Xylokt^®-SOLOpharm (Spray, Drops) Instructions for Use

Instructions
Dosage forms

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

Vasoconstrictor for topical use in ENT practice. 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

Open the list of 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 age-specific dosing instructions for the selected dosage form.

For the 0.05% solution (drops): Instill 1-2 drops into each nostril. For children aged 2 to 6 years, use up to 2-3 times daily. For adults and children over 6 years, use up to 4 times daily.

For the 0.1% solution (spray or drops): Administer one injection or instill 1-2 drops into each nostril. This strength is for adults and children over 6 years only. Use up to 3-4 times daily.

Do not exceed the recommended frequency or duration of use. The maximum treatment duration is 7 days unless directed by a physician.

For pre-procedural use, apply a single dose shortly before the diagnostic procedure to reduce mucosal edema.

Allow at least 4-6 hours between applications. To minimize systemic absorption, use the smallest effective dose for the shortest necessary time.

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 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 benefit-risk ratio for the mother and 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 use in children of different ages for specific dosage forms of xylometazoline. 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 initially possible to 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.

In case of systemic side effects, 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 Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Xylokt^®-SOLOpharm [Grotex, LLC (Russia)]
Nasal spray, metered 35 mcg/1 dose: vial 10 ml (120 doses) or 15 ml (180 doses) with metering nozzle
Nasal spray, metered 140 mcg/1 dose: vial 60 doses or 90 doses with metering nozzle

Marketing Authorization Holder

Grotex, LLC (Russia)

Dosage Forms

	Xylokt^®-SOLOpharm	Nasal spray, metered 35 mcg/1 dose: vial 10 ml (120 doses) or 15 ml (180 doses) with metering nozzle
		Nasal spray, metered 140 mcg/1 dose: vial 60 doses or 90 doses with metering nozzle

Dosage Form, Packaging, and Composition

Nasal spray, metered as a clear, colorless or light yellow liquid.

	1 dose (70 µl)
Xylometazoline hydrochloride	35 mcg

Excipients : benzalkonium chloride – 7 mcg, disodium edetate (Trilon B) – 35 mcg, sodium hydrogen phosphate dihydrate – 140 mcg, sodium dihydrogen phosphate dihydrate – 140 mcg, sodium chloride – 518 mcg, water for injections – 69.4 mg.

10 ml (120 doses) – polyethylene vials (1) with a metering nozzle – cardboard packs.
15 ml (180 doses) – polyethylene vials (1) with a metering nozzle – cardboard packs.

Nasal spray, metered as a clear, colorless or light yellow liquid.

	1 dose (140 µl)
Xylometazoline hydrochloride	140 mcg

Excipients : benzalkonium chloride – 14 mcg, disodium edetate (Trilon B) – 70 mcg, sodium hydrogen phosphate dihydrate – 280 mcg, sodium dihydrogen phosphate dihydrate – 280 mcg, sodium chloride – 1020 mcg, water for injections – 138.75 mg.

10 ml (60 doses) – polyethylene vials (1) with a metering nozzle – cardboard packs.
15 ml (90 doses) – polyethylene vials (1) with a metering nozzle – cardboard packs.

Xylokt^®-SOLOpharm [Grotex, LLC (Russia)]
Nasal drops 0.1%: bottle or dropper bottle 10 ml or 15 ml
Nasal drops 0.05%: bottle or dropper bottle 10 ml or 15 ml

Marketing Authorization Holder

Grotex, LLC (Russia)

Dosage Forms

	Xylokt^®-SOLOpharm	Nasal drops 0.1%: bottle or dropper bottle 10 ml or 15 ml
		Nasal drops 0.05%: bottle or dropper bottle 10 ml or 15 ml

Dosage Form, Packaging, and Composition

Nasal drops as a clear, colorless or light yellow liquid.

	1 ml
Xylometazoline hydrochloride	1 mg

Excipients : benzalkonium chloride – 0.15 mg, disodium edetate dihydrate (Trilon B) – 0.5 mg, sodium hydrogen phosphate dihydrate – 3.54 mg, potassium dihydrogen phosphate – 3.63 mg, sodium chloride – 9 mg, water for injections – up to 1 ml.

10 ml – plastic bottles (1) with a dropper – cardboard packs.
15 ml – plastic bottles (1) with a dropper – cardboard packs.
10 ml – polymer dropper bottles (1) – cardboard packs.
15 ml – polymer dropper bottles (1) – cardboard packs.

Nasal drops as a clear, colorless or light yellow liquid.