Mometasone Sandoz, 50 mcg/dose, 140 doses, metered nasal spray, 18 g, 1 piece, Sandoz buy in Moscow at a low price

Mometasone Sandoz, 1 piece, 18 g, 50 mcg/dose, metered-dose nasal spray

As with any long-term treatment, patients using Mometasone Sandoz® Nasal Spray for several months or longer should be periodically examined by a doctor for possible changes in the nasal mucosa. It is necessary to monitor patients receiving intranasal corticosteroids for a long time.

Possible development of growth retardation in children. If growth retardation is detected in children, it is necessary to reduce the dose of intranasal corticosteroids to the lowest that allows for effective control of symptoms. In addition, the patient should be referred to a pediatrician for consultation.

If a local fungal infection of the nose or throat develops, it may be necessary to discontinue Mometasone Sandoz® nasal spray therapy and undergo special treatment. Irritation of the nasal and pharyngeal mucosa that persists for a long time may also serve as a reason to discontinue treatment with mometasone.

In placebo-controlled clinical trials in children, when a nasal spray containing mometasone was used at a daily dose of 100 mcg for a year, no growth retardation was observed in children. With long-term treatment with a nasal spray containing mometasone, no signs of suppression of the function of the hypothalamic-pituitary-adrenal axis were observed.

Patients who switch to treatment with Mometasone Sandoz® nasal spray after long-term treatment with systemic GCS require special attention. Withdrawal of systemic corticosteroids in such patients can lead to adrenal insufficiency, the subsequent recovery of which may take up to several months. If signs of adrenal insufficiency appear, systemic corticosteroids should be resumed and other necessary measures taken.

When using intranasal corticosteroids, systemic side effects may develop, especially with long-term use in high doses. The likelihood of developing these effects is much less than with the use of oral corticosteroids.

Systemic side effects may vary in individual patients and depending on the glucocorticosteroid drug used. Potential systemic effects include Cushing's syndrome, characteristic Cushingoid signs, adrenal suppression, growth retardation in children and adolescents, cataracts, glaucoma, and less commonly a number of psychological or behavioral effects including psychomotor hyperactivity, sleep disturbance, anxiety, depression, or aggression (especially in children).

During the transition from treatment with systemic corticosteroids to treatment with Mometasone Sandoz® nasal spray, some patients may experience initial withdrawal symptoms of systemic corticosteroids (for example, joint and/or muscle pain, fatigue and depression), despite a decrease in the severity of symptoms associated with damage to the nasal mucosa. Such patients must be specifically reassured of the advisability of continuing treatment with Mometasone Sandoz® nasal spray.

The transition from systemic to local GCS can also reveal allergic diseases such as allergic conjunctivitis and eczema that already existed but were masked by systemic GCS therapy.

Patients treated with glucocorticosteroids have a potentially reduced immune responsiveness and should be warned of their increased risk of infection if exposed to patients with certain infectious diseases (eg, chickenpox, measles), as well as the need for medical advice if such exposure occurs .

If signs of a significant bacterial infection appear (for example, fever, persistent or sharp pain on one side of the face or toothache, swelling in the orbital or periorbital area), immediate medical consultation is required.

When using a nasal spray containing mometasone, there are no signs of atrophy of the nasal mucosa for 12 months. In addition, mometasone furoate tends to help normalize the histological picture when examining biopsies of the nasal mucosa.

The effectiveness and safety of mometasone have not been studied in the treatment of unilateral polyps, polyps associated with cystic fibrosis, and polyps that completely occlude the nasal cavity. If unilateral polyps of an unusual or irregular shape are detected, especially those that are ulcerated or bleeding, additional medical examination is necessary.

The development of visual disturbances has been reported with the use of both systemic and local corticosteroids. If the patient experiences blurred vision or other visual disturbances, the patient should be referred to an ophthalmologist to determine possible causes, which may include the development of cataracts, glaucoma, or rarer diseases (eg, central serous chorioretinopathy) that have been reported with the use of systemic and topical corticosteroids .

Special precautions when disposing of unused medicinal product

The bottle must be discarded after the specified number of uses or 2 months from the date of first use.

Impact on the ability to drive vehicles and operate machinery

No studies have been conducted to study the effect of the drug on the ability to drive vehicles and operate machinery.

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.

Description of the drug APO-MOMETAZONE for intranasal use

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.

Mometasone Sandoz®

The transition from systemic to local GCS can also reveal allergic diseases such as allergic conjunctivitis and eczema that already existed but were masked by systemic GCS therapy.

Special precautions when disposing of unused medicinal product

The bottle must be discarded after the specified number of uses or 2 months from the date of first use.

On the role of mometasone furoate nasal spray in the treatment of chronic nasopharyngeal pathology in children

Currently, the main direction of drug treatment of rhinological pathology is anti-inflammatory therapy [1, 2]. Glucocorticosteroid drugs are known to have the most powerful anti-inflammatory effect. However, long-term courses of tablet and injectable forms of steroid drugs lead to the development of serious side effects and are not used in modern pediatric otorhinolaryngology. The use of topical (inhaled and intranasal) forms of steroid drugs can significantly reduce the risk of developing systemic side effects while maintaining the local anti-inflammatory effect. Modern intranasal glucocorticosteroids (InGCS) are a small and rather heterogeneous group of drugs for administration into the nasal cavity. Having similar pharmacodynamic properties, InGCS differ in some pharmacokinetic characteristics, primarily in terms of systemic bioavailability (according to the Instructions for the medical use of drugs) (Table 1).

Systemic bioavailability of InGCS is the amount of the main active substance that penetrates the systemic bloodstream, expressed as a percentage of the intranasally administered dose of the drug. The first topical InGCS based on beclomethasone, budesonide or triamcinolone, the bioavailability of which ranged from 34 to 44%, with long-term use often suppressed the function of the adrenal cortex, which in severe cases led to the development of symptoms of adrenal insufficiency [3]. In pediatric practice, it was also noted that long-term use of first-generation InGCS led to a slowdown in the growth of children. The high risk of side effects of nasal forms of beclomethasone and budesonide has limited the number of indications for their use. Today, these drugs are used in pediatric practice only in short courses in the complex therapy of allergic and vasomotor rhinitis [2].

New generation drugs InGCS, which include fluticasone propionate, fluticasone furoate and mometasone furoate, are practically free of the above-mentioned undesirable effects. The structure of the molecule of the active substance of these drugs ensures its limited bioavailability (from 2% for fluticasone propionate to ≤ 0.1% for mometasone furoate) and, therefore, a minimal frequency of systemic side effects. If there are appropriate indications, such drugs can be used for a long time. It should also be noted that the new generation of InGCS drugs, which have low systemic bioavailability, are characterized by high affinity for corticosteroid receptors, which determines their high clinical effectiveness [3]. However, sufficient experience with the use of fluticasone drugs has been accumulated only in the treatment of allergic rhinitis. At the same time, the effectiveness of mometasone furoate has been proven in the treatment and prevention of a significantly larger number of rhinological diseases of inflammatory nature in children and adults. Thus, in Russia, mometasone furoate (Nasonex) is the only nasal steroid that is registered for five indications: treatment (in children from 2 years of age) and prevention (in children from 12 years of age and adults) of allergic rhinitis, treatment of acute rhinosinusitis ( including as monotherapy for mild cases) and exacerbation of chronic rhinosinusitis (in children over 12 years of age and adults), as well as nasal polyposis (in patients over 18 years of age).

Clinical studies have been conducted, the results of which indicate the effectiveness of mometasone nasal spray in the treatment of concomitant pathology of the nasopharynx in children, in particular, hypertrophy of adenoid vegetations (hypertrophy of the pharyngeal tonsil, PH) and adenoiditis, although at the moment these conditions as separate nosological forms are not included in the list officially registered indications for the use of Nasonex. In the first randomized placebo-controlled study by Italian otorhinolaryngologists, intranasal use of mometasone furoate at a dosage of 100 mcg per day for 40 days in children with obstructive hypertrophy of adenoid vegetations led to a significant improvement in nasal breathing function in 77.7% of patients due to a decrease in the size of adenoid tissue, while in the control group (placebo), no positive dynamics were noted (mometasone group: n = 30, placebo group: n = 30) [4]. Analysis of the results of another randomized trial also showed a pronounced positive effect of using mometasone furoate nasal spray (100 mcg per day for 8 weeks) in the treatment of children with nasal obstruction caused by hypertrophy of adenoid vegetations. The results of these and a number of other studies of InGCS were included in the Cochrane review. Conclusion from the analysis: In children with moderate to severe HMG, the use of nasal steroids may be recommended as an alternative to surgery in cases where surgery is not urgent or is for some reason unavailable; at the same time, this area of application of InGCS requires further study [5].

A prospective observational study by Korean otolaryngologists of 41 children aged 2–11 years with sleep-disordered breathing (SDB) associated with hypertrophy of the adenoid vegetations was recently completed. The condition was assessed using the Obstructive Sleep Apnea Quality of Life Scale (OSA-18) and lateral neck radiography. Patients received mometasone furoate nasal spray at a dose of 100 mcg per day for 4 weeks. The study results demonstrated a significant clinical effect of mometasone furoate on sleep-disordered breathing, as assessed by both the OSA-18 scale and the adenoid-nasopharyngeal (AN) ratio on radiographs. It is noteworthy that the treatment was effective regardless of the presence of concomitant pathologies in children - sinusitis, allergic rhinitis and obesity [6].

The emerging data on the high risk of developing chronic purulent otitis media during tympanostomy [7] has led to great practical interest in the conservative treatment of exudative otitis media in children, which developed as a complication of chronic pathology of the nasopharynx. In a randomized study of Turkish otorhinolaryngologists, it was found that the use of mometasone furoate nasal spray (100 mcg per day for 6 weeks) significantly more often (42.2% of cases) led to the resolution of otitis media compared to the control group (without treatment) (14 .5%; p Taking into account the leading role of viral infection in the development of chronic pathology of the nasopharynx in children, the data of a laboratory study in which it was found that mometasone furoate reduces the expression of the ICAM-1 molecule, which ensures the adhesion of rhinoviruses to the epithelial cell, deserves attention, and also disrupts pretranscription mechanisms in the development cycle of a viral infection [9].These data suggest that the use of inhaled and nasal forms of mometasone furoate, contrary to previously formed opinion, does not suppress local immunity, increasing the risk of a cold or its complications, but, on the contrary, reduces the risk of developing patient with ARVI or their consequences.

Thus, we can conclude that the use of mometasone furoate nasal spray (Nasonex) both in complex treatment and as monotherapy (in uncomplicated cases) for chronic and acute pathology of the nasopharynx in children is effective, safe and, in most cases, allows avoid surgical interventions. In the modern concept of preserving the pharyngeal tonsil as an organ of regional mucosal immunity in preschool children, the possibility of using the nasal form of mometasone furoate is a key point [10]. Further studies of the clinical effectiveness of mometasone furoate nasal spray in the complex treatment of exudative otitis media in children are also of great interest.