Afrin nasal spray 0.05%, 15ml

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

• sinusitis;

• eustachitis;

• hay fever.

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.

Active ingredient: oxymetazoline hydrochloride - 500 mcg

Excipients : disodium edetate dihydrate - 0.3 mg, sodium hydrogen phosphate - 0.975 mg, 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.

• atrophic rhinitis;

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

• children under 6 years of age.

• hypersensitivity to the components of the drug.

With caution , the drug should be prescribed 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.

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

Composition for 1 ml:

Active ingredient: oxymetazoline hydrochloride - 500 mcg

Excipients : disodium edetate dihydrate - 0.3 mg, sodium hydrogen phosphate - 0.975 mg, 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.

15 ml - vials made of high density polyethylene with a capacity of 20 ml (1) with a fine spray dispenser - cardboard packs.

Clinical and pharmacological group: Vasoconstrictor drug for local use in ENT practice

Pharmaco-therapeutic group: Decongestant - alpha-adrenergic agonist

pharmachologic effect

Topical vasoconstrictor, alpha-adrenostimulant. Oxymetazoline causes vasoconstriction of 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 in the form of a nasal spray, oxymetazoline is practically not detected in blood plasma.

Indications

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

• sinusitis;

• eustachitis;

• hay fever.

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.

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.

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 the components of the drug.

With caution , the drug should be prescribed 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.

Application during pregnancy and lactation

The safety of the drug in pregnant women and during lactation has not been established, therefore, the drug should be prescribed during pregnancy and during breastfeeding only if the expected benefit from using the drug for the mother outweighs the potential risk to the fetus or infant.

Application for impaired renal function

With care: chronic renal failure.

Application in children

The drug is contraindicated for use in children under 6 years of age.

special instructions

With prolonged use (more than one week), the symptoms of nasal congestion may recur.

If it is necessary to continue treatment for more than 5 days, the patient should consult a doctor.

Avoid getting the drug in the eyes.

Influence on the ability to drive vehicles and use mechanisms

The drug, when used correctly and in recommended doses, does not affect driving vehicles and working with mechanisms, however, if side effects such as dizziness occur, the patient should refrain from these types of activities.

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 charcoal.

Drug interactions

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

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

With the simultaneous use of MAO inhibitors (including a period of 14 days after their cancellation), maprotiline and tricyclic antidepressants - an increase in blood pressure.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25 ? C.

Shelf life

Shelf life is 2 years.

Terms of sale

The drug is approved for use as a means of OTC.

Contacts for inquiries

BAYER AG (Germany)

Office in Russia JSC 'BAYER'

107113 Moscow

3rd Rybinskaya St., 18, bldg. 2

Tel .: (495) 231-12-00