AlergoMax (dimethynden maleat) coated tablets 5 mg. №10

active ingredient : desloratadine;

1 tablet contains desloratadine 5 mg;

excipients: calcium hydrophosphate; magnesium stearate cellulose microcrystalline lactose monohydrate, hypromellose; corn starch titanium dioxide (E 171) indigo (E 132).

Film-coated tablets.

Basic physical and chemical properties: film-coated tablets, blue, round, biconvex. The cross section shows two layers.

Antihistamines for systemic use. ATX code R06A X27.

Desloratadine is a non-sedating, long-acting antihistamine that has a selective antagonistic effect on peripheral H1 receptors. After oral administration, desloratadine selectively blocks peripheral histamine H1 receptors.

In in vitro studies, desloratadine has demonstrated its anti-allergic and anti-inflammatory properties on endothelial cells. This was manifested by inhibition of the release of pro-inflammatory cytokines such as IL-4, IL-6, IL-8 and IL-13 from human mast cells/basophils, as well as inhibition of the expression of adhesion molecules such as P-selectin. The clinical significance of these observations still needs to be confirmed.

In high-dose clinical studies in which desloratadine was administered daily at a dose of up to 20 mg for 14 days, no statistically significant changes in the cardiovascular system were observed. In a clinical pharmacological study, when using 45 mg per day (10 times the maximum daily clinical dose) for 10 days, no prolongation of the QT interval was observed.

In patients with allergic rhinitis, Alergomax effectively eliminated symptoms such as sneezing, nasal discharge and itching, as well as eye irritation, tearing and redness, and itching of the palate. Alergomax effectively controlled the symptoms within 24 hours.

Desloratadine almost does not penetrate the central nervous system. In controlled clinical trials, when taken at the recommended dose of 5 mg per day, the incidence of drowsiness did not differ from the placebo group. In clinical studies, a single dose of Alergomax at a daily dose of 7.5 mg had no effect on psychomotor activity.

Alergomax effectively alleviates the severity of seasonal allergic rhinitis, taking into account the total indicator of the questionnaire for assessing the quality of life in rhinoconjunctivitis. The greatest improvement was noted in the items of the questionnaire related to practical problems and daily activities, which limited the symptoms.

Chronic idiopathic urticaria was studied in a clinical model with urticaria conditions. Because histamine release is a causative factor in all forms of urticaria, desloratadine is expected to be effective in alleviating symptoms in other forms of urticaria, including chronic idiopathic urticaria.

In two placebo-controlled 6-week studies in patients with chronic idiopathic urticaria, Alergomax effectively relieved itching and reduced the number and size of urticaria by the end of the first dosing interval. In each study, the effect lasted for a 24-hour dosing interval. Relief of itching by more than 50% was observed in 55% of patients taking desloratadine compared to 19% of patients taking placebo. Taking the drug does not have a significant effect on sleep and daytime activity.

Elimination of symptoms associated with allergic rhinitis, urticaria.

Hypersensitivity to the active substance or to any excipient of the drug or to loratadine.