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Instructions

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Instruction for use: Eucazolin-aqua

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Active substance: Xylometazoline

ATX Code R01AA07 Xylometazoline

Pharmacotherapeutic group:

Decongestant agent - alpha-agonists [alpha agonists]

Decongestant agent - alpha-agonists [decongestant]

The nosological classification (ICD-10)

H66.9 Otitis media, unspecified

Chronic otitis, Otitis, otitis media, middle ear infections, Otitis media in children

J00 Acute nasopharyngitis [runny nose]

Viral rhinitis, Inflammation of the nasopharynx, Inflammatory diseases of the nose, purulent rhinitis, Nasal congestion, Nasal congestion with colds and flu, The difficulty of nasal breathing, The difficulty of nasal breathing for colds, Difficulty in nasal breathing, Difficulty in nasal breathing in colds, nasal, hypersecretion, cold, ARI with rhinitis phenomena, coryza, Acute rhinitis of various origins, Acute rhinitis with thick purulent mucous exudate, Acute nasopharyngitis, Swelling of the mucosa of the nasopharynx, Rhinitis, rhinorrhea, Infectious-inflammatory diseases of ENT organs, heavy cold, rhinopharyngitis, nasopharyngitis

J01 Acute sinusitis

Inflammation of the sinuses, Inflammatory diseases of the paranasal sinuses, Purulent inflammation of the paranasal sinuses, Infectious-inflammatory diseases of ENT organs, Infection of the sinuses, Combined sinusitis, Exacerbation of sinusitis, Acute inflammation of the paranasal sinuses, Acute bacterial sinusitis, Acute sinusitis in adults, Subacute sinusitis, acute Sinusitis, sinusitis

J999 * Diagnosis of Respiratory Diseases

bronchography, bronchoscopy, Diagnostic procedures in the nasal passages, Diagnostic Study of the bronchi, laryngoscopy, Preparing for rhinoscopy, Preparing the patient for bronchoscopy and / or bronhografii, Preparing the patient for bronchoscopy or bronhografii, Preparing the patient for diagnostic procedures in the nasal passages, Preparing the patient for diagnostic procedures in the area of the nasal passages, rhinoscopy, Visualization of the chest cavity, Chest X-ray, Mediastinoscopy

Composition

Spray for nasal administration of 1 g

active substance:

Xylometazoline hydrochloride (in terms of 100% substance) 1 mg

Other ingredients: benzalkonium chloride (in terms of 100% substance) - 0.15 mg Eucalyptus oil - 1 mg, disodium edetate dihydrate - 0.15 mg; propylene glycol - 60 mg; Macrogol 1500 - 50 mg; povidone (15) - 7.5 mg; Hypromellose (5) - 0.5 mg; polysorbate 20 (Tween 20) - 10 mg; Sodium phosphate dodecahydrate - 0.5 mg; Potassium dihydrogen phosphate - 1 mg; Water for injection - up to 1 g

Description

Transparent, slightly yellowish liquid with a specific smell.

pharmachologic effect

decongestant.

pharmacodynamics

Xylometazoline refers to a group of local vasoconstrictive agents (decongestants) with α2-adrenomimeticheskim action provides quick and lasting vasoconstrictive action on blood vessels of the nasal mucosa, eliminating congestion and edema of the mucosa. Facilitates nasal breathing in rhinitis. The action comes after a few minutes and lasts for several hours.

Pharmacokinetics

When applied topically practically not absorbed, the plasma concentrations are so small that they can not be determined by modern analytical methods.

Indications

symptomatic relief of acute rhinitis of different etiology, sinusitis;

adjuvant therapy of acute otitis media (to reduce swelling of the mucous membrane of the nasal cavity);

preparation of the patient for diagnostic manipulations (rhinoscopy).

Contraindications

Hypersensitivity to any component of the drug;

arterial hypertension;

tachycardia;

expressed atherosclerosis;

glaucoma;

atrophic rhinitis;

transfenoidalnaya hypophysectomy or a history of transnasal / transoral surgery exposing the dura mater;

pregnancy;

children's age (up to 6 years).

Precautions: Patients with cardiovascular disease, diabetes, thyroid disease (hyperthyroidism), patients in whom the application of adrenergic drugs there are strong reactions, manifested in the form of insomnia, dizziness, tremor, cardiac arrhythmias, the propensity to increase blood pressure; Patients with benign prostatic hyperplasia, women during lactation.

Pregnancy and breast-feeding

The drug should not be used during pregnancy.

It is not known if xylometazoline is allocated to breast milk, so women who breastfeed children, you can use the drug only when, in the opinion of the physician, the expected benefit to the mother outweighs the potential risk to the child.

Side effects

Frequent and / or long-term use - irritation and / or dryness of the nasal mucosa, burning, and paraesthesia of the nasal mucosa, sneezing, hypersecretion of the mucous membrane of the nasal cavity; swelling of the nasal mucosa, palpitations, tachycardia, arrhythmias, increased blood pressure, headache, vomiting, insomnia, blurred vision; depression.

Interaction

Xylometazoline interacts with other drugs only if the manifestation of resorptive effect.

Other agonists may increase the effect of xylometazoline.

Blockers and sympatholytic, BPC weaken its effect.

The drug increases the hypertensive effect of tricyclic antidepressants and MAO inhibitors.

Dosage and Administration

Intranasal. Adults and children over 6 years - 1 injection in each nostril 3-4 times a day. The course of treatment depends on the course of the disease and should not exceed 5-7 days.

After treatment the drug may be administered again in just a few days.

Overdose

Symptoms: decrease in body temperature, bradycardia, increase in blood pressure.

Treatment: symptomatic.

special instructions

The drug should not be used continuously for long periods (more than 7 days in a row).

Do not exceed the recommended dose of the drug, particularly in the treatment of children and the elderly.

Use caution while driving a car or perform other types of work that trebuyutpovyshennoy concentration and rapid psychomotor reactions.

release Form

Nasal spray, 1 mg / g. 10 g in a flask of brown glass equipped with a metering pump spray for nasal application. Each vial was placed in a pile of cardboard.

Storage conditions of Eucazolin-aqua

The temperature is not higher than 25 ° C.

Keep out of the reach of children.
Shelf life of Eucazolin-aqua

2 years.

Do not use beyond the expiration date printed on the package.

Available without prescription

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