Treatment of seasonal or year-round allergic rhinitis in adults and children aged 2 yEars and Nose and older. Preventive treatment of moderate to severe allergic rhinitis is recommended to start 4 weeks before the expected start of the dusting season; as an auxiliary therapeutic agent in the treatment of acute episodes of sinusitis with antibiotics in adults (including the elderly) and children over 12 yEars and Nose of age; treatment of symptoms of acute rhinosinusitis without signs of severe bacterial infection in adults and children over 12 yEars and Nose of age; treatment of nasal polyps and related symptoms, including nasal congestion and loss of smell, in patients aged 18 and over.
active substance: mometasone;
1 dose of spray contains mometasone furoate 50 mcg;
excipients: microcrystalline cellulose and carmellose sodium; sodium citrate; glycerin; citric acid, monohydrate; polysorbate 80; benzalkonium chloride; purified water.
Etacid Dosage form
Nasal spray, metered, suspension.
Main physical and chemical properties: suspension of white or almost white color.
Anti-edema and other drugs for topical use in diseases of the nasal cavity. Corticosteroids. ATC code R01A D09.
Mometasone is a synthetic topical corticosteroid that has a pronounced anti-inflammatory effect. The local anti-inflammatory effect of mometasone is manifested in doses at which there are no systemic effects.
The mechanism of anti-inflammatory and anti-allergic action of mometasone is mainly related to its ability to inhibit the release of mediators of allergic reactions. It significantly reduces the synthesis / release of leukotrienes from the leukocytes of patients suffering from allergic diseases. In cell culture, it was 10 times more active than other steroids, including beclomethasone, betamethasone, hydrocortisone and dexamethasone in inhibiting the synthesis / release of IL-1, IL-5, IL-6 and TNFα. It is also a potent inhibitor of the production of Th2 cytokines, IL-4 and IL-5 from human CD4 + T cells. Mometasone is also 6 times more active than beclomethasone and betamethasone in inhibiting IL-5 production.
Studies with provocative tests with antigens applied to the nasal mucosa revealed high anti-inflammatory activity of intranasal mometasone in both early and late allergic reactions. This was confirmed by a decrease (compared with 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.
A pronounced clinical effect in the first 12 hours of intranasal mometasone was achieved in 28% of patients with seasonal allergic rhinitis. On average (50%) relief occurred within 35.9 hours. In addition, it has been shown to be significantly effective in reducing the symptoms of visual disturbances (redness, tearing, itching) in patients with seasonal allergic rhinitis.
In clinical trials in patients with nasal polyps, intranasal mometasone showed significant clinical efficacy in relieving nasal congestion, reducing the size of polyps, and restoring smell compared to placebo.
In clinical trials in patients 12 years of age and older, intranasal mometasone 200 mcg twice daily was highly effective in relieving the symptoms of rhinosinusitis compared with placebo. Within 15 days of treatment, the symptoms of rhinosinusitis were assessed by the Major Symptom Score (MSS), facial pain, nasal pressure, pain when pressed, nasal pain, rhinorrhea, mucus on the back of the throat and congestion. nose). The efficacy of amoxicillin 500 mg 3 times daily did not differ significantly from placebo in relieving the symptoms of rhinosinusitis on the MSS scale. During the follow-up period after treatment, the number of relapses in the intranasal mometasone group was low and comparable to the amoxicillin and placebo groups. The duration of treatment of acute rhinosinusitis over 15 days was not estimated.
The bioavailability of mometasone when used as a nasal spray is <1% in blood plasma (according to data obtained using the sensitive method of the lower limit of quantification is 0.25 pg / ml). Mometasone suspension is very poorly absorbed from the gastrointestinal tract, and the small amount that can be swallowed and absorbed undergoes active primary metabolism before excretion, mainly as metabolites in bile and to some extent in urine.
Treatment of seasonal or perennial allergic rhinitis in adults and children over 2 years of age (preventive treatment of allergic rhinitis of moderate and severe course is recommended to begin 4 weeks before the expected start of the pollination season).
As an adjunct to the treatment of acute episodes of sinusitis with antibiotics in adults (including the elderly) and children over 12 years of age.
Treatment of symptoms of acute rhinosinusitis without signs of severe bacterial infection in adults and children over 12 years of age.
Treatment of nasal polyps and related symptoms, including nasal congestion and olfactory loss, in patients over 18 years of age.
Hypersensitivity to the active substance or to any of the excipients.