Nazospray (Spray) Instructions for Use

Marketing Authorization Holder

Lekko, CJS (Russia)

ATC Code

R01AA05 (Oxymetazoline)

Active Substance

Oxymetazoline (Rec.INN registered by WHO)

Dosage Form

Nazospray

Nasal spray 0.05%: bottle 15 ml with sprayer

Dosage Form, Packaging, and Composition

Nasal spray as a clear, colorless or slightly colored solution.

Excipients: benzalkonium chloride – 0.5 mg, boric acid – 17.2 mg, disodium edetate dihydrate – 0.1 mg, sodium tetraborate decahydrate – 0.02 mg, purified water – up to 1 ml.

15 ml – polypropylene bottles (1) with a sprayer and with a first-opening control ring – cardboard packs.

Clinical-Pharmacological Group

Vasoconstrictor drug for topical use in ENT practice

Pharmacotherapeutic Groups

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

Pharmacological Action

Adrenomimetic agent for topical use. It has a vasoconstrictive effect.

When applied intranasally, it reduces swelling of the mucous membrane of the upper respiratory tract.

Pharmacokinetics

When applied intranasally, T_1/2 is 35 hours.

Indications

Difficulty in nasal breathing during colds, sinus inflammation, eustachitis, hay fever, allergic rhinitis.

To relieve swelling before diagnostic manipulations in the nasal passages.

ICD codes

Dosage Regimen

Administer intranasally only.

For adults and children over 6 years: administer one injection into each nostril.

Repeat this dose two to three times daily as needed for nasal congestion.

For children aged 2 to 6 years: administer one injection into each nostril.

Use in this age group only once daily; a single daily application is often sufficient.

Do not use in children under 2 years of age.

Limit the total duration of treatment to 3 to 5 consecutive days.

Do not exceed the recommended dosage and frequency.

Before first use, prime the pump by pressing the spray mechanism several times until a fine mist is produced.

To administer, keep the head upright, insert the tip into the nostril, and spray while breathing in gently through the nose.

If no relief is achieved, discontinue use and consult a physician.

Prolonged use beyond 7 days can lead to rebound congestion (rhinitis medicamentosa).

Adverse Reactions

Local reactions possibly – burning, dryness of the nasal mucosa, sneezing; rarely – after the effect of the application wears off, the development of a strong feeling of nasal congestion (reactive hyperemia).

Systemic reactions multiple overdoses with topical application can lead to tachycardia and increased blood pressure; very rarely – anxiety, insomnia, fatigue, headaches, nausea.

Contraindications

Atrophic rhinitis, closed-angle glaucoma, hypersensitivity to oxymetazoline.

With caution

Use of MAO inhibitors and the period up to 10 days after their intake; use of drugs that promote an increase in blood pressure and the period up to 10 days after their intake; increased intraocular pressure; severe forms of cardiovascular diseases (arterial hypertension, coronary artery disease), thyrotoxicosis, diabetes mellitus, pregnancy, breastfeeding period.

Use in Pregnancy and Lactation

Use with caution during pregnancy and lactation (breastfeeding).

Pediatric Use

It is used in children according to indications in appropriate dosage forms.

Geriatric Use

Use with caution in elderly patients to avoid exacerbation of chronic diseases.

Special Precautions

Long-term use and overdose should be avoided, especially in children.

Effect on the ability to drive vehicles and machinery

When used in doses exceeding the recommended ones, a general effect on the cardiovascular system and central nervous system cannot be excluded.

In such cases, a decrease in the ability to drive vehicles and engage in other potentially hazardous activities is possible.

Drug Interactions

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

Oxymetazoline slows down the absorption of local anesthetics and prolongs their action.

Concomitant use of other vasoconstrictor drugs increases the risk of side effects.

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.