Nasonex nasal spray dosed 50mkg / dose, 120 doses

Seasonal and year-round allergic rhinitis in adolescents and children from 2 years of age.

Acute sinusitis or exacerbation of chronic sinusitis in adults (including the elderly) and adolescents from 12 years of age - as an auxiliary therapeutic agent in antibiotic treatment.

Acute rhinosinusitis with mild to moderate symptoms without signs of severe bacterial infection in patients aged 12 years or more.

Preventive treatment of moderate to severe seasonal allergic rhinitis in adults and adolescents from 12 years of age (recommended two to four weeks before the expected start of the dusting season).

Polyposis of the nose accompanied by impaired nasal breathing and smell in adults (over 18 years old).

Intranasally. Injection of the suspension contained in the vial is carried out using a special dispensing nozzle on the vial.

Before using NasonexЃ nasal spray for the first time, it must be 'calibrated'.

Do not pierce the nasal applicator.

To 'calibrate', press the dispensing nozzle 10 times or until a homogeneous spray appears. The applicator is ready for use.

Tilt your head and inject the medicine into each nasal passage as recommended by your doctor.

If the drug has not been used for 14 days or more, press the dispensing nozzle 2 times or until a homogeneous spray appears.

Tilt your head and inject the medicine into each nasal passage as recommended by your doctor.

Cleaning the dispensing tip

It is important to clean the dispensing tip regularly to avoid malfunctioning. Remove the nozzle dust cap, then carefully remove the spray tip. Thoroughly rinse spray tip and dust cap in warm water and rinse under tap.

Do not try to open the nasal applicator with a needle or other sharp object, as this will damage the applicator and may result in you taking the wrong dose.

Dry the cap and tip in a warm place. Then attach the spray tip to the bottle and screw the dust cap back onto the bottle. When using the nasal spray for the first time after cleaning, recalibrate by pressing the dispensing tip 2 times.

Shake the bottle vigorously before each use.

Treating seasonal or perennial allergic rhinitis

Adults (including the elderly) and adolescents from the age of 12:

The recommended prophylactic and therapeutic dose of the drug is 2 injections (50 ?g of mometasone furoate each) into each nasal passage once a day (total daily dose - 200 ?g). Upon reaching the therapeutic effect for maintenance therapy, it is possible to reduce the dose to 1 injection into each nasal passage once a day (total daily dose - 100 mcg).

If a decrease in the symptoms of the disease cannot be achieved by using the drug in the recommended therapeutic dose, the daily dose can be increased to 4 injections into each nasal passage once a day (total daily dose - 400 mcg). After reducing the symptoms of the disease, a dose reduction is recommended

The onset of action of the drug is usually noted clinically as early as 12 hours after the first use of the drug.

Children 2-11 years old:

The recommended therapeutic dose for the treatment of seasonal or year-round allergic rhinitis is 1 injection (50 mcg of mometasone furoate) into each nasal passage once a day (total daily dose - 100 mcg).

The use of the drug in young children requires adult assistance.

Adjunctive treatment of acute sinusitis or exacerbation of chronic sinusitis

Adults (including the elderly) and adolescents from the age of 12:

The recommended therapeutic dose is 2 injections (50 mcg of mometasone furoate each) into each nasal passage 2 times a day (total daily dose - 400 mcg).

If a decrease in the symptoms of the disease cannot be achieved by using the drug at the recommended therapeutic dose, the daily dose can be increased to 4 injections into each nasal passage 2 times a day (total daily dose - 800 mcg). After reducing the symptoms of the disease, a dose reduction is recommended

Treating acute rhinosinusitis without evidence of severe bacterial infection

The recommended dose for adults and adolescents is 2 injections (50 mcg of mometasone furoate each) into each nasal passage 2 times a day (total daily dose of 400 mcg). If symptoms worsen during treatment, consult a specialist.

Treatment of nasal polyposis

Adults (including the elderly) from 18 years old :

The recommended therapeutic dose is 2 injections (50 mcg of mometasone furoate each) into each nasal passage 2 times a day (total daily dose - 400 mcg).

After reducing the symptoms of the disease, it is recommended to reduce the dose to 2 injections (50 ?g of mometasone furoate each) in each nasal passage once a day (total daily dose - 200 ?g).

1 g of spray contains:

Active ingredient: mometasone furoate (micronized, in the form of monohydrate) in the equivalent of anhydrous mometasone furoate - 0.5 mg.

Excipients: dispersed cellulose (microcrystalline cellulose treated with sodium carmellose) 20.0 mg, glycerol 21.0 mg, citric acid monohydrate 2.0 mg, sodium citrate dihydrate 2.8 mg, polysorbate-80 0.1 mg, benzalkonium chloride (in the form of a 50% solution) 0.2 mg, purified water 0.95 g.

Hypersensitivity to any of the substances that make up the drug.

Recent surgery or nasal trauma with damage to the mucous membrane of the nasal cavity - until the wound heals (due to the inhibitory effect of GCS on the healing process).

Children's age (with seasonal and year-round allergic rhinitis - up to 2 years with acute sinusitis or exacerbation of chronic sinusitis - up to 12 years with polyposis - up to 18 years) - due to the lack of relevant data.

Carefully:

NasonexЃ should be used with caution in case of tuberculosis infection (active or latent) of the respiratory tract, an untreated fungal bacterial systemic viral infection or an infection caused by Herpessimplex with eye damage (as an exception, it is possible to prescribe the drug for these infections as directed by a doctor); the presence of an untreated local infection involving the process of the mucous membrane of the nasal cavity.

Trade name of the drug

NazonexЃ

International non-proprietary name

Mometasone

Dosage form

metered dose nasal spray

Composition

1 g of spray contains:

Active ingredient: mometasone furoate (micronized, in the form of monohydrate) in the equivalent of anhydrous mometasone furoate - 0.5 mg.

Excipients: dispersed cellulose (microcrystalline cellulose treated with sodium carmellose) 20.0 mg, glycerol 21.0 mg, citric acid monohydrate 2.0 mg, sodium citrate dihydrate 2.8 mg, polysorbate-80 0.1 mg, benzalkonium chloride (in the form of a 50% solution) 0.2 mg, purified water 0.95 g.

Description

Suspension is white or almost white.

Pharmacotherapeutic group

Topical glucocorticosteroid

ATX code

R01AD09

Pharmacodynamics:

Mometasone is a synthetic glucocorticosteroid (GCS) for topical use. It has anti-inflammatory and anti-allergic effects when used in doses at which there are no systemic effects. Inhibits the release of inflammatory mediators. Increases the production of lipomodulin, which is an inhibitor of phospholipase A, which causes a decrease in the release of arachidonic acid and. accordingly, inhibition of the synthesis of metabolic products of arachidonic acid - cyclic endoperoxides of prostaglandins. It prevents the marginal accumulation of neutrophils, which reduces the inflammatory exudate and the production of lymphokines inhibits the migration of macrophages, which leads to a decrease in the processes of infiltration and granulation. Reduces inflammation by reducing the formation of chemotaxis substance (effect on 'late'allergy reactions) inhibits the development of an immediate allergic reaction (due to inhibition of the production of metabolites of arachidonic acid and a decrease in the release of inflammatory mediators from mast cells). In studies with provocative tests with the application of antigens to the nasal mucosa, a high anti-inflammatory activity of mometasone was demonstrated both in the early and in the late stages of an allergic reaction. This was confirmed by a decrease (compared with placebo) in the level of histamine and eosinophil activity, as well as a decrease (compared to the baseline) in the number of eosinophils, neutrophils and adhesion proteins of epithelial cells.In studies with provocative tests with the application of antigens to the nasal mucosa, a high anti-inflammatory activity of mometasone was demonstrated both in the early and in the late stages of an allergic reaction. This was confirmed by a decrease (compared with placebo) in the level of histamine and eosinophil activity, as well as a decrease (compared to the baseline) in the number of eosinophils, neutrophils and adhesion proteins of epithelial cells.In studies with provocative tests with the application of antigens to the nasal mucosa, a high anti-inflammatory activity of mometasone was demonstrated both in the early and in the late stages of an allergic reaction. This was confirmed by a decrease (compared with placebo) in the level of histamine and eosinophil activity, as well as a decrease (compared to the baseline) in the number of eosinophils, neutrophils and adhesion proteins of epithelial cells.This was confirmed by a decrease (compared with placebo) in the level of histamine and eosinophil activity, as well as a decrease (compared to the baseline) in the number of eosinophils, neutrophils and adhesion proteins of epithelial cells.This was confirmed by a decrease (compared with placebo) in the level of histamine and eosinophil activity, as well as a decrease (compared to the baseline) in the number of eosinophils, neutrophils and adhesion proteins of epithelial cells.

Pharmacokinetics:

With intranasal administration, the systemic bioavailability of mometasone furoate is <1% (with a sensitivity of the method for the determination of 025 pg / ml). The suspension of mometasone is very poorly absorbed in the gastrointestinal tract, and the small amount of the suspension of mometasone that can enter the gastrointestinal tract after injection into the nasal passage, even before excretion in the urine or bile, undergoes active primary metabolism.

Indications:

Seasonal and year-round allergic rhinitis in adolescents and children from 2 years of age.

Acute sinusitis or exacerbation of chronic sinusitis in adults (including the elderly) and adolescents from 12 years of age - as an auxiliary therapeutic agent in antibiotic treatment.

Acute rhinosinusitis with mild to moderate symptoms without signs of severe bacterial infection in patients aged 12 years or more.

Preventive treatment of moderate to severe seasonal allergic rhinitis in adults and adolescents from 12 years of age (recommended two to four weeks before the expected start of the dusting season).

Polyposis of the nose accompanied by impaired nasal breathing and smell in adults (over 18 years old).

Contraindications:

Hypersensitivity to any of the substances that make up the drug.

Recent surgery or nasal trauma with damage to the mucous membrane of the nasal cavity - until the wound heals (due to the inhibitory effect of GCS on the healing process).

Children's age (with seasonal and year-round allergic rhinitis - up to 2 years with acute sinusitis or exacerbation of chronic sinusitis - up to 12 years with polyposis - up to 18 years) - due to the lack of relevant data.

Carefully:

NasonexЃ should be used with caution in case of tuberculosis infection (active or latent) of the respiratory tract, an untreated fungal bacterial systemic viral infection or an infection caused by Herpessimplex with eye damage (as an exception, it is possible to prescribe the drug for these infections as directed by a doctor); the presence of an untreated local infection involving the process of the mucous membrane of the nasal cavity.

Pregnancy and lactation:

Appropriately designed and well-controlled studies of the drug in pregnant women have not been conducted.

As with the use of other intranasal corticosteroids, NasonexЃ should be prescribed to pregnant or breastfeeding women only if the expected benefit from prescribing the drug justifies the potential risk to the fetus or infant. Infants whose mothers received GCS during pregnancy should be carefully monitored for the possibility of developing adrenal hypofunction.

Method of administration and dosage: