DESCRIPTION : Each 5 ml of AERIUS syrup contains 2.5 mg of desloratadine.
INDICATIONS AND USAGE
AERIUS syrup is indicated for the rapid relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis), such as sneezing, nasal discharge and itching, congestion/stuffiness, as well as ocular itching, tearing and redness, itching of palate and coughing.
AERIUS syrup is also indicated for the relief of symptoms associated with urticaria such as the relief of itching and the size and number of hives. AERIUS SYRUP PIL BY PHARMACIA1.COM
DOSAGE AND ADMINISTRATION
- Children 1 through 5 years of age : 2.5 ml (1.25 mg) AERIUS syrup once a day, with or without a meal.
- Children 6 through 11 years of age : 5 ml (2.5 mg) AERIUS syrup once a day, with or without a meal.
- In adults and adolescents (12 year of age and over) : 10 ml (5 mg) AERIUS syrup once a day, with or without a meal.
- 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 the 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 allergen exposure periods.
No clinically relevant interactions with AERIUS Syrup were observed in clinical trials . There was no effect of food or grapfruit juice on the disposition of desloratadine.
AERIUS syrup taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol.
In clinical trials in a pediatric 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 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%).
In clinical trials in a range of indicadions including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5mg daily, indesirable effects with AERIUS Syrup were reported in 3 % of patients in excess of those treated with placebo. The most frequent adverse events reported in excess of placebo were fatigue (1.2%) dry mouth (0.8%) and headache (0.6%).
Very rare cases of hypersensitivity reactions (including anaphylaxis and rash), tachycardia, palpitations, psychomotor hyperactivity, seizures, elevations of liver enzymes, hepatitis. and increased bilirubin have been reported during the marketing of desloratadine.
Hypersensitivity to the active substance or to any of the excipients or to loratadine.
Efficacy and safety of AERIUS syrup in children under 6 months of age have not been established.
Effects on ability to drive and use machines : No effects on the ability to drive and use machines have been observed.
USAGE DURING PREGNANCY AND LACTATION
No overall effect on rat fertility was observed with desloratadine at an exposure that was 34 times higher than the exposure in humans at the recommended clinical dose. No teratogenic or mutagenic effects were observed in animal trials with desloratadine.
Since no clinical data on exposed pregnancies are available with desloratadine, the safe use of AERIUS syrup during pregnancy has not been established. AERIUS syrup is not to be used during pregnancy unless the potential benefits outweigh the risks.
Desloratadine is excreted into breast milk, therefore the use of AERIUS syrup is not recommended in breast-feeding women.
In the event of overdose, consider standard measures to remove non adsorbed 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 (9 times the clinical dose), no clinically relevant effects were observed.
Desloratadine is not eliminated by hemodialysis; it is not known if it is eliminated by peritoneal dialysis.
Desloratadine is a non-sedating long-acting histamine antagonist with potent, selective peripheral H1-receptor antagonist activity.
Desloratadine has demonstrated anti allergic, antihistaminic, and anti-inflammatory activity. In addition to antihistaminic activity, desloratadine has demonstrated antiallergic and anti-inflammatory activity from numerous in vitro (mainly conducted on cells of human origin) and in vivo studies. These studies have shown that desloratadine inhibits the broad cascade of events that initiate and propagate allergic inflammation.
Patient Information Leaflet
Categories and tags: R06AX27, Desloratadine, ANTIHISTAMINES FOR SYSTEMIC USE, RESPIRATORY SYSTEM.