Xymelin^® Eco (Spray) Instructions for Use

ATC Code

R01AA07 (Xylometazoline)

Active Substance

Xylometazoline (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Decongestant – vasoconstrictor (alpha-adrenergic agonist)

Pharmacotherapeutic Group

Drugs for the treatment of nasal diseases; decongestants and other drugs for topical use; sympathomimetics

Pharmacological Action

A vasoconstrictor for topical use in ENT practice. An alpha-adrenergic agonist.

When applied to the mucous membranes, it causes constriction of the blood vessels of the nasal mucosa, thereby eliminating swelling and hyperemia of the nasal mucosa, and restores the patency of the nasal passages.

In rhinitis, it facilitates nasal breathing.

Pharmacokinetics

When applied topically, it is practically not absorbed; plasma concentrations are so low that they cannot be determined by modern analytical methods.

Indications

To reduce swelling of the nasopharyngeal mucosa and discharge in acute allergic rhinitis, acute respiratory infections with symptoms of rhinitis, sinusitis, hay fever, otitis media; preparation of the patient for diagnostic procedures in the nasal passages.

ICD codes

Dosage Regimen

Administer intranasally only. Adhere strictly to the age-specific dosage form and regimen.

For adults and children aged 12 years and older, administer one spray into each nostril. Use up to three times daily as needed for nasal congestion.

Do not exceed three applications per 24-hour period. The interval between doses must be no less than 4-6 hours.

For children aged 6 to 11 years, use only the pediatric formulation. Administer one spray into each nostril. Limit use to one or two times daily.

Maintain a minimum interval of 6-8 hours between applications in children. Do not exceed the recommended number of doses.

Prior to first use, prime the pump by pressing the spray mechanism several times until a full spray is produced.

Clear nasal passages before use. Tilt head slightly forward and insert nozzle into nostril. Press down firmly while breathing in gently through the nose.

The maximum duration of continuous use is 7 days. Discontinue use if symptoms persist. Prolonged use increases the risk of medication-induced rhinitis and rebound congestion.

Avoid use in children under 6 years of age unless specifically directed by a physician. Do not share the bottle between individuals.

Adverse Reactions

From the immune system uncommon – hypersensitivity reactions (angioedema, skin rash, itching).

From the digestive system rare – nausea, vomiting.

From the nervous system rare – headache; very rare – insomnia, anxiety, fatigue, hallucinations and convulsions (mainly in children).

From the organ of vision very rare – blurred vision.

From the cardiovascular system rare – palpitations, increased blood pressure, tachycardia; very rare – arrhythmia.

Local reactions common – irritation and/or dryness of the nasopharyngeal mucosa, burning and paresthesia of the nasal mucosa, sneezing, hypersecretion of the nasal mucosa; uncommon – swelling of the nasal mucosa, nosebleeds, withdrawal syndrome. Increased swelling of the nasal mucosa (reactive hyperemia) is possible.

Contraindications

Hypersensitivity to xylometazoline; atrophic rhinitis, thyrotoxicosis; inflammatory diseases of the skin or mucous membrane of the nasal vestibule; condition after transsphenoidal hypophysectomy; patients with severe cardiovascular diseases (e.g., coronary artery disease, angina pectoris, tachycardia, arterial hypertension, severe atherosclerosis); patients with a history of surgical interventions on the meninges; patients receiving MAO inhibitors or other drugs that can cause increased blood pressure; patients with increased intraocular pressure, especially with angle-closure glaucoma; during therapy with tricyclic and tetracyclic antidepressants, other topical vasoconstrictors (decongestants); pregnancy; pediatric age – depending on the dosage form.

With caution in patients with hypersensitivity to adrenergic agonists, accompanied by symptoms of insomnia, dizziness, arrhythmia, tremor, increased blood pressure; patients with pheochromocytoma, porphyria; patients with endocrine diseases (e.g., hyperthyroidism, diabetes mellitus); patients with prostatic hyperplasia; during lactation (breastfeeding).

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy.

During lactation, use is possible only as prescribed by a doctor, after a thorough assessment of the expected benefit to the mother versus the potential risk to the child.

Exceeding the recommended doses is not allowed.

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms.

It is necessary to strictly follow the instructions in the drug labels for xylometazoline regarding contraindications for the use of specific dosage forms of xylometazoline in children of different ages.

Recommended doses should not be exceeded in children.

Geriatric Use

Recommended doses should not be exceeded in elderly patients.

Special Precautions

Long-term use (more than 7 days) and overdose of sympathomimetics with a decongestant effect can lead to reactive hyperemia of the nasal mucosa.

As a result, nasal breathing difficulty occurs, which leads to the patient starting to use xylometazoline repeatedly or even constantly.

This can lead to chronic swelling (medication-induced rhinitis), and ultimately even to atrophy of the nasal mucosa (ozena).

In milder cases, to improve the patient’s condition, it is possible to initially stop the administration of the sympathomimetic into one nostril, and after the complaints decrease, continue to administer it into the other nostril, in order to at least partially ensure nasal breathing.

Recommended doses should not be exceeded, especially in children and elderly patients.

Effect on the ability to drive vehicles and operate machinery

With long-term treatment or when using xylometazoline in higher doses, the possibility of its systemic action cannot be excluded.

If systemic side effects develop, it is necessary to refrain from driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Enhancement of the systemic action of xylometazoline is possible with simultaneous use of MAO inhibitors and tricyclic antidepressants.

Simultaneous use of xylometazoline with tetracyclic antidepressants, other topical vasoconstrictors (decongestants), as well as other drugs that increase blood pressure is incompatible.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.