Treatment of seasonal or year-round allergic rhinitis in adults and children older than 2 yEars and Nose. Preventive treatment of allergic rhinitis of medium and severe course 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 older than 12 yEars and Nose. Treatment of nasal polyps and related symptoms, including nasal congestion and loss of smell, in patients over 18 yEars and Nose of age.
active substance: mometasone furoate;
1 dose (100 mg) of the spray contains mometasone furoate (micronized) 50 mcg;
excipients: benzalkonium chloride; citric acid monohydrate, sodium glycerin, carboxymethylcellulose-cellulose, microcrystalline sodium polysorbate 80; purified water.
Forinex Dosage form
Nasal spray, suspension.
Basic physical and chemical properties: white suspension.
Forinex Pharmacotherapeutic group
Decongestants and other topical preparations for diseases of the nasal cavity. Corticosteroids. ATX code R01A D09.
Mometasone furoate – synthetic corticosteroids for topical use, has a pronounced anti-inflammatory effect. The local anti-inflammatory effect of mometasone furoate appears at doses that do not cause systemic effects.
Basically, the mechanism of anti-inflammatory and anti-allergic action of mometasone furoate is associated with its ability to suppress the release of mediators of allergic reactions. Mometasone furoate significantly reduces the synthesis / release of leukotrienes from leukocytes of patients suffering from allergic diseases. Mometasone furoate has been shown to be 10 times more active in cell culture than other steroids, including beclomethasone dipropionate, 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 furoate is also 6 times more active than beclomethasone dipropionate and betamethasone in inhibiting the production of IL-5.
In studies with provocative tests with the application of antigens to the nasal mucosa, high anti-inflammatory activity of the aqueous nasal spray mometasone furoate was found in both the early and late stages of the allergic reaction. This was confirmed by a decrease (compared with placebo) in the level of histamine and eosinophil activity, as well as a decrease (compared to the baseline) in the number of eosinophils, neutrophils and adhesion proteins of epithelial cells.
A pronounced clinical effect in the first 12 hours of application of the water nasal spray mometasone furoate was achieved in 28% of patients with seasonal allergic rhinitis. On average (50%) improvement occurred within 35.9 hours. In addition, mometasone furoate has shown significant efficacy in relieving eye symptoms (redness, lacrimation, itching) in patients with seasonal allergic rhinitis.
In clinical studies involving patients with polyps, mometasone furoate spray has demonstrated significant clinical efficacy in relieving nasal congestion, reducing the size of polyps, and restoring the sense of smell compared to placebo.
In clinical trials involving patients over 12 years of age, mometasone furoate nasal spray 200 mcg twice daily has been shown to be highly effective in reducing rhinosinusitis symptoms compared with placebo. During 15 days of treatment, rhinosinusitis symptoms were assessed on the Major Symptom Score (MSS) (facial pain, pressure in the sinuses, pressure pain, sinus pain, rhinorrhea, mucus draining down the back of the throat and nasal congestion ). The efficacy of amoxicillin 500 mg three times a day did not significantly differ from placebo in reducing the symptoms of rhinosinusitis on the MSS scale. During the follow-up period after completion of treatment, the number of relapses in the mometasone furoate group was low and comparable to the amoxicillin and placebo group. The duration of treatment for acute rhinosinusitis for more than 15 days was not evaluated.
The bioavailability of mometasone furoate when used in the form of a nasal spray is <1% in blood plasma (according to the data obtained using the method, the lower limit of quantitative determination is 0.25 pg / ml). A suspension of mometasone furoate is very poorly absorbed from the gastrointestinal tract, and a small amount that can be swallowed and which can be absorbed undergoes active primary metabolism even before excretion, mainly in the form of metabolites in the bile and to some extent in the urine.
Treatment of seasonal or perennial allergic rhinitis in adults and children over 2 years of age. It is recommended to start prophylactic treatment for moderate to severe allergic rhinitis 4 weeks before the expected start of the dusting season.
As an auxiliary therapeutic agent in the treatment of acute sinusitis with antibiotics in adults (including the elderly) and children over 12 years of age.
Treating symptoms of acute sinusitis 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 loss of smell, in patients over the age of 18.
Hypersensitivity to the active substance or to any inactive component of the drug.