Afrin moisturizing spray called. 0.05% 15ml (Contract Pharmacal Corporation, CANADA)


Afrin Moisturizing nasal spray 0.05% 15ml

A country

Canada
Country of manufacture may vary depending on product batch. Please check with the operator for detailed information when confirming your order.

Active substance

Oxymetazoline

Compound

Active substance: oxymetazoline hydrochloride 0.5 mg.

pharmachologic effect

Pharmacodynamics. Alpha-adrenergic stimulating agent for topical use. Has a vasoconstrictor effect. Oxymetazoline causes vasoconstriction of the mucous membranes of the nose, paranasal sinuses and eustachian tube, which leads to a decrease in their swelling and the release of nasal breathing during allergic and/or infectious-inflammatory rhinitis (runny nose). Due to the presence of excipients in the composition of the drug (microcrystalline cellulose and carmellose sodium and povidone-K29-32). The drug does not flow out of the nose or down the throat, since after administration into the nasal passages the spray becomes more viscous and is retained on the mucous membranes of the nose more effectively than a standard aqueous solution. This drug contains humectants (glycerol and macrogol-1450), promoting moisture retention, which helps provide hydration to dry or irritated nasal mucosa. According to clinical studies, the drug begins to act within 1 minute and the effect lasts up to 12 hours. Pharmacokinetics: When used as a nasal spray, oxymetazoline is practically not detected in the blood plasma.

Indications for use

Symptomatic treatment of rhinitis (runny nose) of allergic and/or infectious-inflammatory etiology, sinusitis, eustachitis, hay fever.

Mode of application

Intranasal. Before each use, you must shake the spray bottle vigorously. Before using the nasal spray for the first time, you must “calibrate” it 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. The frequency of use can be increased to 3 times a day in adults. It is not recommended to exceed the indicated dose.

Interaction

Slows down the absorption of local anesthetic drugs and prolongs their effect. Concomitant use with other vasoconstrictor drugs increases the risk of side effects. With the simultaneous use of monoamine oxidase inhibitors (including a period of 14 days after their discontinuation) and tricyclic antidepressants - an increase in blood pressure.

Side effect

In general, the drug is well tolerated, and possible adverse events are usually mild and transient. Transient dryness and burning of the nasal mucosa, dry mouth and throat, sneezing; increased blood pressure, increased anxiety, nausea, dizziness, headache, insomnia, palpitations, sleep disturbances. With long-term use - tachyphylaxis, reactive hyperemia and atrophy of the nasal mucosa. Benzalkonium chloride, which is part of the drug, can cause local skin reactions.

Contraindications

Hypersensitivity to sympathomimetic drugs, to any component of the drug, atrophic rhinitis, simultaneous use of monoamine oxidase inhibitors (including a period of 14 days after their discontinuation), children under 6 years of age.

Overdose

In case of significant overdose or accidental ingestion, the following are possible: 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). Treatment: symptomatic; in case of accidental ingestion - gastric lavage, activated charcoal. Vasopressor drugs are contraindicated.

special instructions

With caution. Coronary artery disease, arrhythmias, chronic heart failure, severe atherosclerosis, arterial hypertension, hyperthyroidism, thyrotoxicosis, diabetes mellitus, chronic renal failure, angle-closure glaucoma, prostatic hyperplasia with clinical symptoms, pregnancy, lactation. With prolonged use (more than one week), symptoms of nasal congestion may return. If it is necessary to continue treatment for more than 5 days, consultation with a doctor is necessary. Avoid contact of the drug with the eyes. The drug, when used correctly and in recommended doses, does not affect driving or operating machinery, however, if side effects such as dizziness occur, you should refrain from these activities. Use during pregnancy and lactation. Safety of the drug in pregnant women and during lactation has not been established, therefore the drug should be prescribed to pregnant or breastfeeding women only if the expected benefit from using the drug for the mother outweighs the potential risk to the fetus or infant.

Afrin spray naz 0.05% 15ml moisturizing

Compound

Active substance: oxymetazoline hydrochloride - 500 mcg. Excipients: microcrystalline cellulose and sodium carmellose (Avicel RC-591) - 30 mg, sodium hydrogen phosphate - 0.975 mg, sodium dihydrogen phosphate monohydrate - 5.525 mg, disodium edetate dihydrate - 0.3 mg, macrogol 1450 - 50 mg, povidone K29-32 - 30 mg, benzyl alcohol - 2.5 mg, chamomile flavor - 0.2 mg, benzalkonium chloride solution 17% - 1.471 mg, glycerol - 5 mg, purified water - qs up to 1 ml.

Pharmacokinetics

When administered intranasally, T1/2 is 35 hours.

Indications for use

  • Difficulty in nasal breathing due to colds, inflammation of the sinuses, eustachitis, hay fever, allergic rhinitis.
  • To eliminate swelling before diagnostic manipulations in the nasal passages.

Contraindications

Hypersensitivity to sympathomimetic drugs, to any component of the drug, atrophic rhinitis, simultaneous use of monoamine oxidase inhibitors (including the period of 14 days after their discontinuation), children under 6 years of age.
Carefully:

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.

Directions for use and doses

Intranasally.

Before each use, shake the spray bottle vigorously.

Before using the nasal spray for the first time, it is necessary to “calibrate” it 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. The frequency of use can be increased to 3 times a day in adults. It is not recommended to exceed the indicated dose.

Storage conditions

Store out of the reach of children at a temperature not exceeding 25°C.

Best before date

2 years. Do not use after expiration date.

special instructions

With prolonged use (more than one week), symptoms of nasal congestion may recur. If it is necessary to continue treatment for more than 5 days, consultation with a doctor is necessary. Avoid contact of the drug with the eyes.

Description

Vasoconstrictor drug for local use in ENT practice.

Dosage form

Nasal spray in the form of a gel-like suspension of white or almost white color.

Action

Adrenomimetic agent for local use. Has a vasoconstrictor effect. When administered intranasally, swelling of the mucous membrane of the upper respiratory tract decreases.

Side effects

Local reactions: possible - burning, dry nasal mucosa, sneezing; rarely - after the effect of use wears off, a strong feeling of nasal congestion develops (reactive hyperemia).

Systemic reactions: repeated overdose with local use can lead to tachycardia and increased blood pressure; very rarely - anxiety, insomnia, fatigue, headaches, nausea.

Use during pregnancy and breastfeeding

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

Interaction

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

Oxymetazoline slows down the absorption of local anesthetic drugs and prolongs their effect.

Co-administration of other vasoconstrictor drugs increases the risk of side effects.

Overdose

In case of significant overdose or accidental ingestion, the following are possible: 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).

Treatment is symptomatic. In case of accidental ingestion - gastric lavage, activated charcoal.

Vasopressor drugs are contraindicated.

Impact on the ability to drive vehicles and operate machinery

When used in doses higher than recommended, a general effect on the cardiovascular system and central nervous system cannot be excluded. In such cases, the ability to drive vehicles and other potentially hazardous activities may be reduced.

Afrin moisturizing spray called. 0.05% 15ml (Contract Pharmacal Corporation, CANADA)

Compound.

active substance:
oxymetazoline hydrochloride0.5 mg
excipients:
MCC and carmellose sodium (Avicel RC 591) - 30 mg; sodium hydrogen phosphate - 0.975 mg; sodium dihydrogen phosphate monohydrate - 5.525 mg; disodium edetate dihydrate - 0.3 mg; macrogol 1450 - 50 mg; povidone K29-32 - 30 mg; benzyl alcohol - 2.5 mg; lemon flavor - 1.5 mg; benzalkonium chloride solution 17% - 1.471 mg; glycerol - 5 mg; purified water - qs up to 1 ml

Description of the dosage form.

Spray:

white or almost white gel-like suspension with a characteristic citrus odor.
Pharmachologic effect. Anticongestive, alpha-adrenomimetic.

Pharmacodynamics.

Alpha adrenergic stimulant for topical use. Has a vasoconstrictor effect. Oxymetazoline causes vasoconstriction of the mucous membranes of the nose, paranasal sinuses and eustachian tube, which leads to a decrease in their swelling and the release of nasal breathing in allergic and/or infectious-inflammatory rhinitis (runny nose).

Due to the presence of excipients in the composition of the drug (MCC, carmellose sodium and povidone K29-32), Afrin® moisturizing nasal spray does not flow out of the nose or down the throat, because Once introduced into the nasal passages, the spray becomes more viscous and adheres to the nasal mucous membranes more effectively than a standard aqueous solution. This medication contains humectants (glycerol and macrogol 1450) that promote moisture retention, which helps provide hydration to dry or irritated nasal mucosa.

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

Pharmacokinetics.

When used as a nasal spray, oxymetazoline is practically undetectable in blood plasma.

Indications.

● symptomatic treatment of rhinitis (runny nose) of allergic and/or infectious-inflammatory etiology;

● sinusitis;

● eustachitis;

● hay fever.

Contraindications.

● hypersensitivity to sympathomimetic drugs, any component of the drug;

● atrophic rhinitis;

● simultaneous use of MAO inhibitors (including a period of 14 days after their discontinuation);

● children under 6 years of age.

Carefully:

coronary artery disease; arrhythmias; chronic heart failure; severe atherosclerosis; arterial hypertension; hyperthyroidism; diabetes; chronic renal failure; angle-closure glaucoma; prostatic hyperplasia with clinical symptoms; pregnancy; lactation period.

Use during pregnancy and breastfeeding.

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

Side effects.

In general, the drug is well tolerated, and possible adverse events are usually mild and transient.

Transient dryness and burning of the nasal mucosa, dry mouth and throat, sneezing; increased blood pressure, increased anxiety, nausea, dizziness, headache, insomnia, palpitations, sleep disturbances. With long-term use - tachyphylaxis, reactive hyperemia and atrophy of the nasal mucosa. Benzalkonium chloride, which is part of the drug, can cause local skin reactions.

Interaction.

Slows down the absorption of local anesthetic drugs, lengthens their duration of action.

Combined 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 discontinuation), maprotiline and tricyclic antidepressants - an increase in blood pressure.

Method of administration and dose.

Intranasally.

Before each use, shake the spray bottle vigorously. Before using the nasal spray for the first time, it is necessary to “calibrate” it 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. The frequency of use can be increased to 3 times a day in adults. 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, central nervous system depression (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. Vasopressor drugs are contraindicated.

Special instructions.

With prolonged use (more than 1 week), symptoms of nasal congestion may recur. If it is necessary to continue treatment for more than 5 days, consult a doctor.

Avoid contact of the drug with the eyes.

Impact on the ability to drive vehicles and operate machinery.

When used correctly and in recommended doses, the drug does not affect driving or operating machinery, however, if side effects such as dizziness occur, you should refrain from these activities.

Release form.

Nasal spray, 0.05%.

In a hermetically sealed opaque plastic bottle with a capacity of 23 ml with a fine spray dispenser and a protective cap covered with shrink film to control the first opening with the company logo, 15 ml. 1 fl. in a cardboard box.

, Russia.

Manufactured by: Contract Pharmaceuticals Limited. 7600 Dunbrough Crescent Mississauga, ON, Canada L5N 6L6.

Additional information can be obtained at: 107113, Moscow, 3rd Rybinskaya st., 18, building 2.

Tel.; Fax.

Conditions for dispensing from pharmacies.

Over the counter.

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