It stops the release of inflammatory mediators. Lipomodulina increases the production, an inhibitor of phospholipase A, which causes the decrease of arachidonic acid release and, accordingly, suppression of the synthesis of the arachidonic acid metabolism products – cyclic endoperekisey, prostaglandins. It prevents the accumulation of neutrophils boundary, which reduces the production of inflammatory exudate and lymphokines inhibits macrophage migration, reduces infiltration and granulation processes. Reduces testosterone enanthate 250 inflammation by reducing the formation of Substance chemotaxis (impact on “recent” allergic reaction), inhibits the development of immediate allergic reaction (due to inhibition of the production of arachidonic acid metabolites and decrease the release of mast cell mediators of inflammation).
In a provocative tests studies with the application of antigens to mucosa of | bolochku nasal cavity demonstrated the highest antiinflammatory activity mometasone both early and a late phase of an allergic reaction.
This was confirmed by a reduction (compared to placebo) levels of histamine and activity of eosinophils, as well as a decrease (compared to baseline) in eosinophils, neutrophils and epithelial cell adhesion proteins.
In this regard, relevant pharmacokinetic data for this formulation does not exist;(Suspension mometasone very poorly absorbed in the gastrointestinal tract. The small amount of mometasone suspension, which may get into the gastrointestinal tract after nasal inhalation before excretion or bile exposed active primary metabolism.
- Seasonal and perennial allergic rhinitis in adults, adolescents and children from 2 years of age.
- Acute sinusitis and exacerbation of chronic sinusitis in adults (including the elderly) and adolescents 12 years of age – as an auxiliary therapeutic agent in the treatment of antibiotics.
- Prophylactic treatment of seasonal allergic rhinitis, moderate and severe in adults and adolescents from 12 years (recommended for dve- four weeks prior to the expected start of the season dusting).
- Polyposis of the nose, accompanied by violation of nasal breathing and sense of smell, in adults (18 years).Contraindications
- Hypersensitivity to any of the substances included in the preparation.
- The presence of local infection untreated in the process involving the nasal mucosa.
- Recent surgery or trauma to the nasal mucosal damage of the nasal cavity – to healing wounds (because of the inhibiting effect on the healing process GCS).
- Children’s age (with seasonal and perennial allergic rhinitis – up to 2 years, with acute sinusitis and exacerbation of chronic sinusitis – up to 12 years, with polyposis – up to 18 years) – due to the lack of relevant data.Precautions
Testosterone enanthate 250 should be used with caution in tuberculosis infection (active or latent) of the respiratory tract, untreated fungal, bacterial, systemic viral infections or infections caused by Herpes simplex eye disease (as an exception, perhaps the appointment of the drug in these infections as directed by a physician) .
Use during pregnancy and lactation
after intranasal administration of the drug at a therapeutic dose of 400 micrograms per day mometasone not detected in plasma, even in the minimum concentration, therefore, it can be expected that the effect on the fetus will be negligible, and potential toxicity to reproductive function – very low.
However, due to the fact that special, well-controlled studies of the drug in pregnant women has been conducted, Nasonex ® should be administered alternating or nursing only if the expected benefit from the appointment of the drug justifies the potential risk to the fetus or infant.
Infants whose mothers during pregnancy received corticosteroids, should be carefully examined with respect to possible adrenal hypofunction.
Dosing and Administration
Intranasal. Inhalation suspension contained in a bottle spray, carried out by a special dispensing nozzle on the bottle.
Before first use of a nasal spray Nasonex ® necessary to carry out its “calibrated” by pushing the dosing device 6-7 times. After the “calibration” set stereotyped feed drug at which each pressing dispensing device is released about 100 mg of suspension containing mometasone furoate (as the monohydrate) in an amount equivalent to 50 micrograms of anhydrous mometasone furoate. If the nasal spray has not been used for 14 days or longer before a new application must be re “calibration”.
Before each use, need to vigorously shake the spray bottle.
Treatment of seasonal or perennial allergic rhinitis Adults (including the elderly) and adolescents from 12 years of age: The recommended prophylactic and therapeutic dose is 2 inhalations (50 micrograms each) in each nostril 1 per day (total daily dose – 200 mcg) . Upon reaching therapeutic effect for maintenance therapy may reduce the dose to 1 inhalation in each nostril 1 per day (total daily dose – 100 mg). If reduction of symptoms can not be achieved using the drug at the recommended therapeutic dose, the daily dose can be increased to 4 inhalations in each nostril once a day 1 (total daily dose of -400 mg). After reducing the symptoms of the disease it is recommended to decrease the dose. The onset of action of the drug is usually noted clinically within 12 hours after first use of the drug.Children 2-11 years: The recommended therapeutic dose – 1 inhalation (50 micrograms) in each nostril 1 per day (total daily dose – 100 mcg). For the use of the drug young children need pomosch.vzroslyh.
Auxiliary treatment of acute sinusitis and acute exacerbations of chronic sinusitis Adults (including the elderly) and adolescents from 12 years of age: The recommended therapeutic dose is 2 inhalations (50 micrograms each) in sazhduyu nostril 2 times a day (total daily dose – 400 mcg). then if the reduction of symptoms can not be achieved using the drug at the recommended therapeutic dose, the daily dose may be increased to 4 inhalations in each nostril two times a day (total daily dose of -800 mg). After reducing the symptoms of the disease it is recommended to decrease the dose.
Nasal polyposis Treatment of
Adults (including elderly) of 18:
The recommended therapeutic dosage is 2 inhalations (50 mkgch each) per nostril two times a day (total daily dose – 400 mg).
After reducing the symptoms recommended dose reduction to 2 inhalations (50 micrograms each), one in each nostril once daily (total daily dose – 200 mg).
Side effects in adults and adolescents: headache, nasal bleeding (ie bleeding obvious, as well as the allocation of colored mucus or blood clots), sore throat, burning sensation in the nose, irritation of the nasal mucosa, ulceration of the nasal mucosa. Nosebleeds were usually mild and stopped independently, their frequency was slightly greater than with placebo (5%), but equal to testosterone enanthate 250 or less than the appointment of the other nasal corticosteroids, which were used as active controls (some of their incidence of nosebleeds (left to 15%) The incidence of other adverse events was comparable with the frequency of their occurrence in the placebo appointment.. children: nosebleeds, headache, feeling of irritation in the nose, sneezing incidence of these adverse events in. children was comparable to the frequency of their occurrence with placebo. rarely observed hypersensitivity reactions of immediate type ([eg, bronchospasm, dyspnea). very rarely -. anaphylaxis, angioedema, disturbances of taste and smell is also very rarely with intranasal application of corticosteroids observed perforation cases nasal septum and elevated intraocular pressure.
Prolonged use of corticosteroids in high doses, as well as the simultaneous use of several possible GCS inhibition of the function of the hypothalamic-pituitary-adrenal system. Because of the low systemic bioavailability of the drug (<0.1%) it is unlikely that the accidental or intentional overdose require the adoption of any measures in addition to observation with possible subsequent resumption of the drug at the recommended dose.
Interaction with other drugs
Combination therapy with loratadine was well tolerated by patients. Thus it was not observed any influence on the drug concentration in plasma loratadine or its main metabolite.
As with any long-term treatment, patients who use nasal spray Nasonex ® for several months or longer must undergo periodic medical examination for possible changes in the nasal mucosa.
In the case of a local fungal nasal infection or throat may require discontinuation of therapy nasal spray and holding a special treat. Persists for a long time, irritation of the mucous membranes of the nose and throat can also serve as a basis for an end to treating nasal spray.
During the placebo-controlled clinical trials in children, when the nasal spray Nasonex used in a daily dose of 100 mcg during the year, growth retardation in children were observed.
in long-term treatment of nasal spray features suppression of the hypothalamic-pituitary-adrenal system was observed.
Patients who go to the treatment of nasal spray after prolonged therapy corticosteroids systemic effects, require special attention. Cancel systemic effects of glucocorticoids in these patients may lead to the failure of adrenal function, subsequent recovery which may take up to several months. In the event of signs of adrenal insufficiency should resume receiving systemic corticosteroids and take other measures neobhodimyeh. During the transition from the treatment of glucocorticoid systemic effects to the treatment of nasal spray Nasonex ® some patients may experience initial withdrawal symptoms of systemic corticosteroids (eg, pain in the joints and / or muscles, fatigue and depression), despite a decrease in the severity of symptoms associated with lesions nasal mucosa; such patients need to specifically urge the advisability of continuing treatment nasal spray Nasonex ® . The transition from the system to the local glucocorticosteroids may also reveal the already existing, but to mask therapy corticosteroids systemic effects, allergic diseases such as allergic conjunctivitis and eczema.
Patients undergoing treatment with glucocorticosteroids have potentially reduced immune reactivity and should be warned about the increased for their risk of infection in the event of contact with sick certain infectious diseases (eg, chickenpox, measles) and of the need of medical advice if such contact occurred.
if signs of severe bacterial infections (eg, fever, persistent and severe pain on one by a person or dental pain, swelling in the orbital or periorbital area) require immediate medical consultation.
When using a nasal spraytestosterone enanthate 250 for 12 months did not arise signs of atrophy of the nasal mucosa; In addition, mometasone furoate tended to promote the normalization of histology of biopsy samples in studies of the nasal mucosa.
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