Mometasone

Allertec Nazo Nasal Spray is indicated for:

• Treatment of seasonal or year-round allergic rhinitis in adults and children over 2 years of age. Preventive treatment of allergic rhinitis of moderate and severe course is recommended to start 4 weeks before the expected start of the dusting season.
• As an auxiliary therapeutic agent in the treatment of acute sinusitis with antibiotics in adults (including the elderly) and children over 12 years of age.
• Treating symptoms of acute sinusitis without signs of severe bacterial infection in adults and children over 12 years of age.
• Treating nasal polyps and related symptoms, including nasal congestion and loss of smell, in patients over the age of 18.

Structure

Active ingredient: mometasone furoate;

1 dose contains - 50 micrograms of mometasone furoate monohydrate (in terms of the anhydrous form).

Excipients: benzalkonium chloride, glycerin, polysorbate 80, microcrystalline cellulose, carmellose sodium, citric acid, sodium, water for injection.

Contraindications

Hypersensitivity to the active substance or to any inactive component of the drug.

The drug should not be used in the presence of untreated localized infection with lesions of the nasal mucosa.

Since corticosteroids have the effect of inhibiting wound healing, patients who have recently had surgery in the nasal cavity or who have been injured should not use nasal corticosteroids until healing occurs.

Mode of application

Treatment of seasonal or perennial allergic rhinitis. Adults (including the elderly) and children over 12 years of age are recommended a prophylactic and therapeutic dose of the drug is 2 injections (50 μg each) into each nostril 1 time per day (total daily dose - 200 μg). After achieving the therapeutic effect for maintenance therapy, it is advisable to reduce the dose to 1 injection in each nostril 1 time per day (total daily dose - 100 mcg).

If the symptoms of the disease cannot be alleviated by using the drug in the recommended therapeutic dose, the daily dose can be increased to the maximum: 4 injections into each nostril once a day (total daily dose - 400 mcg). After the symptoms have subsided, a dose reduction is recommended.

For children 2-11 years old, the recommended therapeutic dose is 1 injection (50 μg) in each nostril 1 time per day (total daily dose - 100 μg).

Auxiliary treatment of acute sinusitis. Adults (including the elderly) and children over 12 years of age are recommended a therapeutic dose of 2 injections (50 μg) in each nostril 2 times a day (total daily dose - 400 μg).

If the symptoms of the disease cannot be alleviated by using the drug in the recommended therapeutic dose, the daily dose can be increased to 4 injections in each nostril 2 times a day (total daily dose - 800 mcg). After the symptoms have subsided, a dose reduction is recommended.

Acute rhinosinusitis. For adults and children over 12 years of age, the recommended therapeutic dose is 2 injections (50 μg) in each nostril 2 times a day (total daily dose - 400 μg).

Nasal polyps. For patients over 18 years of age (including the elderly), the recommended dose is 2 injections (50 μg) in each nostril 2 times a day (total daily dose - 400 μg). After achieving the clinical effect, it is recommended to reduce the dose to 2 injections in each nostril once a day (total daily dose - 200 mcg).

Application features

Pregnant women

Used by pregnant and lactating women only if the expected benefits of its use outweigh the potential risk to a woman, fetus or baby.

Children

When conducting a placebo-controlled clinical trial in children who received Allertec Nazo at a daily dose of 100 mcg for a year, no growth retardation was observed.

The safety and efficacy of Allertec Nazo have not been investigated in the treatment of nasal polyps in children under the age of 18 years, symptoms of rhinosinusitis - under the age of 12 years, seasonal or perennial allergic rhinitis - in children under 2 years of age.

Overdose

Due to the fact that the systemic bioavailability of the drug is <1%, it is unlikely that with an overdose other measures will be required other than monitoring the patients condition with subsequent use of the drug in the recommended dose.

Inhalation or oral administration of excessive doses of corticosteroids can lead to inhibition of the function of the hypothalamic-pituitary-adrenal system.

Side effects

Headache (8%), nosebleeds (i.e., clear bleeding, as well as bloody mucus or blood clots) (8%), pharyngitis (4%), burning sensation in the nose (2%), irritation (2%) and ulcerative changes (1%) of the nasal mucosa.

Interaction

Allertec Nazo was used concomitantly with loratadine, while there was no effect on the concentration of loratadine or its main metabolite in the blood plasma, and mometasone furoate was not detected in blood plasma even at the minimum concentration. Joint therapy was well tolerated by patients.

With the simultaneous use of mometasone with CYP3A inhibitors, including drugs containing cobicistat, an increased risk of systemic adverse reactions is expected. Such combinations should be avoided, unless the expected benefit of the treatment outweighs the potential risk of systemic adverse reactions of corticosteroids, in such cases careful monitoring of systemic adverse reactions of corticosteroids should be carried out.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life is 2 years.

Shelf life after opening is 2 months.