Description
Pharmacological action
Antiallergic and anti-inflammatory drug for topical use in ENT practice. Azelastine, a phthalazinone derivative, is a long-acting antiallergic.
Azelastine is a selective blocker of histamine H1 receptors, has an antihistamine, anti-allergic and membrane stabilizing effect, reduces capillary permeability and exudation, stabilizes mast cell membranes and prevents the release of biologically active substances from them (histamine, serotonin, leukotrienes, others) causing bronchospasm and contributing to the development of early and late stages of allergic reactions and inflammation.
Mometasone is a synthetic corticosteroids for local use. It has anti-inflammatory and anti-allergic effects when used in doses at which systemic effects do not occur. It inhibits the release of inflammatory mediators. Increases the production of lipomodulin, an inhibitor of phospholipase A, which leads to a decrease in the release of arachidonic acid and, accordingly, inhibition of the synthesis of metabolic products of arachidonic acid – cyclic endoperoxides, prostaglandins.
Prevents marginal accumulation of neutrophils, which reduces inflammatory exudate and lymphokine production, inhibits macrophage migration, and reduces the rate of infiltration and granulation. Reduces inflammation by reducing the formation of chemotaxis substance (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 perennial 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 old – as an auxiliary therapeutic agent in the treatment of antibiotics.
– Acute rhinosinusitis with mild to moderate symptoms without signs of severe bacterial infection in patients aged 12 years or more.
– Prophylactic 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).
– Polyposis of the nose, 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 surgery or nasal injury with damage to the nasal mucosa – before wound healing (due to the inhibitory effect of corticosteroids on the healing process).
– Children’s age (with seasonal and perennial 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.
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 may be prescribed for the listed infections as directed by the doctor), the presence of untreated local infections involving the nasal mucosa.
Pregnancy and lactation
There have been no well-designed and well-controlled studies of the drug in pregnant women.
As with other nasal GCS, Momat Rino should be prescribed to pregnant or breastfeeding women only if the expected benefits of the drug justify the potential risk to the fetus or baby.
Infants whose mothers received GCS during pregnancy should be carefully examined for possible adrenal hypofunction.
Special instructions
As with any long-term treatment, patients who use Momat Rino Nasal Spray for several months or longer should be periodically examined by a doctor for possible changes in the nasal mucosa and possible development of systemic side effects. In the case of the development of a local fungal infection of the nose or pharynx, termination of therapy with Momat Rino nasal spray and special treatment may be required. Persistent irritation of the nasal mucosa and pharynx can also serve as a basis for stopping treatment with this drug.
Patients who switch to treatment with Momat Rino Nasal Spray after prolonged treatment with systemic glucocorticosteroids require special attention. The abolition of systemic glucocorticosteroids in such patients can lead to insufficient adrenal function, the subsequent restoration of which can take up to several months. In case of signs of adrenal insufficiency, systemic glucocorticosteroids should be resumed and other necessary measures taken.
During the transition from treatment with systemic glucocorticosteroids to treatment with Mat Rino nasal spray, some patients may experience initial symptoms of systemic glucocorticosteroid withdrawal (for example, pain in the joints and / or muscles, feeling tired and depressed), despite the decrease in the severity of symptoms associated with damage to the nasal mucosa of such patients must be specifically convinced of the advisability of continuing treatment with Momat Rino nasal spray. The transition from systemic to local glucocorticosteroids can also cause already existing but masked by systemic glucocorticosteroid therapy, allergic diseases such as allergic conjunctivitis and eczema.
Patients treated with glucocorticosteroids, have a potentially reduced immune reactivity and should be warned about the increased risk of infection for them in case of contact with patients with some infectious diseases (for example, chickenpox, measles), as well as the need for medical advice if such contact has occurred.
If signs of a severe bacterial infection appear (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 polyps of irregular shape, bleeding polyps, polyps associated with cystic fibrosis and polyps that completely cover the nasal cavity. One-sided polyps that are irregular in shape or bleeding, should be further examined.
With prolonged use of nasal GCS in high doses, systemic side effects may develop. The likelihood of developing these effects is much less than with systemic corticosteroids, and may vary in individual patients, as well as between different corticosteroids.
Potential systemic effects include Cushing’s syndrome, characteristic symptoms of cushingoid, adrenal gland suppression, growth retardation in children and adolescents, cataracts, glaucoma, and, less commonly, a number of psychological or behavioral effects, including psychomotor hyperactivity, sleep disturbance, anxiety, depression, or aggression ( especially in children).
It is recommended to regularly monitor the growth of children receiving long-term therapy with mometasone. When growth is slowed down, the therapy should be reviewed in order to reduce the dose of mometasone to the minimum effective dose, which allows controlling the symptoms of the disease. In addition, the patient should be referred for a consultation with a pediatrician.
Treatment of corticosteroids with higher doses than recommended may result in clinically significant inhibition of adrenal function. If it is known that high doses of GCS are used, it is necessary to consider the possibility of additional use of systemic GCS during periods of stress or planned surgical intervention.
Composition of
1 dose of spray contains:
Active ingredient:
Mometasone furoate monohydrate – 51.72 μg, in terms of mometasone furoate – 50.00 μg
Excipients:
Avicellum cellulose 59 microcellosa RCAcellose RC 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.
Dosage and Administration
Intranasally. Inhalation of the suspension contained in the vial is carried out using a special metering nozzle on the vial. Before the first use of Momat Rino Nasal Spray, it is necessary to calibrate it. Do not pierce the nasal applicator.
For calibration, press the dosing nozzle 10 times until a spray appears, indicating that the product is ready for use. Tilt your head and inject the drug into each nostril as recommended by your doctor.
If the drug has not been used for 14 days or more, press the dispensing nozzle 2 times until splashes appear. Tilt your head and inject the drug into each nostril as recommended by your doctor.
Cleaning the metering nozzle.
It is important that the dosing nozzle is cleaned regularly to prevent malfunction. Remove the cap, protecting the nozzle from dust, then carefully remove the spray tip. Thoroughly rinse the spray tip and dust cap in warm water and rinse under the tap.
Do not try to open the nasal applicator with a needle or other sharp object, as this will damage the applicator, as a result of which you may take the wrong dose.
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 the bottle. When using the nasal spray for the first time after cleaning, it is necessary to calibrate by pressing the dosing nozzle 2 times.
Shake the bottle vigorously before each use.
Treatment of seasonal or perennial allergic rhinitis
Adults (including the elderly) and adolescents from 12 years:
The recommended prophylactic and therapeutic dose of the drug is 2 inhalations (50 Ñg each) in each nostril once a day (total daily dose – 200 mcg). Upon reaching the therapeutic effect for maintenance therapy, it is possible to reduce the dose to 1 inhalation in each nostril 1 time per day (total daily dose – 100 mcg).
If the symptoms of the disease cannot be reduced by using the drug at the recommended therapeutic dose, the daily dose can be increased to 4 inhalations per nostril once a day (total daily dose is 400 mcg). After reducing the symptoms of the disease, a dose reduction is recommended.
The onset of action of the drug is usually clinically observed 12 hours after the first use of the drug.
Children 2-11 years old:
Recommended therapeutic dose is 1 inhalation (50 mcg) in each nostril once a day (total daily dose is 100 mcg).
Adult use requires adult help. Auxiliary treatment for acute sinusitis or exacerbated chronic sinusitis.
Adults (including the elderly) and adolescents from 12 years:
The recommended prophylactic and therapeutic dose of the drug is 2 inhalations (50 Ñg each) in each nostril 2 times a day (total daily dose – 400 Ñg). If the reduction of the symptoms of the disease cannot be achieved by using the drug in the recommended therapeutic dose, the daily dose can be increased to 4 inhalations in each nostril 2 times a day (total daily dose – 800 mcg). After reducing the symptoms of the disease, a dose reduction is recommended.
Treatment of acute rhinosinusitis without evidence of severe bacterial infection:
The recommended dose for adults and adolescents is 2 inhalations (50 Ñg per nasal passage) 2 times a day (total daily dose 400 Ñg). If symptoms worsen during treatment, a specialist consultation is necessary.
Treatment of nasal polyposis
Adults (including the elderly) from 18 years:
The recommended therapeutic dose of the drug is 2 inhalations (50 Ñg each) in each nostril 2 times a day (total daily dose – 400 Ñg).
After reducing the symptoms of the disease, it is recommended that the dose be reduced to 2 inhalations (50 Ñg each) in each nostril 1 time per day (total daily dose – 200 Ñg).
Side effects
Adults and teenagers.
Adverse events associated with the use of the drug (? 1%) detected during clinical trials in patients with allergic rhinitis or nasal polyposis, and during post-registration use of the drug, regardless of the indications for use are presented below. Undesirable reactions are listed in accordance with the classification of the organ-system class, undesirable reactions are classified by frequency of occurrence.
Nasal bleeding, as a rule, was 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 prescribing other intranasal corticosteroids, which were used as an active control (in some of them, the incidence of nosebleeds amounted to 15%). The frequency of occurrence of all other adverse events was comparable to the frequency of their occurrence with a placebo.
The frequency of adverse reactions is set as follows:
very often (? 1/10)
often (? 1/100, <1/10) rarely (? 1/1000, <1/100). For adverse reactions during the post-registration monitoring period, the frequency has not been established (cannot be determined based on available data). Infectious and parasitic diseases: Often – pharyngitis, upper respiratory tract infection *. Immune System Disorders: Frequency not established – hypersensitivity reactions, including anaphylactic reactions, angioedema, bronchospasm, shortness of breath. Disorders of the nervous system: Often – a headache. Disorders of the organ of vision: Frequency not established – increased intraocular pressure, glaucoma, cataract. Disorders of the respiratory system, chest and mediastinal organs: Very often – nosebleeds ** – often – nosebleeds (i.e., obvious bleeding, as well as the release of 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 (sensation of pharyngeal mucosa irritation) ** Frequency not established – violation of taste and smell. Note: * – detected rarely with the use of the drug twice a day with nasal polyposis, ** – detected with the drug twice a day with nasal polyposis. Children Disorders of the respiratory system, chest and mediastinal organs: nosebleeds (6%), irritation of the nasal mucosa (2%), sneezing (2%). Disorders of the nervous system: headache (3%). The incidence of these adverse events in children was comparable to their incidence with placebo. With the use of intranasal corticosteroids, systemic side effects may develop, especially with prolonged use in high doses. Drug Interactions Combination therapy with loratadine is well tolerated by patients. In this case, no effect of the drug on the plasma concentration of loratadine or its main metabolite is noted. Overdose With prolonged use of corticosteroids in high doses, and also with the simultaneous use of several corticosteroids, inhibition of the function of the hypothalamic-pituitary-adrenal system is possible. Due to the low systemic bioavailability of the drug (<1%, with a sensitivity of the determination method of 0.25 pg / ml), it is unlikely that any accidental or intentional overdose will require any measures other than observation with a possible subsequent resumption of the drug at the recommended dose. Storage conditions In a dark place at a temperature of 15 to 25 ° C. Do not freeze. Keep out of the reach of children. Expiration 2 years. Deystvuyuschee substances mometasone pharmacy terms and conditions without a prescription Appointment Prescribing children, Adult prescribers, Children10 years old10 over 2 years Indications Sinusitis, Allergic rhinitis, Pollinosis, Allergy Possible product names Mat Rino spray nasal dosage. 50 mcg / dose vial 120 doses
