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Azelastine, a phthalazinone derivative, is a long-acting antiallergic agent. Azelastine is a selective H i-histamine blocker, has anti-histamine, antiallergic and membrane-stabilizing effect, reduces capillary permeability and exudation, stabilizes the membranes of mast cells and prevents the release of biologically active substances (histamine, serotonin, creatants, and humans, humans, humans, humans, and humans, humans, humans, humans, humans, humans and respirators, humans and humans, humans, humans, humans and respirators, humans, humans, humans, and humans will not interfere with their release of the active ingredients (histamine, serotonin, human factors, humans, and humans will not interfere). others), causing bronchospasm and contributing to the development of early and late stages of allergic reactions and inflammation.
Mometasone is a synthetic glucocorticosteroid (GCS) for topical use. It has anti-inflammatory and anti-allergic effect when used in doses that do not cause systemic effects. Slows down the release of inflammatory mediators. Increases the production of lipomodulin, which is an inhibitor of phospholipase A, which leads to a decrease in the release of arachidonic acid and, respectively. inhibition of the synthesis of products of the metabolism of arachidonic acid - cyclic endoperoxides, prostaglandins. It warns the marginal accumulation of neutrophils, which reduces inflammatory exudate and production of lymphokines, inhibits the migration of macrophages, leads to a decrease in the processes of infiltration and granulation. Reduces inflammation by reducing the formation of chemotaxis substance (effect on the "late" allergy reactions), inhibits the development of an immediate type allergic reaction (due to inhibition of the production of arachidonic acid metabolites and a decrease in the release of inflammatory mediators from mast cells).
Azelastine hydrochloride. Bioavailability after iptnasal administration is about 40%. The maximum concentration (Cax) in the blood plasma after intranasal use is achieved in 2-3 hours. When applied intranasally at a daily dose of 0.56 mg azelastine hydrochloride, the average equilibrium concentration of azelastine hydrochloride in the plasma 2 hours after administration is 0.65 ng / ml. Doubling the total daily dose to 1.12 mg leads to a steady average plasma concentration of azelastine equal to 1.09 ng / ml. However, despite the relatively high absorption in patients, the systemic exposure after intranasal use is approximately 8 times lower than after oral administration of a daily dose of 4.4 mg azelastine hydrochloride, which is a therapeutic oral dose for the treatment of allergic rhinitis. Intranasal use in patients with allergic rhinitis causes an increase in plasma azelastine levels compared with healthy subjects. Other pharmacokinetic data have been studied with oral administration. Communication with blood proteins 80 - 90%. Metabolized in the liver by oxidation with the participation of the cytochrome P450 system with the formation of the active metabolite dezmetilazelastina. Excreted mainly by the kidneys as inactive metabolites. The elimination half-life (T1 / 2) of azelastine is about 20 hours, its active metabolite dezmetilazelastina is about 45 hours.
Mometasone furoate. With intranasal use, the systemic bioavailability of the furoate momet zone is <1% (with a sensitivity method of determination of 0.25 pg / ml). Mometasone suspension is very poorly absorbed in the gastrointestinal tract, and the small amount of mometasone suspension that can enter the gastrointestinal tract after nasal inhalation, even before excretion with urine or bile, is subjected to an active primary metabolism.
Seasonal allergic rhinitis in adults from 18 years.
1 spray dose contains:
azelastine hydrochloride - 140 mcg, mometasone furoate - 50 mcg.
microcrystalline cellulose (Avicelle RC-591) - 0.910 mg, carmellose sodium -0.021 mg, dextrose - 3,500 mg, polysorbate-80 - 0,0175 mg, benzalkonium chloride - 0.014 mg, disodium edetate-0.035 mg, neotam - 0.0007 mg , citric acid monohydrate - 0.0105 mg, sodium citrate - 0.021 mg, purified water - up to 70 mg.
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Dosage and Administration
It is intranasal. Inhalation of the suspension contained in the vial is carried out using a special dispensing nozzle on the vial. On 1 dose of spray (azelastine hydrochloride - 140 mcg / momstazona furoate - 50 mcg) in each nostril 2 times a day, morning and evening. Duration of treatment is 2 weeks.
The frequency of side effects is defined as follows: Very often:> 1/10; Often: <1/10> 1/100;
11 often: 1/1000; Rarely: <1/1000> 1/10000; Very rare: <1/10000.
Nervous system disorders:
Often: headache, dysgeusia (unpleasant taste) as a result of misuse. namely, if the head is excessively deflected back during insertion.
Very rarely, dizziness (may be caused by the disease itself).
Disorders of the gastrointestinal tract:
Seldom: sensation of irritation of a mucous membrane of a throat, nausea.
Disturbances of the respiratory system, organs of the chest and mediastinum: Often: nasal bleeding, discomfort in the nasal cavity (burning sensation, itching), ulceration of the nasal mucosa, sneezing, pharyngitis, sinusitis, upper respiratory tract infections.
Immune system disorders:
Very rare: hypersensitivity, anaphylactoid reactions.
Violations of the skin and subcutaneous tissues:
Very rarely: rash, pruritus, urticaria.
General disorders and disorders at the site of administration:
Very rarely: fatigue, drowsiness, weakness (may be caused by the disease itself).
With prolonged use of glucocorticosteroids (GCS) in high doses may develop systemic side effects, including glaucoma and cataracts.
Hypersensitivity to any of the components of the drug.
- Recent surgery or injury of the nose with damage to the mucous membrane of the nasal cavity - until the wound heals (due to the inhibitory effect of the SCS on the healing process).
Children's age up to 18 years - due to the lack of relevant data.
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 an untreated infection with involvement in the mucous process shell of the nasal cavity.
Use during pregnancy and lactation
A properly planned and buried controlled study of the drug in pregnant women has not been conducted.
Azelastine hydrochloride can cause toxicity during fetal development in mice, rats and rabbits.
The use of the drug during pregnancy and during breastfeeding is contraindicated.
Azelastine. There were no clinically significant interactions with other drugs with the intranasal use of azelastip.
Mometasone furoate. Combination therapy with loratadine was well tolerated by patients. However, no effect of the drug on the concentration of Lora-Tadin or its main metabolite in the blood plasma was noted. In these studies, mometasone furoate was not detected in the blood plasma (with a sensitivity of the method of determination of 50 pg / ml).
Pregnancy and Lactation
As with any long-term treatment, patients using Mo-mat Reno Advance nasal spray for several months or longer should periodically be examined by a physician for possible changes in the nasal mucosa, nasal septum perforation (very rarely) and the possible development of systemic side effects. effects. In the event of a local nasal or pharynx fungal infection, it may be necessary to discontinue Momate Rhino® Advance nasal spray therapy and conduct special treatment.In case of development of persistent irritation of the nasopharynx, it is necessary to resolve the issue of discontinuing therapy.
Patients who switch to treatment with Momate Rhino® Advance nasal spray after long-term treatment with systemic glucocorticosteroids require special attention. Cancellation of systemic-acting glucocorticosteroids in such patients may lead to insufficient adrenal function, the subsequent recovery of which may take up to several months. In case of signs of adrenal insufficiency, you should resume taking systemic corticosteroids and take other necessary measures.
During the transition from treatment with glucocorticosteroids of systemic action to treatment with nasal spray Momate Rhino® Advance, some patients may experience initial withdrawal symptoms of systemic glucocorticosteroids (for example, pain in joints and / or muscles, feeling tired and depressed), despite a reduction in the severity of symptoms associated lesion of the nasal mucosa; such patients need to be specifically convinced of the advisability of continuing treatment with the nasal spray Momate Rhino® Advance. The transition from systemic to local glucocorticosteroids can also reveal pre-existing, but masked therapy with glucocorticosteroids of systemic action, allergic diseases such as allergic conjunctivitis and eczema.
When using intranasal steroids in doses higher than recommended, or in sensitive patients at recommended doses, systemic effects of glucocorticosteroids and suppression of the adrenal glands can develop. When such changes occur, the use of the Momate Rhino® Advance nasal spray should be gradually discontinued, in accordance with the procedures adopted to stop taking oral glucocorticosteroids.
Patients who are treated with glucocorticosteroids have potentially reduced immune reactivity and should be warned about the increased risk of infection in case of contact with patients with certain infectious diseases (eg, chicken pox, measles), and the need for medical advice if such contact has occurred .
If signs of 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 consultation is required. Glucocorticosteroids for nasal and inhalation use can cause the development of glaucoma and / or cataracts. Therefore, careful monitoring of patients with vision changes, as well as patients who have previously had increased intraocular pressure, glaucoma and / or cataracts, should be carried out.
Influence on ability to drive vehicles and engage in other activities
In rare cases, fatigue, fatigue, dizziness and weakness, which may be the result of the disease itself, may develop with the use of the Momate Rhino® Advance nasal spray. In such cases, you should avoid driving and working with complex mechanisms.
At the moment, cases of overdose of the drug with inranasal application is unknown. In case of an overdose of azelastine as a result of accidental ingestion, there may be disturbances in the nervous system (drowsiness, confusion, tachycardia, hypotension). Therapy for these disorders is symptomatic. With prolonged use of glucocorticosteroids in high doses, as well as with the simultaneous use of several corticosteroids, the hypothalamic-pituitary-adrenal system may be inhibited.Due to the low systemic bioavailability of the drug, it is unlikely that in case of accidental or deliberate overdose any measures other than observation will be required, with possible subsequent resumption of the drug in the recommended dose.
- Brand name: Momate Rhino®
- Active ingredient: Azelastine, mometasone
- Dosage form: Spray - White or almost white suspension
- Manufacturer: Glenmark
- Country of Origin: India