Mometasone Sandoz - Instructions For Use Of The Spray, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Mometasone Sandoz

Mometasone Sandoz: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. Drug interactions
12. 12. Analogs
13. 13. Terms and conditions of storage
14. 14. Terms of dispensing from pharmacies
15. 15. Reviews
16. 16. Price in pharmacies

Latin name: Mometasone Sandoz

ATX code: R01AD09

Active ingredient: mometasone (Mometasone)

Manufacturer: LEK d.d. (LEK dd) (Slovenia)

Description and photo update: 09.10.2019

Prices in pharmacies: from 264 rubles.

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Mometasone Sandoz is a glucocorticosteroid (GCS) for topical use.

Release form and composition

Dosage form - nasal spray: white homogeneous suspension [in a cardboard box 1, 2 or 3 vials made of high density polyethylene, equipped with a dosing device and a protective cap, each containing 10/17/18 g of suspension (60/120/140 doses, respectively), and instructions for the use of Mometasone Sandoz].

Composition of 1 spray dose:

• active substance: mometasone furoate monohydrate - 0.0517 mg (which is 0.05 mg in terms of the anhydrous substance);
• auxiliary components: benzalkonium chloride - 0.02 mg; polysorbate-80 - 0.01 mg; sodium citrate dihydrate - 0.28 mg; citric acid monohydrate - 0.2 mg; glycerin - 2.1 mg; sodium carmellose (Avicel RC-591 - a mixture of microcrystalline cellulose and sodium carmellose, 89 and 11%, respectively) and microcrystalline cellulose - 2 mg; water for injection - up to 100 mg.

Pharmacological properties

Pharmacodynamics

Mometasone belongs to the group of synthetic corticosteroids used topically. It has anti-inflammatory and anti-allergic properties.

Mometasone Sandoz has a local anti-inflammatory effect at doses that do not cause systemic effects.

The pharmacological actions of Mometasone Sandoz also include:

• inhibition of the release of inflammatory mediators;
• increased production of lipomodulin (phospholipase A inhibitor), which helps to reduce the release of arachidonic acid and the formation of prostaglandins (its active metabolites). Together with a decrease in the release of inflammatory mediators from mast cells, this leads to inhibition of the onset of immediate allergic reactions;
• prevention of marginal accumulation of neutrophils, which helps to reduce the migration of macrophages, the production of lymphokines, inflammatory exudate, the severity of the processes of granulation and infiltration;
• reduction of late symptoms of allergic reactions by reducing the formation of chemotaxis substance.

Studies carried out using provocative texts, during which antigens were applied to the nasal mucosa, revealed a high anti-inflammatory activity of mometasone both in the early and late stages of an allergic reaction. Compared with the placebo group, there was a decrease in the concentration of histamine, the activity of eosinophils, neutrophils, and epithelial cell adhesion proteins.

Pharmacokinetics

The systemic bioavailability of mometasone furoate with intranasal use is less than 1% (the sensitivity of the determination method is 0.25 pg per 1 ml). In the gastrointestinal tract, the substance is very poorly absorbed. That small amount of suspension, which, after being injected into the nasal passage, can enter the gastrointestinal tract, undergoes active primary metabolism even before excretion with bile or urine.

Indications for use

• perennial / seasonal allergic rhinitis (in children over 2 years of age, adolescents and adults);
• acute sinusitis or exacerbation of chronic sinusitis - in addition to antibiotic therapy as an adjuvant drug (in adolescents from 12 years of age and adults, including elderly patients);
• acute rhinosinusitis with mild / moderate manifestations without symptoms of severe bacterial infection (in adolescents over 12 years of age and adults);
• prevention of moderate / severe seasonal allergic rhinitis 14–28 days before the expected start of the dusting season (in adolescents over 12 years of age and adults);
• nasal polyposis, against the background of which there is a violation of the sense of smell and nasal breathing (in adults from 18 years old).

Contraindications

Absolute:

• recent surgery or nasal injury, in which there is damage to the nasal mucosa (until the wound heals, since corticosteroids have an inhibitory effect on regeneration processes);
• children's age: nasal polyposis - under 18 years old; acute or exacerbation of chronic sinusitis - under 12 years of age; seasonal / perennial allergic rhinitis - under 2 years of age;
• individual intolerance to the components of the drug.

Relative (Mometasone Sandoz is prescribed under medical supervision):

• latent or active tuberculosis infection of the respiratory tract;
• an untreated bacterial, fungal, systemic viral infection, or an infection caused by herpes simplex or eye damage;
• untreated local infection in which the nasal mucosa is involved in the pathological process;
• pregnancy and lactation.

Mometasone Sandoz, instructions for use: method and dosage

Spray Mometasone Sandoz is used intranasally - injected into the nasal cavity from a bottle through a special dosing device. Do not pierce the nasal applicator.

Before using Mometasone Sandoz for the first time, it is recommended to perform approximately 10 calibration strokes on the dosing device (until a consistent-looking suspension is delivered). After that, a stereotyped spray delivery will be established, during which, when the dispenser is pressed, 100 mg of the drug is ejected (corresponding to 50 μg of mometasone).

In cases where the drug is not used for 14 days or more, before injection into the nasal passage, recalibration is carried out by two calibration clicks.

The suspension bottle should be shaken vigorously before each use. When using, it is necessary to tilt the head and inject the spray into each nasal passage in accordance with the recommendations given by the attending physician.

For the treatment of seasonal and year-round allergic rhinitis, adolescents over 12 years of age and adults, including elderly patients, are prescribed 2 injections into each nasal passage (prophylactic and therapeutic dose) once a day. The total daily dose of mometasone is 200 mcg. As a maintenance treatment, after achieving a therapeutic effect, the dose can be reduced to 1 injection in each nasal passage once a day (the total daily dose of mometasone is 100 μg).

If the use of Mometasone Sandoz in the recommended therapeutic dose does not lead to a decrease in the manifestations of pathology, it is allowed to increase the daily dose to 4 injections in each nasal passage once a day (the total daily dose rises to 400 mcg). As soon as the signs of the disease have subsided, it is recommended to lower the dose of the suspension.

Usually, the onset of action of Mometasone Sandoz is noted clinically 12 hours after the first administration of the spray.

For children aged 2 years and older, for the treatment of year-round / seasonal allergic rhinitis, Mometasone Sandoz is prescribed in a therapeutic dose - 1 injection into each nasal passage once a day (the total daily dose of mometasone is 100 mcg). Young children need adult help when using the spray.

If the use of the drug in the recommended therapeutic dose does not lead to a decrease in the manifestations of pathology, an increase in the daily dose up to 4 injections into each nasal passage 2 times a day is allowed (the total dose is increased to 800 mcg per day). As soon as the symptoms of the disease decrease, the dose of Mometasone Sandoz is reduced.

The recommended daily dose for adolescents and adults in the treatment of acute rhinosinusitis, not accompanied by symptoms of a severe bacterial infection, is 2 injections into each nasal passage 2 times a day (the total dose of mometasone is 400 mcg per day). If, against the background of the use of Mometasone Sandoz, there is a worsening of the manifestations of the disease, you should consult a doctor for advice.

For the treatment of nasal polyposis, adult patients, including elderly patients, use 2 injections of the suspension in each nasal passage 2 times a day. The total daily dose of Mometasone Sandoz is 400 mcg. As soon as the manifestations of the pathology begin to decrease, the dose is reduced to 2 injections into each nasal passage once a day. The total daily dose is correspondingly reduced to 200 mcg.

Side effects

The nosebleeds that occur during therapy with the drug were usually moderate and stopped on their own. The frequency of their occurrence in comparison with the placebo group was slightly higher, however, equal or less than when using other intranasal GCS, which were used for active control (in some cases, the incidence of nosebleeds reached 15%).

The incidence of all other side effects was comparable to that in the placebo group.

The overall incidence of adverse events in patients who received therapy for nasal polyposis was comparable to that in patients with allergic rhinitis.

In the group of patients taking mometasone furoate for the treatment of acute rhinosinusitis, the overall incidence of side effects was comparable to that of allergic rhinitis and placebo.

The use of intranasal corticosteroids can lead to systemic side effects, especially if they are received for a long time and in high doses.

Possible adverse reactions [> 10% - very common; (> 1% and 0.1% and 0.01% and <0.1%) - rarely; (<0.01%, including isolated messages) - very rare; frequency unknown - according to the available data, it was not possible to establish the frequency of occurrence]:

• parasitic and infectious pathologies: often - pharyngitis, upper respiratory tract infections;
• immune system: frequency unknown - hypersensitivity reactions, including shortness of breath, bronchospasm, angioedema, anaphylactic reactions;
• nervous system: often - headache;
• organ of vision: frequency unknown - central serous chorioretinopathy, blurred vision, cataract, glaucoma, increased intraocular pressure;
• respiratory system, chest and mediastinal organs: very often - nosebleeds; often - ulceration / irritation of the nasal mucosa, burning sensation in the nose, nosebleeds (obvious bleeding and the release of blood clots or mucus stained with blood);
• gastrointestinal tract: often - throat irritation (sensation of irritation of the pharyngeal mucosa); frequency unknown - taste disturbance.

Side effects that have been reported with the use of mometasone furoate in children include:

• nervous system: headache (3%);
• respiratory system, chest and mediastinal organs: sneezing (2%), irritation of the nasal mucosa (2%), nosebleeds (6%).

The incidence of these events in children was comparable to that in the placebo group.

Overdose

The main symptoms: prolonged use of high-dose GCS or the combined use of several GCS can lead to inhibition of the hypothalamic-pituitary-adrenal system.

Therapy: since mometasone furoate has a low systemic bioavailability (less than 1%), it is unlikely that there is a need to take any special measures in case of an overdose, other than medical supervision and subsequent use of Mometasone Sandoz according to the recommended dosing regimen.

special instructions

As with any long-term therapy, patients receiving Mometasone Sandoz for several months or more are advised to periodically undergo a doctor's examination in order to identify possible changes in the nasal mucosa. For patients who receive intranasal corticosteroids for a long time, constant medical supervision should be established.

Growth retardation is possible in children during therapy. If it is detected, the dose of intranasal corticosteroids is reduced to the lowest, at which the symptoms of the underlying disease are effectively stopped, and the patient is referred to the pediatrician for consultation.

With the development of a local fungal infection of the pharynx or nose, it may be necessary to cancel Mometasone Sandoz and conduct special therapy. Persistent irritation of the nasal mucosa and pharynx may also serve as a basis for discontinuation of the drug.

In children who participated in placebo-controlled clinical studies, during which they received a nasal spray containing mometasone at a daily dose of 100 μg for 12 months, there was no growth retardation. Long-term therapy with mometasone for intranasal use did not lead to suppression of the function of the hypothalamic-pituitary-adrenal system.

Patients who switch from long-term therapy with systemic GCS to treatment with Mometasone Sandoz require special attention. Cancellation of systemic GCS in such cases can cause adrenal insufficiency, which may take up to several months to recover. When symptoms of adrenal insufficiency appear, they resume taking systemic corticosteroids and take other necessary measures.

When treating with intranasal corticosteroids, systemic side effects may develop, especially against the background of prolonged use of such drugs in high doses. The risk of these effects is significantly less than when taking oral corticosteroids.

Systemic adverse events may differ both in individual patients and depending on the prescribed GCS. Potential systemic effects include:

• suppression of adrenal function;
• Cushing's syndrome;
• characteristic manifestations of a kushingoid;
• glaucoma;
• cataract;
• growth retardation in children and adolescents;
• psychological or behavioral effects, including sleep disturbance, depression, anxiety, psychomotor hyperactivity and aggression, especially in children.

In some patients, when switching from therapy with systemic corticosteroids to treatment with Mometasone Sandoz, there may be initial signs of cancellation of systemic corticosteroids (for example, depression, fatigue, muscle and / or joint pain) despite a decrease in the severity of symptoms associated with damage to the mucous membrane nose. It is recommended that such patients be convinced of the advisability of continuing to use the drug.

When switching from systemic corticosteroids to local ones, allergic pathologies, such as eczema and allergic conjunctivitis, which already exist, but masked by the treatment of corticosteroids of systemic action, can also be found.

Patients receiving corticosteroids have a potentially decreased immune reactivity. They should be warned about their increased likelihood of infection through contact with patients who have some infectious diseases (for example, measles, chickenpox). They should also be aware of the need to seek medical advice if such contact took place.

If symptoms of a severe bacterial infection appear (for example, swelling in the periorbital or orbital region, persistent or sharp pain on one side of the face, toothache, fever), it is important to consult a doctor immediately for advice.

Patients who have used the nasal spray for 12 months do not experience symptoms of atrophy of the nasal mucosa. When conducting a study of biopsies of the nasal mucosa, a tendency of mometasone furoate to contribute to the normalization of the histological picture can be detected.

The safety and efficacy of using Mometasone Sandoz for polyps that completely cover the nasal cavity, polyps associated with cystic fibrosis or unilateral polyps have not been established. If unilateral polyps of irregular or unusual shape are detected, especially bleeding or ulcerated polyps, additional medical examination should be carried out.

Violations of the organ of vision were detected both with the use of systemic and local GCS. If visual impairment occurs, including blurred vision, the patient should be referred to an ophthalmologist to establish potential causes, which may include the development of glaucoma, cataracts, or more rare pathologies (for example, central serous chorioretinopathy), which have been reported with the use of such drugs.

The vial with the drug is disposed of after the specified number of uses or after 2 months have passed since the first use.

Application during pregnancy and lactation

Mometasone Sandoz, like other intranasal corticosteroids, during pregnancy / lactation can be used with caution only in cases where the predicted benefit to the mother outweighs the possible risks to the fetus or child.

Well-designed and well-controlled studies of the use of mometasone during pregnancy have not been conducted.

For infants whose mothers received GCS therapy during pregnancy, careful observation should be established in order to identify the possible development of hypofunction of the adrenal cortex.

Pediatric use

Nasal spray Mometasone Sandoz is not prescribed for patients under the age of 18 for the treatment of nasal polyposis, under 12 years for the treatment of acute or exacerbation of chronic sinusitis, under 2 years for seasonal / perennial allergic rhinitis.

Drug interactions

The combined use of mometasone furoate with loratadine was well tolerated by patients. At the same time, no effect of the substance on the content of loratadine or its main metabolite in the blood plasma was detected. In the studies conducted, the drug was not detected in blood plasma (the sensitivity of the determination method was 50 pg per 1 ml).

The combined use of the drug with inhibitors of the CYP3A isoenzyme, including with cobicistat-containing drugs, may increase the likelihood of its systemic effects. It is recommended to avoid such combinations in cases where the expected benefits of therapy do not outweigh the possible risks. When prescribing a combination of these drugs, it is important to carefully monitor the occurrence of systemic effects of GCS.

Analogs

The analogues of Mometasone Sandoz are Nazonex, Elokom, Monovo, Nosefrin, Mometason-Akrikhin, Dezrinit, Momenza, Momat Rino, Gistan-N, Momezal Allergo, Asmanex Twistheiler, Mometasone, Momat, Avecort, Momederm.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 25 ° C. Keep out of the reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Mometasone Sandoz

According to reviews, Mometasone Sandoz is an affordable, safe and effective drug used in the treatment of rhinitis, allergies and adenoiditis in children and adults.

Price for Mometasone Sandoz in pharmacies

The approximate price for Mometasone Sandoz is: 1 bottle with 60 doses (10 g of suspension) in the package - from 274 to 313 rubles; in the package 1 bottle with 140 doses (18 g of suspension) - from 352 to 399 rubles.

Mometasone Sandoz: prices in online pharmacies

Drug name Price Pharmacy

Mometasone Sandoz nasal spray. 50mcg / dose vial 10g 60 doses 264 r Buy

Mometasone Sandoz 50 mcg / dose 60 doses nasal spray dosed 10 g 1 pc. 264 r Buy

Mometasone Sandoz 50 μg / dose 140 doses nasal spray dosed 18 g 1 pc. 276 r Buy

Mometasone Sandoz nasal spray. 50mcg / dose vial 18g 140 doses RUB 300 Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!