Instructions Glenspray nasal spray dosed suspension 50 mcg/dose bottle of 60 doses with spray pump
Composition
active ingredient: mometasone furoate;
1 dose contains mometasone furoate monohydrate equivalent to mometasone furoate 50 mcg;
Excipients: microcrystalline cellulose and sodium carboxymethylcellulose; glycerin; citric acid monohydrate; sodium citrate; polysorbate 80; benzalkonium chloride; water for injections.
Dosage form
Nasal spray, metered dose; suspension.
Main physicochemical properties: white or almost white translucent viscous suspension.
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 with a pronounced anti-inflammatory effect. Corticosteroids demonstrate a wide range of effects on various cells, namely heparinocytes, eosinophils, neutrophils, macrophages, lymphocytes, as well as on inflammatory mediators (histamine, eicosanoids, leukotrienes and cytokines). The mechanism of anti-inflammatory and anti-allergic action of mometasone furoate is mainly associated with its ability to inhibit the release of mediators of allergic reactions.
Mometasone furoate significantly inhibits the release of leukotrienes from leukocytes in allergic patients. In cell culture studies, mometasone furoate demonstrated marked activity in inhibiting the synthesis and release of IL-1, IL-5, IL-6, and TNFα, and it also effectively inhibited leukotriene production. In addition, it is extremely active in inhibiting the synthesis of Th2 cytokines, IL-4, and IL-5 from human CD4+ T cells.
Studies have shown that mometasone furoate in the form of a nasal spray 50 mcg/dose when applied topically reduces the level of some mediators of the early and late phase of the allergic reaction, reduces (compared to placebo) the level of histamine and eosinophil cationic protein, and reduces (compared to baseline) the number of eosinophils, neutrophils, and epithelial cell adhesion proteins.
Pharmacokinetics.
The bioavailability of mometasone furoate when administered as a nasal spray is < 1% in plasma (the lower limit of quantification is 0.25 pg/mL based on data obtained using a sensitive quantitative method). Mometasone furoate suspension is 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 a limited extent, in the urine.
Indication
Treatment of seasonal or perennial allergic rhinitis in adults and children aged 2 years and over. Prophylactic treatment of moderate to severe allergic rhinitis is recommended to begin 4 weeks before the expected start of the pollen season.
As an adjunctive therapy in the antibiotic treatment of acute episodes of sinusitis in adults (including elderly patients) and children aged 12 years and older.
Treatment of symptoms of acute rhinosinusitis without evidence of severe bacterial infection in adults and children aged 12 years and older.
Treatment of nasal polyps and associated symptoms, including nasal congestion and loss of smell, in patients aged 18 years and older.
Contraindication
Hypersensitivity to mometasone furoate or to any other component of the drug.
Untreated local infection of the nasal mucosa.
Nasal trauma or recent nasal surgery.
Interaction with other medicinal products and other types of interactions
Mometasone furoate nasal spray was administered concomitantly with loratadine. No effect on plasma concentrations of loratadine or its major metabolite was observed, and mometasone furoate was not detected in plasma, even at low concentrations. The combination therapy was well tolerated by patients.
Data on interactions with other drugs are not presented.
Application features
The use of the drug in young children must be carried out with the help of adults.
The drug should not be used in the presence of untreated local infection involving the nasal mucosa.
After 12 months of treatment with mometasone furoate nasal spray, 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 and/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 treatment with the drug.
Although the drug controls nasal symptoms in most patients, concomitant use of appropriate adjunctive therapy may result in additional relief of other symptoms, particularly ocular symptoms.
No evidence of hypothalamic-pituitary-adrenal axis suppression has been observed with long-term treatment with mometasone furoate nasal spray. Patients transferred to nasal spray after long-term systemic corticosteroid therapy should be carefully monitored. Discontinuation of systemic corticosteroids in such patients may result in adrenal insufficiency, which may require resumption of systemic corticosteroid therapy and the use of other appropriate treatment.
When switching from systemic corticosteroid therapy to Glenspray, some patients may experience symptoms of corticosteroid withdrawal (e.g. joint and/or muscle pain, fatigue and depression) along with relief of nasal symptoms. Such patients should be specifically advised to continue treatment with the spray. Switching therapy may also reveal allergic diseases (e.g. allergic conjunctivitis, eczema, etc.) that have developed previously and were masked by systemic corticosteroid therapy.
Patients taking corticosteroids may potentially have reduced immune reactivity and should be warned about the increased risk of infection when in contact with patients with certain infectious diseases (such as chickenpox, measles), as well as the need to consult a doctor if such contact occurs.
The potential risk of Cushing's syndrome may occur with prolonged use of the drug at high doses.
Cases of nasal septal perforation or increased intraocular pressure have been reported very rarely following the use of intranasal corticosteroids.
In placebo-controlled clinical trials in children treated with mometasone furoate nasal spray at a daily dose of 100 mcg for 1 year, no growth retardation was observed.
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 pain or toothache, orbital or periorbital swelling/edema, or worsening of symptoms after initial improvement.
Use during pregnancy or breastfeeding
No special studies of the drug's effects have been conducted in pregnant women.
As with other intranasal corticosteroids, Glenspray should be used in pregnant and lactating women 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 monitored for possible adrenal hypofunction.
Ability to influence reaction speed when driving vehicles or other mechanisms
Unknown.
Method of administration and doses
The drug is intended for intranasal use only.
Treatment of seasonal or perennial allergic rhinitis: for adults (including elderly patients) 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.
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 cannot be obtained within the first 48 hours, so the patient needs to continue regular use to achieve the full therapeutic effect.
Adjunctive treatment of acute episodes of sinusitis. For adults (including the elderly) and children aged 12 years and over, the recommended therapeutic dose is 2 sprays (50 mcg) in each nostril 2 times a day (total daily dose – 400 mcg).
If relief of symptoms is not achieved by using the drug in the recommended therapeutic dose, the daily dose can be increased to 4 sprays in each nostril 2 times a day (total daily dose - 800 mcg). After relief of symptoms, it is recommended to reduce the dose.
Acute rhinosinusitis. The recommended therapeutic dose for adults and children aged 12 years and over is 2 sprays (50 mcg) in each nostril 2 times a day (total daily dose – 400 mcg).
Nasal polyps. For patients aged 18 years and over (including the elderly), the recommended dose is 2 sprays (50 mcg) in each nostril 2 times a day (total daily dose – 400 mcg). After achieving a clinical effect, it is recommended to reduce the dose to 2 sprays in each nostril 1 time a day (total daily dose – 200 mcg). If after 5-6 weeks of treatment with the recommended doses, a clinical effect is not observed, an alternative therapy should be chosen.
Using a nasal spray
Before each use, shake the bottle vigorously. Then remove the protective cap. Before using the bottle for the first time, it should be calibrated. Calibration is carried out by approximately 10 presses of the dosing device, while establishing a stereotypical delivery of the drug substance, in which each press releases approximately 100 mg of suspension containing 50 mcg of mometasone (one dose). If the nasal spray has not been used for 14 days or longer, before the next use, it is necessary to spray again by 2 presses until a full delivery is observed. Do not pierce the nozzle before starting use.
Before each use, the nose should be thoroughly cleaned of mucus. After cleaning the nose, the suspension is injected into each nostril, while the head should be kept slightly tilted downwards. After use, the spray tip should be wiped and covered with a protective cap.
Children
In placebo-controlled clinical trials in children treated with mometasone furoate nasal spray at a daily dose of 100 mcg for one year, no growth retardation was observed.
The safety and efficacy of the drug in the treatment of nasal polyps in children and adolescents (under 18 years of age), symptoms of rhinosinusitis in children under 12 years of age, and seasonal or perennial allergic rhinitis in children under 2 years of age have not been studied.
Overdose
Due to the fact that the systemic bioavailability of the drug is less than 1% (according to the results of a sensitive quantitative method, the lower limit of quantification is 0.25 pg/ml), it is unlikely that in case of overdose, other measures will be required, except for monitoring the patient's condition with subsequent use of the drug at the recommended dose.
Inhaled or oral administration of high doses of corticosteroids for a long time can lead to suppression of the function of the hypothalamic-pituitary-adrenal system.
Adverse reactions
In clinical trials in seasonal and perennial allergic rhinitis, the following adverse events were reported with mometasone furoate: headache, epistaxis (i.e., obvious bleeding, bloody mucus, or blood clots), pharyngitis, nasal burning, irritation, and ulceration of the nasal mucosa. These adverse events are typical of any nasal spray containing corticosteroids. Epistaxis was self-limiting and mild, occurring somewhat more frequently than with placebo, but less frequently than with other intranasal corticosteroids studied as active controls (some of which had an incidence of up to 15%). The incidence of other adverse events was comparable to that seen with placebo.
In children, the incidence of adverse events, including nosebleeds, headache, nasal irritation, and sneezing, was comparable to that with placebo.
Immediate allergic reactions (e.g. bronchospasm, dyspnoea) may occasionally occur after intranasal administration of mometasone furoate. Anaphylactic reactions and angioedema have been reported very rarely.
Isolated cases of taste and smell disorders have been reported.
When mometasone furoate was used as an adjunct in the treatment of acute sinusitis, the following adverse events were observed at a frequency comparable to placebo: headache, pharyngitis, nasal burning sensation, and nasal mucosa irritation. Epistaxis was mild and the frequency of occurrence was also comparable to placebo (5% and 4%, respectively).
Upper respiratory tract infections were reported in 1% of patients treated with the drug for nasal polyps, which was comparable to placebo.
Very rarely, cases of nasal septal perforation or increased intraocular pressure have been reported with intranasal use of corticosteroids.
Rare cases of glaucoma and/or cataracts have been reported with the use of intranasal corticosteroids.
Expiration date
2 years.
Storage conditions
Store in a dark place at a temperature not exceeding 30 °C. Do not freeze. Keep out of the reach of children.
Packaging
60 or 120 doses in a polyethylene bottle. 1 bottle with a dosing pump-sprayer, closed with a cap, in a cardboard box.
Vacation category
According to the recipe.
Producer
Glenmark Pharmaceuticals Ltd. / Glenmark Pharmaceuticals Ltd.
Location of the manufacturer and its business address
Unit III, Village Kishanpura, Baddi-Nalagarh Road, Tehsil Baddi, Distt. Solan (HP) 173 205, India.
