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Composition:


active ingredients: mometasone furoate and azelastine hydrochloride;


1 dose contains mometasone furoate 50 mcg and azelastine hydrochloride 140 MCG;


excipients: microcrystalline cellulose and sodium carboxymethylcellulose; sodium carmelose; anhydrous glucose; polysorbate 80; benzalkonium chloride; disodium edetate; neotam; citric acid, monohydrate; sodium citrate; water for injection.


Dosage form. Nasal spray, dosed, suspension.


Basic physical and chemical properties: white or almost white suspension.


Pharmacotherapeutic group.


Decongestants and other topical medications for diseases of the nasal cavity. Corticosteroids. ATX code R01A D.

Clinical characteristics.


Indications.


Seasonal allergic rhinitis.


Year-round allergic rhinitis.


Contraindications.


Hypersensitivity to azelastine hydrochloride, mometasone furoate or other components of the drug.


Untreated local infection of the nasal mucosa.


A nose injury or a recent nose operation.


Interactions with other drugs and other types of interactions.


Special Studies of the drug interaction of a combination in fixed doses of azelastine hydrochloride and mometasone furoate in the form of a nasal spray have not been conducted. Below are data on individual components that make up the drug. Since mometasone and azelastine affect different types of receptors, drug interaction with this combination is not expected.


Azelastine hydrochloride


Central nervous system depressants


Concomitant use of azelastine with alcohol or other central nervous system depressants may reduce concentration and worsen central nervous system functions.


Erythromycin and ketoconazole


ECG evaluation of patients who simultaneously administered oral azelastine hydrochloride and erythromycin or ketoconazole shows that there is no clinically significant effect on the QT interval (or QTc value). Oral administration of erythromycin at a dose of 500 mg 3 times a day for 7 days did not affect the pharmacokinetics of azelastine and the value of QTc. Ketoconazole, when administered at a dose of 200 mg 2 times a day for 7 days, prevented the measurement of plasma concentrations of azelastine by analytical high-performance liquid chromatography (HPLC); however, no effect on the QTc value was observed.


Cimetidine


Cimetidine at a dose of 400 mg twice daily when co-administered orally with azelastine hydrochloride at a dose of 4 mg twice daily increases the average Cmax and AUC of the latter by approximately 65 %.


Mometasone furoate


Cytochrome P450 3A4 inhibitors


Ketoconazole


Mometasone furoate is mainly metabolized in the liver. In vitro studies have confirmed the primary role of cytochrome CYP3A4 in the metabolism of this compound. Concomitant use with ketoconazole, a potent CYP3A4 inhibitor, may increase plasma concentrations of mometasone furoate.


Ritonavir


Ritonavir as a protease inhibitor can inhibit the metabolism of mometasone furoate when used concomitantly, which leads to an increase in the systemic effect of the latter and an increased risk of side effects.


Loratadine


Clinical drug interaction studies have been conducted with loratadine. No interaction was observed.


Application features.


Azelastine hydrochloride


In clinical trials, drowsiness has been reported in some patients treated with azelastine hydrochloride as a nasal spray. During treatment with the drug, patients should refrain from work that requires increased concentration of attention and speed of reactions.


Concomitant use of azelastine nasal spray with alcohol or other central nervous system depressants should be avoided due to possible suppression of central nervous system functions.


Mometasone furoate


Local effect on the nose


Nosebleeds


In clinical trials, nosebleeds were more common in patients with allergic rhinitis treated with mometasone furoate as a nasal spray than in those treated with placebo.


Fungal infection


In clinical studies of mometasone furoate in the form of a nasal spray of 50 mcg/dose, in some cases, the development of localized fungal infection of the nose and pharynx (Candida albicans) was observed. In case of fungal infection, the drug should be discontinued and appropriate treatment should be initiated.


Perforation of the nasal septum


Isolated cases of nasal septal perforation have been reported after the use of intranasal corticosteroids. As with any long-term treatment, patients who use mometasone furoate nasal spray for several months or longer should be periodically examined for possible changes in the nasal mucosa.


Deterioration of wound healing


Due to the inhibitory effect of corticosteroids on wound healing, patients who have recently had nasal septal ulcers, nasal surgery, or a nasal injury should not use nasal corticosteroids until they have fully recovered.


Visual impairment


When using systemic and local corticosteroids (including intranasal, inhaled and intraocular administration), visual disturbances may occur. If symptoms such as blurred vision or other visual impairments occur, the patient should be examined by an ophthalmologist to assess possible causes of visual impairment, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy, which have been reported after the use of systemic and topical corticosteroids.


Hypersensitivity reactions


Hypersensitivity reactions, including cases of wheezing, may occur after intranasal administration of mometasone furoate. In this case, therapy with the drug should be discontinued.


Immunosuppression


Patients treated with drugs that suppress the immune system are more susceptible to infections than healthy people. For example, chickenpox and measles are more severe in children and adults with reduced immunity who use corticosteroids. Such patients require special attention and the use of antiviral drugs or vaccination. The effect of the dose, method, and duration of corticosteroid use on the risk of generalized infection is still unknown.


Mometasone furoate nasal spray should be used with caution or not at all in patients with active or latent tuberculosis infection of the respiratory tract, as well as with untreated fungal, bacterial, systemic viral infection or herpes simplex infection with eye damage.


Effect on the hypothalamic-pituitary-adrenal system


Hyperadrenocorticism and adrenal suppression


With prolonged use of intranasal corticosteroids, especially in high doses, systemic effects such as hyperadrenocorticism and adrenal suppression may occur. It is important that when the therapeutic effect is achieved, the dose of intranasal corticosteroids is reduced to the minimum effective dose that controls the course of the disease in order to avoid the development of systemic side effects.


If there are signs of undesirable systemic effects, treatment with mometasone furoate nasal spray should be gradually discontinued.


Influence on growth dynamics in children


Corticosteroids can lead to growth retardation in children. It is recommended to regularly monitor the growth dynamics of children who are treated with intranasal corticosteroids for a long time.


Glenspray active contains benzalkonium chloride, which can cause irritation of the nasal mucosa and bronchospasm.


It should be remembered that corticosteroids have a particularly powerful diabetogenic effect and can lead to an increase in hepatic gluconeogenesis and a decrease in glucose uptake by peripheral tissues and hyperglycemia.


Use in elderly patients.


There are no clinical data on the safety of using the drug in elderly patients.


Use during pregnancy or lactation.


Special Studies of the effect of the drug during pregnancy or lactation have not been conducted.


Use during pregnancy.


Azelastine hydrochloride. Adequate and controlled clinical trials involving pregnant women have not been conducted. In animal experiments, azelastine hydrochloride caused embryotoxicity.


Mometasone furoate. Adequate and controlled clinical trials involving pregnant women have not been conducted.


It should be noted that due to the natural increase in corticosteroid production during pregnancy, most women require lower doses of exogenous corticosteroids, and many of them do not require corticosteroid treatment during pregnancy.


Use during breast-feeding.


Azelastine hydrochloride. It is not known whether azelastine hydrochloride is excreted in human breast milk.


Mometasone furoate. It is not known whether mometasone furoate is excreted in human breast milk.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


Special Studies of the effect of the drug on the ability to drive vehicles and other mechanisms have not been conducted.


Since there have been reports of drowsiness in some patients who have used azelastine hydrochloride in the dosage form of a nasal spray in clinical trials, during treatment with the drug, patients should refrain from work that requires increased concentration of attention and speed of reactions.


Dosage and administration.


The drug is intended for intranasal use only.


Adults and children over 12 years of age. The recommended dose is 1 injection in each nostril 2 times a day.


Patients with impaired renal function. Dose adjustment is not required in patients with mild renal insufficiency (creatinine clearance > 79 mL/min). In patients with moderate to severe renal insufficiency (creatinine clearance 79 mL/min – > 10 mL/min), the drug should be used with caution and under strict medical supervision.


Patients with hepatic insufficiency. No dose adjustment is required.


Application of nasal spray


Before each application, the bottle should be gently shaken for 5 seconds. Then remove the protective cap. Before using the bottle for the first time, press the dosing device 6 times in a row. If the nasal spray has not been used for more than 7 Days, press the metering spray pump again 6 times in a row before use.


Before each application, you should thoroughly clean your nose of mucus. After cleaning the nose, the suspension is injected into each nostril, while the head should be kept slightly tilted down. After application, the spray tip should be wiped and covered with a protective cap.


Children.

There is insufficient clinical experience with the use of the drug in children under 12 years of age, so it should not be used in patients of this age category.


Overdose.


There are no reports of overdose with Glenspray active.


In case of acute overdose, disorders of the central nervous system (drowsiness, dizziness) are possible. Oral single administration of azelastine hydrochloride at a dose of up to 16 mg during clinical trials did not increase the frequency of serious adverse effects. Treatment is symptomatic. The antidote is unknown.


There are no reports of acute or chronic overdose of mometasone furoate as a nasal spray. Single intranasal doses of up to 4 mg and oral inhaled doses of up to 8 mg have been reported in volunteers without any side effects.


Chronic overdose of any corticosteroid can lead to symptoms of hypercorticism.


Adverse reactions.


During the clinical trial, side effects associated with the use of nasal spray containing azelastine hydrochloride and mometasone furoate were reported in 11 patients out of 282 who participated in the study. A total of 18 cases of adverse reactions associated with treatment with a combination of azelastine and mometasone were reported. The most common adverse reactions were headache and dysgeusia. Other adverse reactions included drowsiness, lethargy, nausea, dyspepsia, and sneezing. Most of the side effects were mild, and no serious adverse reactions were reported during the study.


The following are the adverse reactions that were observed with the use of individual components of the drug.


Azelastine hydrochloride nasal spray


Often (1-10%): a specific bitter taste may appear after applying the spray (most often due to the wrong method of application, namely when the head is too tilted back during the injection of the drug), which in some cases can lead to nausea.


Infrequently (0.1-1%): temporary irritation of the inflamed nasal mucosa may occur along with symptoms such as burning, itching, sneezing, and nosebleeds.


In very rare cases ('Yanka).


Post-marketing experience


Adverse reactions detected during post-marketing use of azelastine nasal spray: abdominal pain, burning nose, nausea, sweet taste, throat irritation, anaphylactoid reactions, irritation at the site of application, atrial fibrillation, visual impairment (blurred vision, cataracts, glaucoma, central serous chorioretinopathy (see below). section" application features")), chest pain, confusion, dizziness, shortness of breath, facial edema, hypertension, involuntary muscle contractions, nervousness, rapid heartbeat, paresthesia, parosmia, paroxysmal sneezing, itching, rash, impaired or lost sense of smell and/or taste, tachycardia, immunological tolerance, urinary retention, xerophthalmia. Since these reactions relate to a population of undetermined size, it is not always possible to reliably estimate their frequency or establish a causal relationship with the use of the drug.


Mometasone furoate nasal spray


Respiratory, thoracic and mediastinal disorders: nosebleeds, pharyngitis, burning or irritation in the nose, nasal ulcers – often (1-10 %).


General disorders and local reactions: headache – often (1-10 %).


The nosebleeds were mostly mild and did not require medical intervention.


Children most often had nosebleeds, headaches, irritation of the nasal mucosa, sneezing.


Systemic side effects during treatment with nasal corticosteroids may occur when high doses are used for a long time.


Post-marketing experience


Adverse reactions detected during post-marketing use of mometasone furoate nasal spray: burning and irritation in the nose, anaphylaxis and angioedema, impaired taste and smell, and perforation of the nasal septum.


The use of a nasal spray containing azelastine hydrochloride and mometasone furoate in patients may lead to an increase in ALT and AST levels.


The use of Glenspray active can lead to the development of disorders of the kidneys and urinary system (hematuria).


Corticosteroids stimulate the secretion of acid and pepsin, which can lead to the development of gastritis and hyperchlorhydria.

Tags: Glenspray [Azelastine, Mometasone]