Expiration date: 05/2026
The composition and form of issue
Nasal spray dosed:
1 dose contains mometasone furoate (as monohydrate) 50 mcg,
inactive ingredients: dispersible cellulose BP 65 cps, glycerol, sodium citrate dihydrate, citric acid monohydrate, Polysorbate 80, benzalkonium chloride, phenylethyl alcohol, purified water,
in a plastic bottle with a valve metering action for 60 doses, in a cardboard box 1 vial.
Pharmacological action:
Nasonex – corticosteroids for intranasal use. Anti-inflammatory and antiallergic action. Local anti-inflammatory effect of the drug is when it is applied at doses in which there is systemic effects.
Nasonex, indications
Treatment of allergic rhinitis (seasonal and perennial) in adults, adolescents and children 2 years of age, aggravation of sinusitis (complex therapy with antibiotics) in adult (including elderly) and children 12 years of age, prophylaxis of seasonal allergic rhinitis moderate and severe (recommended for 2-4 weeks before the anticipated start of the season dusting).
Contraindications:
Hypersensitivity to any component of the drug, the presence of untreated local infection with involvement of the mucous membrane of the nasal cavity, recent surgery or injury of nose (to the wound), TB infection (active or latent) of the respiratory tract, untreated fungal, bacterial, viral systemic infection or an infection caused by Herpes simplex c defeat eye (exceptionally, the appointment of the drug in these cases may the doctor with great care), children up to age 2 years (no data on the safety application).
Application of pregnancy and breastfeeding
After intranasal application of the preparation in maximum therapeutic dose of mometasone is not detected in blood plasma even in minimal concentrations, and therefore, it can be expected that its effect on the fetus is negligible, and the potential toxicity for reproductive function — are very low. However, due to the fact that a special, well-controlled studies of the action of the drug in pregnant women has not been conducted Nasonex should be appointed for pregnant women, breastfeeding mothers or women of childbearing age only if the expected benefits from their use justifies the potential risk to the fetus and newborn. Newborns whose mothers during pregnancy used GCS, they should be carefully evaluated to identify possible hypofunction of the adrenal glands.
Method of application and doses
The intranasal route. Nasonex is used in the form of inhalation suspension, contained in a bottle of spray. Inhalations are performed through a special dispensing nozzle on the bottle. Before first use Nasonex nasal spray must be "calibrated" by pressing the metering device 6-7 times. After "calibration" is the stereotypical submission of medicinal substances, in which every button is released approximately 100 mg of mometasone furoate suspension, containing mometasone furoate monohydrate in a quantity equivalent chemically pure 50 micrograms mometasone furoate. If nasal spray has not been used for 14 days or longer before the new use requires re-calibration. Before each use it is necessary to vigorously shake the bottle of spray.
Treatment of seasonal or perennial allergic rhinitis adults (including elderly) and adolescents 12 years of age typically recommended preventive and therapeutic dose is 2 inhalations (50 mcg each) per nostril once daily (total daily dose 200 mcg). After achieving the desired therapeutic effect for maintenance therapy appropriate to decrease the dose to 1 inhalation in each nostril 1 time a day (total daily dose 100 mcg).
If reduction of symptoms is not achieved with the use of the drug in the recommended therapeutic dose, daily dose may be increased to 4 inhalations in each nostril 1 time a day (total daily dose 400 mcg). After the reduction of symptoms recommended dose reduction. The onset of action of the drug is usually noted clinically during the first 12 h after the first administration.
Children 2-11 years: the recommended therapeutic dose is 1 inhalation (50 mcg) in each nostril once daily (total daily dose 100 mcg).
For the treatment of acute exacerbations of chronic sinusitis in the complex therapy with antibiotics adults (including elderly persons) and children from 12 years: 100 micrograms (2 injection) in each nostril 2 times a day.
Adjuvant treatment of exacerbations of sinusitis Adults (including elderly) and adolescents 12 years: the recommended therapeutic dose is 2 inhalations (50 mcg) in each nostril 2 times a day (total daily dose 400 mcg). The total daily dose - 400 mcg.
Side effects:
In the treatment of seasonal or perennial allergic rhinitis. In adults: - nosebleeds (explicit or selection stained with blood mucus or blood clots) - sore throat, - burning sensation in nose - irritation of the nasal mucosa. Nosebleeds usually stop on their own, were not heavy, they appeared with a frequency somewhat greater than with placebo (5%), but equal to or less than other corticosteroids to intranasal use, which was used as active control (some of them the incidence of nasal bleeding up to 15%). The incidence of all other adverse events was comparable with the frequency of occurrence for the appointment of a placebo. In children: - nosebleeds, - headache, - a feeling of irritation in the nose, - sneezing. The incidence of these undesirable effects in children were comparable to the frequency of occurrence for the use of placebo. When treating acute sinusitis (when using spray Nasonex as a subsidiary means). In adults and adolescents: - headache - sore throat, - burning sensation in nose - irritation of the nasal mucosa. Nosebleeds were moderately expressed, the frequency of their occurrence in the application Nasonex was also comparable to the frequency of nasal bleeding when using a placebo (5% vs. 4%, respectively). Very rarely with intranasal application of corticosteroids have been cases of nasal septum perforation or increased intraocular pressure.
Storage conditions
In protected from light place, at temperature not above 25 °C.
