Momat Rhino nasal spray 50 µg/dose bottle, 120 doses

Composition

1 dose of spray contains: Active ingredient: Mometasone furoate monohydrate – 51.72 mcg, in terms of mometasone furoate-50.00 mcg; Excipients: Avicel RC-591 [microcrystalline cellulose, sodium carmellose] – 2.00 mg, glycerol-2.10 mg, citric acid monohydrate-0.20 mg, sodium citrate dihydrate-0.28 mg, polysorbate-80-0.01 mg, benzalkonium chloride-0.02 mg, water for injection-up to 100 mg

Pharmacological action

Mometasone is a synthetic topical corticosteroid. It has an anti-inflammatory and anti-allergic effect when used in doses that do not cause systemic effects.

Inhibits the release of inflammatory mediators. Increases the production of lipomodulin, which is an inhibitor of phospholipase A, which causes a decrease in the release of arachidonic acid and, accordingly, inhibits the synthesis of arachidonic acid metabolism products – cyclic endoperoxides, prostaglandins.

It prevents the marginal accumulation of neutrophils, which reduces inflammatory exudate and lymphokine production, inhibits macrophage migration, and reduces the processes of infiltration and granulation.

Reduces inflammation by reducing the formation of the chemotaxis substance (the effect on “late” allergy reactions), inhibits the development of an immediate allergic reaction (due to inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells).

Indications

-Seasonal and year-round allergic rhinitis in adults, adolescents and children from 2 years of age. – Acute sinusitis or exacerbation of chronic sinusitis in adults (including the elderly) and adolescents from 12 years of age – as an auxiliary therapeutic agent in the treatment with antibiotics. – Acute rhinosinusitis with mild to moderate symptoms without signs of severe bacterial infection in patients aged 12 years or more. – Preventive treatment of seasonal allergic rhinitis of moderate and severe course in adults and adolescents from 12 years of age (recommended two to four weeks before the expected start of the dusting season). – Nasal polyposis, accompanied by a violation of nasal breathing and smell, in adults (from 18 years).

Contraindications

-Hypersensitivity to any of the components of the drug. – Recent surgical intervention or nasal trauma with damage to the nasal mucosa – before the wound heals (due to the inhibitory effect of corticosteroids on the healing process). – Children’s age (with seasonal and year-round allergic rhinitis-up to 2 years, with acute sinusitis or exacerbation of chronic sinusitis – up to 12 years, with polyposis-up to 18 years) – due to the lack of relevant data. With caution: Tuberculosis infection (active and 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 an untreated local infection involving the nasal mucosa.

Side effects

Adults and teenagers. Adverse events associated with the use of the drug (≥1%), identified during clinical studies in patients with allergic rhinitis or nasal polyposis, and during the period of post-marketing use of the drug, regardless of the indication for use, are presented below. Adverse reactions are listed according to the classification of the systemic-organ class, and adverse reactions are classified by frequency of occurrence. Nosebleeds were usually moderate and stopped on their own, the frequency of their occurrence was slightly higher than when using placebo (5%), but equal to or less than when using other intranasal corticosteroids that were used as active controls (in some of them, the frequency of occurrence of nosebleeds was up to 15%). The incidence of all other adverse events was comparable to that of placebo. The frequency of adverse reactions is set as follows:

• very common (≥1/10);
• common (≥1/100, <1/10);
• rare (≥1/1000,

For adverse reactions during post-marketing follow-up, the frequency has not been established (cannot be determined based on available data). Infectious and parasitic diseases: Often – pharyngitis, upper respiratory tract infections*. Immune system disorders: Frequency not established-hypersensitivity reactions, including anaphylactic reactions, angioedema, bronchospasm, shortness of breath. Nervous system disorders: Often – headache. Visual disturbances:  The frequency is not established-increased intraocular pressure, glaucoma, cataracts. Respiratory, thoracic and mediastinal disorders: Very often – nosebleeds**; Often-nosebleeds (i. e. obvious bleeding, as well as discharge of blood-stained mucus or blood clots), burning sensation in the nose, irritation of the nasal mucosa, ulceration of the nasal mucosa; – frequency not established – perforation of the nasal septum. Disorders of the gastrointestinal tract: Often-pharyngeal irritation (feeling of irritation of the pharyngeal mucosa)** ;- frequency not established-violation of taste and smell. Note: * – detected with a frequency of “rarely” when using the drug twice a day for nasal polyposis, ** – detected when using the drug twice a day for nasal polyposis. Detainments from the respiratory system, chest and mediastinal organs: nosebleeds (6%), irritation of the nasal mucosa (2%), sneezing (2%). Nervous system disorders: headache (3%). The incidence of these adverse events in children was comparable to that of placebo. When using intranasal corticosteroids, systemic side effects may develop, especially if they are used for a long time in high doses.

Interaction

Combination therapy with loratadine is well tolerated by patients. However, there is no effect of the drug on the plasma concentration of loratadine or its main metabolite.

How to take, course of use and dosage

Intranasally. The suspension contained in the bottle is inhaled using a special dosing nozzle on the bottle. Before applying Momat Reno nasal spray for the first time, it is necessary to “calibrate”it. Do not pierce the nasal applicator. To perform “calibration”, you need to press the dosing nozzle 10 times, until splashes appear, which indicates that the drug is ready for use. Tilt your head and inject the medicine into each nostril as recommended by your doctor. If the medicine has not been used for 14 days or longer, press the dosing nozzle 2 times until the spray appears. Tilt your head and inject the medicine into each nostril as recommended by your doctor. Cleaning the metering nozzle. It is important to clean the dosing nozzle regularly to avoid its incorrect operation. Remove the cap that protects the nozzle from dust, then carefully remove the spray tip. Rinse the spray tip and dust cap thoroughly in warm water and rinse under the tap. Do not attempt to open the nasal applicator with a needle or other sharp object, as this will damage the applicator and you may take the wrong dose of the drug. Dry the cap and tip in a warm place. After that, attach the spray tip to the bottle and screw the dust cap back on to the bottle. When using the nasal spray for the first time after cleaning, it is necessary to perform a “calibration” by pressing the dosing nozzle 2 times. Before each use, it is necessary to shake the bottle intensively. Treatment of seasonal or year-round allergic rhinitis Adults (including the elderly) and adolescents from 12 years of age: The recommended preventive and therapeutic dose of the drug is 2 inhalations (50 mcg each) in each nostril 1 time a day (the total daily dose is 200 mcg). After achieving the therapeutic effect for maintenance therapy, it is possible to reduce the dose to 1 inhalation in each nostril 1 time a day (the total daily dose is 100 mcg). If it is not possible to reduce the symptoms of the disease by using the drug at the recommended therapeutic dose, the daily dose can be increased to 4 inhalations in each nostril 1 time a day (the total daily dose is 400 mcg). After reducing the symptoms of the disease, it is recommended to reduce the dose. The onset of action of the drug is usually noted clinically as early as 12 hours after the first use of the drug. Children 2-11 years old: The recommended therapeutic dose is 1 inhalation (50 mcg) in each nostril once a day (the total daily dose is 100 mcg). The use of the drug in young children requires the help of adults. Auxiliary treatment of acute sinusitis or acute chronic sinusitisadults (including the elderly) and adolescents from 12 years of age: The recommended preventive and therapeutic dose of the drug is 2 inhalations (50 mcg each) in each nostril 2 times a day (the total daily dose is 400 mcg). If it is not possible to reduce the symptoms of the disease by using the drug at the recommended therapeutic dose, the daily dose can be increased to 4 inhalations in each nostril 2 times a day (the total daily dose is 800 mcg). After reducing the symptoms of the disease, it is recommended to reduce the dose.Treatment of acute rhinosinusitis without signs of severe bacterial infection:The recommended dose for adults and adolescents is 2 inhalations (50 mcg in each nasal passage) 2 times a day (a total daily dose of 400 mcg). If symptoms worsen during treatment, consult a specialist. Treatment of nasal polyposis:Adults (including the elderly) over 18 years of age:The recommended therapeutic dose of the drug is 2 inhalations (50 mcg each) in each nostril 2 times a day (the total daily dose is 400 mcg). After reducing the symptoms of the disease, it is recommended to reduce the dose to 2 inhalations (50 mcg each) in each nostril 1 time a day (the total daily dose is 200 mcg).

Overdose

With prolonged use of corticosteroids in high doses, as well as with the simultaneous use of several corticosteroids, it is possible to inhibit the function of the hypothalamic-pituitary-adrenal system. Due to the low systemic bioavailability of the drug (

Special instructions

As with any long-term treatment, patients who have been using Momat Reno nasal spray for several months or longer should be periodically checked by a doctor for possible changes in the nasal mucosa and the possible development of systemic side effects. If a local fungal infection of the nose or pharynx develops, it may be necessary to stop Momat Reno nasal spray therapy and conduct special treatment. Persistent irritation of the nasal and pharyngeal mucosa for a long time can also serve as a reason for discontinuing treatment with this drug. Patients who switch to Momat Reno nasal spray treatment after long-term therapy with systemic glucocorticosteroids require special attention. Withdrawal of systemic glucocorticosteroids in such patients may lead to insufficient adrenal function, the subsequent recovery of which may take up to several months. If signs of adrenal insufficiency appear, you should resume taking systemic glucocorticosteroids and take other necessary measures. During the transition from systemic glucocorticosteroid treatment to Momat Reno nasal spray treatment, some patients may experience initial symptoms of withdrawal of systemic glucocorticosteroids (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 should be specifically persuaded to continue treatment with Momat Reno nasal spray. Switching from systemic to local glucocorticosteroids can also cause allergic diseases, such as allergic conjunctivitis and eczema, that already exist but are masked by systemic glucocorticoid therapy. Patients treated with glucocorticosteroids have potentially reduced immune reactivity and should be warned about their increased risk of infection if they come into contact with patients with certain infectious diseases (for example, chickenpox, measles), as well as about the need for medical advice if such contact has occurred. If there are signs of a severe bacterial infection (for example, fever, persistent and sharp pain on one side of the face or toothache, swelling in the orbital or periorbital area), immediate medical advice is required. The efficacy and safety of mometasone has not been studied in the treatment of unilateral irregular polyps, bleeding polyps, polyps associated with cystic fibrosis, and polyps that completely cover the nasal cavity. Unilateral polyps that are irregularly shaped or bleeding should be further examined. With prolonged use of high-dose nasal corticosteroids, systemic side effects may develop. These effects are much less likely to occur than with systemic corticosteroids, and may vary from patient to patient, as well as between different corticosteroids. Potential systemic effects include Cushing’s syndrome, characteristic signs of Cushing’s disease, adrenal suppression, growth retardation in children and adolescents, cataracts, glaucoma, and, more rarely, a number of psychological or behavioral effects, including psychomotor hyperactivity, sleep disorders, anxiety, depression, or aggression (especially in children). It is recommended to regularly monitor the growth of children receiving long-term mometasone therapy. If growth slows down, the current therapy should be reviewed to reduce the dose of mometasone to the minimum effective dose that allows you to control the symptoms of the disease. In addition, the patient should be referred for consultation with a pediatrician. Treatment with corticosteroids at higher doses than recommended may lead to clinically significant suppression of adrenal function. If it is known that high doses of corticosteroids are used, it is necessary to consider the possibility of additional use of systemic corticosteroids during periods of stress or elective surgery.

Storage conditions

In a dark place at a temperature of 15 to 25 °C. Do not freeze it. Keep out of reach of children.

Shelf

life is 2 years.

Active ingredient

Mometasone

Dosage form

nasal spray

Purpose

Children as prescribed by a doctor, Children over 2 years of age, Adults as prescribed by a doctor

Indications

Allergy, Allergic Rhinitis, Nasal Polyposis, Pollinosis, Sinusitis