Relief of symptoms associated with seasonal allergic rhinitis (AR), chronic idiopathic urticaria (CIU).
Hypersensitivity to the active substance, to any of the excipients, or to loratadine.
Children under the age of 1 year of age, severe renal insufficiency, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicdbine.This medicdbinal product contains the colouring agent E110 which may cause allergic reactions. For full details see prescribing information.
In clinical trials in a paediatric population, Aerius syrup was administered to a total of 246 children aged 6 months through 11 years. The overall incidence of adverse events in children 2 through 11 years of age was similar for the Aerius syrup and the placebo groups. In infants and toddlers aged 6 to 23 months, the most frequent adverse events reported in excess of placebo were diarrhoea (3.7 %), fever (2.3 %) and insomnia (2.3 %).
At the recommended dose, in clinical trials involving adults and adolescents in a range of indications including allergic rhinitis and chronic idiopathic urticaria, undesirable effects with Aerius were reported in 3 % of patients in excess of those treated with placebo. The most frequent of adverse events reported in excess of placebo were fatigue (1.2 %), dry mouth (0.8 %) and headache (0.6 %). Other undesirable effects reported very rarely during the post-marketing period are listed in the following table. For full details see prescribing information.
No clinically relevant interactions were observed in clinical trials in which erythromycin or ketoconazole were co-administered. In a clinical pharmacology trial, tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol. For full details see prescribing information.
Aerius may be taken without regard to mealtime for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and chronic idiopathic urticaria. The prescriber should be aware that most cases of rhinitis below 2 years of age are of infectious origin and there are no data supporting the treatment of infectious rhinitis with Aerius.
Children 1 through 5 years of age: 2.5 ml (1.25 mg) Aerius syrup once a day.
Children 6 through 11 years of age: 5 ml (2.5 mg) Aerius syrup once a day.
In adults and adolescents (12 years of age and over): 10 ml (5 mg) Aerius syrup once a day. Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient’s disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance. In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods. For full details see prescribing information.
In the event of overdose, consider standard measures to remove unabsorbed active substance. Symptomatic and supportive treatment is recommended. Based on a multiple dose clinical trial in adults and adolescents, in which up to 45 mg of desloratadine was administered (nine times the clinical dose), no clinically relevant effects were observed. Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal dialysis.
PREGNANCY & LACTATION
Desloratadine was not teratogenic in animal studies. The safe use of the medicinal product during pregnancy has not been established. The use of Aerius during pregnancy is therefore not recommended. Desloratadine is excreted into breast milk, therefore the use of Aerius is not recommended in breastfeeding women.
MANUFACTURER & DISTRIBUTER:
Manufacturer: Schering-Plough Labo N.V., Belgium
License Holder: MSD Israel