Eridez coated tablets 5 mg. №10

Description

Eridez Composition
active substance: desloratadine;

1 tablet contains desloratadine 5 mg;

excipients: calcium hydrogen phosphate, microcrystalline cellulose, lactose monohydrate, corn starch, magnesium stearate, opadray 85 F blue.

Eridez Dosage form
Film-coated tablets.

Basic physical and chemical properties: film-coated tablets, round in shape with a blue biconvex surface.

Pharmacotherapeutic group
Antihistamines for systemic use. ATX code R06A X27.

Pharmacodynamics
Desloratadine is a selective blocker of peripheral histamine H1 receptors, does not cause sedation. Desloratadine is the primary active metabolite of loratadine. After oral administration, desloratadine selectively blocks peripheral H1-histamine receptors and does not cross the blood-brain barrier.

In addition to antihistamine activity, desloratadine has anti-allergic and anti-inflammatory effects. It was found that desloratadine suppresses a cascade of various reactions underlying the development of allergic inflammation, namely: the release of pro-inflammatory cytokines such as IL-4, IL-6, IL-8, IL-13 from human mast cells / basophils, as well as inhibition of expression adhesion molecules such as P-selectin. The clinical significance of these observations still needs confirmation.

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 the maximum daily clinical dose) for 10 days, no prolongation of the QT interval was observed.

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

Desloratadine hardly penetrates 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.

Desloratadine does not cross the blood-brain barrier, does not affect psychomotor function when taking a dose of up to 7.5 mg.

Desloratadine 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 on the items on the questionnaire 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 forms of urticaria other than chronic idiopathic urticaria.
In two placebo-controlled 6-week studies in patients with chronic idiopathic urticaria, desloratadine effectively relieved pruritus and reduced the number and size of urticaria by the end of the first dosing interval. In each study, the effect lasted over a 24 hour dosing interval. Itching relief of more than 50% was seen in 55% of patients taking desloratadine compared with 19% of patients taking placebo. Taking the drug does not significantly affect sleep and daytime activity.

Pharmacokinetics
Desloratadine begins to be determined in plasma within 30 minutes after administration. The maximum concentration of desloratadine in blood plasma is reached on average after 3 hours, the half-life is on average 27 hours. The degree of cumulation of desloratadine corresponds to its half-life (approximately 27 hours) and the frequency of use (1 time per day). The bioavailability of desloratadine is dose proportional, ranging from 5 to 20 mg.

Desloratadine moderately (83-87%) binds to blood plasma proteins. When using desloratadine at a dose of 5 to 20 mg once a day for 14 days, no signs of clinically significant cumulation of the drug were detected.

Food (high-fat, high-calorie breakfast) or grapefruit juice does not affect the distribution of desloratadine.

Eridez Indications
Elimination of symptoms associated with:

allergic rhinitis (see section “Pharmacodynamics”);
urticaria (see section “Pharmacodynamics”).

Contraindications
Hypersensitivity to the active substance or any component of the drug, or to loratadine.