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