Nasonex nasal spray dosed 50mcg/dose 140 doses №1

Name:
Nasonex spray naz.dozir.50mkgd in vial 140dose in pack No. 1
Description:
White or almost white opaque suspension. The main active substance Mometasone Release form nasal spray Dosage 140 doses Pharmacological properties Pharmacodynamics Mechanism of action Mometasone furoate ? glucocorticosteroid for topical use, which has a local anti-inflammatory effect, manifested in doses at which systemic effects do not occur. It is likely that the main mechanism of the anti-allergic and anti-inflammatory action of mometasone furoate is associated with its ability to inhibit the release of mediators of allergic reactions. Mometasone furoate significantly reduces the release of leukotrienes from the leukocytes of patients suffering from allergic diseases. Mometasone furoate showed high activity in cell culture against the inhibition of the synthesis/release of IL-1, IL-5, IL-6 and TNFα. It is also a potent inhibitor of leukotriene production. In addition, it is also a potent inhibitor of the production of Th2 cytokines, IL-4 and IL-5 from human CD4* T cells. In studies with provocative tests with the application of antigens to the nasal mucosa, the anti-inflammatory activity of Nasonex nasal spray was revealed both in the early and late stages of an allergic reaction. This was confirmed by a decrease (compared with placebo) in histamine levels and eosinophil activity, as well as a decrease (compared to baseline) in the number of eosinophils, neutrophils and epithelial cell adhesion proteins. In 28% of patients with seasonal allergic rhinitis, Nasonex nasal spray showed a clinically significant onset of action within 12 hours after the first dose. On average (50%), relief occurred within 35.9 hours. Children was not observed. There are limited data on the safety and efficacy of Nasonex Nasal Spray in children aged 3 to 5 years and an appropriate dose range cannot be established. In a study of 48 children aged 3 to 5 years treated with mometasone furoate intranasally at 50, 100, or 200 mcg/day for 14 days, there were no significant differences compared with placebo in mean change in plasma cortisol levels in response to for a stimulation test with tetracosactrin. Pharmacokinetics The bioavailability of mometasone furoate when used in the form of an aqueous nasal spray is < 1% in plasma, using a quantitative determination method with a sensitivity threshold of 0.25 pg / ml. Distribution Not considered because mometasone is very poorly absorbed when administered intranasally. Metabolism A small amount of the drug, which can be swallowed and absorbed, undergoes active primary metabolism in the liver. Withdrawal The absorbed amount of mometasone furoate is actively metabolized, and the metabolites are excreted in the urine and bile. Indications for use Treatment of seasonal or year-round allergic rhinitis in adults and children aged 2 years and older. acute rhinosinusitis without signs of severe bacterial infection in adults and children aged 12 years and older. Treatment of nasal polyps and associated symptoms, including nasal congestion and loss of smell, in patients aged 18 years and older. Dosage and administration Treatment of seasonal or perennial allergic rhinitis : for adults (including the elderly) and adolescents over the age of 12 years, the recommended prophylactic and therapeutic dose of the drug is 2 injections (50 mcg each) in each nostril 1 time per day (total daily dose? 200 mcg). After achieving a therapeutic effect for maintenance therapy, it is advisable to reduce the dose to 1 injection in each nostril 1 time per day (total daily dose ≥ 100 mcg). If relief of the symptoms of the disease cannot be achieved using the drug at the recommended therapeutic dose, the daily dose may be increased to the maximum: 4 injections in each nostril 1 time per day (total daily dose ≥ 400 mcg). After easing the symptoms of the disease, a dose reduction is recommended. In some patients with seasonal allergic rhinitis, this drug has demonstrated a clinically significant onset of action within 12 hours after the first dose. However, the full benefit of the treatment cannot be obtained in the first 48 hours, so the patient must continue regular use to achieve the full therapeutic effect. Nasonex nasal spray treatment may be started a few days before the start of the pollinating season in patients with a history of moderate to severe seasonal allergic rhinitis. For children aged 2-11 years, the recommended therapeutic dose is 1 injection (50 mcg each) in each nostril once a day (total daily dose ? 100 mcg). Acute rhinosinusitis. For adults (including the elderly) and children aged 12 years and older, the recommended therapeutic dose is 2 injections (50 mcg) in each nostril 2 times a day (total daily dose ≥ 400 mcg). nasal polyps. For patients over 18 years of age (including the elderly), the recommended dose is 2 injections (50 mcg each) in each nostril once a day (total daily dose ? 200 mcg). If after 5-6 weeks of treatment there is no improvement in the symptoms of the disease, the dose may be increased to two injections in each nasal passage 2 times a day (total daily dose? 400 mcg). The dose should be gradually reduced to a lower dose that provides effective control of the symptoms of the disease. If after 5-6 weeks of treatment there is no improvement in the symptoms of the disease, the patient's condition should be reviewed and alternative methods of treatment should be considered. Preparing the nasal spray for use Nasonex Nasal Spray has a dust cap that protects the sprayer and keeps it clean. Don't forget to take it off before spraying and put it back on after use. Before the first use, it is necessary to “calibrate” the spray by 10 clicks of the dosing device until the spray begins to spray: 1. Gently shake the bottle. 2. Place your index and middle fingers on either side of the atomizer and your thumb under the vial. Do not pierce the nasal applicator. 3. Point the sprayer away from you, and then press down with your fingers 10 times until the spray begins to spray. If the nasal spray has not been used for 14 days or more, a re- "calibration" is necessary, which is carried out by pressing the dosing device 2 times until the spray appears. How to use the nasal spray 1. Gently shake the bottle and remove the dust cap 2. Blow your nose gently. 3. Close one nostril and place the nebulizer in the other nostril. Tilt your head slightly forward, holding the vial upright. 4. Start inhaling gently or slowly through the nose and at the same time inject the spray into the nostril by pressing the dosing device once. 5. Exhale through your mouth. Repeat step 4 to spray a second time in the same nostril, if applicable. 6. Pull the nebulizer out of that nostril and exhale through your mouth. 7. Repeat steps 3-6 for the second nostril. Thoroughly wipe the atomizer with a clean handkerchief or tissue after using the spray, put on the dust cap. Cleaning the nasal spray It is important to clean the nasal spray nozzle regularly, otherwise it will not work properly. Remove the dust cap and carefully remove the sprayer. Wash the nozzle and dust cap with warm water and then rinse under running water. object, as this may damage the device and lead to incorrect dosing of the medicinal substance. Dry the nebulizer and dust cap in a warm place. Place the nebulizer on the spray bottle and put on the dust cap. cleaning. If you have used more Nasonex than you should Tell your doctor if you have accidentally used more than you were told. Using steroids for a long time or in large amounts can sometimes affect some of your hormones. In children, it can affect growth and development. If you forget to use Nasonex If you forget to use the nasal spray at the right time, use it as soon as you remember and then continue as before. Do not take a double dose to make up for a forgotten dose. Use during pregnancy and lactation Pregnancy There is no or limited information on the use of mometasone furoate in pregnant women. Animal studies have shown reproductive toxicity. As with other intranasal corticosteroids, Nasonex nasal spray should only be used in pregnant women if the expected benefit justifies the potential risk to the mother, fetus or infant. Infants whose mothers used corticosteroids during pregnancy should be carefully examined for possible hypofunction of the adrenal glands. Lactation It is not known whether mometasone furoate is excreted in human breast milk. As with other intranasal corticosteroids, a decision should be made whether to discontinue breastfeeding or discontinue/withhold Nasonex Nasal Spray therapy, taking into account the benefits of breastfeeding for the baby and the benefits of treatment for the woman. PrecautionsImmunosuppression Nasonex nasal spray should be used with caution or not at all in patients with active or latent tuberculosis infection of the respiratory tract, as well as in untreated fungal, bacterial or systemic viral infections. Patients using corticosteroids may potentially have 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), as well as the need to consult a doctor if such contact occurs. Local nasal effects In a study involving patients with perennial rhinitis, after 12 months of treatment with Nasonex nasal spray, there were no signs of atrophy of the nasal mucosa; in addition, mometasone furoate contributed to the normalization of the histological picture of the nasal mucosa. However, patients using Nasonex nasal spray for several months or longer should be periodically examined for possible changes in the nasal mucosa. If a local fungal infection of the nose or pharynx develops, it may be necessary to stop therapy with Nasonex nasal spray or to undergo special treatment. Irritation of the nasal and pharyngeal mucosa, which persists for a long time, may also be an indication to stop treatment with Nasonex Nasal Spray. The use of Nasonex is not recommended in case of perforation of the nasal septum. In clinical studies, nosebleeds were observed at a higher frequency than with placebo. Nosebleeds stopped spontaneously and were moderate. Nasonex nasal spray contains benzalkonium chloride, which can cause irritation of the nasal mucosa. Systemic effects of corticosteroids Systemic effects may occur with the use of nasal corticosteroids, especially when administered at high doses and with prolonged use. These effects are less likely than with oral corticosteroids and may differ between patients and between different corticosteroid agents. Potential systemic effects may include Cushing's syndrome, Cushingoid symptoms, adrenal suppression, growth retardation in children and adolescents, cataracts, glaucoma, and, less commonly, psychiatric or behavioral disorders including psychomotor agitation, hyperactivity, sleep disturbances, anxiety, depression, or aggression (especially in children). After the use of intranasal corticosteroids, cases of increased intraocular pressure have been reported. With the use of systemic and local corticosteroids (including intranasal, inhalation and intraocular administration), visual disturbances may occur. If symptoms such as blurred vision or other visual disturbances occur, the patient should be evaluated by an ophthalmologist to evaluate possible causes of visual impairment, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy, which have been reported after corticosteroid use systemic and local action. Patients switching to Nasonex Nasal Spray after long-term treatment with systemic corticosteroids should be closely monitored. Discontinuation of systemic corticosteroids in these patients may lead to adrenal insufficiency, for several months before restoration of the function of the hypothalamic-pituitary-adrenal system. If these patients show signs and symptoms of adrenal insufficiency or withdrawal symptoms (eg, joint and/or muscle pain, initial fatigue, and depression) despite improvement in nasal symptoms, systemic corticosteroids should be restarted, other therapies, and appropriate measures taken. Such a change in therapy may also reveal pre-existing allergic conditions such as allergic conjunctivitis and eczema that have developed earlier and were masked by systemic corticosteroid therapy. Treatment with doses higher than those recommended may result in clinically significant adrenal suppression. If there is evidence that higher than recommended doses are used, then the use of an additional systemic corticosteroid during periods of stress or elective surgery should be considered. Nasal polyps The safety and efficacy of Nasonex Nasal Spray in the treatment of unilateral polyps, polyps associated with cystic fibrosis, or polyps that completely obstruct the nasal passage have not been studied. Unilateral polyps with an unusual or irregular shape, especially those that are ulcerated or bleeding, require a more in-depth examination. Effects on Growth in Children It is recommended that growth be carefully monitored in children receiving long-term treatment with nasal corticosteroids. If growth is retarded, treatment should be reconsidered to reduce the dose of nasal corticosteroid, if possible, to the lowest dose that provides effective control of symptoms of the disease. In addition, referral of the patient to a pediatrician should be considered. Non-nasal symptoms Although Nasonex Nasal Spray will control nasal symptoms in most patients, concomitant use of appropriate adjunctive treatment may provide additional relief of other symptoms, in particular ocular symptoms. Children. When conducting placebo-controlled clinical trials in children using Nasonex at a daily dose of 100 mcg during the year, no growth retardation was observed in children. However, the long-term effects of intranasal/inhaled steroids have not been definitively investigated. The physician should carefully monitor the growth and development of children receiving long-term treatment with glucocorticosteroids. The safety and efficacy of Nasonex have not been studied in the treatment of nasal polyps in children and adolescents under 18 years of age, symptoms of rhinosinusitis in children under 12 years of age, seasonal or perennial allergic rhinitis in children under 2 years of age. The use of high doses or long-term treatment with glucocorticosteroids can lead to systemic side effects, including growth retardation in children. The long-term effect of intranasal/inhaled steroids in children has not been fully investigated. The physician should carefully monitor the growth and development of children receiving long-term treatment with glucocorticosteroids. In a study of 49 children who received 100 mg of Nasonex daily for 1 year, no decrease in growth rate was observed. Interactions with other drugs Clinical interaction studies have been conducted with loratadine. No interaction was observed. Mometasone furoate is metabolized by CYP3A4. Co-administration with potent inhibitors of CYP3A4 (eg, ketoconazole, itraconazole, clarithromycin, ritonavir, drugs containing cobicistat) may increase plasma corticosteroid concentrations and potentially increase the risk of systemic corticosteroid adverse reactions. Consideration should be given to the benefits of concomitant use of corticosteroids and the potential risk of systemic reactions to corticosteroids, as well as to monitor the patient's condition regarding the occurrence of the above adverse reactions. Contraindications Hypersensitivity to the active substance, mometasone furoate, or any of the excipients. Nasonex Nasal Spray should not be used in the presence of an untreated localized infection involving the nasal mucosa, such as herpes simplex. Because corticosteroids delay wound healing, intranasal corticosteroids should not be given to patients who have recently undergone surgery or trauma to the nose until the wound has completely healed. Composition 1 spray dose contains mometasone furoate monohydrate in an amount equivalent to 50 mcg mometasone furoate (anhydrous); excipients: dispersed cellulose, glycerin, sodium citrate dihydrate, citric acid, polysorbate-80, benzalkonium chloride, purified water. OverdoseSymptoms Inhalation or oral administration of excessive doses of corticosteroids can lead to depression of the function of the hypothalamic-pituitary-adrenal system. Treatment Due to the systemic bioavailability of Nasonex Nasal Spray is < 1%, it is unlikely that overdose will require other measures than monitoring the patient's condition, followed by resumption of the drug at the appropriate prescribed dosage. Adverse Effects Brief summary of the safety profile Nosebleeds were generally self-limiting, moderate, slightly more common than placebo (5%) but less common than other intranasal corticosteroids used as active controls in allergic clinical trials. rhinitis (in some of them the incidence of nosebleeds was up to 15%). The incidence of all other adverse reactions was comparable to that of placebo. In patients treated for nasal polyps, the overall incidence of adverse reactions was similar to that observed in patients with allergic rhinitis. Systemic effects may occur with the use of nasal corticosteroids, especially at high doses and with prolonged use. List of Adverse Reactions Table 1 lists treatment-related adverse reactions (≥ 1%) reported in clinical studies in patients with allergic rhinitis or nasal polyps and in post-marketing reports, regardless of indication. Adverse reactions are presented according to the main class of the MedDRA organ system. Within each organ system class, adverse reactions are categorized according to frequency. The frequency categories were as follows: very common (? 1/10); often (? 1/100 and < 1/10); infrequently (? 1/1000 and < 1/100). The frequency of post-marketing adverse reactions is defined as “unknown (cannot be determined from the available data)”. Children In children, the incidence of reported adverse reactions in clinical studies, ie, epistaxis (6%), headache (3%), nasal irritation (2%) and sneezing (2%), was comparable to placebo. Storage conditions Store at a temperature not exceeding 25 ° C, out of the reach of children. Do not freeze. 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