Xylometazoline - instructions for use, dose, side effects, contraindications

Excipients: Benzalkonium chloride-0.15 mg, disodium edetate 0.47 mg, potassium dihydrogen phosphate 3.63 mg, sodium hydrogen phosphate dihydrate 3.54 mg, sodium chloride 9.00 mg, purified water up to 1 ml.

Dosage 0.1%:

Active substance: xylometazoline hydrochloride - 1.00 mg;

Composition per ml:

Xylometazoline [with the flavor of eucalyptus]:

Dosage of 0.05%:

Active substance: xylometazoline hydrochloride - 0.50 mg;

Excipients: Benzalkonium chloride -0.15 mg, disodium edetate 0.50 mg, potassium dihydrogen phosphate 3.63 mg, sodium hydrogen phosphate dihydrate 3.54 mg, sodium chloride 7.00 mg, eucalyptus leaf-shaped oil 0.50 mg, sorbitol 8.00 mg, glycerol 4.00 mg, macrogol glyceryl hydroxy stearate 3.40 mg, purified water up to 1 ml.

Dosage 0.1%:

Active substance: xylometazoline hydrochloride - 1.00 mg;

Excipients: Benzalkonium chloride 0.15 mg, disodium edetate 0.50 mg, potassium dihydrogen phosphate 3.63 mg, sodium hydrogen phosphate dihydrate 3.54 mg, sodium chloride 7.00 mg, eucalyptus rosaceous leaf oil 0.50 mg mg, sorbitol 8.00 mg, glycerol 4.00 mg, macrogol glyceryl hydroxy stearate 3.40 mg, purified water up to 1 ml.

Description:

Xylometazoline:

Colorless or slightly colored transparent liquid, with a weak characteristic odor.

Xylometazoline [with the flavor of eucalyptus]:

Colorless or slightly colored transparent liquid with a characteristic odor.

Pharmacotherapeutic group:Antitussive medication - alpha-adrenomimetic

ATX: & nbsp

R.01.A.A.07 Xylometazoline

Pharmacodynamics:

Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with alpha-adrenomimetic activity, causes narrowing of the blood vessels of the mucous membrane of the nasal cavity, thus eliminating the edema and hyperemia of the nasal mucosa, restoring the nasal passages, facilitating nasal breathing.

The effect of the drug comes in a few minutes after its application and lasts up to 10 hours.

Pharmacokinetics:

With topical application, the drug is practically not absorbed, so its concentration in the blood plasma is very small.

Indications:

Applied in acute respiratory diseases with phenomena of rhinitis (rhinitis), acute allergic rhinitis, sinusitis, eustachitis, pollinosis, with average otitis (as part of combination therapy to reduce edema of the nasopharyngeal mucosa).

Preparation of the patient for diagnostic manipulations in the nasal passages.

Contraindications:

Hypersensitivity to xylometazoline and other drug components, arterial hypertension, tachycardia, severe atherosclerosis, glaucoma, atrophic rhinitis, hyperthyroidism, surgical interventions on the meninges (in the anamnesis), conditions after transsphenoidal hypophysectomy, children's age (up to 2 years - for 0.05 % spray, up to 6 years for 0.1% spray), pregnancy.

Do not use with monoamine oxidase inhibitors and tricyclic antidepressants (including the period of 14 days after their withdrawal).

Carefully:

Diabetes mellitus, porphyria, pheochromocytoma, diseases of the cardiovascular system (including ischemic heart disease), prostatic hyperplasia, lactation.

With increased sensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure.

Pregnancy and lactation:

During pregnancy, the use of the drug is contraindicated.

During lactation, the drug should only be used as directed by the doctor, after a thorough assessment of the risk-benefit relationship for the mother and child.Do not exceed the recommended dosage.

Dosing and Administration:

Intranasally.

Before application, it is necessary to clean the nasal passages.

Spraying is carried out after removing the protective cap from the sprayer. Before the first application it is necessary to test spray into the air. The atomizer is injected into the nose and, pressing on its base, is sprayed for 1 second.

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, it is worth taking a little air through the nose, which contributes to the optimal administration of the drug.

For adults and children over the age of 6 years (0.1% spray): one injection from the nebulizer into each nasal passage, usually enough 3 injections per day; Do not use more than 3 times a day.

For children aged 2 to 6 years (0.05% spray): one injection from the nebulizer into each nasal passage 1 or 2 times a day.

Do not apply the drug without interruption for more than 5-7 days, unless the doctor has recommended a different duration of treatment.

After completion of therapy, the drug can be re-administered only after a few days.

As for the duration of use in children, always consult a doctor.

In the case of chronic rhinitis the drug "Xylometazoline" 0.05% and 0.1% can be used only under the supervision of a doctor, given the risk of atrophy of the nasal mucosa.

During the introduction of the drug, the bottle should be kept up by the spray gun!

Side effects:

With frequent and / or long-term use - irritation and / or dryness of the mucous membrane of the nasopharynx, burning and paresthesia of the nasal mucosa, sneezing, hypersecretion of the mucous membrane of the nasal cavity; edema of the mucous membrane of the nasal cavity, bleeding from the nose; vomiting, headache, palpitations, increased blood pressure, tachycardia, arrhythmia, insomnia, anxiety, fatigue, hallucinations and convulsions (mainly in children); visual impairment, depression (with prolonged use of high doses), hypersensitivity reactions (angioedema, skin rashes, itching), nausea.

Benzalkonium chloride, which is part of the drug, can cause irritation of the mucous membrane of the nasal cavity and bronchospasm.

Overdose:

When an overdose or accidental intake of the drug inside the drug can cause: nausea, vomiting,cyanosis, fever, a sharp decrease in body temperature, dyspnea, severe dizziness, increased sweating, headache, respiratory depression, coma and convulsions, bradycardia, arrhythmia, tachycardia, increased blood pressure. Following the increase in blood pressure, there may be a sharp decrease in blood pressure.

Treatment: symptomatic. Observe the patient for several hours. In case of severe poisoning with cardiac arrest, resuscitation should last at least 1 hour.

At casual reception inside - gastric lavage, reception of the activated coal.

Interaction:

It is possible to enhance the systemic effect while using monoamine oxidase inhibitors and tricyclic antidepressants.

Special instructions:

Long-term use (more than 7 days) and an overdose of sympathomimetics, which have a decongestive effect, can lead to reactive hyperemia of the nasal mucosa. As a result, there is difficulty in nasal breathing, which leads to the fact that the patient begins to use the drug repeatedly or even constantly. This can lead to chronic swelling (medical rhinitis),and eventually even to the atrophy of the mucous membrane of the nose (ozen).

Do not exceed recommended doses, especially in children and the elderly.

It is not recommended to apply the drug in continuous mode for more than 7 days.

Avoid getting the drug in the eye (the drug affects the eyesight).

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

In the case of systemic side effects (headache, palpitations, increased blood pressure, visual impairment), it is necessary to refrain from driving and practicing other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Spray nasal, 0.05% and 0.1%.

Spray nasal [with the flavor of eucalyptus] 0.05%, 0.1%.

Packaging:

10, 20 ml in bottles of glass-colored orange glass, or polypropylene polymer bottles or polyethylene terephthalate bottles for medicines, equipped with a plastic dissector, or with or without a pump, sealed with caps screwed with the control of the first opening.

One bottle together with the instruction for use is placed in a cardboard package (bundle).

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

Xylometazoline: 3 years.

Xylometazoline [with the flavor of eucalyptus]: 2 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-003608

Date of registration:04.05.2016 / 30.01.2017

Expiration Date:04.05.2021

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Representation: & nbspOZONE LLC OZONE LLC Russia

Information update date: & nbsp05.02.2018

Illustrated instructions

Instructions

Xylometazoline (Xylometazoline)