Erius tablets p/o 5mg №10×1

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Erius tab p/o 5 mg in a blister pack No. 10×1
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The main active ingredient Desloratadine Release form Tablets Dosage 5 mg Pharmacological properties Pharmacodynamics Desloratadine is a non-sedating long-acting antihistamine drug with a selective antagonistic effect on peripheral H1-histamine receptors. After oral administration, desloratadine selectively blocks peripheral H1-histamine receptors, since the substance does not penetrate the blood-brain barrier. In vitro studies have shown that desloratadine has anti-allergic effects, including inhibition of the release of pro-inflammatory cytokines, including IL-4, IL-6, IL-8 and IL-13, from human mast cells/basophils, and also inhibits the expression of the adhesion molecule P -selectin in endothelial cells. The clinical significance of these data remains unknown. In multiple dose clinical studies, daily use of desloratadine at a dose of less than 20 mg for 14 days was not accompanied by statistically or clinically significant changes in the cardiovascular system. In a clinical pharmacological study on the use of the drug Erius at a dose of 45 mg / day (9 times higher than the therapeutic dose), no prolongation of the QTc interval was observed for 10 days. In interaction studies with ketoconazole and erythromycin, there were no clinically significant changes in plasma concentrations of desloratadine. Erius does not penetrate the blood-brain barrier. In controlled clinical trials, when using the recommended dose of 5 mg, the frequency of drowsiness did not exceed that in the placebo group. In clinical studies, Erius did not affect psychomotor function when taking a dose of not more than 7.5 mg. In a single dose study in adults, desloratadine 5 mg had no effect on standard flight performance parameters, including increased subjective drowsiness or impaired ability to perform flight tasks. In clinical and pharmacological studies, desloratadine did not increase the effects of alcohol, such as impaired psychomotor function and drowsiness. Psychomotor test results were not significantly different between patients treated with desloratadine and placebo alone or in combination with alcohol. In patients with allergic rhinitis, Erius was effective in relieving symptoms such as sneezing, nasal discharge and itching, as well as itching and redness of the eyes, watery eyes, and itchy palate. Erius effectively controls the symptoms within 24 hours. The effectiveness of Erius tablets has not been unequivocally demonstrated in studies in adolescents aged 12-17 years. In addition to the established classification of rhinitis (seasonal and year-round), allergic rhinitis can be divided into intermittent and persistent on the basis of the duration of symptoms. Intermittent rhinitis has symptoms less than 4 days per week or less than 4 weeks per year. With persistent rhinitis – more than 4 days a week or more than 4 weeks a year. Erius quite effectively alleviated the condition of patients with seasonal allergic rhinitis according to the results of the total score of the questionnaire for the quality of life of patients with rhinoconjunctivitis. The greatest improvement was noted in the area of practical problems and daily activities limited by the presence of symptoms. As a clinical model of urticaria, chronic idiopathic urticaria has been studied based on the similarity of their underlying pathophysiological mechanisms, regardless of etiology, and the absence of problems in a prospective recruitment of patients suffering from a chronic disease. Since histamine release is a causative factor in all types of urticaria, desloratadine is expected to be effective in relieving the symptoms of other types of urticaria, including chronic idiopathic urticaria, as indicated in the clinical guidelines. In two placebo-controlled six-week trials in patients with chronic idiopathic urticaria, Erius was effective in relieving itching and reducing the size and number of rashes after the first course of treatment. In each study, the effect persisted for up to 24 hours post-dose. As in other studies of antihistamines in chronic idiopathic urticaria, a minority of patients who were considered resistant to antihistamine treatment were excluded. Relief of pruritus of more than 50% was observed in 55% of patients treated with desloratadine, compared with 19% of patients who received placebo. Treatment with Aerius also significantly reduced the negative impact of the disease on sleep and activity during the day, which was determined on a four-point scale used to evaluate these variables. Pharmacokinetics Desloratadine begins to be determined in plasma within 30 minutes after ingestion. The maximum concentration of desloratadine in plasma is reached after an average of 3 hours, the half-life is on average 27 hours. The degree of accumulation of desloratadine corresponds to its half-life (approximately 27 hours) and the frequency of application (once a day). The bioavailability of desloratadine was dose proportional in the range of 5 to 20 mg. In a pharmacokinetic study in which patient demographics were comparable to those in the general population of individuals with seasonal allergic rhinitis, 4% of subjects achieved higher concentrations of desloratadine. This percentage may vary by ethnicity. The maximum concentration of desloratadine was almost 3 times higher after about 7 hours with a terminal elimination half-life lasting about 89 hours. The safety profile of these subjects did not differ from that of the general population. Desloratadine is moderately (83-87%) bound to plasma proteins. When using desloratadine at a dose of 5-20 mg once a day for 14 days, no signs of clinically significant cumulation of the drug were found. The enzymes responsible for the metabolism of desloratadine have not yet been established, and therefore the possibility of interaction with other medicinal products cannot be completely excluded. The results of in vivo and in vitro studies have shown that desloratadine does not inhibit CYP3A4 or CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein. In a study with a single dose of desloratadine at a dose of 7.5 mg, it was found that food (fat high-calorie breakfast) or grapefruit juice did not affect the distribution of desloratadine. Patients with impaired renal function The pharmacokinetics of desloratadine in patients with chronic renal failure (CRF) was compared with the pharmacokinetics in healthy subjects in one single dose study and one multiple dose study. In a single dose study, exposure to desloratadine was approximately 2 and 2.5 times greater in patients with mild/moderate and severe CKD, respectively, than in healthy subjects. In a multi-dose study, steady state was reached after day 11, and compared with healthy subjects, exposure to desloratadine was approximately 1.5 times greater in patients with mild to moderate CKD and approximately 2.5 times greater in patients with severe CKD. . In both studies, changes in exposure (AUC and Cmax) to desloratadine and 3-hydroxydesloratadine were not clinically significant. Indications for use To relieve the symptoms of allergic rhinitis, such as itching and redness of the eyes, watery eyes, sneezing, itching and discharge from the nose, itching of the palate. To relieve symptoms associated with hives such as itching and rash. Dosage and administration To relieve symptoms associated with allergic rhinitis (including intermittent and persistent) and urticaria, Erius is taken with or without food. Adults and children over 12 years old: 1 tablet 1 time per day. Therapy for intermittent allergic rhinitis (symptoms less than 4 days per week or less than 4 weeks per year) should be carried out taking into account the data of the anamnesis: stop after the disappearance of symptoms and resume after their reappearance. In persistent allergic rhinitis (symptoms more than 4 days a week or more than 4 weeks a year), treatment should be continued throughout the entire period of exposure to the allergen. Children The safety and efficacy of the drug in children under 12 years of age have not been established. No data available. Experience in clinical trials with desloratadine in adolescents 12 to 17 years of age is limited. Elderly patients Safety and efficacy in elderly patients have not been established. Patients with impaired renal function In patients with severe renal insufficiency, use with caution. Patients with hepatic impairment No data are available for use in patients with hepatic impairment. If you forget to take your medicine on time, take the missed dose as soon as possible. Then continue taking Erius at the usual time. Do not take a double dose of tablets to make up for a missed dose. Use during pregnancy and lactation If you are planning to have a child, are pregnant (or think you are pregnant) or are breastfeeding, ask your doctor or pharmacist for advice before taking Erius. If you are pregnant or breastfeeding, Erius is not recommended. Precautions The efficacy and safety of the drug Erius in the form of tablets in children under 12 years of age has not been studied (since the tablet is indivisible, and the dose of the tablet is calculated for children over 12 years of age). Desloratadine should be used with caution in patients with a personal or family history of seizures, and especially in young children who are more prone to seizures when treated with desloratadine. The physician may consider discontinuing desloratadine in patients who experience seizures during treatment. The tablets contain lactose, so the drug is not used in patients with congenital galactose intolerance, Lapp lactase deficiency and glucose-galactose malabsorption. Interaction with other drugs Clinically significant changes in the plasma concentration of desloratadine with repeated co-administration with ketoconazole, erythromycin, azithromycin, fluoxetine, cimetidine were not found. Interaction with other drugs is not known. In a clinical pharmacological study, taking Erius tablets simultaneously with alcohol did not increase the adverse effects of alcohol on psychomotor function. However, in the post-marketing period, cases of alcohol intolerance and intoxication have been reported. Therefore, caution is advised if alcohol is taken concomitantly with the drug. Children Interaction studies have only been conducted in adults. If you are taking any medications, consult your doctor about the possibility of using the drug. Contraindications Hypersensitivity to any of the components of the drug or loratadine. Composition 1 tablet contains active ingredient: desloratadine 5 mg; excipients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, corn starch, talc; shell: lactose monohydrate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, aluminum blue lacquer FD&C No. 2, carnauba wax, white wax. Overdose The drug should be taken in accordance with the doctor’s recommendations. In case of accidental overdose, serious adverse events are not expected. Undesirable reactions can be observed, which are described when taking the usual therapeutic doses, but the degree of their severity in case of an overdose may be higher. If you have taken more Erius tablets than recommended, tell your doctor, pharmacist or other healthcare professional immediately. Side effects Like all medicines, Erius can cause side effects, although not everyone experiences them. During the use of Erius, cases of severe allergic reactions (difficulty breathing, wheezing, itching, urticaria and swelling) were very rarely observed. In the event of these adverse reactions, you should stop taking the drug and consult a doctor immediately. Side effects observed during clinical studies in adults were approximately similar to adverse events when taking placebo. However, fatigue, dry mouth, and headache were more common than with placebo. Headache was reported as the most common side effect in adolescents. According to the results of clinical studies of the drug Erius, the following side effects were noted: often (in more than 1 person out of 10): fatigue, dry mouth, headache. Adults The following side effects have been reported during post-marketing use of Erius: very rare (may affect up to 1 in 10,000 people): severe allergic reactions, rash, increased or irregular heartbeat, rapid heartbeat, stomach pain, nausea, vomiting, indigestion , diarrhea, dizziness, drowsiness, sleep disturbances, muscle pain, hallucinations, convulsions, marked restlessness, inflammation of the liver, abnormal results of liver function tests; frequency not known (frequency cannot be estimated from the available data): unusual weakness, yellowing of the skin and/or eyes, increased sensitivity of the skin to the sun (even on cloudy days) and to ultraviolet radiation (for example, when visiting a solarium), changes in heart rate , non-standard behavior, aggression, increased appetite, weight gain. Children Frequency unknown: weak heartbeat, change in heart rate, unusual behavior, aggression. Reporting adverse reactions In case of any adverse reactions, you should consult your doctor. This recommendation applies to any possible adverse reactions, including those not listed in the package insert. You can also report adverse reactions to the National Adverse Drug Reaction Information Database, including information on drug failures. Website address: rceth.by By reporting adverse reactions, you help to get more information about the safety of the drug. Storage conditions Store in a dry place, out of reach of children, at a temperature not exceeding 30 °C. Buy Erius tablets p/o 5mg No. 10×1