal administration of the drug.

    Nasal drops 0.05% are prescribed for children from 2 to 5 years: 1-2 drops in each nasal passage 1-3 times a day should not be used more than 3 times a day. Children from 6 to years - 2-4 drops in each nostril 2-3 times a day, should not be used more than 3 times a day. The drug in children should be administered under the supervision of adults.

    Side effects:

    Classification of incidence of adverse reactions:

    very often - more than 1/10 appointments (> = 10%); often more than 1/100, but less than 1/10 of prescriptions (> = 1%, but <= 10%); infrequently - more than 1/1000, but less than 1/100 of prescriptions (> = 0,1%, but <= 1%); rarely - more than 1/10000, but less than 1/1000 appointments (> = 0.01%, but <= 0.1%); very rarely - less than 1/10000 prescriptions (<= 0.01%).

    From the immune system:

    Very rarely: reactions hypersensitivity (angioedemacue edema, rash, itching);

    From the nervous system:

    Often: headache;

    Rarely: insomnia, depression (with prolonged use in high doses); From the sense organs:

    Very rarely: violation of the clarity of visual perception;

    From the cardiovascular system: Rarely: palpitations, increased blood pressure;

    Very rarely: arrhythmia, tachycardia;

    From the respiratory system:

    Often: irritation or dryness of the mucous membrane of the nasopharynx, burning, tingling, sneezing, hypersecretion of the mucous membrane of the nasopharynx;

    From the side of the digestive system: Often: nausea;

    Rarely: vomiting;

    Local reactions:

    Often: a burning sensation in the place of application.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.
    Overdose:

    Symptoms: increased side effects, in particular, increased heart rate, increased blood pressure, sometimes confusion may occur.

    Treatment is symptomatic, under the supervision of a doctor.
    Interaction:It is not recommended to apply continuously for more than 10 days. Do not exceed recommended doses, especially in children and the elderly. Long (more than 10 days) or excessive use of the drug can cause the effect of a "ricochet" (drug rhinitis).
    Special instructions:It is not recommended to apply continuously for more than 10 days.Do not exceed recommended doses, especially in children and the elderly. Long (more than 10 days) or excessive use of the drug can cause the effect of a "ricochet" (drug rhinitis)
    Effect on the ability to drive transp. cf. and fur:Xylometazoline does not affect the ability to drive a vehicle and machinery.
    Form release / dosage:

    Nasal Spray 0.1%: in 10 ml plastic bottle (spray) of white low-density polyethylene with a screw cap of high density polyethylene, provided with a first opening control system. The bottle together with the instruction for use is enclosed in a pack of cardboard.

    Nasal drops 0.05%: to 10 ml in dark glass vials with screw aluminum lid provided with the first opening control system complete with screw-krshzhoy pipette. One bottle together with the instruction for use is placed in a pack of cardboard.

    Packaging:bottles of dark glass (1) / complete with a pipette cover made of polyethylene / polystyrene / rubber / cardboard-tipped containers
    Storage conditions:

    At temperatures not exceeding 30 ° C, in places not accessible to children.

    Shelf life:

    3 years. Do not use after the date shown on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N013788 / 02
    Date of registration:19.11.2007
    The owner of the registration certificate:Sandoz Private LimitedSandoz Private Limited India
    Manufacturer: & nbsp
    Representation: & nbspSANDOZ SANDOZ Switzerland
    Information update date: & nbsp29.04.2013
    Illustrated instructions
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