Allergostop (desloratadine) coated tablets 5 mg. №20

active substance: desloratadine;

1 tablet contains desloratadine (calculated as 100% substance) 5 mg;

excipients: lactose, monohydrate; calcium hydrogen phosphate dihydrate; microcrystalline cellulose; potato starch; pregelatinized starch; sodium starch glycolate (type A); talc; magnesium stearate;

shell composition: Opadry II blue (polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol (macrogol), talc, brilliant blue (E 133), indigo carmine (E 132)); Opadry II white (polyvinyl alcohol, titanium dioxide (E 171), polyethylene glycol (macrogol), talc).

Antihistamines for systemic use. ATX code R06A X27.

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

Desloratadine demonstrated its anti-allergic and anti-inflammatory properties on endothelial cells in in vitro studies. 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 remains 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, statistically significant changes in the cardiovascular system were not observed. In a clinical-pharmacological study when using 45 mg per day (10 times more than the maximum daily clinical dose) for 10 days, prolongation of the QT interval was not observed.

In patients with allergic rhinitis, desloratadine effectively eliminated symptoms such as sneezing, nasal discharge and itching, as well as eye irritation, tearing and redness, itchy palate. Desloratadine effectively controlled symptoms for 24 hours.

Desloratadine almost does not penetrate into the central nervous system. In controlled clinical studies, when taking the recommended dose of 5 mg per day, the frequency of drowsiness did not differ from the placebo group. In clinical studies, a single dose of desloratadine in a daily dose of 7.5 mg did not affect psychomotor activity.

Desloratadine effectively relieves the severity of the course of seasonal allergic rhinitis, taking into account the total index of quality of life surveys in rhinoconjunctivitis.

The greatest improvement was noted in questionnaire items related to practical problems and daily activities that limited symptoms.

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

In two placebo-controlled 6-week studies in patients with chronic idiopathic urticaria, desloratadine was effective in relieving pruritus and reducing the number and size of urticaria by the end of the first dosing interval. In each study, the effect lasted throughout the 24-hour dosing interval. Relief of pruritus by more than 50% was noted in 55% of patients taking desloratadine tablets compared with 19% of patients taking placebo. Taking desloratadine tablets 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 auxiliary components of the drug.

Adults and adolescents (from 12 years of age): 1 tablet 1 time per day, regardless of food intake, for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria.

Therapy of intermittent allergic rhinitis (presence of symptoms less than 4 days a week or less than 4 weeks) must be carried out taking into account the anamnesis data: stop after the disappearance of symptoms and resume after their occurrence. With persistent allergic rhinitis (presence of symptoms more than 4 days a week and more than 4 weeks), it is necessary to continue the treatment with desloratadine tablets during the entire period of contact with the allergen.