SCAR SPRAY NASAL 50MCG/DOSE

Indications and usage

- treatment of seasonal and year-round allergic rhinitis in adults and children over 2 years old;

- acute sinusitis or exacerbation of chronic sinusitis in adults (including the elderly) and children over 12 years of age - as an adjunct in antibiotic treatment;

- prevention of moderate seasonal and allergic rhinitis in adults and children over 12 years old (recommended 4 weeks before the start of the dusting season);

- treatment of nasal polyposis in adults older than 18 years.

The drug is used intranasally. The injection of spray into the nasal cavity contained in the vial, is carried out using a special dispensing device.

Before the first use of the spray, it is necessary to make about 10 “calibration” presses on the dosing device. After the “calibration”, a stereotypical flow of the drug is established, with each press of the metering device emitting 100 mg of suspension, which corresponds to 50 μg of mometasone. If the drug has not been used for 14 days or more, then “calibration” must be repeated before the new use.

Before each use of the spray, it is necessary to shake the bottle vigorously.

Seasonal and perennial allergic rhinitis

Adults (includingelderly) and children over 12 years old appoint 2 injections (50 mcg each) in each nasal passage 1 time / day (total daily dose - 200 mcg). After achieving the desired effect, the dose of the drug for maintenance therapy is 1 injection (50 mcg) in each nasal passage 1 time / day (total daily dose is 100 mcg). If necessary, the dose of the drug can be increased to 4 injections (50 mcg each) in each nasal passage 1 time / day (total daily dose - 400 mcg).

Children aged 2 to 11 years appoint 1 injection (50 mcg) in each nasal passage 1 time / day (total daily dose - 100 mcg).

Positive dynamics of clinical symptoms is observed, as a rule, during the first 12 hours after the first use of the drug.

Acute sinusitis or exacerbation of chronic sinusitis

Adults (including older ones) and children over 12 years old - 2 injections (50 mcg each) in each nasal passage 2 times / day (total daily dose - 400 mcg). If necessary, the dose of the drug can be increased to 4 injections (50 mcg each) in each nasal passage 2 times / day (total daily dose - 800 mcg). After reducing the symptoms, a dose reduction is recommended.

Polyposis of the nose

Adults (including elderly) from 18 years appoint 2 injections (50 mcg each) in each nasal passage 2 times / day (total daily dose - 400 mcg). After reducing the symptoms of the disease, it is recommended to reduce the dose to 2 injections (50 mcg each) in each nasal passage 1 time / day (total daily dose - 200 mcg).

Adverse reactions

The frequency of side effects is presented in accordance with the following classification: very often (≥10%); often (≥1%, <10%); infrequently (≥0.1%, <1%); rarely (≥0.01%, <0.1%); very rarely (<0.01%, including isolated cases).

Allergic reactions: rarely, hypersensitivity reactions, incl. bronchospasm, shortness of breath; very rarely - anaphylaxis, angioedema.

Nervous system: often - headache (in adults and children). Children had growth retardation, psychomotor hyperactivity, sleep disturbance, anxiety, depression, aggressive behavior.

Respiratory: often in adults - nasal bleeding, burning sensation in the nasal cavity, ulceration of the nasal mucosa, sensation of irritation of the nasal mucosa, pharyngitis, upper respiratory tract infections; very rarely - nasal septum perforation. Nosebleeds, as a rule, stopped on their own and were not heavy; they occurred with a frequency slightly higher than with placebo (5%), but equal to or less than with other studied SCS for intranasal use, which were used as an active control (in some of them the frequency of nasal bleeding was up to 15%). The incidence of other side effects was comparable to that with placebo; often in children - nosebleeds, a feeling of irritation of the nasal mucosa, sneezing. The incidence of all of these adverse events in children was comparable to the frequency of placebo.

Gastrointestinal: rarely - a feeling of irritation of the pharyngeal mucosa.

Other: rarely - a violation of smell, a violation of taste, glaucoma, increased intraocular pressure, cataracts.

Contraindications

- recent surgery or trauma of the nose - before the wound heals (due to the inhibitory effect of the SCS on the healing process);

- children's age (for seasonal and year-round allergic rhinitis - up to 2 years; for acute sinusitis or exacerbations of chronic sinusitis - up to 12 years; for nose polyposis - up to 18 years);

- Hypersensitivity to mometasone or any of the components of the drug.

WITH caution the drug should be prescribed for tuberculosis (active or latent) of the respiratory tract; fungal, bacterial or systemic viral infection (including Herpes simplex with eye damage); long-term therapy GCS; the presence of untreated local infection with involvement in the process of the nasal mucosa; pregnancy and breastfeeding.

Pregnancy and Breastfeeding

Special studies on the safety of mometasone during pregnancy and during breastfeeding have not been conducted.

As with other nasal corticosteroids, the drug Desrinit should be prescribed during pregnancy and lactation only if the expected benefit to the mother outweighs the potential risk to the fetus and child. Newborns whose mothers used GCS during pregnancy should be carefully examined to identify possible adrenal hypofunction.

Use in children

The drug is contraindicated in children (for seasonal and year-round allergic rhinitis - up to 2 years; for acute sinusitis or exacerbations of chronic sinusitis - up to 12 years; for nasal polyposis - up to 18 years).

Special notes

When using mometasone for 12 months, no signs of atrophy of the nasal mucosa were noted. In the study of biopsy specimens of the nasal mucosa, it was revealed that mometasone showed a tendency to normalize the histological picture. When using the drug for a long time (as with any long-term treatment), periodic examination of the nasal mucosa by a otorhinolaryngologist is necessary.

With the development of a local fungal infection of the nose or pharynx, drug treatment is recommended to stop and begin specific therapy.

Continued for a long time, irritation of the mucous membrane of the nasal cavity and pharynx is an indication for discontinuation of the drug.

With prolonged use of the drug, no signs of suppressing the function of the hypothalamic-pituitary-adrenal system were observed.

Patients who switch to therapy with mometasone after long-term treatment of systemic corticosteroids require special attention. Canceling GCS of a systemic action in these patients may lead to a lack of adrenal function, which may require appropriate action.

During the transition from treatment of systemic corticosteroids to mometasone therapy, some patients may experience GCS withdrawal symptoms for systemic use (for example, pain in the joints and / or muscles, fatigue,depression), despite the reduction in the severity of symptoms associated with lesions of the nasal mucosa, such patients need to be specifically convinced of the desirability of continuing treatment with Desrinit. The transition from systemic corticosteroids to local corticosteroids can also reveal pre-existing, but masked, therapy of corticosteroids of systemic action, allergic diseases such as allergic conjunctivitis and eczema.

The efficacy and safety of mometasone has not been studied in the treatment of unilateral polyps, polyps associated with cystic fibrosis and polyps that completely cover the nasal cavity. Unilateral polyps of irregular shape or bleeding should be further examined.

Patients who receive GCS therapy have reduced immune reactivity, so they should be warned about the increased risk of infection when they come into contact with patients with certain infectious diseases (for example, chicken pox, measles), and also about the need for medical advice if such contact has occurred.

With prolonged use of nasal GCS in high doses may develop systemic side effects. The likelihood of these effects is much less than with the use of systemic corticosteroids, and may vary in individual patients, as well as between different corticosteroids. Potential systemic effects include Cushing's syndrome, characteristic signs of cushingoid, suppression of adrenal function,growth retardation in children and adolescents, cataracts, glaucoma, and, rarely, a number of psychological or behavioral effects, including psychomotor hyperactivity, sleep disturbance, anxiety, depression, or aggression (especially in children).

It is recommended to regularly monitor the growth of children receiving long-term therapy with mometasone. When growth is slowed down, ongoing therapy should be reviewed in order to reduce the dose of mometasone to the minimum effective, allowing to control the symptoms of the disease. In addition, the patient should be referred for consultation to the pediatrician.

Treatment of corticosteroids in doses exceeding the recommended, can lead to clinically significant inhibition of adrenal function. If it is known that GCS is used in high doses, it is necessary to consider the possibility of additional use of systemic GCS during periods of stress or planned surgical intervention.

Influence on ability to drive motor transport and control mechanisms

Studies on the impact on the ability to drive vehicles and mechanisms have been conducted.

The drug has a low (<1%) systemic bioavailability, so it is unlikely that overdose will require the adoption of any special measures, in addition to observation and subsequent administration at the recommended dose.

With prolonged use of GCS in high doses or with the simultaneous use of several GCS, it is possible to suppress the hypothalamic-pituitary-adrenal system.

The simultaneous use of mometasone with loratadine did not lead to a change in the concentration of loratadine or its main metabolite in the blood plasma, while the presence of mometasone in the plasma was not determined even at the minimum concentration.

Studies of drug interaction mometazon with other drugs have not been conducted.

The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C; do not freeze.