Edem (desloratadine) coated tablets 5 mg. №30

Description

Edem tablets №30 The composition of the drug:

active substance: desloratadine;

1 tablet contains desloratadine in terms of anhydrous 100% substance 5 mg;

Excipients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, lactose monohydrate, corn starch, hypromellose, calcium stearate, Opadry II 85F 30571 Blue (iron oxide red (E 172), polyvinyl alcohol, titanium dioxide and E1) 132), polyethylene glycol).

Edem tablets №30 Dosage form.

Coated tablets.

Round tablets with a biconvex surface, coated with a blue coating.

Name and location of the manufacturer.

PJSC “Farmak”.

Ukraine, 04080, Kyiv, street Frunze, 63.

Pharmacotherapeutic group. Antihistamines for systemic use.

ATC code R06A X27.

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

In in vitro studies, desloratadine has demonstrated its antiallergic properties on endothelial cells. This was manifested by inhibition of the secretion of anti-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.

Numerous studies have shown that, in addition to antihistaminic activity, desloratadine has anti-allergic and anti-inflammatory effects. Desloratadine does not cause changes in the cardiovascular system, does not penetrate the central nervous system and does not affect psychomotor function.

In patients with allergic rhinitis, desloratadine effectively relieves symptoms such as sneezing, runny nose and itching, as well as eye irritation, tearing and redness, and itchy palate. Desloratadine effectively controls symptoms for 24 hours.

Plasma concentrations of desloratadine can be determined 30 minutes after administration. Desloratadine is well absorbed, the maximum concentration is reached after about 3 hours; the half-life is approximately 27 hours. The degree of accumulation of desloratadine corresponded to its half-life (approximately 27 hours) and frequency of administration once daily. The bioavailability of desloratadine was proportional to the dose in the range of 5 to 20 mg. Desloratadine is moderately bound to plasma proteins (83-87%). At a dose of desloratadine (5 to 20 mg) once a day for 14 days, no signs of clinically significant accumulation of the drug were detected.

Food (fatty high-calorie breakfast) does not affect the pharmacokinetics of desloratadine. It was also found that grapefruit juice does not affect the pharmacokinetics of desloratadine.

Edem tablets №30 Indications for use.

Elimination of symptoms associated with:

– allergic rhinitis (sneezing, runny nose, itching, swelling and nasal congestion, itching and redness of the eyes, tearing, itching in the palate and cough);

– urticaria (itching, rash).

Contraindication.

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

Appropriate safety precautions for use.

In patients with severe renal insufficiency, Edem® should be taken under the supervision of a physician. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Special caveats.

Use during pregnancy or breastfeeding.

Desloratadine has not been shown to be teratogenic in animal studies. The safety of the drug during pregnancy has not been established, so the use of Edem® during pregnancy is not recommended.

Desloratadine passes into breast milk, so the use of Edem® in breastfeeding women is not recommended.