AERIUS Syrup

For the rapid relief of symptoms associated with allergic rhinitis, such as sneezing, nasal discharge and itching, congestion/stuffiness, as well as ocular itching, tearing and redness, itching or palate and coughing.

AERIUS are also indicated for the relief of symptoms associated with urticaria such as the relief of itching and the size and number of hives.

Posology and Method of administration

Adults (including geriatric patients) and children 12 years of age and older:

10mL once a day, with or without a meal for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria.

Children 6-11 years of age:

5mL once a day, with or without a meal for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria.

Children 1-5 years of age:

2.5mL once a day, with or without a meal for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria.

Children 6 -11 months of age:

2mL once a day, with or without a meal for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria.

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 allergen exposure periods.

In patients who are hypersensitive to this medication or to any of its ingredients, or to loratadine.

In infants and toddlers aged 6-23 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 indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5mg daily, undesirable effects with these tablets were reported in 3% of patients in excess of those treated with placebo. The most frequent adverse events reported in excess off placebo were fatigue (1.2%), dry mouth (0.8%) and headache (0.6%).

Very rare cases of hypersensitivity reactions, including anaphylaxis and rash, have been reported during the marketing of desloratadine. In addition, cases of tachycardia, palpitations, seizures, psychomotor hyperactivity, somnolence, elevated liver enzymes and bilirubin, and hepatitis have been reported very rarely.

No clinically relevant interactions with desloratadine were observed in clinical trials in which azithromycin, erythromycin, ketoconazole, fluoxetine or cimetidine was co-administered.

There was no effect of food or grapefruit juice on the disposition of desloratadine.

Pregnancy

This medicine is not be used during pregnancy unless the potential benefits outweigh the risks.

(See the package insert about the details.)

Lactation

Desloratadine passes into breast milk, therefore, breastfeeding is not recommended in lactating women taking desloratadine.

Desloratadine showed no mutagenic effects in in vitro and in vivo mutagenicity studies.

Efficacy and safety of this syrup in children under 6 months of age have not been established.

After oral administration, desloratadine selectively blocks peripheral histamine H1-receptors because the drug is effectively excluded from entry to the central nervous system (CNS).

(See the package insert about the details.)