Name:
Erius syrup 60ml
Description:
Transparent orange liquid. Main active ingredient Desloratadine Product form syrup Dosage 2.5 mg / 5 ml 60 ml Pharmacological properties After oral administration, desloratadine selectively blocks peripheral H1-histamine receptors, since the substance does not penetrate the blood-brain barrier. The safety of Erius syrup has been demonstrated in three studies involving children. When taking the recommended doses of desloratadine, its plasma concentrations in children and adults were comparable. Thus, since the course of allergic rhinitis/chronic idiopathic urticaria and the profile of desloratadine in adults and children are similar, data on the efficacy of desloratadine in adults can be extrapolated to children. Desloratadine does not cross the blood-brain barrier. In controlled clinical trials at the recommended dose of 5 mg/day for adults and adolescents, the incidence of drowsiness did not exceed that in the placebo group. In clinical and pharmacological studies in adults, desloratadine did not increase the effects of alcohol, such as impaired psychomotor function or drowsiness. Psychomotor test results were not significantly different between patients treated with desloratadine and placebo alone or in combination with alcohol. 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. In intermittent rhinitis, symptoms occur less than 4 days per week or less than 4 weeks. With persistent rhinitis – 4 or more days a week and more than 4 weeks. Pharmacokinetics Desloratadine begins to be determined in plasma in adults and adolescents within 30 minutes after administration. The maximum concentration of desloratadine in plasma is reached after about 3 hours; the half-life in the final phase is about 27 hours. The degree of accumulation of desloratadine corresponds to its half-life (about 27 hours) and the frequency of use (once a day). The bioavailability of desloratadine was dose proportional in the range of 5 to 20 mg. Desloratadine is moderately (83-87%) bound to plasma proteins. When taking desloratadine by adults and adolescents once a day (at a dose of 5-20 mg) for 14 days, no signs of clinically significant cumulation of the active substance were found. In a single-dose crossover study, desloratadine tablets and syrup were found to be bioequivalent. The enzyme responsible for the metabolism of desloratadine has not been established, and therefore the possibility of interaction with other drugs cannot be completely excluded. Indications for use For the relief of symptoms of allergic rhinitis (inflammation of the nasal passages caused by allergies such as hay fever or dust mite allergy) in adults, adolescents and children 1 year of age and older. These symptoms include sneezing, itching and discharge from the nose, itchy palate, itchy and red eyes, and watery eyes. To relieve symptoms associated with hives (a skin condition caused by allergies). These symptoms include itching and rash. Erius relieves these symptoms for the whole day, helps to resume normal daily activities and restore sleep. Dosage and administration Take orally, regardless of food intake. Children: aged 1 to 5 years – 2.5 ml of syrup (1.25 mg of desloratadine) once a day; from 6 to 11 years – 5 ml of syrup (2.5 mg of desloratadine) once a day. Adults and adolescents (≥ 12 years of age): 10 ml syrup (5 mg desloratadine) once daily. Therapy for intermittent allergic rhinitis (symptoms less than 4 days a week or less than 4 weeks) 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), treatment should be continued throughout the entire period of exposure to the allergen. 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 Erius syrup to make up for a missed dose. Children. The safety and efficacy of the drug in children under 1 year of age have not been established. No data available. There is limited clinical experience with the use of desloratadine in children and adolescents 1 to 17 years of age. Most cases of rhinitis under the age of 2 years are of infectious origin, and there are no data for the treatment of infectious rhinitis with Aerius. Elderly patients. Safety and efficacy in elderly patients have not been established. Patients with impaired renal function. In patients with severe renal insufficiency, Erius should be used with caution. Patients with impaired liver function. Data on the use of Erius in patients with impaired liver function are not available. Use during pregnancy and lactation The safety of use in pregnant women has not been established, therefore it is not recommended to prescribe during pregnancy. Desloratadine passes into breast milk, so Erius should not be given to women who are breastfeeding. Precautions Desloratadine should be used with caution in patients with a personal or family history of seizures, and especially in young children who are more likely to experience seizures when treated with desloratadine. The physician may consider discontinuing desloratadine in patients who experience seizures during treatment. Erius syrup contains sucrose and sorbitol, so the drug is not used in patients with congenital fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase deficiency. Erius syrup contains less than 1 mmol (23 mg sodium) per 10 ml, i.e. essentially no sodium. Talk to your doctor, pharmacist or other healthcare professional before taking Erius if you have kidney disease. Effects on ability to drive and use machines At the recommended dose, Erius will not affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended that you do not engage in mentally demanding activities, such as driving a car or operating machinery, until you have established your own response to the drug. Interaction with other drugs Clinically significant changes in the plasma concentration of desloratadine with repeated co-administration with ketoconazole, erythromycin, azithromycin, cimetidine were not found. In a clinical pharmacological study, taking Erius 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 performed in adults. Contraindications Hypersensitivity to any of the components of the drug or loratadine. Composition 1 ml of syrup contains the active substance: desloratadine 0.5 mg; excipients: propylene glycol, liquid sorbitol, citric acid, sodium citrate dihydrate, disodium edetate, sodium benzoate, sucrose, fragrance (No. 15864), yellow dye No. 6 (E110), purified water. Overdose If you have taken more Erius than you should, take the drug as you are advised. 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 syrup than you have been prescribed, tell your doctor, pharmacist or other healthcare professional immediately. Side effects Like all medicines, this medicine can cause side effects, although not everyone experiences them. During the use of Erius syrup, 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. In clinical studies, in most children and adults, side effects were about the same as those observed when testing the placebo solution or tablets. However, more common side effects in children under 2 years of age were diarrhea, fever, and insomnia, and in adults, fatigue, dry mouth, and headache compared with placebo. The following side effects have been observed in clinical studies with Erius: Children. Common in children under 2 years of age (may affect up to 1 in 10 people): diarrhea, fever, insomnia. Adults. Common (may affect up to 1 in 10 people): fatigue, dry mouth, headache. The following adverse reactions have been reported in the post-registration period: Adults. Very rare (may affect up to 1 in 10,000 people): severe allergic reactions, rash, fast or irregular heartbeat, palpitations, stomach pain, nausea, vomiting, indigestion, diarrhea, dizziness, drowsiness, sleep disturbances, muscle pain, hallucinations, seizures, restlessness, inflammation of the liver, abnormal results of liver function tests. Frequency not known (cannot be estimated from the available data): unusual weakness, yellowing of the skin and/or eyes, skin sensitivity to sunlight and artificial ultraviolet radiation, such as when visiting a solarium, changes in heart rate, unusual behavior, aggression, increased appetite, weight gain. Children. Frequency unknown (based on the available data, the frequency of occurrence cannot be determined): slow heart rate, change in heart rate. Providing reports of 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 information database on adverse drug reactions, including information on drug failure, at rceth.by. By reporting adverse reactions, you help to get more information about the safety of the drug. Storage conditions Keep out of the reach of children at a temperature not exceeding 30 ° C. Buy Erius syrup 0.5 mg / ml 60 ml No. 1 Price for Erius syrup 0.5 mg / ml 60 ml No. 1 one
INN | DESLORATADINE |
---|---|
The code | 82 910 |
Barcode | 4 250 369 506 194 |
Active substance | Desloratadine |
Manufacturer | Bayer Cons. Care AG, pr-no for Schering-Plau Labo N.V., Belgium |
Importer | Foreign trade unitary enterprise "BELTRANSFER-MED", 220073 Minsk, Olshevsky str., 20/11-24, 8th floor, room 20 |
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