Xymelin^® (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

Decongestant – alpha-adrenomimetic

Pharmacological Action

Xylometazoline belongs to the group of topical vasoconstrictors (decongestants) with alpha-adrenomimetic action. It causes constriction of the blood vessels of the nasal mucosa, eliminating swelling and hyperemia of the nasopharyngeal mucosa. It facilitates nasal breathing.

In therapeutic concentrations, it does not irritate the nasal mucosa and does not cause hyperemia. The action begins 2 minutes after application and lasts for 10-12 hours.

In vitro studies have shown that Xylometazoline suppresses the infectious activity of human rhinovirus, which causes the “common cold”.

Pharmacokinetics

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

Indications

• Acute respiratory diseases with symptoms of rhinitis;
• Acute allergic rhinitis;
• Hay fever;
• Sinusitis;
• Eustachitis;
• Otitis media (to reduce swelling of the nasopharyngeal mucosa);
• Preparation of the patient for diagnostic manipulations in the nasal passages.

ICD codes

Dosage Regimen

Drops

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

Spray

The drug is used intranasally.

Nasal spray 0.05% is prescribed for children aged 2 to 6 years, 1 spray into each nostril 1-2 times/day. Should not be used more than 3 times/day.

Nasal spray 0.1% is prescribed for adults and children over 6 years old, 1 spray into each nostril (if necessary, the spray can be repeated). Should not be used more than 3 times/day.

The drug should be used for no more than 10 days.

In children, the drug should be used only under adult supervision.

1 spray of Xymelin^® 0.05% contains about 35 mcg of xylometazoline hydrochloride; 1 spray of Xymelin^® 0.1% contains about 140 mcg of xylometazoline hydrochloride.

The drug should be used only according to the indications, method of application, and in the doses specified in the instructions.

During the administration of the drug, the bottle should be held with the sprayer pointing upwards.

Adverse Reactions

Classification of the frequency of adverse reactions: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000).

Immune system disorders very rare – hypersensitivity reactions (angioedema, rash, itching).

Nervous system disorders rare – insomnia, depression (with long-term use in high doses); very rare – anxiety, fatigue, headache, hallucinations and convulsions (mainly in children).

Eye disorders very rare – blurred vision.

Cardiac and vascular disorders rare – palpitations, increased blood pressure; very rare – tachycardia, arrhythmia.

Respiratory, thoracic and mediastinal disorders common – irritation and/or dryness of the nasal mucosa, burning, tingling, sneezing, hypersecretion of the nasopharyngeal mucosa; uncommon – nasal congestion (reactive hyperemia), especially after prolonged and frequent use); rare – nosebleed.

Gastrointestinal disorders common – nausea; rare – vomiting, stomach discomfort.

If any of the side effects listed in the instructions get worse, or if any other side effects not listed in the instructions are noticed, the patient should inform the doctor.

Contraindications

• Hypersensitivity to the components of the drug;
• Arterial hypertension;
• Tachycardia;
• Severe atherosclerosis;
• Glaucoma;
• Dry rhinitis or atrophic rhinitis;
• Hyperthyroidism;
• Condition after transsphenoidal hypophysectomy;
• Surgical interventions on the meninges (in history);
• Pregnancy;
• Children under 2 years of age (for Xymelin^® 0.05%);
• Children under 6 years of age (for Xymelin^® 0.1%);
• Therapy with MAO inhibitors or tricyclic antidepressants, including the period of 14 days after their discontinuation.

With caution diabetes mellitus; pheochromocytoma; diseases of the cardiovascular system, including coronary artery disease, angina pectoris III-IV functional class; porphyria; breastfeeding period; prostatic hyperplasia; atherosclerosis; with increased sensitivity to adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, increased blood pressure.

Use in Pregnancy and Lactation

The use of the drug during pregnancy is contraindicated.

During lactation, Xymelin^® should be used only after careful assessment of the benefit to the mother versus the risk to the breastfed infant; exceeding the recommended dose is not allowed.

Pediatric Use

Xymelin^® 0.05% is contraindicated in children under 2 years of age, Xymelin^® 0.1% – in children under 6 years of age.

Special Precautions

It is not recommended to use the drug continuously for more than 10 days. If symptoms persist after this time, it is necessary to consult a doctor.

The recommended doses should not be exceeded, especially in children and the elderly.

Long-term (more than 10 days) or excessive use of the drug can cause a “rebound” effect (medication rhinitis) and/or atrophy of the nasal mucosa.

Overdose

Symptoms Xylometazoline, when administered topically in excessive doses or when accidentally ingested, can cause severe dizziness, increased and irregular pulse, increased sweating, sharp decrease in body temperature, headache, drowsiness, bradycardia, increased blood pressure, respiratory depression, coma and convulsions. A sharp decrease in blood pressure may follow its increase.

Treatment appropriate supportive measures should be taken for any suspicion of overdose; in some cases, immediate symptomatic treatment under medical supervision is indicated. These measures should include monitoring the patient for several hours. In case of severe poisoning with cardiac arrest, resuscitation should continue for at least 1 hour.

Drug Interactions

The use of xylometazoline is contraindicated in patients receiving MAO inhibitors or tricyclic antidepressants, including the period of 14 days after their discontinuation.

Concomitant use of tri- or tetracyclic antidepressants and sympathomimetics may lead to an increase in the sympathomimetic effect of xylometazoline, so such a combination should be avoided.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is available without a prescription.

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.