Nasonex Spray Nasal Dose. 50mcg 60dose
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Active ingredients
Mometasone
Release form
Spray
Composition
In 1 dose: mometasone furoate (micronized, in the form of monohydrate) 50 mcg. Excipients: dispersed cellulose (microcrystalline cellulose, treated with carmellose sodium) - 20 mg, glycerol - 21 mg, citric acid monohydrate - 2 mg, sodium citrate dihydrate - 2.8 mg, polysorbate 80 - 0.1 mg, benzalkonium chloride (in the form of a 50% solution ) - 0.2 mg, purified water - 950 mg.
Pharmacological effect
GCS for local use. It has anti-inflammatory and anti-allergic effect when used in doses at which no systemic effects occur. It 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 endoperoxides, 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 arachidonic acid metabolite production and reduced release of inflammatory mediators from mast cells). In studies with provocative tests with antigens applied to the mucous membrane The nasal cavity was shown to have a high anti-inflammatory activity of mometasone, both in the early and late stages of allergic reaktsii.Eto was confirmed reduction (compared to placebo) concentration of histamine and eosinophil activity and a decrease (compared to baseline), number of eosinophils, neutrophils and epithelial cell adhesion proteins.
Pharmacokinetics
Absorption When used intranasally, mometasone furoate has a systemic bioavailability of less than 1% (with a detection rate of 0.25 pg / ml). Momethasone is very poorly absorbed from the gastrointestinal tract. Metabolism and excretion through the liver. Excreted in urine and bile.
Indications
- seasonal and year-round allergic rhinitis in adults, adolescents and children from 2 years; - acute sinusitis or exacerbation of chronic sinusitis in adults (including the elderly) and adolescents from 12 years of age - as an auxiliary therapeutic agent for treatment with antibiotics; - acute rhinosinusitis with mild and moderately severe symptoms without signs of severe bacterial infection in patients aged 12 years and older - prevention of seasonal allergic rhinitis moderate to severe in adults and adolescents from 12 a (recommended for 2-4 weeks before the expected start of the season dusting) - nasal polyposis, followed by a violation of nasal breathing and sense of smell in adults (18 years).
Contraindications
- hypersensitivity to the components of the drug; - recent surgery or trauma of the nose with damage to the nasal mucosa - until the wound heals (due to the inhibitory effect of GCS on the healing processes); - children and adolescents (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;
Precautionary measures
The drug should be used with caution in case of tuberculosis infection (active or 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 infection with involvement in the process of the nasal mucosa.
Use during pregnancy and lactation
Special, well-controlled studies of the safety of the drug Nasonex; during pregnancy was not carried out. As with other corticosteroids for intranasal use, Nasonex; should be prescribed during pregnancy and during breastfeeding only if the expected benefit from its use justifies the potential risk to the fetus or infant. Infants whose mothers received GCS during pregnancy should be carefully examined to identify possible adrenal hypofunction.
Dosage and administration
The drug is used intranasally. Treatment of seasonal or year-round allergic rhinitis. Adults (including elderly patients) and adolescents from 12 years old. Recommended prophylactic and therapeutic dose of the drug is 2 inhalations (50 mcg each) in each nostril 1 time / 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 / day (total daily dose - 100 mcg). If the reduction of disease symptoms cannot be achieved using the drug at the recommended therapeutic dose, the daily dose may be increased to 4 inhalations into each nostril 1 time / day (total daily dose - 400 mcg). After reducing the symptoms of the disease, a dose reduction is recommended. The onset of the drug is usually observed clinically as early as 12 hours after the first use of the drug. Children aged 2 to 11 years The recommended therapeutic dose is 1 inhalation (50 mcg) in each nostril 1 time / day (total daily Dose - 100 mcg. For the use of the drug in young children requires the help of adults. The adjuvant treatment of acute sinusitis or exacerbation of chronic sinusitis Adults (including elderly patients) and adolescents from 12 years oldRecommended The therapeutic dose is 2 inhalations (50 mcg each) in each nostril 2 times / day (total daily dose - 400 mcg). If the symptoms of the disease cannot be reduced using the drug at the recommended therapeutic dose, the daily dose can be increased to 4 inhalations in each nostril 2 times / day (total daily dose - 800 mcg). After reducing the symptoms of the disease, a dose reduction is recommended. Treatment of acute rhinosinusitis without signs of severe bacterial infection. The recommended dose for adults and adolescents is 2 inhalations of 50 mcg each nasal course 2 times / day (total daily dose of 400 mcg). If symptoms worsen during treatment, specialist consultation is necessary. Treatment of nasal polyposis For adults (including elderly patients) from 18 years of age, the recommended therapeutic dose is 2 inhalations (50 mcg each) in each nostril 2 times / day (total daily dose - 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 / day (total daily dose - 200 mcg). Nasonex preparation rules; Inhalation of the suspension contained in the spray vial,carried out using a special dispensing nozzle on the bottle. Before the first use of the nasal spray Nasonex; It is necessary to calibrate by pressing the dosing device 10 times, until sprays appear, indicating that the drug is ready for use. Tilt your head and inject the drug into each nostril as advised by the attending physician. If the nasal spray has not been used for 14 days or longer, you need to press the dispensing nozzle 2 times until a spray appears. Before each use it is necessary to shake the bottle vigorously. Cleaning the dispensing nozzleIt is important that you regularly tit dispensing nozzle, to avoid a malfunction. It is necessary to remove the cap protecting the nozzle from dust, then carefully remove the tip for spraying. Rinse the spray tip and the cap to protect it against dust in warm water and rinse it under the tap. Do not try to open the nasal applicator with a needle or other sharp object, as this will cause damage to the applicator, with the result that you can get the wrong dose of the drug. You should dry the cap and the tip in a warm place. After that, you need to attach the tip to spray on the bottle and reattach the cap to protect against dust from the bottle. When using the nasal spray for the first time after cleaning, it is necessary to recalibrate by pressing the dispensing tip 2 times.
Side effects
Adults and adolescentsThe adverse events associated with the use of the drug (more than 1%) identified during clinical studies in patients with allergic rhinitis or nasal polyposis, and during the post-registration use of the drug, regardless of indications for use, are presented in Table 1. Adverse reactions are listed in according to the classification of system-organ classes MedDRA. Within each system-organ class, undesirable reactions were classified according to the frequency of occurrence. Nasal bleeding was usually moderate and stopped independently, 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 (for some of them, the incidence of nosebleeds was up to 15%).The incidence of all other adverse events was comparable to the frequency of their occurrence when prescribing a placebo. Children Violations of the respiratory system, chest organs and mediastinum: nasal bleeding (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 the frequency of their occurrence when using placebo. With the use of intranasal GCS, systemic symptoms may develop cing effects, especially with prolonged use of nasal corticosteroids at high doses
Overdose
With prolonged use of GCS in high doses or with the simultaneous use of several GCS, hypothalamic-pituitary-adrenal system may be inhibited. The drug has a low systemic bioavailability (less than 1%, with a detection method sensitivity of 0.25 pg / ml) any special measures will be required, in addition to observation, with the possible subsequent resumption of the drug in the recommended dose.
Interaction with other drugs
Combination 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 Nasonex nasal spray; for several months and longer, should be periodically examined by a doctor for possible changes in the nasal mucosa. It is necessary to monitor patients receiving intranasal GCS for a long time. Perhaps the development of growth retardation in children. In case of detection of growth retardation in children, it is necessary to reduce the dose of intranasal GCS to the lowest, allowing to effectively control the symptoms. In addition, the patient should be referred for consultation to the pediatrician. In case of a local fungal infection of the nose or pharynx, it may be necessary to discontinue the Nasonex nasal spray therapy; and conducting special treatment.Prolonged irritation of the nasal and pharyngeal mucous membranes can also serve as a basis for discontinuing nasonex nasal spray;. When conducting placebo-controlled clinical trials in children, when nasal spray Nasonex; used at a daily dose of 100 mcg for a year, growth retardation in children was not observed. With prolonged treatment with a nasonex nasal spray; signs of suppression of the hypothalamic-pituitary-adrenal system was not observed. Patients who are starting treatment with Nasonex nasal spray; after long-term therapy of corticosteroids of systemic action, they require special attention. Cancellation of the GCS of a systemic effect in such patients may lead to an insufficiency of the adrenal function, the subsequent recovery of which can take up to several months. If signs of adrenal insufficiency appear, systemic corticosteroids should be resumed and other necessary measures taken. With the use of intranasal corticosteroids, systemic side effects may develop, especially with prolonged use at high doses. The likelihood of these effects is significantly less than with the use of oral corticosteroids. Systemic side effects may vary both in individual patients, and depending on the used GCS. Potential systemic effects include Cushing's syndrome, characteristic signs of cushingoid, suppression of adrenal function, growth retardation in children and adolescents, cataracts, glaucoma, and more rarely a number of psychological or behavioral effects, including psychomotor hyperactivity, sleep disturbance, anxiety, depression, or aggression (especially children). During the transition from the treatment of corticosteroids of systemic action to the treatment of Nasonex nasal spray; Some patients may experience initial withdrawal symptoms of systemic corticosteroids (for example, pain in the joints and / or muscles, fatigue and depression), despite the reduction in the severity of symptoms associated with lesions of the nasal mucosa. Such patients need to be specifically convinced of the advisability of continuing treatment with the Nasonex nasal spray; The transition from systemic to local GCS may also reveal already existing,but allergic diseases masked by GKS systemic therapy, such as allergic conjunctivitis and eczema. 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, varicella smallpox, measles), and the need for medical advice, if such contact has occurred. If signs of 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) appear, immediate medical consultation is required. When using the Nasonex nasal spray; for 12 months there were no signs of atrophy of the nasal mucosa. In addition, mometasone furoate tended to contribute to the normalization of the histological pattern in the study of nasal mucosal biopsy specimens. The efficacy and safety of mometasone has not been studied in the treatment of unilateral polyps, cystic fibrosis-associated polyps and polyps that completely cover the nasal cavity. Forms, especially ulcerated or bleeding, require additional medical examination. The effect on the ability to manage t nsportnymi means and work with mehanizmamiNet data on the effect of the drug Nasonex; on the ability to drive a car or moving machinery.