Nokspay (Spray) Instructions for Use

Marketing Authorization Holder

Sperko Ukraine SP (Ukraine)

ATC Code

R01AA05 (Oxymetazoline)

Active Substance

Oxymetazoline (Rec.INN WHO registered)

Dosage Form

Nokspay

Nasal spray 0.05%: bottle 20 ml with spray cap

Dosage Form, Packaging, and Composition

Nasal spray in the form of a colorless or slightly yellowish, clear liquid with a specific odor.

Excipients: levomenthol – 0.25 mg, racemic camphor – 0.15 mg, eucalyptol (cineole) – 0.075 mg, benzalkonium chloride – 0.2 mg, sodium dihydrogen phosphate monohydrate – 2 mg, disodium edetate (Trilon B) – 0.1 mg, propylene glycol – 100 mg, 0.1M sodium hydroxide or hydrochloric acid solution – to pH 4.5, purified water – sufficient quantity to 1 ml.

20 ml – polymer bottles (1) with spray caps and caps with first-opening control – cardboard packs.

Clinical-Pharmacological Group

Vasoconstrictor drug for topical use in ENT practice

Pharmacotherapeutic Group

Decongestants and other topical agents. Sympathomimetics

Pharmacological Action

Nokspay is an α-adrenomimetic, an imidazoline derivative, and belongs to the vasoconstrictor agents for topical application.

When entering the nasal cavity, the drug constricts the arterioles of the nasal mucosa, resulting in reduced edema, hyperemia, exudation, restoration of nasal breathing, and reduced nasal discharge.

Nokspay also reduces the swelling of the mucosa around the opening of the Eustachian tube, improving drainage in Eustachitis and otitis media.

The essential oils included in the drug help eliminate irritation of the nasal mucosa and protect it from excessive drying.

Pharmacokinetics

Local constriction of the vessels of the nasal mucosa and paranasal sinuses occurs within 5-10 minutes after spraying Nokspray into the nasal cavity and lasts up to 10-12 hours.

Indications

• Acute rhinitis of allergic or infectious-inflammatory etiology;
• Sinusitis;
• Nasal congestion and difficult nasal breathing in colds;
• Eustachitis, otitis media;
• To facilitate rhinoscopy and other manipulations in the nasal cavity.

ICD codes

Dosage Regimen

The tip of the bottle nozzle is inserted into each nasal passage and the bottle is pressed sharply once. During spraying, air is drawn in through the nose. You should not tilt your head back or turn the bottle over when spraying Nokspray.

For children aged 6 to 12 years, use 1 spray into each nasal passage 2 times/day. For children over 12 years and adults, use 1-2 sprays into each nasal passage 2 times/day.

The duration of use should not exceed 7 days.

Adverse Reactions

Sometimes a sensation of burning or dryness of the nasal membranes, sneezing.

In rare cases reactive hyperemia.

Multiple overdoses with topical nasal application lead to systemic sympathomimetic effects such as tachycardia, insomnia, anxiety, increased blood pressure, headache, nausea.

Very rarely, the use of Nokspray may lead to the development of severe hypersensitivity reactions (including Quincke’s edema).

If side effects occur, the use of the drug must be discontinued and a doctor should be consulted.

Contraindications

• Hypersensitivity to the components of the drug;
• Atrophic rhinitis;
• Children under 6 years of age;
• Pregnancy;
• Lactation period.

Use with caution in chronic heart failure, arrhythmia, severe atherosclerosis, arterial hypertension, thyrotoxicosis, diabetes mellitus, chronic renal failure, closed-angle glaucoma, prostatic hyperplasia with clinical symptoms; with simultaneous use of MAO inhibitors, tricyclic antidepressants.

To prevent the spread of infection, one bottle should not be used by several persons. Long-term use and overdose of the drug should be avoided. Long-term use of decongestants may lead to a decrease in their effectiveness. Abuse of these agents can cause atrophy of the nasal mucosa and reactive hyperemia with drug-induced rhinitis.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, the drug is used only in case of extreme necessity, when the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Use in Renal Impairment

Use with caution in chronic renal failure.

Pediatric Use

Nokspay is used in children over 6 years of age.

Special Precautions

Use in pediatrics

Nokspay is used in children from 6 years of age.

Effect on the ability to drive vehicles and operate machinery

In recommended doses, the drug does not affect the speed of psychomotor reactions.

Overdose

With significant overdose or accidental ingestion, the following symptoms may occur: miosis, nausea, vomiting, cyanosis, hyperthermia, tachycardia, arrhythmia, vascular insufficiency, arterial hypertension, respiratory disorders, pulmonary edema, cardiac arrest, mental disorders. Very rarely – depression of CNS functions with possible development of coma.

Treatment for drug overdose includes gastric lavage and symptomatic therapy.

Drug Interactions

Nokspay should not be used simultaneously with other topical vasoconstrictors and intranasal agents, as well as with tricyclic antidepressants and MAO inhibitors.

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 – 3 years. Do not use the drug 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.