Nosephrine spray 50mcg / dose, 120 dose

For intranasal use: treatment of seasonal and year-round allergic rhinitis in adults, 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 and older; prevention of moderate and severe seasonal allergic rhinitis in adults and adolescents from 12 years old; nasal polyposis, accompanied by impaired nasal breathing and smell in adults.

The dosage regimen is set individually, depending on the indications, the age of the patient, and the dosage form used.

Nasal spray

active substance: mometasone

Hypersensitivity to mometasone; 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 and adolescents up to 18 years old with nasal polyposis; children under 12 years of age with acute sinusitis or exacerbation of chronic sinusitis; children under 2 years of age with seasonal and year-round allergic rhinitis.

pharmachologic effect

Intranasal corticosteroids. It has anti-inflammatory and anti-allergic effects.

The mechanism of anti-allergic and anti-inflammatory action is due to the ability to inhibit 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, prostaglandins. Prevents marginal accumulation of neutrophils, which reduces inflammatory exudate and the production of lymphokines, inhibits the migration of macrophages, and leads to a decrease in the processes of infiltration and granulation. Reduces inflammation by reducing the formation of chemotaxis substance (influence on late allergy reactions),inhibits the development of an immediate-type 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 vitro, mometasone furoate significantly inhibits the release of leukotrienes from leukocytes. In cell cultures, mometasone furoate demonstrated a high ability to inhibit the synthesis and release of IL-1, IL-5, IL-6, as well as TNF?; it is also an inhibitor of leukotriene production, as well as an extremely potent inhibitor of Th2 cytokines, IL-4 and IL-5, human CD4 + T cells.

When studied in preclinical models, mometasone reduced the accumulation of inflammatory cells (including eosinophils), penetrated the walls of the upper and lower respiratory tract, and also improved lung function after a provocative test. Mometasone reduced the number of lymphocytes and the concentration of mRNA of the cytokines IL-4 and IL-5.

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 baseline) in the number of eosinophils, neutrophils and epithelial cell adhesion proteins.

Pharmacokinetics

After intranasal administration, the systemic bioavailability of mometasone is low, in particular, due to low absorption and significant first-pass metabolism when mometasone is swallowed. When used in recommended doses, the plasma concentration of mometasone is near or below the detection threshold (50 pg / ml). As a consequence, it is impossible to determine either the T1 / 2 or the Vd of mometasone after inhalation. It is excreted in urine and bile.

Indications of the active substances of the drug Mometasone SandozЃ

For intranasal use: treatment of seasonal and year-round allergic rhinitis in adults, 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 and older; prevention of moderate and severe seasonal allergic rhinitis in adults and adolescents from 12 years old; nasal polyposis, accompanied by impaired nasal breathing and smell in adults.

Side effect

On the part of the respiratory system: with intranasal use, nosebleeds, pharyngitis, a burning sensation in the nose, sneezing are possible; irritation of the nasal mucosa; very rarely with intranasal use - cases of perforation of the nasal septum.

Others: headache is possible.

Contraindications for use

Hypersensitivity to mometasone; 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 and adolescents up to 18 years old with nasal polyposis; children under 12 years of age with acute sinusitis or exacerbation of chronic sinusitis; children under 2 years of age with seasonal and year-round allergic rhinitis.

Application during pregnancy and lactation

There have been no adequate and well-controlled studies of the use of mometasone during pregnancy. It is not known whether mometasone is excreted in breast milk.

Intranasal use of mometasone during pregnancy and during breastfeeding is possible only if the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Newborns whose mothers received GCS during pregnancy should be monitored for possible symptoms of adrenal cortex insufficiency.

special instructions

With caution, mometasone should be used for tuberculous infection (active or latent) of the respiratory tract, untreated fungal, bacterial, systemic viral infection or infection caused by Herpes simplex with eye damage (as an exception, it is possible to prescribe the drug for the listed infections as directed by a doctor), the presence of untreated local infection with involvement in the process of the mucous membrane of the nasal cavity.

With prolonged intranasal use of mometasone, a periodic examination of the nasal mucosa by an ENT doctor is necessary. With the development of a local bacterial or fungal infection of the nose or pharynx, it is recommended to stop treatment and begin special treatment. Irritation of the mucous membrane of the nasal cavity and pharynx, which persists for a long time, is an indication for discontinuation of the drug.

When switching from GCS for systemic use to intranasal use of mometasone, special care is required because of the possible risk of adrenal insufficiency. After the cancellation of systemic corticosteroids, it takes several months to restore the function of the hypothalamic-pituitary-adrenal system.

During stressful situations, including trauma, surgical interventions, infectious diseases or a severe attack of bronchial asthma, patients who previously received GCS for systemic use require the additional appointment of a short course of systemic GCS, which are then gradually canceled as the symptoms subside.

When switching from systemic corticosteroids, intranasal use of mometasone may manifest concomitant allergic diseases, the symptoms of which were previously suppressed by the use of systemic corticosteroids. During this period, some patients may experience signs of cancellation of systemic GCS, including pain in muscles and / or joints, depression, a feeling of fatigue, despite the fact that lung function indicators are stable or even improve. If there are signs of adrenal insufficiency, the dose of GCS for systemic use should be temporarily increased, and in the future, their cancellation should be carried out more smoothly.

Patients receiving GCS or other immunosuppressants should be advised to avoid contact with patients with certain infections (chickenpox, measles) and be sure to consult a doctor if such contact has occurred (especially important when used in adolescents over 12 years old).

To maintain a low potential for suppressing the hypothalamic-pituitary-adrenal system, the recommended doses should not be exceeded, and the dose of mometasone in each patient should be titrated to achieve the minimum effective.

When using mometasone, it should be borne in mind that the effect on cortisol production may vary from patient to patient.

The onset of candidiasis may require appropriate antifungal therapy or discontinuation of mometasone.

Use in pediatrics

It is recommended to regularly monitor the growth of adolescents receiving long-term mometasone therapy. If growth is slowed down, the therapy should be reviewed in order to reduce the dose of mometasone to the minimum effective dose to control the symptoms of the disease.

When conducting placebo-controlled clinical studies in children with intranasal use of mometasone at a dose of 100 ?g / day for a year, no growth retardation was observed.