Mometasone Sandoz nasal spray doses 50 µg 60 DOZES
Directions for use and doses
Intranasally.
The spray contained in the bottle is injected into the nasal cavity using a special dosing device. Do not pierce the nasal applicator.
Before using the spray for the first time, it is necessary to make about 10 “calibration” clicks on the dispensing device until the supply of the same-looking spray is established. After “calibration,” a stereotypical supply of the drug is established, in which with each click on the dosing device, 100 mg of suspension is released, which corresponds to 50 mcg of mometasone.
If the drug has not been used for 14 days or more, then before using it again, it is necessary to re-calibrate it by performing two “calibration” clicks.
Before each use of the spray, shake the bottle vigorously. When using, tilt your head and inject the medication into each nasal passage as directed by your healthcare professional.
Treatment of seasonal and year-round allergic rhinitis
Adults (including the elderly) and adolescents from 12 years of age
The recommended preventive and therapeutic dose of the drug is 2 injections (50 mcg of mometasone furoate each) into each nasal passage once a day (total daily dose - 200 mcg).
After achieving a therapeutic effect for maintenance therapy, it is possible to reduce the dose to 1 injection into each nasal passage 1 time per day (total daily dose - 100 mcg).
If a reduction in the symptoms of the disease cannot be achieved by using the drug at the recommended therapeutic dose, the daily dose of the drug can be increased to 4 injections into each nasal passage once a day (total daily dose - 400 mcg). After the symptoms of the disease decrease, a dose reduction is recommended.
The onset of action of the drug is usually observed clinically within 12 hours after the first use of the drug.
Children from 2 to 11 years old
The recommended therapeutic dose for the treatment of seasonal or year-round allergic rhinitis is 1 injection (50 mcg of mometasone furoate) into each nasal passage once a day (total daily dose - 100 mcg).
To use the drug in young children, adult assistance is required.
Adjuvant treatment of acute sinusitis or exacerbation of chronic sinusitis
Adults (including the elderly) and adolescents from 12 years of age
The recommended therapeutic dose is 2 injections (50 mcg of mometasone furoate each) into each nasal passage 2 times a day (total daily dose 400 mcg).
If a reduction in the symptoms of the disease cannot be achieved by using the drug at the recommended therapeutic dose, the daily dose can be increased to 4 injections into each nasal passage 2 times a day (total daily dose - 800 mcg). After the symptoms of the disease decrease, a dose reduction is recommended.
Treatment of acute rhinosinusitis without signs of severe bacterial infection
The recommended dose for adults and adolescents is 2 injections (50 mcg of mometasone furoate each) into each nasal passage 2 times a day (total daily dose 400 mcg). If symptoms worsen during treatment, consultation with a specialist is necessary.
Treatment of nasal polyposis
Adults (including older people) over 18 years of age
The recommended therapeutic dose is 2 injections (50 mcg of mometasone furoate each) into each nasal passage 2 times a day (total daily dose - 400 mcg).
After the symptoms of the disease have reduced, it is recommended to reduce the dose to 2 injections (50 mcg of mometasone furoate each) into each nasal passage once a day (total daily dose of 200 mcg).
Mometasone Sandoz nasal spray 50mcg/dose fl 18g N1
Registration Certificate Holder
SANDOZ (Slovenia)
Dosage form
Medicine - Mometasone Sandoz® (Mometasonesandoz)
Description
Nasal spray
in the form of a homogeneous white suspension.
1 dose
mometasone furoate monohydrate 0.0517 mg, which corresponds to the content of mometasone furoate 0.05 mg
Excipients
: microcrystalline cellulose and carmellose sodium (Avicel RC-591) - 2 mg, glycerin - 2.1 mg, citric acid monohydrate - 0.2 mg, sodium citrate dihydrate - 0.28 mg, polysorbate 80 - 0.01 mg, benzalkonium chloride - 0.02 mg, water d/ and - up to 100 mg.
10 g (60 doses) - bottles (1) - cardboard packs. 10 g (60 doses) - bottles (2) - cardboard packs. 10 g (60 doses) - bottles (3) - cardboard packs. 17 g (120 doses) - bottles (1) - cardboard packs. 17 g (120 doses) - bottles (2) - cardboard packs. 17 g (120 doses) - bottles (3) - cardboard packs. 18 g (140 doses) - bottles (1) - cardboard packs. 18 g (140 doses) - bottles (2) - cardboard packs. 18 g (140 doses) - bottles (3) - cardboard packs.
Indications
Treatment of seasonal and year-round allergic rhinitis in adults, adolescents and children over 2 years of age; acute sinusitis or exacerbation of chronic sinusitis in adults (including the elderly) and adolescents over 12 years of age (as an auxiliary therapeutic agent in antibiotic treatment); acute rhinosinusitis with mild to moderate symptoms without signs of severe bacterial infection in patients aged 12 years and older; prevention of seasonal allergic rhinitis of moderate and severe course in adults and adolescents from 12 years of age; nasal polyposis, accompanied by impaired nasal breathing and sense of smell in adults.
Contraindications for use
Hypersensitivity to mometasone; recent surgery or trauma to the nose with damage to the mucous membrane of the nasal cavity - before the wound heals (due to the inhibitory effect of GCS on the healing processes); childhood and adolescence up to 18 years with nasal polyposis; children under 12 years of age with acute sinusitis or exacerbation of chronic sinusitis; children under 2 years of age with seasonal and year-round allergic rhinitis.
pharmachologic effect
GCS for intranasal use. Has anti-inflammatory and anti-allergic effects.
The mechanism of antiallergic and anti-inflammatory action is due to the ability to inhibit 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 arachidonic acid metabolic products - cyclic endoperoxides, prostaglandins. Prevents the marginal accumulation of neutrophils, which reduces inflammatory exudate and the production of lymphokines, inhibits the migration of macrophages, and leads to a decrease in the processes of infiltration and granulation. Reduces inflammation by reducing the formation of a chemotaxis substance (impact on late allergy reactions), inhibits the development of an immediate allergic reaction (due to inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells).
In vitro, mometasone furoate significantly inhibits the release of leukotrienes from leukocytes. In cell cultures, mometasone furoate demonstrated a high ability to inhibit the synthesis and release of IL-1, IL-5, IL-6, as well as TNFα; it is also an inhibitor of leukotriene production, as well as an extremely potent inhibitor of Th2 cytokines, IL-4 and IL-5, by human CD4+ T cells.
When studied in preclinical models, mometasone reduced the accumulation of inflammatory cells (including eosinophils), penetrated into the walls of the upper and lower respiratory tract, and also improved lung function after a challenge test. Mometasone decreased the number of lymphocytes and the concentration of mRNA for the cytokines IL-4 and IL-5.
In studies with provocative tests with the application of antigens to the nasal mucosa, the high anti-inflammatory activity of mometasone was demonstrated, both in the early and late stages of the allergic reaction. This was confirmed by a decrease (compared to 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
Dosage regimen
The dosage regimen is set individually, depending on the indications, the age of the patient, and the dosage form used.
Side effect
From the respiratory system:
with intranasal use, nosebleeds, pharyngitis, a burning sensation in the nose, and sneezing are possible; irritation of the nasal mucosa; very rarely with intranasal use - cases of perforation of the nasal septum.
Other:
possible headache.
special instructions
Mometasone should be used with caution in case of tuberculosis 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, the drug can be prescribed for these infections as directed by a doctor), the presence of untreated local infection involving the nasal mucosa.
With long-term intranasal use of mometasone, periodic examination of the nasal mucosa by an ENT doctor is necessary. If a local bacterial or fungal infection of the nose or throat develops, it is recommended to stop treatment and begin special treatment. Irritation of the mucous membrane of the nasal cavity and pharynx that persists for a long time is an indication for discontinuation of the drug.
When switching from GCS for systemic use to intranasal use of mometasone, special caution is required due to the possible risk of developing adrenal insufficiency. After discontinuation of systemic corticosteroids, it takes several months to restore the function of the hypothalamic-pituitary-adrenal axis.
During stressful situations, including trauma, surgery, infectious diseases or a severe attack of bronchial asthma, patients who have previously received corticosteroids for systemic use require an additional prescription of a short course of systemic corticosteroids, which are then gradually withdrawn as symptoms subside.
When switching from systemic corticosteroids, intranasal use of mometasone may result in the manifestation of concomitant allergic diseases, the symptoms of which were previously suppressed by the use of systemic corticosteroids. During this period, some patients may experience signs of withdrawal from systemic corticosteroids, including muscle and/or joint pain, depression, and fatigue, despite the fact that pulmonary function tests are stable or even improving. If signs of adrenal insufficiency occur, the dose of GCS for systemic use should be temporarily increased, and subsequently discontinued more gradually.
Patients receiving corticosteroids or other immunosuppressants should be advised to avoid contact with patients with certain infections (chicken pox, measles) and be sure to consult a doctor if such contact occurs (especially important when used in adolescents over 12 years of age).
To maintain a low potential for hypothalamic-pituitary-adrenal axis suppression, recommended doses should not be exceeded, and the dose of mometasone should be titrated to the minimum effective dose in each patient.
When using mometasone, it should be taken into account that the effect on cortisol production may vary between patients.
The occurrence of candidiasis may require appropriate antifungal therapy or discontinuation of mometasone.
Use in pediatrics
It is recommended to regularly monitor the growth of adolescents receiving long-term therapy with mometasone. If growth slows, therapy should be reconsidered in order to reduce the dose of mometasone to the minimum effective dose to control the symptoms of the disease.
In placebo-controlled clinical studies in children with intranasal use of mometasone at a dose of 100 mcg/day for a year, no growth retardation was observed.
Use during pregnancy and breastfeeding
Restrictions during pregnancy - With caution. Restrictions when breastfeeding - With caution.
There have been no adequate and well-controlled studies of the use of mometasone during pregnancy. It is not known whether mometasone is excreted in breast milk.
Intranasal use of mometasone during pregnancy and breastfeeding is possible only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.
Newborns whose mothers received corticosteroids during pregnancy should be monitored for possible symptoms of adrenal insufficiency.
Mometasone (Mometasonum)
The drug interacts with intracellular glucocorticoid receptors, promoting the release of the receptor from connection with immunophilin and heat shock proteins 70 and 90. Penetration of the activated receptor into the nucleus, binding to glucocorticoid-sensitive regulatory elements of DNA - a specific effect on gene expression (activation and suppression). Interaction with other protein transcription factors, including NFκB and AP-1, which regulate the expression of many immune system proteins, resulting in suppression of the expression of genes encoding some cytokines, collagenase and stromelysins.
The anti-inflammatory effect of mometasone is due to several factors.
1. The drug induces the synthesis of lipocortin, which inhibits the activity of phospholipase A2. Inhibition of phospholipase A2-mediated hydrolysis of membrane phospholipids in damaged tissues prevents the formation of arachidonic acid. Impaired formation of arachidonic acid actually means inhibition of prostaglandin synthesis, since arachidonic acid is a substrate for further metabolism through the cyclooxygenase pathway, as well as through the lipoxygenase pathway with a corresponding inhibition of leukotriene synthesis.
2. The anti-inflammatory effect of glucocorticoids is potentiated by their ability to inhibit the expression of COX-2 genes, which also leads to a decrease in the synthesis of prostaglandins at the site of inflammation, including pro-inflammatory prostaglandins E2 and I2.
3. Mometasone inhibits the expression of intercellular adhesion molecules in the endothelium of blood vessels, disrupting the penetration of neutrophils and monocytes into the site of inflammation. After the administration of glucocorticoids, an increase in the concentration of neutrophils in the blood is noted (due to their receipt from the bone marrow and due to the restriction of migration from the blood vessels). This causes a decrease in the number of neutrophils at the site of inflammation.
Mometasone inhibits the transcription of genes for cytokines that stimulate the inflammatory and immune response (IL-1, IL-2, IL-6, IL-8), as well as tumor necrosis factor (and some others). Also noted is a decrease in the transcription rate and increased degradation of receptor genes for IL-1 and IL-2, inhibition of transcription of metalloproteinase genes (collagenase, elastase and others) involved in increasing the permeability of the vascular wall, in the processes of scarring and destruction of cartilage tissue in joint diseases.
The immunosuppressive effect is due to inhibition of transcription of DNA encoding the major histocompatibility complex, proinflammatory cytokines and inhibition of T-lymphocyte proliferation. Leads to a decrease in the number of T-lymphocytes and their influence on B-lymphocytes, inhibits the production of immunoglobulins. Reduces the formation and increases the breakdown of components of the complement system.
The antiallergic effect is associated with inhibition of the synthesis of allergy mediators, degranulation of mast cells and the release of allergy mediators, and therefore it is effective for immediate allergic reactions.
