Momat Rhino nasal spray 50 µg/dose bottle, 60 doses

Composition

1 dose contains:

Active ingredients:

mometasone furoate monohydrate is 51.72 mcg, which corresponds to a mometasone furoate content of 50 mcg.

Excipients: avicel RC-591 (cellulose microcrystalline, carmellose sodium) 2 mg, glycerol – 2.1 mg, citric acid monohydrate – 0.2 mg, sodium citrate dihydrate – 0.28 mg, Polysorbate 80 – 0.01 mg, benzalkonium chloride 0.02 mg, water d/and – up to 100 mg.

Pharmacological effects

of corticosteroids intranasal use. It has an anti-inflammatory and anti-allergic effect.

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, inhibits the synthesis of arachidonic acid metabolism products – cyclic endoperoxides, prostaglandins.

It prevents the marginal accumulation of neutrophils, which reduces inflammatory exudate and lymphokine production, inhibits macrophage migration, and reduces the processes of infiltration and granulation.

Reduces inflammation by reducing the formation of the chemotaxis substance (influence on late allergic reactions), inhibits the development of an immediate allergic reaction (due to inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells).

In vitro, mometasone furoate significantly inhibits the release of leukotrienes from white blood cells. In cell cultures, mometasone furoate has demonstrated a high ability to inhibit the synthesis and release of IL-1, IL-5, IL-6, and TNFa; it is also an inhibitor of leukotriene production, as well as an extremely potent inhibitor of Th2 cytokines, IL-4 and IL-5, and human CD4+ T cells.

When tested in preclinical models, mometasone reduced the accumulation of inflammatory cells (including eosinophils), was introduced into the walls of the upper and lower respiratory tracts, and also improved lung function after a provocative test. Mometasone reduced the number of lymphocytes and the mRNA concentration of 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 late stages of an allergic reaction. This was confirmed by a decrease (compared to placebo) in histamine levels and eosinophil activity, as well as a decrease (compared to baseline) in the number of eosinophils, neutrophils, and epithelial cell adhesion proteins.

Indications

For intranasal use: treatment of seasonal and perennial allergic rhinitis in adults, adolescents and children 2 years of age;

acute sinusitis or acute exacerbation of chronic sinusitis in adults (including the elderly) and adolescents from 12 years (as adjuvant therapeutic agent in the treatment with antibiotics);

acute rhinosinusitis with mild and moderately severe symptoms with no signs of serious bacterial infection in patients aged 12 years and older;

prophylaxis of seasonal allergic rhinitis moderate and severe in adults and adolescents from 12 years of age; nasal polyposis, accompanied by a violation of nasal breathing and sense of smell in adults.

Contraindications

Hypersensitivity to mometasone;

recent surgery or trauma to the nose with damage to the mucous membrane of the nasal cavity to the wound (due to the inhibitory effect of corticosteroids on the healing process);

childhood and adolescence to 18 years, with polyposis of the nose;

children’s age up to 12 years with acute sinusitis or chronic sinusitis;

children’s age up to 2 years with seasonal and perennial allergic rhinitis.

Side effects

From the respiratory system: nasal bleeding, pharyngitis, burning sensation in the nose, sneezing, irritation of the nasal mucosa are possible with intranasal use; very rarely with intranasal use – cases of perforation of the nasal septum. Other: possible headache.

Interaction

Combination therapy with loratadine is well tolerated by patients. However, there is no effect of the drug on the plasma concentration of loratadine or its main metabolite.

How to take, course of use and dosage

Intranasally. The suspension contained in the bottle is inhaled using a special dosing nozzle on the bottle. Before applying Momat Reno nasal spray for the first time, it is necessary to “calibrate”it. Do not pierce the nasal applicator. To perform “calibration”, you need to press the dosing nozzle 10 times, until splashes appear, which indicates that the drug is ready for use.

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

If the medicine has not been used for 14 days or longer, press the dosing nozzle 2 times until the spray appears.

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

Cleaning the metering nozzle.

It is important to clean the dosing nozzle regularly to avoid its incorrect operation. Remove the cap that protects the nozzle from dust, then carefully remove the spray tip. Rinse the spray tip and dust cap thoroughly in warm water and rinse under the tap.

Do not attempt to open the nasal applicator with a needle or other sharp object, as this will damage the applicator and you may take the wrong dose of the drug.

Dry the cap and tip in a warm place. After that, attach the spray tip to the bottle and screw the dust cap back on to the bottle. When using the nasal spray for the first time after cleaning, it is necessary to perform a “calibration” by pressing the dosing nozzle 2 times.

Before each use, it is necessary to shake the bottle intensively.

Treatment of seasonal or year-round allergic rhinitis

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

The recommended preventive and therapeutic dose of the drug is 2 inhalations (50 mcg each) in each nostril 1 time a day (the total daily dose is 200 mcg). After achieving the therapeutic effect for maintenance therapy, it is possible to reduce the dose to 1 inhalation in each nostril 1 time a day (the total daily dose is 100 mcg).

If it is not possible to reduce the symptoms of the disease by using the drug at the recommended therapeutic dose, the daily dose can be increased to 4 inhalations in each nostril 1 time a day (the total daily dose is 400 mcg). After reducing the symptoms of the disease, it is recommended to reduce the dose.

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 is 1 inhalation (50 mcg) in each nostril once a day (the total daily dose is 100 mcg). The use of the drug in young children requires the help of adults.

Auxiliary treatment of acute sinusitis or acute chronic sinusitis

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

The recommended preventive and therapeutic dose of the drug is 2 inhalations (50 mcg each) in each nostril 2 times a day (the total daily dose is 400 mcg). If it is not possible to reduce the symptoms of the disease by using the drug at the recommended therapeutic dose, the daily dose can be increased to 4 inhalations in each nostril 2 times a day (the total daily dose is 800 mcg). After reducing the symptoms of the disease, it is recommended to reduce the dose.

Treatment of acute rhinosinusitis without signs of severe bacterial infection:

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

Treatment of nasal polyposis:

Adults (including the elderly) over 18 years of age:

The recommended therapeutic dose of the drug is 2 inhalations (50 mcg each) in each nostril 2 times a day (the total daily dose is 400 mcg).

After reducing the symptoms of the disease, it is recommended to reduce the dose to 2 inhalations (50 mcg each) in each nostril 1 time a day (the total daily dose is 200 mcg).

Overdose

With prolonged use of corticosteroids in high doses, as well as with the simultaneous use of several corticosteroids, it is possible to inhibit the function of the hypothalamic-pituitary-adrenal system. Due to the low systemic bioavailability of the drug (

Special instructions

Mometasone should be used with caution in cases of tuberculosis 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, the drug may be prescribed for these infections as directed by a doctor), the presence of untreated local infection involving the nasal mucosa.

With prolonged intranasal use of mometasone, a periodic examination of the nasal mucosa by an ENT doctor is necessary.If a local bacterial or fungal infection of the nose or pharynx develops, it is recommended to stop treatment and start special treatment. Prolonged irritation of the nasal and pharyngeal mucosa is an indication for discontinuation of the drug. When switching from corticosteroids for systemic use to intranasal use of mometasone, special caution is required due to the possible risk of developing adrenal insufficiency. After discontinuation of systemic corticosteroids, it takes several months to restore the function of the hypothalamic-pituitary-adrenal system.

During stressful situations, including injuries, surgery, infectious diseases, or a severe asthma attack, patients who have previously received corticosteroids for systemic use need an additional short course of systemic corticosteroids, which are then gradually discontinued as symptoms subside.

When switching from systemic corticosteroids to intranasal mometasone, concomitant allergic diseases may occur, the symptoms of which were previously suppressed by the use of systemic corticosteroids. During this period, some patients may experience signs of withdrawal from systemic corticosteroids, including muscle and/or joint pain, depression, and fatigue, despite the fact that lung function indicators are stable or even improving. If there are signs of adrenal insufficiency, you should temporarily increase the dose of corticosteroids for systemic use, and then cancel them more smoothly.

Patients receiving corticosteroids 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 of age).

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

When using mometasone, it should be taken into account that the effect on cortisol production may vary from patient to patient.

The occurrence 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 slows down, the current therapy should be reviewed to reduce the dose of mometasone to the minimum effective dose that allows you to control the symptoms of the disease.

In placebo-controlled clinical trials in children with intranasal use of mometasone at a dose of 100 mcg/day for a year, growth retardation was not observed.

Form of production

Nasal spray dosed in the form of a semi-transparent to opaque consistency of a thick suspension from white to almost white in color.

60 doses-polyethylene bottles with a dosing device (1) – cardboard packs.

Storage conditions

In a dark place at a temperature of 15 to 25 °C. Do not freeze it. Keep out of reach of children.

Shelf

life is 2 years.

Active ingredient

Mometasone

Dosage Form

Spray nasal