Universal reference book for medicines
Name of the drug: DEZRINIT (DEZRINIT)

Active substance: mometasone

Type: GCS for intranasal administration

Manufacturer: Teva Pharmaceutical Industries (Israel) manufactured by TEVA Czech Industries (Czech Republic)
Composition, form of production and packaging

Spray nasal dosed in the form of a suspension of milky white color, without agglomerates.

1 dose

mometasone furoate monohydrate 52 μg,

which corresponds to the content of mometasone furoate 50 μg

Auxiliary substances: Avicel RC-591 (microcrystalline cellulose, carmellose sodium) 2 mg, glycerol 2.1 mg, benzalkonium chloride solution 500 g / l 40 μg, polysorbate 80 10 μg, citric acid monohydrate 200 μg, sodium citrate dihydrate - 280 mcg, water q / u - sufficient amount to 100 mg.

10 g (60 doses) - polyethylene bottles with a dispenser (1) - packs of cardboard.

18 g (140 doses) - polyethylene bottles with dosing device (1) - packs cardboard.

18 g (140 doses) - polyethylene bottles with a dispenser (2) - packs of cardboard.

18 g (140 doses) - polyethylene bottles with a dosing device (3) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

GCS for topical application.
Mometasone has an anti-inflammatory and anti-allergic effect. The local anti-inflammatory effect of the drug is manifested when it is used in doses, in which no systemic effects occur.
It inhibits 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. It prevents the accumulation of neutrophils, which reduces inflammatory exudate and production of lymphokines, inhibits the migration of macrophages, leads to a decrease in the processes of infiltration and granulation. Reduces inflammation due to decreased formation of chemotaxis substance (influence on late allergy reactions), inhibits the development of an immediate allergic reaction (by inhibiting the formation of metabolites of arachidonic acid and reducing the release of inflammatory mediators from mast cells).
In studies with provocative tests with application of antigens to the nasal mucosa, high anti-inflammatory activity of the drug was demonstrated, both at early and late stages of the allergic reaction.
When compared with placebo, a decrease in the level of histamine and eosinophil activity, as well as a decrease (compared with the initial) of the number of eosinophils, neutrophils and proteins of epithelial cells.
PHARMACOKINETICS

In intranasal application, the systemic bioavailability of mometasone fuorate is <1% (with a sensitivity of 0.25 pg / ml).
A small amount of active substance that can enter the digestive tract with intranasal application is absorbed to a small extent and is actively biotransformed when "first passed" through the liver.
INDICATIONS

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

- Acute sinusitis or exacerbation of chronic sinusitis in adults (including the elderly) and children over 12 years of age - as an aid in the treatment of antibiotics;

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

- Treatment of polyposis of the nose in adults over 18 years.

DOSING MODE

The drug is administered intranasally.
Injection of the spray into the nasal cavity contained in the vial is carried out by means of a special dosing device.
Before using the spray for the first time, it is necessary to perform about 10 "calibration" pressures on the dispenser.
After the "calibration", a stereotypic drug delivery is established, at which every injection of the dosing device releases 100 mg of suspension, which corresponds to 50 μg of mometasone. If the drug is not used for 14 days or more, then a new "calibration" should be repeated before a new application.
Before each use of the spray, it is necessary to vigorously shake the bottle.

Seasonal and year-round allergic rhinitis

Adults (including the elderly) and children over 12 years of age are prescribed 2 injections (50 μg each) in each nasal passage 1 time / day (total daily dose - 200 μg).
After achieving the desired effect, the dose of the drug for maintenance therapy is 1 injection (50 μg) in each nasal passage 1 time / day (total daily dose - 100 μg). If necessary, the dose of the drug can be increased to 4 injections (50 μg each) in each nasal passage 1 time / day (total daily dose - 400 μg).
Children aged 2 to 11 years are prescribed 1 injection (50 μg) in each nasal passage 1 time / day (total daily dose is 100 μg).

The positive dynamics of clinical symptoms is noted, as a rule, within the first 12 hours after the first use of the drug.

Auxiliary treatment of acute sinusitis or exacerbation of chronic sinusitis

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

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

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.
From the nervous system: often - headache (in adults and children).
Children experienced growth retardation, psychomotor hyperactivity, sleep disturbance, anxiety, depression, aggressive behavior.
On the part of the respiratory system: often in adults - nosebleeds, burning in the nasal cavity, ulceration of the mucous membrane of the nasal cavity, sensation of irritation of the mucous membrane of the nasal cavity, pharyngitis, infections of the upper respiratory tract;
very rarely - perforation of the nasal septum. Nasal bleeding, as a rule, stopped on their own and was not severe; they appeared with a frequency slightly higher than when using placebo (5%), but equal to or less than with the use of other investigated GCS for intranasal use, which were used as active controls (in some of whom the incidence of nasal bleeding was up to 15%) . The incidence of other side effects was comparable to that of placebo; often in children - nasal bleeding, a sensation of irritation of the mucous membrane of the nasal cavity, sneezing. The incidence of all these adverse events in children was comparable to the placebo frequency.
From the digestive system: rarely - a sensation of irritation of the mucous membrane of the pharynx.

Other: rarely - impaired sense of smell, taste, glaucoma, increased intraocular pressure, cataract.

CONTRAINDICATIONS

- recent surgical intervention or trauma to the nose - until the wound is healed (due to the inhibitory effect of GCS on healing processes);

- Children's age (with seasonal and allergic rhinitis all year round - up to 2 years, with acute sinusitis or exacerbations of chronic sinusitis - up to 12 years, with polyposis of the nose - up to 18 years);

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

With caution should prescribe the drug for tuberculosis (active or latent) of the airways;
fungal, bacterial or systemic viral infection (including Herpes simplex with eye damage); long-term therapy with SCS; presence of untreated local infection involving the mucous membrane of the nasal cavity; pregnancy and during breastfeeding.
PREGNANCY AND LACTATION

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

As with other nasal SCS, the drug Desinitis should be prescribed during pregnancy and lactation only if the expected benefit to the mother exceeds the potential risk to the fetus and the baby.
Newborns whose mothers used SCS during pregnancy should be carefully examined to identify possible hypofunction of the adrenal glands.
APPLICATION FOR CHILDREN

Contraindicated the use of the drug in childhood (with seasonal and allergic rhinitis all year round - up to 2 years, with acute sinusitis or exacerbations of chronic sinusitis - up to 12 years, with polyposis of the nose - up to 18 years).

SPECIAL INSTRUCTIONS

With the application of mometasone for 12 months, no signs of atrophy of the nasal mucosa were noted.
When examining biopsies of the nasal mucosa, it was found that mometasone tended to normalize the histological pattern. When using the drug for a long time (as with any long-term treatment), periodic examination of the nasal mucosa by an otorhinolaryngologist is necessary.
When developing a local fungal infection of the nose or throat, the drug should be stopped and specific therapy initiated.

The long-term irritation of the mucous membrane of the nasal cavity and pharynx is an indication for the withdrawal of the drug.

With prolonged use of the drug, signs of suppression of the hypothalamic-pituitary-adrenal system were not observed.

Patients who switch to therapy with mometasone after long-term treatment with SCS of systemic action require special attention.
The abolition of SCS systemic action in such patients can lead to adrenal insufficiency, which may require appropriate measures.
During the transition from treatment with GCS systemic action to mometasone therapy in some patients, symptoms of cancellation of GCS for systemic use (eg, joint and / or muscle pain, fatigue, depression) may occur, despite a decrease in the severity of symptoms associated with mucosal lesions nose, such patients, it is necessary to specially convince in the expediency of continuation of treatment with the drug Desrinitis.
Transition from GCS systemic action to local SCS can also reveal already existing, but masked by GCS therapy 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 inspected.
Patients undergoing GCS therapy have a decreased immune reactivity, so they should be warned about the increased risk of infection when communicating with patients with certain infectious diseases (for example, chicken pox, measles), and about the need for medical advice if such contact occurs.

With prolonged use of nasal SCS in high doses, it is possible to develop systemic side effects.
The probability of developing these effects is much less than when using systemic GCS, and may differ in individual patients, as well as between different GCS. Potential systemic effects include Cushing's syndrome, characteristic cushingoid symptoms, suppression of adrenal function, growth retardation in children and adolescents, cataracts, glaucoma and, more rarely, a number of psychological or behavioral effects, including psychomotor hyperactivity, sleep disturbance, anxiety, depression or aggression in children).
It is recommended to regularly monitor the growth of children receiving long-term therapy with mometasone.
If the growth slows down, ongoing therapy should be reviewed to reduce the dose of mometasone to a minimum effective dose, which allows controlling the symptoms of the disease. In addition, you should refer the patient to a consultation with the pediatrician.
Treatment with SCS in doses exceeding the recommended levels can lead to clinically significant suppression of adrenal function.
If it is known that SCS is used in high doses, it is necessary to consider the possibility of additional use of systemic SCS during periods of stress or planned surgical intervention.
Impact on the ability to drive vehicles and manage mechanisms

Studies to study the effect on the ability to drive vehicles and mechanisms were not carried out.

OVERDOSE

The drug has a low (<1%) systemic bioavailability, so it is unlikely that an overdose will require the adoption of any special measures other than follow-up and subsequent administration at the recommended dose.

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

DRUG INTERACTION

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 was not detected in the plasma even at the minimum concentration.

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

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

DEZR-RU-00085-DOK-Pharm

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C;
Do not freeze. Shelf life - 2 years.
Shelf life of the opened bottle is 2 months.
Do not use after expiry date.
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