Active substanceXylometazolineXylometazoline
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  • Dosage form: & nbspnasal dosing spray
    Composition:
    1 ml of the preparation contains:
    Active substance: xylometazoline hydrochloride 1 mg.
    Excipients: sodium dihydrogenphosphate dihydrate 5 mg, sodium hydrogen phosphate dodecahydrate 1.7 mg, disodium edetate 0.5 mg, benzalkonium chloride 50% solution 0.1 mg (in terms of benzalkonium chloride 0.05 mg), sorbitol 70% 20 mg, hypromellose- 4 thousand.5 mg, sodium chloride 4 mg, water purified to 1 ml.
    Description:

    a clear, colorless solution with practically no odor.

    Pharmacotherapeutic group:anticonvulsant - alpha-adrenomimetic.
    ATX: & nbsp

    R.01.A.A.07   Xylometazoline

    Pharmacodynamics:

    Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with a-adrenomimetic action, causes narrowing of the blood vessels of the nasal mucosa, eliminating edema and hyperemia of the mucous membrane of the nasopharynx. Relieves nasal breathing in rhinitis.

    Otrivin® is well tolerated by patients with sensitive mucous membranes, its effect does not prevent the separation of mucus. Otrivin® has a balanced pH value, characteristic of the nasal cavity. The composition of the drug includes inactive components - sorbitol and hypromellose (methylhydroxypropylcellulose), which are humectants. Thus, the moisturizing formula reduces the symptoms of irritation and dryness of the nasal mucosa, arising from prolonged use of xylometazoline.

    In therapeutic concentrations, the drug does not irritates the mucous membrane, does not cause hyperemia. Action comes through several minutes and continues for 12 hours.

    Pharmacokinetics:

    With topical application practically not absorbed, concentrations in the plasma is below the detection limit.

    Indications:

    Acute respiratory diseases with 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 drug, arterial hypertension, tachycardia, severe atherosclerosis, glaucoma, atrophic rhinitis, hyperthyroidism, condition after transsphenoidal hypophysectomy, surgical interventions on brain shells (in the anamnesis), children's age up to 12 years.

    Carefully:

    diabetes; diseases of the cardiovascular system (including IHD, angina pectoris); hyperplasia prostate gland; with increased sensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure.

    Pregnancy and lactation:

    The drug should not be used during the period pregnancy.During lactation the drug should be applied only after careful assess the risk-benefit relationship for the mother and baby, under the supervision of a doctor. Do not exceed the recommended dosage.

    Dosing and Administration:

    Intranasally.

    Adults and children over 12 years: 1 Injection into each nasal passage 3 times a day. Do not use more than 3 times a day.

    Side effects:

    Frequency classification adverse reactions:

    Often

    (> = 10); often (> = 1/100, <1/10); infrequently (> = 1/1000, <1/100); rarely (> = 1/10000, <1/1000); very rarely (<1/10000).

    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.

    Overdose:Symptoms: increased side effects, in in particular, tachycardia, arrhythmia, increased blood pressure, sometimes confusion may occur. Treatment is symptomatic, under the supervision of a doctor.
    Interaction:Incompatible with monoamine oxidase inhibitors and tricyclic antidepressants.
    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 may cause effect "ricochet" (drug rhinitis).
    Effect on the ability to drive transp. cf. and fur:Xylometazoline has no effect on the ability to drive a vehicle and machinery.
    Form release / dosage:

    Spray nasal dosed 0,1 %.

    Packaging:

    For 10 ml or 15 ml of the drug in white or clear bottle of high density polyethylene, equipped with a pump metering device with a tip and with protective cap of polyethylene. Vial with Instructions for use are placed in a pack of cardboard.

    Storage conditions:

    At temperatures not higher than 30 ° C, out of reach of children.

    Shelf life:3 years Do not use after the expiration date.
    Terms of leave from pharmacies:Without recipe
    Registration number:П N011649 / 04
    Date of registration:10.09.2008
    The owner of the registration certificate:Новартис Консьюмер Хелс САНовартис Консьюмер Хелс СА Switzerland
    Manufacturer: & nbsp
    Representation: & nbspNOVARTIS CONSUMER HELS S.A. (part of Novartis groups) NOVARTIS CONSUMER HELS S.A.(part of Novartis groups) Switzerland
    Information update date: & nbsp27.05.2014
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