Instructions for Evkazoline Aqua nasal spray 1 mg/g bottle 10 ml
Composition
active ingredient: xylometazoline;
1 g of spray contains xylometazoline hydrochloride, calculated as 100% substance, 1 mg;
Excipients: benzalkonium chloride; eucalyptus oil; disodium edetate; propylene glycol; polyethylene glycol 1500; povidone; hypromellose; polysorbate 20; sodium hydrogen phosphate dodecahydrate; potassium dihydrogen phosphate; purified water.
Dosage form
Nasal spray.
Main physicochemical properties: the drug, when released from the bottle through a pump-dispenser with a nasal spray, is sprayed in the form of an aerosol jet, which has a specific odor and consists of liquid particles dispersed in the air.
Pharmacotherapeutic group
Drugs used in diseases of the nasal cavity. Anti-edematous and other drugs for local use in diseases of the nasal cavity. Sympathomimetics, simple drugs. ATX code R01A A07.
Pharmacological properties
Pharmacodynamics.
Xylometazoline is a sympathomimetic agent that acts on α-adrenergic receptors.
Xylometazoline, when applied nasally, causes constriction of the blood vessels of the nasal mucosa and adjacent areas of the nasopharynx, thus eliminating edema and hyperemia of the nasal and nasopharynx mucosa, and also reduces the associated increased mucus secretion and facilitates the removal of blocked secretions from the nose, which leads to cleansing of the nasal passages and facilitating nasal breathing.
The drug begins to work within 2 minutes after application and lasts up to 12 hours (for example, throughout the night).
The drug is well tolerated by patients with sensitive mucous membranes and does not reduce mucociliary function. Research results have shown that xylometazoline reduces the infectious activity of human rhinovirus, which is associated with the common cold.
Pharmacokinetics.
When applied topically, xylometazoline is practically not absorbed, the concentration of xylometazoline in blood plasma is so low that it is practically undetectable (the concentration in blood plasma is close to the detection limit).
Xylometazoline does not have mutagenic properties. Also, in animal studies, no teratogenic effects of xylometazoline were detected.
Indication
Symptomatic treatment of nasal congestion due to colds, hay fever, other allergic rhinitis, and sinusitis.
To facilitate the outflow of secretions in diseases of the paranasal sinuses.
Adjunctive therapy in cases of otitis media (to eliminate swelling of the nasal mucosa).
To facilitate rhinoscopy.
Contraindication
Hypersensitivity to xylometazoline or any other component of the drug, acute coronary disease, coronary asthma, hyperthyroidism, angle-closure glaucoma, transsphenoidal hypophysectomy and surgical interventions with meningeal exposure in history, dry rhinitis (rhinitis sicca) or atrophic rhinitis. Concomitant treatment with MAO inhibitors and within 2 weeks after their discontinuation.
Interaction with other medicinal products and other types of interactions
Monoamine oxidase inhibitors (MAOIs): Xylometazoline may potentiate the effects of monoamine oxidase inhibitors and induce hypertensive crisis. Do not use xylometazoline in patients who are taking or have taken MAOIs within the last two weeks.
Tri- and tetracyclic antidepressants: with simultaneous use of tri- or tetracyclic antidepressants and sympathomimetic drugs, the sympathomimetic effect of xylometazoline may be enhanced, therefore the simultaneous use of such drugs is not recommended.
When used together with β-blockers, it may cause bronchial spasm or a decrease in blood pressure.
Application features
The drug should not be used for more than 10 consecutive days. Prolonged or excessive use may lead to the recurrence of nasal congestion and/or atrophy of the nasal mucosa.
The drug, like other sympathomimetics, should be prescribed with caution to patients who have strong reactions to adrenergic agents, manifested as insomnia, dizziness, tremor, cardiac arrhythmia or increased blood pressure.
The recommended dose of the drug should not be exceeded, especially when treating children and the elderly.
The drug should be prescribed with caution to patients with cardiovascular diseases, arterial hypertension, diabetes mellitus, pheochromocytoma, prostatic hypertrophy, and should not be used in patients receiving treatment with MAO inhibitors and within 2 weeks after discontinuing their use.
The drug contains benzalkonium chloride, which may cause irritation of the nasal mucosa.
Use during pregnancy or breastfeeding
The drug should not be used during pregnancy due to its potential vasoconstrictor effect.
There is no evidence of any adverse effects on the infant. It is not known whether xylometazoline is excreted in breast milk, therefore caution is required and the drug should be used during breastfeeding only as directed by a physician.
There are no adequate data on the effect of the drug on fertility. Since the systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is extremely low.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug usually has no or negligible influence on the ability to drive or operate machinery.
Method of administration and doses
Evkazoline® Aqua, nasal spray, is for use in adults and children over 12 years of age.
Adults and children aged 12 years and over:
1 spray into each nasal passage up to 3 times a day as needed. Apply no more than 3 times into each nasal passage per day. The duration of treatment depends on the course of the disease and should not exceed 10 consecutive days.
The metered spray ensures accurate dosing and proper distribution of the solution over the surface of the nasal mucosa.
Before use, prime the dosing device by pumping it several times until the spray starts to come out into the air. The dosing device will be ready for immediate use the next time it is used.
The spray should be applied as follows:
Clean your nose thoroughly before using the drug;
The bottle should be held vertically, supporting the bottom with your thumb and placing the tip between two fingers;
tilt the bottle slightly and insert the tip into the nostril;
inject and simultaneously take a light breath through your nose;
after use, clean and dry the tip before replacing the cap;
To prevent infection, each vial of the drug can only be used by one person.
The last application is recommended immediately before bedtime.
Children
The drug should not be used in children under 12 years of age.
Overdose
Excessive topical application of xylometazoline hydrochloride or accidental ingestion may result in severe dizziness, sweating, a significant decrease in body temperature, headache, bradycardia, arterial hypertension, respiratory depression, coma and convulsions. Elevated blood pressure may change to low blood pressure. Young children are more sensitive to toxicity than adults.
All patients with suspected overdose should be given appropriate supportive measures and, if necessary, immediate symptomatic treatment under medical supervision. Medical care should include observation of the patient for several hours. In the case of severe overdose accompanied by cardiac arrest, resuscitation measures should last at least 1 hour.
Adverse reactions
On the part of the immune system:
rare (<1/10,000): hypersensitivity reactions, including angioedema, rash, itching.
From the nervous system:
common (≥1/100, <1/10): headache.
On the part of the organs of vision:
rare (<1/10,000): temporary visual impairment.
From the cardiovascular system:
rare (<1/10,000): irregular or rapid heartbeat.
Respiratory, thoracic and mediastinal disorders:
common (≥1/100, <1/10): dryness or discomfort of the nasal mucosa;
uncommon (≥ 1/1000 - < 1/100): epistaxis.
From the gastrointestinal system:
common (≥1/100, <1/10): nausea.
General disorders and administration site conditions:
common (≥1/100, <1/10): burning sensation at the application site.
Expiration date
2 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in a place protected from light at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
10 g per bottle. 1 bottle per pack.
Vacation category
Without a prescription.
Producer
JSC "Farmak".
Location of the manufacturer and its business address.
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
