Momat Rino Advance Spray nasal doses. 150 doses
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Active ingredients
Azelastine + Mometasone
Release form
Spray
Composition
In 1 dose: azelastine hydrochloride 140 mcg, mometasone furoate 50 mcg. Adjuvants: microcrystalline cellulose (Avitsel RC-591) - 0.91 mg, carmellose sodium - 0.021 mg, dextrose - 3.5 mg, polysorbate 80 - 0.0175 mg, benzalkonium chloride - 0.0 mg, disodium edetate - 0.035 mg, neotame - 0.0007 mg, citric acid monohydrate - 0.0105 mg, sodium citrate - 0.021 mg, purified water - up to 70 mg.
Pharmacological effect
Combined medication with anti-allergic and anti-inflammatory effects for local use in ENT-practice. Azelastin, a phthalazinone derivative, is a long-acting antiallergic agent. Azelastine is a selective blocker of histamine H1 receptors, has an antihistamine, 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, leukotrieny, activists, activists, activists, and activists). causing bronchospasm and promoting the development of early and late stages of allergic reactions and inflammation. Mometasone is a synthetic GCS for months good use. It has anti-inflammatory and anti-allergic effects when used in doses that do not cause systemic effects. Slows down the release of inflammatory mediators. It increases the production of lipomodulin, which is an inhibitor of phospholipase A, which causes a decrease in the release of arachidonic acid and, accordingly, inhibition of the synthesis of products of the metabolism of arachidonic acid - cyclic endoperexia, prostaglandins. It warns the regional 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 a chemotaxis substance (effect on late allergy reactions), inhibits the development of an immediate type of allergic reaction (due to inhibition of the production of arachidonic acid metabolites and reduced release of inflammatory mediators from mast cells).
Pharmacokinetics
Azelastine hydrochloride Absorption and Distribution The bioavailability after intranasal administration is about 40%. Cmax in plasma after intranasal administration is achieved in 2–3 hours. When administered intranasally at a daily dose of 0.56 mg azelastine hydrochloride, the average Css of azelastine hydrochloride in 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, systemic exposure after intranasal administration 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 volunteers. Other pharmacokinetic data have been studied using orally. Binding to blood proteins 80-90%. Metabolism and excretion Metabolized in the liver through oxidation involving the cytochrome P450 system the formation of the active metabolite dezmetilazelastina. It is mainly excreted by the kidneys as inactive metabolites. T1 / 2 azelastine - about 20 hours, its active metabolite dezmetilazelastina - about 45 hours. Mometasone furoate When used intranasally, the systemic bioavailability of mometasone furoate is less than 1% (with a sensitivity method of determining 0.25 pg / ml). The mometasone suspension is very poorly absorbed from the gastrointestinal tract, and the small amount of mometasone suspension that can get into the gastrointestinal tract after nasal inhalation, even before excretion with urine or bile, is subjected to an active primary metabolism.
Indications
Seasonal allergic rhinitis in adults from 18 years.
Contraindications
- recent surgery or injury of the nose with damage to the nasal mucosa - to wound healing (due to the inhibitory effect of GCS on the healing process); - children and adolescents under 18 years of age (due to lack of relevant data); - hypersensitivity to any from the components of the drug.
Precautionary measures
Precautions should be prescribed drug for tuberculosis infection (active and latent) 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 these infections as directed by the doctor), the presence of an untreated infection with involvement in the nasal mucosa.
Use during pregnancy and lactation
Properly planned and well-controlled studies of the drug in pregnant women have not been conducted. Azelastina hydrochloride can cause toxicity during fetal development in mice, rats and rabbits. Use of the drug during pregnancy and during breastfeeding is contraindicated.
Dosage and administration
The drug is used intranasally. Inhalation of the suspension contained in the vial is carried out using a special dispensing nozzle per vial. Assign 1 dose of spray (azelastine hydrochloride 140 mcg / mometasone furoate 50 mcg) in each nostril 2 times / day in the morning and evening. The duration of the course of treatment is 2 weeks. Guidelines for the use of a bottle with a dosing device1. Remove the protective cap.2. Before the first use of the nasal spray, it is necessary to calibrate it by pressing the dispensing device about 10 times. If a nasal spray has not been used for 7 days or longer, recalibration is required by pressing the dispensing device about 2 times, or by pressing on the lid until a spray appears when pressed. It is necessary to place the index and middle fingers on the sides of the nasal adapter, and the thumb on the bottom of the vial and, while breathing in through the nose, press. Do not pierce the nasal adapter. When spraying, do not direct into eyes. Before use, clean the nostrils whenever possible. Pinch one nostril, and insert the end of the nasal adapter into the other nostril, while holding the bottle vertically. Quickly and sharply press the adapter. Do not spray on the nasal septum. To exhale through the mouth.5. Repeat the steps described in paragraph 3 for the other nostril. Wipe the nasal adapter with a clean cloth and put on a protective cap. Instructions for cleaning the nasal adapter1. Remove the protective cap.2. Carefully remove the nasal adapter by pulling up.Rinse the nasal adapter with cold running water on both sides and dry. Do not use any ancillary items (such as needles or sharp objects) to clean the adapter to prevent damage to it. Rinse the protective cap with cold running water and dry. Install the nasal adapter in place. Ensure that the stem of the vial is placed in the center of the nasal adapter. Perform calibration by 2 presses of the metering device, or by pressing on the lid until a fine dispersion starts to emerge steadily when pressed. Do not spray into the eyes. Wear protective cap.
Side effects
The frequency of side effects is defined as follows: very often (more than 1/10); often (less than 1/10, greater than 1/100); infrequently (less than 1/100, more than 1/1000); rarely (less than 1/1000, more than 1/10 000); very rarely (less than 1/10 000). From the nervous system: often - headache, dysgeusia (unpleasant taste) as a result of improper use, namely, if the head is excessively deflected back during administration; very rarely - dizziness (may be caused by the disease itself). On the part of the digestive system: rarely - a feeling of irritation of the pharyngeal mucosa, nausea. On the part of the respiratory system: often - nasal bleeding, discomfort in the nasal cavity (burning sensation, itching), ulceration of the mucous nasal membrane, sneezing, pharyngitis, sinusitis, upper respiratory tract infections. From the immune system: very rarely - hypersensitivity, anaphylactoid reactions, urticaria. From the skin and subcutaneous tissues: very rarely - rash, cutaneous d.Prochie: very rarely - fatigue, drowsiness, weakness (can be caused by disease) .If prolonged use of corticosteroids at high doses may develop systemic side effects, including glaucoma and cataracts.
Overdose
Currently, there are no known cases of drug overdose with intranasal use. Symptoms: in case of azelastine overdose as a result of accidental ingestion, disturbances in the nervous system (drowsiness, confusion, tachycardia, hypotension) are possible. Treatment: symptomatic therapy. With prolonged use of GCS in high doses, as well as with the simultaneous use of several GCS, hypothalamic-pituitary-adrenal system may be inhibited.Due to the low systemic bioavailability of the drug, it is unlikely that in case of an accidental or deliberate overdose, it will be necessary to take any measures other than observation with possible subsequent resumption of the drug in the recommended dose.
Interaction with other drugs
Azelastine In the intranasal administration of azelastine, no clinically significant interaction with other drugs was detected. Mometasone furoate Combined therapy with loratadine was well tolerated by patients. However, no effect of the drug on the concentration of loratadine 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).
special instructions
As with any long-term treatment, patients using Momat Rino Nasal Nasal Spray for several months or longer should be examined periodically by a doctor for possible changes in the nasal mucosa, nasal septum perforation (very rarely) and the possible development of systemic side effects. If a local fungal infection of the nose or pharynx develops, it may be necessary to discontinue the Momat Rino Advance nasal spray therapy and conduct special treatment. In the case of the development of persistent irritation of the nasopharynx, it is necessary to resolve the issue of discontinuing therapy. Patients who proceed to treatment with Momat Rino Advance nasal spray after long-term treatment of GCS of systemic action require special attention. Canceling the GCS of a systemic action in such patients may lead to insufficient adrenal function, the subsequent recovery of which can take up to several months. If there are signs of adrenal insufficiency, you should resume taking systemic corticosteroids and take other necessary measures. During the transition from treatment of corticosteroids of systemic action to treatment with nasal spray Momat Rino Advance, some patients may experience initial withdrawal symptoms of systemic corticosteroids (eg, joint pain and / or muscles, feeling tired and depressed), despite the reduction in the severity of symptoms associated with lesions of the nasal mucosa; such patients need to be specifically convinced of the desirability of continuing treatment with the nasal spray Momat Rino Advance.The transition from systemic to local corticosteroids can also reveal pre-existing, but masked therapy with corticosteroids of systemic action, allergic diseases such as allergic conjunctivitis and eczema. Systemic medications can be used with intranasal steroids in recommended doses or recommended doses in sensitive patients. GCS effects and adrenal suppression. When such changes occur, the use of Momat Rino Advance nasal spray should be gradually discontinued, in accordance with the procedures taken to stop taking oral GCS. Patients treated with GCS 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 (for example, chickenpox, measles), as well as the need for medical advice, if such contact has occurred. AI expressed signs of bacterial infection (eg, fever, persistent and severe pain on one side of the face or dental pain, swelling in the orbital or periorbital) require immediate medical konsultatsiya.GKS for nasal and inhalation application can cause glaucoma and / or cataracts. Therefore, you should carefully monitor patients with vision changes, as well as patients who have previously had elevated intraocular pressure, glaucoma and / or cataracts. Effects on the ability to drive vehicles and control mechanisms In rare cases, fatigue, fatigue, dizziness and weakness, which may be the result of the disease itself, may develop with the use of a nasal spray Momat Rino Advance. In such cases, you should avoid driving and working with complex mechanisms.