Xylometazoline (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 Groups

Decongestant – vasoconstrictor (alpha-adrenergic agonist)
Decongestant – alpha-adrenergic agonist

Pharmacological Action

Vasoconstrictor for topical use in ENT practice. 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

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.

Drops

Used intranasally. The dose depends on the dosage form used and the age of the patient.

Spray

Intranasally.

Adults and children over 6 years old: 1 spray of 0.1% xylometazoline solution into each nostril 2-3 times a day.

Children aged 2 to 6 years: use 0.05% xylometazoline solution, 1 spray into each nostril 1-2 times a day.

The drug should not be used more than 3 times a day. The course of treatment for rhinitis should not exceed 5-7 days.

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; childhood – depending on the dosage form.

With caution: 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, difficulty in nasal breathing 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 mechanisms

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

Xylometazoline [Apteki 36,6, CJS (Russia)]
Nasal drops 0.05%: bottle 10 ml or 15 ml

Marketing Authorization Holder

Apteki 36,6, CJS (Russia)

Manufactured By

Lens-Pharm, LLC (Russia)

Dosage Form

Xylometazoline

Nasal drops 0.05%: bottle 10 ml or 15 ml

Dosage Form, Packaging, and Composition

Nasal drops 0.05%	1 ml
Xylometazoline hydrochloride	500 mcg

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

Xylometazoline [Apteki 36,6, CJS (Russia)]
Nasal drops 0.1%: bottle 10 ml or 15 ml

Marketing Authorization Holder

Apteki 36,6, CJS (Russia)

Manufactured By

Lens-Pharm, LLC (Russia)

Dosage Form

Xylometazoline

Nasal drops 0.1%: bottle 10 ml or 15 ml

Dosage Form, Packaging, and Composition

Nasal drops 0.1%	1 ml
Xylometazoline hydrochloride	1 mg

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

Xylometazoline [Apteki 36,6, CJS (Russia)]
Nasal spray 0.05%: 10 ml or 15 ml bottle

Marketing Authorization Holder

Apteki 36,6, CJS (Russia)

Manufactured By

Lens-Pharm, LLC (Russia)

Dosage Form

Xylometazoline

Nasal spray 0.05%: 10 ml or 15 ml bottle

Dosage Form, Packaging, and Composition

Nasal spray 0.05%	1 ml
Xylometazoline hydrochloride	500 mcg

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

Xylometazoline [Apteki 36,6, CJS (Russia)]
Nasal spray 0.1%: vial 10 ml or 15 ml

Marketing Authorization Holder

Apteki 36,6, CJS (Russia)

Manufactured By

Lens-Pharm, LLC (Russia)

Dosage Form

Xylometazoline

Nasal spray 0.1%: vial 10 ml or 15 ml

Dosage Form, Packaging, and Composition

Nasal spray 0.1%	1 ml
Xylometazoline hydrochloride	1 mg

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

Xylometazoline [Atoll LLC (Russia)]
Eucalyptus nasal spray 0.1%: vial 10 ml or 20 ml
Nasal spray 0.1%: bottle 10 ml or 20 ml
Eucalyptus nasal spray 0.05%: vial 10 ml or 20 ml
Nasal spray 0.05%: 10 mL or 20 mL bottle

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Forms

	Xylometazoline	Eucalyptus nasal spray 0.1%: vial 10 ml or 20 ml
		Nasal spray 0.1%: bottle 10 ml or 20 ml
		Eucalyptus nasal spray 0.05%: vial 10 ml or 20 ml
		Nasal spray 0.05%: 10 mL or 20 mL bottle

Dosage Form, Packaging, and Composition

Nasal spray 0.1% in the form of a colorless or slightly colored transparent liquid with a faint characteristic odor.

	1 ml
Xylometazoline hydrochloride	1 mg

Excipients: benzalkonium chloride – 0.15 mg, disodium edetate – 0.5 mg, potassium dihydrogen phosphate – 3.63 mg, sodium phosphate dibasic dihydrate – 3.54 mg, sodium chloride – 7 mg, eucalyptus oil – 0.5 mg, sorbitol – 8 mg, glycerol – 4 mg, macrogol glyceryl hydroxystearate – 3.4 mg, purified water – up to 1 ml.

10 ml – bottles with a sprayer (1) – cardboard packs.
20 ml – bottles with a sprayer (1) – cardboard packs.

Nasal spray 0.1% in the form of a colorless or slightly colored transparent liquid with a faint characteristic odor.

	1 ml
Xylometazoline hydrochloride	1 mg

Excipients: benzalkonium chloride – 0.15 mg, disodium edetate – 0.47 mg, potassium dihydrogen phosphate – 3.63 mg, sodium phosphate dibasic dihydrate – 3.54 mg, sodium chloride – 9 mg, purified water – up to 1 ml.

10 ml – bottles with a sprayer (1) – cardboard packs.
20 ml – bottles with a sprayer (1) – cardboard packs.

Nasal spray 0.05% in the form of a colorless or slightly colored transparent liquid with a faint characteristic odor.

	1 ml
Xylometazoline hydrochloride	0.5 mg

10 ml – bottles with a sprayer (1) – cardboard packs.
20 ml – bottles with a sprayer (1) – cardboard packs.

Nasal spray 0.05% in the form of a colorless or slightly colored transparent liquid with a faint characteristic odor.

	1 ml
Xylometazoline hydrochloride	0.5 mg

10 ml – bottles with a sprayer (1) – cardboard packs.
20 ml – bottles with a sprayer (1) – cardboard packs.

Xylometazoline [West, LLC (Russia)]
Nasal drops 0.1%: bottle or dropper bottle 10 ml, 15 ml, 20 ml, or 25 ml
Nasal drops 0.05%: bottle or dropper bottle 10 ml, 15 ml, 20 ml, or 25 ml

Marketing Authorization Holder

West, LLC (Russia)

Manufactured By

Samaramedprom, OJSC (Russia)

Dosage Forms

	Xylometazoline	Nasal drops 0.1%: bottle or dropper bottle 10 ml, 15 ml, 20 ml, or 25 ml
		Nasal drops 0.05%: bottle or dropper bottle 10 ml, 15 ml, 20 ml, or 25 ml

Dosage Form, Packaging, and Composition

Nasal drops colorless or with a brownish-yellowish tint, transparent.

	1 ml
Xylometazoline hydrochloride	1 mg

Excipients: benzalkonium chloride 50% solution (calculated as anhydrous benzalkonium chloride), disodium edetate dihydrate (Trilon B), potassium dihydrogen phosphate, sodium phosphate dibasic dodecahydrate, sodium chloride, purified water.

10 ml – bottles (1) – cardboard packs.
10 ml – dropper bottles (1) – cardboard packs.
15 ml – bottles (1) – cardboard packs.
15 ml – dropper bottles (1) – cardboard packs.
20 ml – bottles (1) – cardboard packs.
20 ml – dropper bottles (1) – cardboard packs.
25 ml – bottles (1) – cardboard packs.
25 ml – dropper bottles (1) – cardboard packs.

Nasal drops colorless or with a brownish-yellowish tint, transparent.

	1 ml
Xylometazoline hydrochloride	0.5 mg

Xylometazoline [Vips-Med, LLC (Russia)]
Nasal drops 0.1%: bottle 10 ml or 15 ml
Nasal drops 0.05%: bottle 10 ml or 15 ml

Marketing Authorization Holder

Vips-Med, LLC (Russia)

Dosage Forms

	Xylometazoline	Nasal drops 0.1%: bottle 10 ml or 15 ml
		Nasal drops 0.05%: bottle 10 ml or 15 ml

Dosage Form, Packaging, and Composition

Nasal drops 0.1% are colorless or slightly yellowish, transparent.

	1 ml
Xylometazoline hydrochloride	1 mg

Excipients: benzalkonium chloride – 0.15 mg, disodium edetate – 0.5 mg, potassium dihydrogen phosphate – 3.63 mg, sodium phosphate dibasic dodecahydrate – 7.13 mg, sodium chloride – 9 mg, purified water – up to 1 ml.

10 ml – polyethylene bottles (1) – cardboard packs.
15 ml – polyethylene bottles (1) – cardboard packs.

Nasal drops 0.05% are colorless or slightly yellowish, transparent.

	1 ml
Xylometazoline hydrochloride	500 mcg

10 ml – polyethylene bottles (1) – cardboard packs.
15 ml – polyethylene bottles (1) – cardboard packs.

Xylometazoline [Vips-Med, LLC (Russia)]
Nasal spray 0.05%: vial 10 ml

Marketing Authorization Holder

Vips-Med, LLC (Russia)

Dosage Form

Xylometazoline

Nasal spray 0.05%: vial 10 ml

Dosage Form, Packaging, and Composition

Nasal spray 0.05%	1 ml
Xylometazoline hydrochloride	500 mcg

10 ml – bottles with a sprayer (1) – cardboard packs.

Xylometazoline [Vips-Med, LLC (Russia)]
Nasal spray 0.1%: bottle 10 ml

Marketing Authorization Holder

Vips-Med, LLC (Russia)

Dosage Form

Xylometazoline

Nasal spray 0.1%: bottle 10 ml

Dosage Form, Packaging, and Composition

Nasal spray 0.1%	1 ml
Xylometazoline hydrochloride	1 mg

10 ml – bottles with a sprayer (1) – cardboard packs.

Xylometazoline [Vips-Med, LLC (Russia)]
Eucalyptus nasal spray 0.1%: vial 10 ml or 20 ml
Eucalyptus nasal spray 0.05%: vial 10 ml or 20 ml

Marketing Authorization Holder

Vips-Med, LLC (Russia)

Dosage Forms

	Xylometazoline	Eucalyptus nasal spray 0.1%: vial 10 ml or 20 ml
		Eucalyptus nasal spray 0.05%: vial 10 ml or 20 ml

Dosage Form, Packaging, and Composition

Nasal spray 0.05% eucalyptus is a colorless or slightly colored liquid with a characteristic odor.

	1 ml
Xylometazoline hydrochloride	500 mcg

Excipients: benzalkonium chloride 150 mcg/ml, disodium edetate dihydrate 500 mcg/ml, potassium dihydrogen phosphate 3.63 mg/ml, sodium phosphate dibasic dodecahydrate 7.13 mg/ml, sodium chloride 7 mg/ml, eucalyptus oil 500 mcg/ml, sorbitol 8 mg/ml, glycerol 4 mg/ml, macrogol glyceryl hydroxystearate 3.4 mg/ml, purified water up to 1 ml.

10 ml – bottles with a sprayer (1) – cardboard packs.
20 ml – bottles with a sprayer (1) – cardboard packs.

Nasal spray 0.1% eucalyptus is a colorless or slightly colored liquid with a characteristic odor.

	1 ml
Xylometazoline hydrochloride	1 mg

10 ml – bottles with a sprayer (1) – cardboard packs.
20 ml – bottles with a sprayer (1) – cardboard packs.

Xylometazoline [Dalkhimpharm, JSC (Russia)]
Nasal drops 0.1%: 10 ml dropper bottle
Nasal drops 0.05%: 10 ml dropper bottle

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Forms

	Xylometazoline	Nasal drops 0.1%: 10 ml dropper bottle
		Nasal drops 0.05%: 10 ml dropper bottle

Dosage Form, Packaging, and Composition

Nasal drops in the form of a transparent, colorless or light yellow solution, a colorless or slightly brownish liquid.

	1 ml
Xylometazoline hydrochloride	1 mg

Excipients: sodium chloride – 9 mg, potassium hydrogen phosphate – 8.25 mg, disodium hydrogen phosphate dihydrate – 1.91 mg, disodium edetate (Trilon B) – 0.5 mg, benzalkonium chloride – 0.15 mg, water for injections – up to 1 ml.

10 ml – dropper bottles (1) – cardboard packs.

Nasal drops in the form of a transparent, colorless or light yellow solution, a colorless or slightly brownish liquid.

	1 ml
Xylometazoline hydrochloride	0.5 mg

10 ml – dropper bottles (1) – cardboard packs.

Xylometazoline [Genel RD, LLC (Russia)]
Nasal drops 0.1%: bottle or dropper bottle 10 ml, 15 ml, 20 ml, or 25 ml.
Nasal drops 0.05%: bottle or dropper bottle 10 ml, 15 ml, 20 ml, or 25 ml.

Marketing Authorization Holder

Genel RD, LLC (Russia)

Manufactured By

Samaramedprom, OJSC (Russia)

Dosage Forms

	Xylometazoline	Nasal drops 0.1%: bottle or dropper bottle 10 ml, 15 ml, 20 ml, or 25 ml.
		Nasal drops 0.05%: bottle or dropper bottle 10 ml, 15 ml, 20 ml, or 25 ml.

Dosage Form, Packaging, and Composition

Nasal drops – a colorless or brownish-yellowish transparent liquid.

	1 ml
Xylometazoline hydrochloride	1 mg

Excipients: benzalkonium chloride 50% solution – 0.3 mg (in terms of anhydrous benzalkonium chloride – 0.15 mg), disodium edetate dihydrate (Trilon B) – 0.5 mg, potassium dihydrogen phosphate – 3.63 mg, sodium phosphate dibasic dodecahydrate – 7.13 mg, sodium chloride – 9 mg, purified water – up to 1 ml.

10 ml – bottles (1) – cardboard packs (1).
15 ml – bottles (1) – cardboard packs (1).
20 ml – bottles (1) – cardboard packs (1).
25 ml – bottles (1) – cardboard packs (1).
10 ml – dropper bottles (1) – cardboard packs (1).
15 ml – dropper bottles (1) – cardboard packs (1).
20 ml – dropper bottles (1) – cardboard packs (1).
25 ml – dropper bottles (1) – cardboard packs (1).

Nasal drops – a colorless or brownish-yellowish transparent liquid.

	1 ml
Xylometazoline hydrochloride	0.5 mg

Xylometazoline [Ivanovo Pharmaceutical Factory PJSC (Russia)]
Nasal drops 0.1%: bottle or dropper bottle 10 ml, 15 ml, 20 ml, or 25 ml
Nasal drops 0.05%: bottle or dropper bottle 10 ml, 15 ml, 20 ml, or 25 ml

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

Dosage Forms

	Xylometazoline	Nasal drops 0.1%: bottle or dropper bottle 10 ml, 15 ml, 20 ml, or 25 ml
		Nasal drops 0.05%: bottle or dropper bottle 10 ml, 15 ml, 20 ml, or 25 ml

Dosage Form, Packaging, and Composition

Nasal drops in the form of a transparent, colorless or brownish-yellowish liquid.

	1 ml
Xylometazoline hydrochloride	1 mg

Excipients: benzalkonium chloride 50% solution (in terms of anhydrous benzalkonium chloride), disodium edetate dihydrate, potassium dihydrogen phosphate, sodium phosphate dibasic dodecahydrate, sodium chloride, purified water – up to 1 ml.

10 ml – bottles (1) with dropper caps – cardboard packs.
15 ml – bottles (1) with dropper caps – cardboard packs.
20 ml – bottles (1) with dropper caps – cardboard packs.
25 ml – bottles (1) with dropper caps – cardboard packs.
10 ml – dropper bottles (1) – cardboard packs.
15 ml – dropper bottles (1) – cardboard packs.
20 ml – dropper bottles (1) – cardboard packs.
25 ml – dropper bottles (1) – cardboard packs.

Nasal drops in the form of a transparent, colorless or brownish-yellowish liquid.

	1 ml
Xylometazoline hydrochloride	0.5 mg

Xylometazoline [Slavic Pharmacy, LLC (Russia)]
Nasal drops 1%: 10 ml or 15 ml bottle

Marketing Authorization Holder

Slavic Pharmacy, LLC (Russia)

Dosage Form

Xylometazoline

Nasal drops 1%: 10 ml or 15 ml bottle

Dosage Form, Packaging, and Composition

Nasal drops in the form of a transparent, colorless or slightly colored liquid.

	1 ml
Xylometazoline hydrochloride	1 mg

Excipients: benzalkonium chloride 0.15 mg, disodium edetate dihydrate 0.5 mg, sodium phosphate dibasic dodecahydrate 7.13 mg, potassium dihydrogen phosphate 3.63 mg, sodium chloride 9 mg, purified water up to 1 ml.

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

Xylometazoline [Slavic Pharmacy, LLC (Russia)]
Nasal drops 0.5%: 10 ml or 15 ml bottle

Marketing Authorization Holder

Slavic Pharmacy, LLC (Russia)

Dosage Form

Xylometazoline

Nasal drops 0.5%: 10 ml or 15 ml bottle

Dosage Form, Packaging, and Composition

Nasal drops in the form of a transparent, colorless or slightly colored liquid.

	1 ml
Xylometazoline hydrochloride	0.5 mg

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

Xylometazoline [Slavic Pharmacy, LLC (Russia)]
Nasal spray 500 mcg/1 ml: bottle 10, 15, or 20 ml

Marketing Authorization Holder

Slavic Pharmacy, LLC (Russia)

Dosage Form

Xylometazoline

Nasal spray 500 mcg/1 ml: bottle 10, 15, or 20 ml

Dosage Form, Packaging, and Composition

Nasal spray	1 ml
Xylometazoline hydrochloride	500 mcg

10 ml – plastic bottles (1) with a sprayer – cardboard packs.
15 ml – plastic bottles (1) with a sprayer – cardboard packs.
20 ml – plastic bottles (1) with a sprayer – cardboard packs.

Xylometazoline [Slavic Pharmacy, LLC (Russia)]
Nasal spray 1 mg/1 ml: bottle 10, 15, or 20 ml

Marketing Authorization Holder

Slavic Pharmacy, LLC (Russia)

Dosage Form

Xylometazoline

Nasal spray 1 mg/1 ml: bottle 10, 15, or 20 ml

Dosage Form, Packaging, and Composition

Nasal spray	1 ml
Xylometazoline hydrochloride	1 mg

10 ml – plastic bottles (1) with a sprayer – cardboard packs.
15 ml – plastic bottles (1) with a sprayer – cardboard packs.
20 ml – plastic bottles (1) with a sprayer – cardboard packs.

Xylometazoline [Tula Pharmaceutical Factory, LLC (Russia)]
Nasal spray 0.1%: vial 10 ml, 15 ml, 20 ml, 25 ml, 30 ml, 35 ml, 40 ml, 45 ml, or 50 ml with dispenser/sprayer
Nasal spray 0.05%: bottle 10 ml, 15 ml, 20 ml, 25 ml, 30 ml, 35 ml, 40 ml, 45 ml, or 50 ml with a dispenser/sprayer

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Forms

	Xylometazoline	Nasal spray 0.1%: vial 10 ml, 15 ml, 20 ml, 25 ml, 30 ml, 35 ml, 40 ml, 45 ml, or 50 ml with dispenser/sprayer
		Nasal spray 0.05%: bottle 10 ml, 15 ml, 20 ml, 25 ml, 30 ml, 35 ml, 40 ml, 45 ml, or 50 ml with a dispenser/sprayer

Dosage Form, Packaging, and Composition

Nasal spray in the form of a colorless or almost colorless, transparent solution.

	1 ml
Xylometazoline hydrochloride	1 mg

Excipients: benzalkonium chloride – 0.15 mg, disodium edetate dihydrate – 0.5 mg, potassium dihydrogen phosphate – 3.63 mg, sodium phosphate dibasic dodecahydrate – 7.13 mg, sodium chloride – 9 mg, purified water – up to 1 ml.

10 ml – bottles (1) with a dispenser/sprayer nozzle – cardboard packs.
15 ml – bottles (1) with a dispenser/sprayer nozzle – cardboard packs.
20 ml – bottles (1) with a dispenser/sprayer nozzle – cardboard packs.
25 ml – bottles (1) with a dispenser/sprayer nozzle – cardboard packs.
30 ml – bottles (1) with a dispenser/sprayer nozzle – cardboard packs.
35 ml – bottles (1) with a dispenser/sprayer nozzle – cardboard packs.
40 ml – bottles (1) with a dispenser/sprayer nozzle – cardboard packs.
45 ml – bottles (1) with a dispenser/sprayer nozzle – cardboard packs.
50 ml – bottles (1) with a dispenser/sprayer nozzle – cardboard packs.

Nasal spray as a colorless or almost colorless, clear solution.

	1 ml
Xylometazoline hydrochloride	0.5 mg

Excipients: benzalkonium chloride – 0.15 mg, disodium edetate dihydrate – 0.5 mg, potassium dihydrogen phosphate – 3.63 mg, sodium hydrogen phosphate dodecahydrate – 7.13 mg, sodium chloride – 9 mg, purified water – up to 1 ml.

10 ml – bottles (1) with a dosing nozzle/sprayer – cardboard packs.
15 ml – bottles (1) with a dosing nozzle/sprayer – cardboard packs.
20 ml – bottles (1) with a dosing nozzle/sprayer – cardboard packs.
25 ml – bottles (1) with a dosing nozzle/sprayer – cardboard packs.
30 ml – bottles (1) with a dosing nozzle/sprayer – cardboard packs.
35 ml – bottles (1) with a dosing nozzle/sprayer – cardboard packs.
40 ml – bottles (1) with a dosing nozzle/sprayer – cardboard packs.
45 ml – bottles (1) with a dosing nozzle/sprayer – cardboard packs.
50 ml – bottles (1) with a dosing nozzle/sprayer – cardboard packs.

Xylometazoline [Pharmregister LLC (Russia)]
Nasal drops 0.1%: bottle 5 ml, 10 ml, 15 ml, 20 ml, 25 ml, 30 ml, 35 ml, 40 ml, 45 ml, or 50 ml with dropper cap
Nasal drops 0.05%: bottle 5 ml, 10 ml, 15 ml, 20 ml, 25 ml, 30 ml, 35 ml, 40 ml, 45 ml, or 50 ml with dropper cap

Marketing Authorization Holder

Pharmregister LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Forms

	Xylometazoline	Nasal drops 0.1%: bottle 5 ml, 10 ml, 15 ml, 20 ml, 25 ml, 30 ml, 35 ml, 40 ml, 45 ml, or 50 ml with dropper cap
		Nasal drops 0.05%: bottle 5 ml, 10 ml, 15 ml, 20 ml, 25 ml, 30 ml, 35 ml, 40 ml, 45 ml, or 50 ml with dropper cap

Dosage Form, Packaging, and Composition

Nasal drops as a clear, colorless or almost colorless solution.

	1 ml
Xylometazoline hydrochloride	1 mg

5 ml – bottles (1) – cardboard packs.
10 ml – bottles (1) – cardboard packs.
15 ml – bottles (1) – cardboard packs.
20 ml – bottles (1) – cardboard packs.
25 ml – bottles (1) – cardboard packs.
30 ml – bottles (1) – cardboard packs.
35 ml – bottles (1) – cardboard packs.
40 ml – bottles (1) – cardboard packs.
45 ml – bottles (1) – cardboard packs.
50 ml – bottles (1) – cardboard packs.

Nasal drops as a clear, colorless or almost colorless solution.

	1 ml
Xylometazoline hydrochloride	0.5 mg

Xylometazoline [Pharmregister LLC (Russia)]
Nasal spray 0.1%: bottle 20 ml 1 pc.
Nasal spray 0.05%: bottle 20 ml 1 pc.

Marketing Authorization Holder

Pharmregister LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Forms

	Xylometazoline	Nasal spray 0.1%: bottle 20 ml 1 pc.
		Nasal spray 0.05%: bottle 20 ml 1 pc.

Dosage Form, Packaging, and Composition

Nasal spray as a clear, colorless or almost colorless solution.

	1 ml
Xylometazoline hydrochloride	1 mg

20 ml – bottles (1) with a dosing nozzle or spray nozzle – cardboard packs.

Nasal spray as a clear, colorless or almost colorless solution.

	1 ml
Xylometazoline hydrochloride	0.5 mg

20 ml – bottles (1) with a dosing nozzle or spray nozzle – cardboard packs.

Xylometazoline [Pharmstandard-UfaVITA OJSC (Russia)]
Nasal drops 0.1%: dropper bottle 10 ml
Nasal drops 0.05%: dropper bottle 10 ml

Marketing Authorization Holder

Pharmstandard-UfaVITA OJSC (Russia)

Dosage Forms

	Xylometazoline	Nasal drops 0.1%: dropper bottle 10 ml
		Nasal drops 0.05%: dropper bottle 10 ml

Dosage Form, Packaging, and Composition

Nasal drops as a clear, colorless or slightly brownish liquid.

	1 ml
Xylometazoline hydrochloride	1 mg

10 ml – dropper bottles (1) – cardboard packs.

Nasal drops as a clear, colorless or slightly brownish liquid.

	1 ml
Xylometazoline hydrochloride	0.5 mg

10 ml – dropper bottles (1) – cardboard packs.

Xylometazoline [Formula-FR, LLC (Russia)]
Nasal spray 0.1%: bottle 20 ml
Nasal spray 0.05%: bottle 20 ml

Marketing Authorization Holder

Formula-FR, LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Forms

	Xylometazoline	Nasal spray 0.1%: bottle 20 ml
		Nasal spray 0.05%: bottle 20 ml

Dosage Form, Packaging, and Composition

Nasal spray as a colorless or almost colorless, clear solution.

	1 ml
Xylometazoline hydrochloride	1 mg

20 ml – orange glass bottles with a dispenser or sprayer (1) – cardboard packs.
20 ml – polymer bottles with a dispenser or sprayer (1) – cardboard packs.

Nasal spray as a colorless or almost colorless, clear solution.

	1 ml
Xylometazoline hydrochloride	0.5 mg

20 ml – orange glass bottles with a dispenser or sprayer (1) – cardboard packs.
20 ml – polymer bottles with a dispenser or sprayer (1) – cardboard packs.

Xylometazoline [Evapharm, LLC (Russia)]
Nasal drops 0.1%: bottle or dropper bottle 10 ml
Nasal drops 0.05%: bottle or dropper bottle 10 ml

Marketing Authorization Holder

Evapharm, LLC (Russia)

Manufactured By

Armavir Biopharmaceutical Plant, FSE (Russia)

Dosage Forms

	Xylometazoline	Nasal drops 0.1%: bottle or dropper bottle 10 ml
		Nasal drops 0.05%: bottle or dropper bottle 10 ml

Dosage Form, Packaging, and Composition

Nasal drops 0.1% as a clear, colorless or slightly colored liquid.

	1 ml
Xylometazoline hydrochloride	1 mg

Excipients: benzalkonium chloride (calculated as anhydrous) – 0.2 mg, sodium dihydrogen phosphate dihydrate – 10.62 mg, sodium hydrogen phosphate dodecahydrate – 2 mg, sodium chloride – 4.8 mg, purified water – up to 1 ml.

10 ml – glass bottles (1) – cardboard packs.
10 ml – glass bottles with a dropper cap (1) – cardboard packs.
10 ml – polyethylene dropper bottles (1) – cardboard packs.

Nasal drops 0.05% as a clear, colorless or slightly colored liquid.

	1 ml
Xylometazoline hydrochloride	0.5 mg

10 ml – glass bottles (1) – cardboard packs.
10 ml – glass bottles with a dropper cap (1) – cardboard packs.
10 ml – polyethylene dropper bottles (1) – cardboard packs.

Medixlife (Author)

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