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Xylong (Spray, Drops) Instructions for Use

ATC Code

R01AB06 (Xylometazoline in combination with other drugs)

Active Substances

Dexpanthenol (Rec.INN registered by WHO)

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, combinations without corticosteroids

Pharmacological Action

A combined medicinal product for topical use.

Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with alpha-adrenomimetic activity. It causes constriction of the blood vessels of the nasal mucosa, restores the patency of the nasal passages, and facilitates nasal breathing. The drug’s effect usually begins within a few minutes after application and lasts up to 10 hours.

Dexpanthenol is a B vitamin, a derivative of pantothenic acid. Dexpanthenol is converted in the body into pantothenic acid, which is a component of coenzyme A and is involved in acetylation processes, carbohydrate and fat metabolism, and in the synthesis of acetylcholine, corticosteroids, and porphyrins. It stimulates the regeneration of the skin and mucous membranes, normalizes cellular metabolism, accelerates mitosis, and increases the strength of collagen fibers. It has a regenerating, metabolic, and weak anti-inflammatory effect.

Pharmacokinetics

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

Dexpanthenol, when applied topically, is rapidly absorbed by the skin and converted into pantothenic acid, which binds to plasma proteins (mainly to beta-globulin and albumin). Its concentration in the blood is 0.5-1 mg/l, in blood serum – 100 µg/l. Pantothenic acid is not metabolized in the body (except for incorporation into CoA) and is excreted unchanged.

Indications

Acute respiratory diseases with symptoms of rhinitis; acute allergic rhinitis; vasomotor rhinitis; sinusitis; otitis media (as part of combination therapy to reduce swelling of the nasopharyngeal mucosa); to facilitate rhinoscopy; to restore impaired nasal breathing after surgical interventions in the nasal cavity.

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
J30.0 Vasomotor rhinitis
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
CA08.3 Vasomotor 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.

For intranasal use only. Administer the spray or drops with the head in an upright position.

For adults and children over 6 years of age, administer one spray or 2-3 drops into each nostril.

Apply the medication three to four times daily, as needed for nasal congestion.

The maximum duration of continuous treatment is 5 days. Do not exceed this duration.

For children aged 2 to 6 years, use only the pediatric formulation and consult a physician for appropriate dosage.

This product is contraindicated for children under 2 years of age.

Before administration, clear the nasal passages by gently blowing the nose.

Avoid frequent or prolonged use beyond the recommended duration to prevent rebound congestion.

If symptoms persist after 5 days, discontinue use and seek medical advice.

Adverse Reactions

With frequent and/or prolonged use: irritation and/or dryness of the nasopharyngeal mucosa, burning, tingling, sneezing, hypersecretion, allergic reactions, swelling of the nasal mucosa, vomiting, headache, dry rhinitis, palpitations, increased blood pressure, insomnia, visual disturbances, depression (with long-term use of high doses).

Contraindications

Arterial hypertension; tachycardia; severe atherosclerosis; atrophic rhinitis; hyperthyroidism; porphyria; prostatic hyperplasia; glaucoma; surgical interventions on the meninges (in history); children under 2 years of age; children under 6 years of age (for dosage forms intended for older children and adults); simultaneous therapy with MAO inhibitors and tricyclic antidepressants; hypersensitivity to the components of the medicinal product.

With caution

Diabetes mellitus, pheochromocytoma.

Use in Pregnancy and Lactation

Use during pregnancy and lactation (breastfeeding) is not recommended.

Pediatric Use

Contraindicated in children under 6 years of age.

Special Precautions

It is necessary to clean the nasal passages before use.

Should not be used for more than 5 days.

Influence on the ability to drive vehicles and mechanisms

During the period of use, precautions should be observed, or driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions should be avoided.

Drug Interactions

With simultaneous use of MAO inhibitors and tricyclic antidepressants, an increase in systemic action is possible.

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

Marketing Authorization Holder

Lekko, CJS (Russia)

Dosage Form

Bottle OTC Icon Xylong Nasal drops 1 mg+50 mg/1 ml: dropper bottle 15 ml

Dosage Form, Packaging, and Composition

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

1 ml
Xylometazoline hydrochloride 1 mg
Dexpanthenol 50 mg

Excipients : sodium citrate dihydrate – 5.09 mg, sodium chloride – 2.5 mg, hypromellose – 1 mg, benzalkonium chloride – 0.15 mg, citric acid monohydrate – to pH 4.4 (3.5 mg), purified water – up to 1 ml.

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

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Bottle OTC Icon Xylong Metered-dose nasal spray 0.1 mg+5 mg/1 dose: bottle 15 ml (100 doses)

Dosage Form, Packaging, and Composition

Metered-dose nasal spray in the form of a transparent, colorless liquid.

1 dose
Xylometazoline hydrochloride 0.1 mg
Dexpanthenol 5 mg

Excipients : sodium citrate dihydrate – 0.509 mg, sodium chloride – 0.25 mg, hypromellose – 0.1 mg, benzalkonium chloride – 0.015 mg, citric acid monohydrate – 0.35 mg, purified water – up to 100 µl.

15 ml (100 doses) – polymer bottles (1) with a metering pump complete with a spray nozzle – cardboard packs.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Bottle OTC Icon Xylong Kids Metered-dose nasal spray 0.05 mg+5 mg/1 dose: bottle 15 ml (100 doses)

Dosage Form, Packaging, and Composition

Metered-dose nasal spray in the form of a transparent, colorless liquid.

1 dose
Xylometazoline hydrochloride 0.05 mg
Dexpanthenol 5 mg

Excipients : sodium citrate dihydrate – 0.509 mg, sodium chloride – 0.25 mg, hypromellose – 0.1 mg, benzalkonium chloride – 0.015 mg, citric acid monohydrate – 0.35 mg, purified water – up to 100 µl.

15 ml (100 doses) – polymer bottles (1) with a metering pump complete with a spray nozzle – cardboard packs.

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