Aerius ® syrup is used for the following indications:
The active ingredient is desloratadine (1 ml of syrup contains 0.5 mg of desloratadine).
Excipients: propylene glycol, sorbitol solution that does not crystallize, citric acid anhydrous, sodium citrate dihydrate, sodium benzoate (E 211), disodium edetate, sucrose, natural and artificial flavor with chewing gum flavor (No. 15864), yellow dye FD&C No. 6 (E 110), purified water.
Hypersensitivity to desloratadine, to any auxiliary component of the preparation, or to loratadine.
To eliminate the symptoms associated with allergic rhinitis (including intermittent and persistent) and urticaria, "Aerius ®" is used regardless of food intake in the doses indicated below.
10 ml of syrup (5 mg desloratadine) once a day.
Therapy of intermittent allergic rhinitis (the presence of symptoms less than 4 days a week or less than 4 weeks) should be carried out taking into account the history data: stop after the symptoms disappear and restore after their reoccurrence. With persistent allergic rhinitis (the presence of symptoms more than 4 days a week or more than 4 weeks), it is necessary to continue treatment during the entire period of contact with the allergen.
The efficacy and safety of using Aerius ® syrup for children under 6 months of age have not been established. The preparation is not recommended for children under 6 months of age for the treatment of chronic idiopathic urticaria and for children under 12 months for the treatment of allergic rhinitis. For treatment, the following dosage regimen is used:
children aged 6 to 11 months - 2 ml of syrup (1 mg desloratadine) once a day;
children aged 1 to 5 years - 2.5 ml of syrup (1.25 mg desloratadine) once a day;
children aged 6 to 11 years - 5 ml of syrup (2.5 mg desloratadine) once a day.
Pregnant
As a precautionary measure, it is advisable to avoid the use of Aerius ® during pregnancy.
Desloratadine passes into breast milk, therefore, women who are breastfeeding are advised to determine whether it is necessary to stop breastfeeding or avoid the use of the preparation, given the benefits of breastfeeding for the baby and the benefits of using the preparation for the mother.
Drivers
The data of clinical studies indicate that this syrup does not affect or has a slight effect on the ability to drive vehicles or other mechanisms. Patients should be advised that most people do not experience drowsiness. It should be borne in mind that individual preparation reactions may differ. Patients are advised not to engage in activities requiring concentration, such as driving or using other machinery, until they have determined their response to the preparation.
In case of an overdose, standard measures are used to remove the non-adsorbed active substance, symptomatic treatment is used.
When using desloratadine in a dose of up to 45 mg (which is 9 times higher than the recommended ones), no clinically significant effects were observed in clinical trials in adults and adolescents.
Desloratadine is not removed by hemodialysis, and the possibility of its removal by peritoneal dialysis has not been established.
In clinical trials for indications, including allergic rhinitis and chronic idiopathic urticaria, adverse effects were reported 3% more frequently in patients receiving 5 mg daily than in patients receiving placebo.
The most commonly reported side effects compared to placebo were fatigue (1.2%), dry mouth (0.8%), and headache (0.6%).
In children aged 6 to 23 months, the most frequent (compared with placebo) adverse events were diarrhea (3.7%), fever (2.3%) and insomnia (2.3%).
Store at a temperature not exceeding 30 ° C, out of the reach of children.
Shelf life is 2 years.
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