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Mometasone

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Available since: 2019-09-19

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Clinical Pharmacology

Pharmacodynamics

Mometasone is a synthetic GCS for local use. It has anti-inflammatory and anti-allergic effect when used in doses that do not cause systemic effects. Slows down the release of inflammatory mediators. Increases the production of lipomodulin, which is an inhibitor of phospholipase A, which leads to a decrease in the release of arachidonic acid and, accordingly, inhibition of the synthesis of products of the metabolism of arachidonic acid - cyclic endoperexia, PG. It warns the marginal 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 by reducing the formation of a chemotaxis substance (effect on late allergy reactions), inhibits the development of an immediate type allergic reaction (due to inhibition of arachidonic acid metabolite production and a decrease in inflammatory mediators release from mast cells).

In studies with provocative tests with the application of antigens on the mucous membrane of the nasal cavity, a high anti-inflammatory activity of mometasone was demonstrated in both the early and late stages of the allergic reaction. This was confirmed by a decrease (compared to placebo) of histamine level and eosinophil activity, as well as a decrease (compared to baseline) of the number of eosinophils, neutrophils and epithelial cell adhesion proteins.

Pharmacokinetics

With intranasal use, mometasone has a systemic bioavailability of less than 1% (with a detection method sensitivity of 0.25 pg / ml).

The mometasone suspension is very poorly absorbed in the gastrointestinal tract, and the small amount of mometasone suspension that can enter the gastrointestinal tract after nasal inhalation, even before excretion by the kidneys or with bile, is subjected to an active primary metabolism.

Indications

seasonal or year-round allergic rhinitis in adults, adolescents and children from 2 years;

acute sinusitis or exacerbation of chronic sinusitis in adults (including the elderly) and adolescents from the age of 12 as part of complex therapy;

acute rhinosinusitis with mild and moderately severe symptoms without signs of severe bacterial infection in patients aged 12 years and older;

prophylactic treatment of moderate-to-severe seasonal allergic rhinitis in adults and adolescents from the age of 12 (recommended 2–4 weeks before the expected start of the dusting season);

nasal polyposis, accompanied by a violation of nasal breathing and smell, in adults (18 years).

Composition

active substance:

mometasone furoate 50 mcg

excipients: MCC and sodium carboxymethylcellulose - 2000 mcg; glycerol - 2100 mcg; citric acid monohydrate - 200 mcg; sodium citrate dihydrate - 280 mcg; polysorbate 80 - 10 mcg; benzalkonium chloride (50% solution) - 40 mcg; purified water - up to 0.1 g

Mometasone is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Nozephrine			spray
Momate Rhino®	Glenmark	India	spray
Skinlight	Nizhpharm	Russia	cream
Dezrinit	Teva	Israel	spray
Avecort	Green Dubrava	Russia	ointment
Asmanex Twisthaler	Schering-Plough	USA	powder
Momate	Glenmark	India	ointment
Momate	Glenmark	India	cream
Nasonex	Schering-Plough Labo N.V	Belgium	spray
Elocom	Schering-Plough	USA	cream
Elocom	Schering-Plough	USA	ointment

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Dosage and Administration

At the first signs of SARS (for 5 days)

Children from 1 to 3 years old - 2 spray doses in each nasal passage 3-4 times a day (single dose - 20,000 IU, daily dose: - 60000-80000 IU);

Children from 3 to 14 years old - 2 spray doses 4-5 times a day (single dose - 20000 IU, daily dose - 80000-100000 IU);

Adults - 3 spray doses 5-6 times a day (single dose - 30,000 IU, daily dose - 150000-180000 IU).

For the prevention of respiratory viral infections

In contact with the patient and during hypothermia - in accordance with the age dosage 2 times a day for 5-7 days. If necessary, preventive courses are repeated. With a single contact, a single injection is enough.

With a seasonal increase in incidence - in accordance with the age dosage once in the morning with an interval of 1-2 days.

Adverse reactions

Side effects

In adults and adolescents: headache, nasal bleeding (i.e. obvious bleeding, and discharge of blood-stained mucus or blood clots), pharyngitis, burning sensation in the nose, irritation of the nasal mucosa, ulceration of the nasal mucosa, infections of the upper respiratory tract sensation of irritation of the pharyngeal mucosa. Nosebleeds, as a rule, were moderate and stopped on their own, the frequency of their occurrence was slightly higher than when using placebo (5%), but equal to or less than when other nasal GCSs were used, which were used as active controls (some of their incidence of nosebleeds was up to 15%). The incidence of all other adverse events was comparable to that for the placebo.

In children: nasal bleeding, headache, sensation of irritation in the nose, sneezing. The incidence of these adverse events in children was comparable to that in placebo.

Rarely observed hypersensitivity reactions of the immediate type (including bronchospasm, shortness of breath).

Very rarely - anaphylaxis, angioedema, taste disturbance and smell.

It is also very rare - cases of perforation of the nasal septum and elevated IOP have been noted with intranasal GCS.

With prolonged use of nasal GCS in high doses may develop systemic side effects. Potential systemic effects include Cushing's syndrome, characteristic signs of cushingoid, 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 (especially children).

Contraindications

Hypersensitivity to mometasone or any of the components that make up the drug;
recent surgery or injury of the nose with damage to the nasal mucosa - to wound healing (due to the inhibitory effect of GCS on the healing process);
children age (with seasonal and year-round allergic rhinitis - up to 2 years, with acute sinusitis or exacerbation of chronic sinusitis - up to 12 years, with polyposis - up to 18 years) due to the lack of relevant data.
With care: 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 use the drug for the listed infections as directed by a physician); untreated local infection with involvement in the process of the mucous membrane of the nasal cavity; long-term therapy GKS systemic action; pregnancy; breastfeeding period.

Drug interactions

With simultaneous use of mometasone with loratadine, good tolerance was observed by patients.No effect of mometasone on the concentration of loratadine or its main metabolite in the blood plasma was noted.

Research interaction with other drugs were not conducted.

Pregnancy and Lactation

Studies of the drug in pregnant women and women who are breastfeeding, was not conducted. As with the use of other nasal GCS, the drug Nozephrin should be used during pregnancy and during breastfeeding only if the expected benefit to the mother outweighs the potential risk to the fetus or newborn.

Newborns whose mothers used the drug Nozephrin during pregnancy should be carefully examined to identify possible adrenal hypofunction.

Special instructions

Do not use in ophthalmology.

When using the drug for a long time (for several months or longer), periodic medical examination is necessary for timely detection of possible changes in the nasal mucosa.

In the case of the development of a local fungal infection of the nose or pharynx, it may be necessary to discontinue drug therapy and conduct special treatment. Continued for a long time, irritation of the mucous membrane of the nasal cavity and pharynx is also an indication for the withdrawal of drug therapy.

Patients who switch to treatment with Nosefrin® nasal spray after a long-term treatment of systemic corticosteroids require special attention. Canceling the GCS of a systemic effect in such patients may lead to a deficiency in adrenal function, which may take several months to recover. In case of signs of adrenal insufficiency, you should resume taking systemic corticosteroids and take other necessary measures.

During the transition from treatment of systemic corticosteroids to the treatment of nosephrine nasal spray, some patients may experience withdrawal of systemic corticosteroids (including pain in the joints and / or muscles, tiredness and depression). Such patients need to be convinced of the desirability of continuing treatment with Nosefrin® nasal spray. The transition from systemic to local corticosteroids can also reveal previously developed allergic diseases, such as allergic conjunctivitis and eczema, which were previously masked by systemic corticosteroids therapy.

Patients using GCS have potentially reduced immune reactivity and should be warned about the increased risk of infection in case of contact with patients with certain infectious diseases (including chicken pox, measles), and also about the need to consult a doctor if Contact has occurred.

Requires regular monitoring of patients receiving the drug for a long time. 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 more rarely a number of psychological or behavioral effects, including psychomotor hyperactivity, sleep disturbance, anxiety, depression, or aggression (especially children).

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

Treatment of corticosteroids with higher doses than recommended can lead to clinically significant inhibition of adrenal function.

If there are signs of severe bacterial infection (including fever, persistent and sharp pain on one side of the face or toothache, swelling in the orbital or periorbital area), it is necessary to consult a doctor immediately.

When using mometasone in a medicinal form, a nasal spray for 12 months showed no signs of atrophy of the nasal mucosa.

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 polyps should be further examined.

Influence on ability to drive vehicles and mechanisms. Data on the negative effect of the drug in recommended doses on the ability to drive vehicles and mechanisms, as well as to perform other activities requiring concentration of attention and speed of psychomotor reactions, are not available.

Overdosage

Symptoms: depression of the function of the hypothalamic-pituitary-adrenal system (may occur in the case of prolonged use of GCS in high doses, as well as with the simultaneous use of several GCS).

Treatment: due to the low systemic bioavailability of the drug (less than 1% with a sensitivity method of 0.25 pg / ml), it is unlikely that with an accidental or deliberate overdose, you will need to take any measures other than observation with possible subsequent resumption of the drug in the recommended dose. If necessary, symptomatic treatment.