Xilen® (Spray, Drops) Instructions for Use
ATC Code
R01AA07 (Xylometazoline)
Active Substance
Xylometazoline (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Vasoconstrictor drug for topical use in ENT practice
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-adrenomimetic. 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
| ICD-10 code | Indication |
| H66 | Suppurative and unspecified otitis media |
| J00 | Acute nasopharyngitis (common cold) |
| J01 | Acute sinusitis |
| J06.9 | Acute upper respiratory infection, unspecified |
| J30.1 | Allergic rhinitis due to pollen |
| J30.3 | Other allergic rhinitis (perennial allergic rhinitis) |
| J32 | Chronic sinusitis |
| Z51.4 | Preparatory procedures for subsequent treatment or examination, not elsewhere classified |
| ICD-11 code | Indication |
| AA9Z | Unspecified suppurative otitis media |
| CA00 | Acute nasopharyngitis |
| CA01 | Acute rhinosinusitis |
| CA07.0 | Acute upper respiratory tract infection of unspecified site |
| CA08.00 | Allergic rhinitis due to pollen |
| CA08.03 | Other allergic rhinitis |
| CA0A.Z | Chronic rhinosinusitis, unspecified |
| QB9A | Preparatory procedures for subsequent treatment |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Administer intranasally only. Adhere strictly to the dosing schedule based on the specific product formulation and the patient’s age.
For the nasal spray (0.1% solution): Adults and children aged 6 years and older administer one spray into each nostril. Repeat this dose up to three times daily as needed for nasal congestion.
For the nasal drops (0.05% solution): Children aged 2 to 6 years administer one to two drops into each nostril. Repeat this dose up to two times daily as required.
For the nasal drops (0.1% solution): Adults and children aged 6 years and older administer one to two drops into each nostril. Repeat this dose up to three times daily as needed.
Do not use for more than 7 consecutive days without medical supervision. Prolonged use can cause rebound congestion (medicamentous rhinitis).
Prior to application, gently clear the nasal passages. For spray use, keep the head upright and squeeze the pump briskly. For drops, tilt the head back slightly during instillation.
Avoid exceeding the recommended frequency and duration of use. Do not use in children under 2 years of age unless specifically directed by a physician.
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 angle-closure glaucoma; during therapy with tricyclic and tetracyclic antidepressants, other topical vasoconstrictors (decongestants); pregnancy; pediatric age – depending on the dosage form.
With caution patients with hypersensitivity to adrenomimetics, 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 ratio of the intended benefit for the mother to the potential risk for 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 (medicinal rhinitis), and ultimately even to atrophy of the nasal mucosa (ozena).
In milder cases, to improve the patient’s condition, it is possible to first 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 25°C (77°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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Nasal drops 0.05%: bottle 10 ml
Marketing Authorization Holder
Veropharm, LLC (Russia)
Dosage Form
 |
Xilen® | Nasal drops 0.05%: bottle 10 ml |
Dosage Form, Packaging, and Composition
| Nasal drops 0.05% | 1 ml |
| Xylometazoline hydrochloride | 500 mcg |
10 ml – polymer bottles (1) – cardboard packs.
0.1% nasal drops: 10 ml bottle or dropper bottle
Marketing Authorization Holder
Veropharm, LLC (Russia)
Dosage Form
|
Xilen® | 0.1% nasal drops: 10 ml bottle or dropper bottle |
Dosage Form, Packaging, and Composition
| Nasal drops 0.1% | 1 ml |
| Xylometazoline hydrochloride | 1 mg |
10 ml – polymer bottles (1) – cardboard packs.
Nasal spray 0.05%: dropper bottle or 10, 15, 20 or 30 ml bottle
Marketing Authorization Holder
Veropharm, LLC (Russia)
Dosage Form
|
Xilen® | Nasal spray 0.05%: dropper bottle or 10, 15, 20 or 30 ml bottle |
Dosage Form, Packaging, and Composition
| Nasal spray | 1 ml |
| Xylometazoline hydrochloride | 500 mcg |
10 ml – polymer dropper bottles (1) – cardboard packs.
15 ml – polymer dropper bottles (1) – cardboard packs.
20 ml – polymer dropper bottles (1) – cardboard packs.
30 ml – polymer dropper bottles (1) – cardboard packs.
10 ml – polymer bottles (1) for nasal spray – cardboard packs.
15 ml – polymer bottles (1) for nasal spray – cardboard packs.
20 ml – polymer bottles (1) for nasal spray – cardboard packs.
30 ml – polymer bottles (1) for nasal spray – cardboard packs.
Nasal spray 0.1%: dropper bottle or 10, 15, 20 or 30 ml bottle
Marketing Authorization Holder
Veropharm, LLC (Russia)
Dosage Form
|
Xilen® | Nasal spray 0.1%: dropper bottle or 10, 15, 20 or 30 ml bottle |
Dosage Form, Packaging, and Composition
| Nasal spray | 1 ml |
| Xylometazoline hydrochloride | 1 mg |
10 ml – polymer dropper bottles (1) – cardboard packs.
15 ml – polymer dropper bottles (1) – cardboard packs.
20 ml – polymer dropper bottles (1) – cardboard packs.
30 ml – polymer dropper bottles (1) – cardboard packs.
10 ml – polymer bottles (1) for nasal spray – cardboard packs.
15 ml – polymer bottles (1) for nasal spray – cardboard packs.
20 ml – polymer bottles (1) for nasal spray – cardboard packs.
30 ml – polymer bottles (1) for nasal spray – cardboard packs.
Nasal spray (with camphor and menthol scent) 0.1%: 10 g, 15 g or 20 g bottle
Marketing Authorization Holder
Veropharm, JSC (Russia)
Dosage Form
|
Xilen® NEO | Nasal spray (with camphor and menthol scent) 0.1%: 10 g, 15 g or 20 g bottle |
Dosage Form, Packaging, and Composition
Nasal spray with camphor and menthol scent in the form of an opaque, white, gel-like or liquid mass with a very faint odor of camphor and menthol and thixotropic properties (thickens at rest and liquefies when shaken), which is in a bottle sealed with a dosing pump, equipped with a spray nozzle with a protective cap; the drug is dispensed from the bottle through the spray nozzle in the form of an aerosol cloud, which is particles of a viscous liquid dispersed in a gas medium.
| 100 g | |
| Xylometazoline hydrochloride | 0.1 g |
Excipients : benzyl alcohol – 0.25 g, benzalkonium chloride – 0.01 g, disodium edetate dihydrate (Trilon B) – 0.015 g, racemic camphor – 0.005 g, levomenthol – 0.008 g, povidone K17 – 0.25 g, microcrystalline cellulose – 4 g, sodium carboxymethylcellulose – 4 g, macrogol 400 – 21.5 g, sodium dihydrogen phosphate dihydrate – 0.75 g, disodium hydrogen phosphate dodecahydrate – 0.15 g, purified water – up to 100 g.
10 g – glass bottles (1) – cardboard packs.
15 g – glass bottles (1) – cardboard packs.
20 g – glass bottles (1) – cardboard packs.
![Xilen® [Spray, Drops] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Xilen® [Spray, Drops] 2")