Instructions Mometasone-Teva nasal spray suspension 50 mcg/dose bottle 60 doses
Composition
active ingredient: mometasone furoate;
1 metered dose (0.1 ml) contains mometasone furoate monohydrate (as mometasone furoate) 50 mcg;
Excipients: microcrystalline cellulose and carmellose sodium, glycerin, benzalkonium chloride solution, polysorbate 80, citric acid monohydrate, sodium citrate dihydrate, water for injections.
Dosage form
Nasal spray, suspension.
Main physicochemical properties: milky-white suspension without agglomerates.
Pharmacotherapeutic group
Anti-edematous and other drugs for local use in diseases of the nasal cavity. Corticosteroids. ATX code R01A D09.
Pharmacological properties
Pharmacodynamics
Mometasone furoate is a synthetic corticosteroid for topical use that has a pronounced anti-inflammatory effect. The local anti-inflammatory effect of mometasone furoate is manifested in doses at which systemic effects do not occur.
The mechanism of anti-inflammatory and antiallergic action of mometasone furoate is mainly related to its ability to inhibit 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 demonstrated 10-fold greater activity 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-fold more active than beclomethasone dipropionate and betamethasone in inhibiting the production of IL-5.
In nasal challenge studies, mometasone furoate demonstrated high anti-inflammatory activity in both the early and late stages of allergic reactions, as evidenced by a reduction (compared to placebo) in histamine and eosinophil activity, as well as a reduction (compared to baseline) in eosinophils, neutrophils, and epithelial cell adhesion proteins.
A significant clinical effect within the first 12 hours of using mometasone furoate spray was achieved in 28% of patients with seasonal allergic rhinitis. On average (50%) relief occurred within 35.9 hours. In addition, mometasone furoate showed significant efficacy in reducing ocular symptoms (redness, tearing, itching) in patients with seasonal allergic rhinitis.
Mometasone furoate was reported to demonstrate significant clinical efficacy in relieving nasal congestion, reducing polyp size, and restoring smell in patients with nasal polyps compared to placebo.
Pharmacokinetics
The bioavailability of mometasone furoate when administered as a nasal spray is < 1% in plasma (based on data obtained using a sensitive method with a lower limit of quantification of 0.25 pg/mL). Mometasone furoate suspension is very poorly absorbed from the gastrointestinal tract, and the small amount that can be swallowed and absorbed undergoes extensive first-pass metabolism before being excreted primarily as metabolites in the bile and, to some extent, in the urine.
Indication
Treatment of seasonal or perennial allergic rhinitis in adults and children aged 3 years and over. Prophylactic treatment of moderate to severe allergic rhinitis is recommended to be started 4 weeks before the expected start of the pollen season. Treatment of nasal polyps and associated symptoms, including nasal congestion and loss of smell, in patients aged 18 years and over.
Contraindication
Hypersensitivity to the active substance or to any auxiliary component of the medicinal product.
The drug should not be used in the presence of untreated localized infection involving the nasal mucosa, such as herpes simplex.
Because of the ability of corticosteroids to inhibit wound healing, nasal corticosteroids should not be used until healing has occurred in patients who have recently had nasal surgery or trauma.
Interaction with other medicinal products and other types of interactions
In a clinical drug interaction study with loratadine, no interaction was found.
Concomitant therapy with CYP3A inhibitors, particularly those containing cobicistat, is expected to increase the risk of systemic adverse reactions. This combination should be avoided unless the expected benefit outweighs the increased risk of systemic corticosteroid adverse reactions. In such cases, patients should be monitored for systemic corticosteroid adverse reactions.
Application features
The use of the drug in young children must be carried out with the help of adults.
The drug Mometasone-Teva should be used with caution or not used at all in patients with active or latent tuberculosis infection of the respiratory tract, as well as in untreated fungal, bacterial, systemic viral infections.
Patients taking corticosteroids may potentially be immunosuppressed and should be warned of the increased risk of infection from contact with patients with certain infectious diseases (such as chickenpox, measles), and of the need to consult a doctor if such contact occurs.
Local effects
After 12 months of treatment with mometasone furoate in patients with perennial allergic rhinitis, there was no evidence of atrophy of the nasal mucosa; in addition, mometasone furoate contributed to the normalization of the histological picture of the nasal mucosa. As with any long-term treatment, patients using the drug for several months or more should be periodically examined for possible changes in the nasal mucosa. In the event of the development of a local fungal infection of the nose or pharynx, it may be necessary to discontinue therapy with the drug or to conduct appropriate treatment. Irritation of the nasal mucosa and pharynx that persists for a long time may also be an indication for discontinuation of the drug.
The use of mometasone furoate is not recommended in case of nasal septal perforation.
In clinical trials, the incidence of epistaxis was higher compared to placebo. Epistaxis was generally mild and self-limiting.
Systemic effects of corticosteroids
Systemic effects of nasal corticosteroids may occur, particularly at high doses intended for prolonged use. These effects occur much less frequently than with oral corticosteroids and may vary from patient to patient and between corticosteroid agents. Potential systemic effects may include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataracts, glaucoma, and, less commonly, a range of psychological or behavioral effects, including psychomotor hyperactivity, sleep disorders, anxiety, depression, or aggression (particularly in children).
Cases of increased intraocular pressure have been reported following the use of nasal corticosteroids.
Patients who are transferred to nasal spray therapy after long-term systemic corticosteroid therapy should be carefully observed. Discontinuation of systemic corticosteroids in these patients may result in adrenal insufficiency. If these patients exhibit signs and symptoms of adrenal insufficiency or withdrawal syndrome (e.g., joint and/or muscle pain, fatigue, and depression) despite resolution of nasal symptoms, systemic corticosteroids should be resumed in conjunction with other treatments and appropriate measures should be taken. Pre-existing allergic conditions, such as allergic conjunctivitis and eczema, which were previously controlled by systemic corticosteroid therapy, may also be re-exposed during this transfer. Such patients should be specifically advised to continue treatment with the spray.
With prolonged use of mometasone furoate, no signs of suppression of the function of the hypothalamic-pituitary-adrenal system were observed.
Use of doses higher than recommended may result in clinically significant adrenal suppression. If there is evidence of use of doses higher than recommended, the use of additional systemic corticosteroid should be considered during periods of stress or elective surgery.
Nasal polyps
The safety and effectiveness of mometasone furoate nasal spray for the treatment of unilateral polyps, polyps associated with cystic fibrosis, or polyps that completely cover the nasal cavity have not been studied.
For unilateral polyps that are atypical, especially with ulceration and bleeding, additional examination is necessary.
Vision impairment
Visual disturbances may occur with the use of systemic and topical corticosteroids. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be referred to an ophthalmologist for evaluation of possible causes, which may include cataracts, glaucoma, or rare conditions such as central serous chorioretinopathy, which have been reported following the use of systemic and topical corticosteroids.
Impact on growth in children
It is recommended that children receiving long-term treatment with nasal corticosteroids have their height measured regularly. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid, if possible, to the lowest dose at which effective control of symptoms is maintained. In addition, the patient should be referred to a pediatrician. No growth retardation has been reported in children receiving mometasone furoate at a daily dose of 100 mcg for 1 year.
Non-nasal symptoms
Patients should be advised to seek immediate medical attention if they develop signs or symptoms of a serious bacterial infection, such as fever, severe unilateral facial or dental pain, orbital or periorbital swelling/edema, or worsening of symptoms after initial improvement.
Mometasone furoate contains benzalkonium chloride as a preservative, which may cause nasal irritation. With prolonged use, benzalkonium chloride may cause swelling of the nasal mucosa. In the event of such a reaction (persistent nasal congestion), preservative-free nasal preparations should be used whenever possible; however, if such preparations are not available, another dosage form should be chosen.
Ability to influence reaction speed when driving vehicles or other mechanisms
Unknown.
Use during pregnancy or breastfeeding
Pregnancy. There are limited or no data on the effects of mometasone furoate when used during pregnancy. Animal studies have shown reproductive toxicity. Clinical studies in pregnant women have not been conducted. As with other nasal corticosteroids, Mometasone Furoate should be used in pregnancy only if the potential benefit justifies the potential risk to the mother, fetus, or infant. Infants whose mothers have used corticosteroids during pregnancy should be carefully observed for possible adrenal hypofunction.
Breastfeeding. It is not known whether mometasone furoate is excreted in human milk. As with other nasal corticosteroids, a decision must be made whether to discontinue breast-feeding or to discontinue/abstain from mometasone furoate nasal spray therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Reproductive function: There are no clinical data on the effect of mometasone furoate on fertility. Animal studies have shown reproductive toxicity, but no effect on fertility.
Method of administration and doses
Before using the first dose, shake the bottle well and press the spray pump ten times (until a uniform spray is obtained). If the spray pump has not been used for 14 days or more, the spray pump must be re-primed by pressing it twice until a uniform spray is obtained. Shake the bottle well before each use. After using the number of doses indicated on the label, or 2 months after first use, the bottle should be discarded.
After priming the Mometasone-Teva spray pump, each injection delivers approximately 100 mg of mometasone furoate suspension, containing the equivalent of mometasone furoate monohydrate – 50 mcg of mometasone furoate into each nostril.
Treatment of seasonal or perennial allergic rhinitis: for adults (including the elderly) and children over 12 years of age, the recommended prophylactic and therapeutic dose of the drug is 2 injections (50 mcg each) into each nostril once a day (total daily dose - 200 mcg). After achieving a therapeutic effect, for maintenance therapy, it is advisable to reduce the dose to 1 injection into each nostril once a day (total daily dose - 100 mcg).
If the symptoms of the disease cannot be alleviated by using the drug in the recommended therapeutic dose, the daily dose can be increased to the maximum: 4 sprays into each nostril once a day (total daily dose - 400 mcg). After the symptoms of the disease have subsided, it is recommended to reduce the dose.
For children aged 3–11 years, the recommended therapeutic dose is 1 spray (50 mcg) in each nostril once daily (total daily dose – 100 mcg).
Treatment with mometasone furoate nasal spray in patients with a history of moderate to severe symptoms of seasonal allergic rhinitis can be initiated a few days before the expected start of the flowering season.
The drug has demonstrated a clinically significant onset of action within 12 hours of the first application in some patients with seasonal allergic rhinitis. However, the full benefit of treatment may not be obtained within the first 48 hours, so the patient needs to continue regular use to achieve the full therapeutic effect.
Nasal polyps: For adults (including the elderly), the recommended dose is 2 sprays (50 mcg) in each nostril once daily (total daily dose 200 mcg). If symptomatic relief is not achieved after 5-6 weeks of treatment, the daily dose may be increased to 2 sprays in each nostril twice daily (total daily dose 400 mcg). After achieving clinical benefit, it is recommended to reduce the dose to 2 sprays in each nostril once daily (total daily dose 200 mcg). If symptomatic relief is not achieved after 5-6 weeks of treatment with twice daily, alternative treatments should be considered.
The study of the efficacy and safety of mometasone furoate nasal spray for the treatment of nasal polyposis lasted four months.
Children
Seasonal or perennial allergic rhinitis
Nasal polyps
The safety and efficacy of Mometasone-Teva in children under 18 years of age have not been studied.
Overdose
Due to the low systemic bioavailability of the drug (< 1%), it is unlikely that any measures other than monitoring the patient's condition with continued use of the drug at the recommended dose will be required in case of overdose.
Inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of the function of the hypothalamic-pituitary-adrenal axis.
Adverse reactions
In clinical trials of allergic rhinitis, epistaxis was generally self-limiting, mild, and occurred somewhat more frequently than with placebo (5%), but was comparable to or less frequently than with other nasal corticosteroids studied and used as active controls (up to 15%). The incidence of other adverse reactions was comparable to that of placebo. In patients with nasal polyps, the overall incidence of adverse reactions was similar to that observed in patients with allergic rhinitis.
Systemic effects of nasal corticosteroids are more likely to occur when used in high doses and for prolonged periods.
The following adverse reactions (≥ 1%) observed during clinical trials in patients with allergic rhinitis or nasal polyposis and during post-marketing use are listed.
Adverse reactions are classified by system organ class and frequency. The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100). The frequency of adverse reactions in post-marketing studies was considered “not known” (cannot be estimated from the available data).
Infections and infestations: Common: pharyngitis, upper respiratory tract infection2.
Immune system disorders Not known: hypersensitivity, including anaphylactic reactions, angioedema, bronchospasm and dyspnoea.
Nervous system disorders: Common: headache.
On the part of the organs of vision. Not known: glaucoma, increased intraocular pressure, cataract, blurred vision.
Respiratory, thoracic and mediastinal disorders Very common: epistaxis1 Common: epistaxis, burning sensation of the nasal mucosa, irritation of the nasal mucosa, ulceration of the nasal mucosa Not known: perforation of the nasal septum.
Gastrointestinal disorders: Common: throat irritation1. Not known: taste and smell disorders.
¹ Observed when used twice daily for the treatment of nasal polyposis.
² Reported uncommonly when used twice daily for the treatment of nasal polyposis.
Children
In children, the incidence of adverse reactions reported during clinical trials, such as nosebleeds (6%), headache (3%), nasal irritation (2%), and sneezing (2%), was comparable to that seen with placebo.
Expiration date
2 years.
From the moment of first use – 8 weeks.
Storage conditions
Store at a temperature not exceeding 25 °C. Keep out of the reach of children. Do not freeze.
Packaging
10 g (60 doses) in a high-density polyethylene bottle with a polypropylene metering spray pump and a sprayer closed with a polypropylene cap. 1 bottle in a cardboard box.
Vacation category
According to the recipe.
Producer
Teva Czech Industries s.r.o.
Location of the manufacturer and its business address
Ostravska Street 305/29, Komarov, 747 70 Opava, Czech Republic.
