Zvezdochka noz (Drops) Instructions for Use

Marketing Authorization Holder

Dominanta-Service, JSC (Russia)

Manufactured By

Danapha Pharmaceutical, Joint Stock Company (Vietnam)

ATC Code

R01AA07 (Xylometazoline)

Active Substance

Xylometazoline (Rec.INN registered by WHO)

Dosage Forms

	Zvezdochka noz	Nasal drops 0.1%: dropper bottle 10 ml, 15 ml or 20 ml
	Zvezdochka noz	Nasal drops 0.05%: dropper bottle 10 ml, 15 ml or 20 ml
	Zvezdochka noz	Nasal spray 0.1%: bottle with sprayer 10 ml, 15 ml, 20 ml, 30 ml

Dosage Form, Packaging, and Composition

Zvezdochka noz

Nasal drops as a clear, colorless liquid.

Excipients: benzalkonium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, sodium chloride, disodium edetate dihydrate, purified water.

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

Zvezdochka noz

Nasal drops as a clear, colorless liquid.

Excipients: benzalkonium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, sodium chloride, disodium edetate dihydrate, purified water.

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

Zvezdochka noz

Nasal spray as a clear, colorless liquid.

Excipients: benzalkonium chloride, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate, sodium chloride, disodium edetate dihydrate, purified water.

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

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

Alpha-adrenergic agonist. Constricts the blood vessels of the nasal mucosa, eliminating edema and hyperemia of the mucous membrane. Facilitates nasal breathing in rhinitis.

The effect occurs within a few minutes and lasts for several hours.

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

ICD codes

Dosage Regimen

Administer intranasally only. Select the appropriate concentration based on the patient’s age.

For adults and children over 6 years, use the 0.1% solution. Instill 2-3 drops into each nasal passage.

For children aged 2 to 6 years, use the 0.05% solution. Instill 1-2 drops into each nasal passage.

Administer the drops 2-3 times per day as needed for nasal congestion. The maximum frequency is three times in 24 hours.

Before use, clear the nasal passages. Tilt the head back slightly during administration.

Limit the duration of use. Do not use for more than 3-5 consecutive days without medical supervision.

Prolonged use may lead to rebound congestion (rhinitis medicamentosa) and reduced efficacy.

If symptoms persist beyond one week, discontinue use and consult a physician.

Adverse Reactions

During use, it may cause burning in the nose and throat, local irritation, paresthesia, sneezing, hypersecretion, and dryness of the nasal mucosa. Allergic reactions are possible.

Rarely – swelling of the nasal mucosa, palpitations, tachycardia, arrhythmias, increased blood pressure, headache, nausea, vomiting, insomnia, visual disturbances; depression (with long-term use in high doses).

If symptoms occur, discontinue use of the drug and consult a doctor.

Contraindications

• Arterial hypertension;
• Tachycardia;
• Severe atherosclerosis;
• Glaucoma;
• Atrophic rhinitis;
• Thyrotoxicosis;
• Surgical interventions on the meninges (in history);
• Pregnancy;
• Childhood (under 6 years);
• Hypersensitivity to the components of the drug.

With caution: lactation period, coronary artery disease (angina pectoris), prostatic hyperplasia, diabetes mellitus.

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy. Use with caution during lactation.

Pediatric Use

Contraindicated in children under 6 years of age.

For children over 6 years old, 2-3 drops into each nasal passage 2-3 times/day.

Special Precautions

Frequent and prolonged use is not recommended for chronic diseases of the nasopharynx. For colds in cases where crusts form in the nose, it is preferable to prescribe in the form of a gel.

Overdose

Symptoms in case of accidental poisoning with xylometazoline when taken orally may include mydriasis, nausea, vomiting, cyanosis, fever, spasms, tachycardia, cardiac arrhythmia, collapse, cardiac arrest, hypertension, pulmonary edema, respiratory disorders, mental disorders, suppression of CNS function accompanied by drowsiness, decreased body temperature, bradycardia, hypotension, apnea, coma.

Treatment: gastric lavage, administration of activated charcoal, mechanical ventilation if necessary. To reduce blood pressure – phentolamine IV slowly at a dose of 5 mg or orally at a dose of 100 mg.

Vasopressors are contraindicated. If necessary, use antipyretics and anticonvulsants.

Drug Interactions

Do not use simultaneously with MAO inhibitors and tricyclic antidepressants.

Storage Conditions

Store the drug at a temperature from 15°C (59°F) to 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life 3 years.

Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.