Allertec Nazo spray nasal dosed suspension 50 mcg/dose bottle for 140 doses with dosing pump-sprayer

Active ingredient: mometasone furoate;

1 dose contains – 50 mcg of mometasone furoate monohydrate (calculated as anhydrous form).

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

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

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

Because corticosteroids have the effect of suppressing wound healing, patients who have recently had surgery in the nasal cavity or who have had trauma should not use nasal corticosteroids until healing has occurred.

Treatment of seasonal or perennial allergic rhinitis. For adults (including the elderly) and children over 12 years of age, the recommended prophylactic and therapeutic dose of the drug is 2 injections (50 mcg each) into each nostril once a day (total daily dose – 200 mcg). After achieving a therapeutic effect, for maintenance therapy, it is advisable to reduce the dose to 1 injection into each nostril once a 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 sprays into each nostril once a day (total daily dose – 400 mcg). After the symptoms of the disease have subsided, it is recommended to reduce the dose.

For children 2-11 years of age, the recommended therapeutic dose is 1 spray (50 mcg) in each nostril once a day (total daily dose – 100 mcg).

Adjunctive treatment of acute sinusitis. For adults (including the elderly) and children over 12 years of age, the recommended therapeutic dose is 2 sprays (50 mcg) in each nostril 2 times a day (total daily dose – 400 mcg).

If the symptoms of the disease are not relieved by using the drug in the recommended therapeutic dose, the daily dose can be increased to 4 sprays in each nostril 2 times a day (total daily dose – 800 mcg). After the symptoms of the disease have subsided, it is recommended to reduce the dose.

Acute rhinosinusitis. The recommended therapeutic dose for adults and children over 12 years of age is 2 sprays (50 mcg) in each nostril 2 times a day (total daily dose – 400 mcg).

Nasal polyps. For patients over 18 years of age (including the elderly), the recommended dose is 2 sprays (50 mcg) in each nostril 2 times a day (total daily dose – 400 mcg). After achieving a clinical effect, it is recommended to reduce the dose to 2 sprays in each nostril 1 time a day (total daily dose – 200 mcg).

Pregnant women

It is used in pregnant and breastfeeding women only if the expected benefit from its use outweighs the potential risk to the woman, fetus or infant.

Children

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

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

Due to the fact that the systemic bioavailability of the drug is <1%, it is unlikely that in case of overdose, other measures will be required, except for monitoring the patient’s condition with subsequent use of the drug at the recommended dose.

Inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of the function of the hypothalamic-pituitary-adrenal axis.

Headache (8%), nosebleeds (i.e., obvious 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.

The drug Allertec Nazo was used simultaneously with loratadine, while no effect on the plasma concentration of loratadine or its main metabolite was noted, and mometasone furoate was not detected in the blood plasma even in minimal concentrations. The combined therapy was well tolerated by patients.

Concomitant use of mometasone with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic adverse reactions. Such combinations should be avoided unless the expected benefit of treatment outweighs the potential risk of systemic corticosteroid adverse reactions, in which case careful monitoring for systemic corticosteroid adverse reactions should be performed.

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

Keep out of reach of children.

Shelf life – 2 years.

Shelf life after opening is 2 months.