Description

Release form, composition and packaging

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Nasal spray 0.05% in the form of a gel-like suspension of white or almost white color, with a characteristic citrus odor.

1 ml

oxymetazoline hydrochloride 500 mcg

disodium edetate dihydrate - 300 μg, sodium hydrogen phosphate - 975 μg, sodium dihydrogen phosphate monohydrate - 5.525 mg, povidone K29-32 - 30 mg, benzalkonium chloride solution 17% - 1.471 mg, macrogol 1450 - 50 mg, benzyl alcohol - 2.5 mg, cellulose microcrystalline and sodium carmellose (avicel RC-591) - 30 mg, lemon flavoring - 1.5 mg, purified water - qs up to 1 ml.

15 ml - plastic bottles with a dosing device (1) - cardboard packs.

pharmachologic effect

Topical vasoconstrictor, alpha-adrenostimulant.

Oxymetazoline causes vasoconstriction in the mucous membranes of the nose, paranasal sinuses and the Eustachian tube, which leads to a decrease in their edema and facilitates nasal breathing in allergic and / or infectious-inflammatory rhinitis.

Due to the presence of nasal excipients in the spray (microcrystalline cellulose and sodium carmellose, povidone-K29-32), the drug does not flow out of the nose and does not drain into the throat, because

after being introduced into the nasal passages, the spray becomes more viscous and adheres to the nasal mucosa more effectively than a standard aqueous solution.

According to clinical studies, the drug begins to act within 1 minute, the effect lasts up to 12 hours.

Pharmacokinetics

When used as a nasal spray, oxymetazoline is practically not detected in blood plasma.

Indications for use

- symptomatic therapy of rhinitis of allergic and / or infectious-inflammatory etiology

- sinusitis

- eustachitis

- hay fever.

Contraindications for use

- atrophic rhinitis

- simultaneous use of MAO inhibitors (including a period of 14 days after their cancellation)

- children under 6 years of age.

- hypersensitivity to drug components.

Care should be taken to prescribe the drug for coronary artery disease, arrhythmias, chronic heart failure, severe atherosclerosis, arterial hypertension, hyperthyroidism, diabetes mellitus, chronic renal failure, angle-closure glaucoma, prostatic hyperplasia with clinical symptoms, pregnancy, lactation.

Dosage regimen

The drug is administered intranasally.

Shake the bottle vigorously before each use.

Before using the nasal spray for the first time, it must be calibrated" by pressing the spray head several times.

Adults and children over 6 years old - 2-3 injections into each nasal passage with an interval of 10-12 hours. In adults, the frequency of application can be increased up to 3 times / day.

It is not recommended to exceed the indicated dose.

Overdose

Symptoms: with a significant overdose or accidental ingestion, nausea, vomiting, cyanosis, fever, tachycardia, arrhythmia, increased blood pressure, shortness of breath, mental disorders, depression of the central nervous system (drowsiness, decreased body temperature, bradycardia, decreased blood pressure, respiratory arrest and coma) are possible.

Treatment: symptomatic

in case of accidental ingestion - gastric lavage, activated carbon.

Side effect

Local reactions: transient dryness and burning of the nasal mucosa, dry mouth and throat, sneezing.

With prolonged use - tachyphylaxis, reactive hyperemia and atrophy of the nasal mucosa.

Benzalkonium chloride, which is part of the drug, can cause irritation of the nasal mucosa.

Systemic reactions: increased blood pressure, increased anxiety, nausea, dizziness, headache, insomnia, palpitations, sleep disturbances.

Drug interactions

The drug slows down the absorption of local anesthetic drugs, lengthens the time of their action.

Combined use with other vasoconstrictor drugs

Name ENG

AFRIN

Clinical and pharmacological group

A vasoconstrictor drug for local use in ENT practice

ATX code

Oxymetazoline

Dosage

0.05% x 15ml

Structure

1 ml contains: Active ingredient: oxymetazoline hydrochloride 0.5 mg

Excipients: disodium edetate dihydrate - 300 μg, sodium hydrogen phosphate - 975 μg, sodium dihydrogen phosphate monohydrate - 5.525 mg, povidone K29-32 - 30 mg, benzalkonium chloride solution 17% - 1.471 mg, macrogol 1450 - 50 mg, benzyl alcohol - 2.5 mg, microcrystalline cellulose and sodium carmellose (Avicel RC-591) - 30 mg, lemon flavoring - 1.5 mg, purified water - qs up to 1 ml.

Indications

Symptomatic therapy of rhinitis (rhinitis) of allergic and / or infectious-inflammatory etiology

sinusitis

eustachitis

hay fever.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 2 years

Contraindications

atrophic rhinitis

simultaneous use of MAO inhibitors (including a period of 14 days after their cancellation)

children under 6 years of age.

hypersensitivity to drug components.

Care should be taken to prescribe the drug for coronary artery disease, arrhythmias, chronic heart failure, severe atherosclerosis, arterial hypertension, hyperthyroidism, diabetes mellitus, chronic renal failure, angle-closure glaucoma, prostatic hyperplasia with clinical symptoms, pregnancy, lactation.

INN / Active ingredient

Oxymetazoline

Specifications