What is Neoclarityn?
Neoclarityn is a drug containing the active substance desloratadine. It is available as 5 mg tablets, as a 5 mg oral lyophilisate (dispersible tablet), in orodispersible tablets (tablets that dissolve in the mouth) of 2.5 and 5 mg, in syrup of 0, 5 mg / ml and as a solution oral 0.5 mg / ml.
What is Neoclarityn used for?
Neoclarityn is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, such as hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, whose symptoms include itching and rash).
The medicine can only be obtained with a prescription.
How is Neoclarityn used?
The recommended dose for adults and adolescents (starting at 12) is 5 mg once a day. The dose for children depends on age. For children one to five years the dose is 1.25 mg once a day, taken in the form of 2.5 ml of syrup or oral solution. For children aged six to eleven, the dose is 2.5 mg once a day, taken either as 5 ml syrup or oral solution or as a 2.5 mg orodispersible tablet. Adults and adolescents can take the medicine in any form.
Neoclarityn can be taken with or without food.
How does Neoclarityn work?
Desloratadine, the active ingredient in Neoclarityn, is an antihistamine that works by blocking the receptors on which histamine, a substance in the body, that allergic symptoms normally attaches. When the receptors are blocked, histamine has no effect and this leads to a decrease in allergic symptoms.
What studies have been carried out on Neoclarityn?
Overall, Neoclarityn has been the subject of eight studies involving 4, 800 adult and adolescent patients with allergic rhinitis (including four studies on seasonal allergic rhinitis and two studies with patients also with asthma). The efficacy of Neoclarityn was measured by observing the change in symptoms (nasal bleeding, itching, sneezing and congestion) before and after two to four weeks of treatment.
Neoclarityn has also been studied in 416 patients with urticaria. Efficacy was measured by observing changes in symptoms (itching, number and size of rashes, interference with sleep and daytime functions) before and after six weeks of treatment.
In all the studies, the efficacy of Neoclarityn was compared with that of a placebo (a dummy treatment).
Additional studies have been presented to show that syrup, oral solution and orodispersible tablets are treated by the body in the same way as tablets and to show that they can be safely given to children.
What benefit has Neoclarityn shown during the studies?
In allergic rhinitis, observing the results of all the studies as a whole, two weeks of treatment with 5 mg of Neoclarityn resulted in an average decrease in the score of symptoms of 25 - 32%, compared to a decrease of 12 - 26% in patients treated with placebo. Regarding the two studies on urticaria, the decrease in symptom score after six weeks of treatment with Neoclarityn was 58% and 67% compared to 40% and 33% in patients treated with placebo.
What is the risk associated with Neoclarityn?
The most common side effects in adults and adolescents are fatigue (fatigue 1.2%), dry mouth (0.8%) and headache (0.6%). The side effects observed in children are similar. In children under the age of two the most common side effects are diarrhea (3.7%), fever (2.3%) and insomnia (2.3%). For the full list of all side effects reported with Neoclarityn, see the Package Leaflet.
Neoclarityn should not be used in people who are hypersensitive (allergic) to desloratadine, loratadine or to any of the other ingredients.
Why has Neoclarityn been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Neoclarityn's benefits are greater than its risks for alleviating the symptoms associated with allergic rhinitis or hives. The committee recommended the granting of a marketing authorization for Neoclarityn.
More information on Neoclarityn
On 15 January 2001, the European Commission granted a marketing authorization valid throughout the European Union for Neoclarityn to SP Europe. The authorization was renewed on January 15, 2006.
The full EPAR for Neoclarityn can be found here.
Last update of this summary: 04-2008.
