Edem coated tablets of 5 mg blister pack of 30 pcs

Active substance: desloratadine;

Composition

• 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 (E 171), talc, indigo carmine (E 132), polyethylene glycol).

Release form

Coated tablets.

Pharmacodynamics. 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.

In in vitro studies, desloratadine demonstrated its antiallergic properties on endothelial cells. This was manifested by inhibition of the release of anti-inflammatory cytokines such as interleukin (IL)-4, -6, -8 and -13 from human mast cells/basophils, as well as inhibition of the expression of adhesion molecules such as P-selectin.

The results of numerous studies indicate that, in addition to antihistaminic activity, desloratadine has an anti-allergic and anti-inflammatory effect. Desloratadine does not cause changes in the cardiovascular system, does not penetrate into the central nervous system and does not affect psychomotor function.

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

Pharmacokinetics. The concentration of desloratadine in blood plasma can be determined 30 minutes after administration. Desloratadine is well absorbed, C _max is reached after about 3 hours; T _½ ≈27 h. The degree of cumulation of desloratadine corresponded to its T _½ (≈27 h) and the frequency of administration once a day. The bioavailability of desloratadine was proportional to the dose in the range from 5 to 20 mg. Desloratadine moderately binds to blood plasma proteins (83-87%). When using desloratadine in a dose of 5 to 20 mg once a day for 14 days, no signs of clinically significant drug accumulation were detected.

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

Elimination of symptoms associated with allergic rhinitis (sneezing, discharge from the nose, itching, swelling and congestion of the nose, itching and redness of the eyes, lacrimation, itching in the palate and cough), urticaria (itching, rash).

Adults and children over 12 years of age are prescribed the drug in a dose of 5 mg (1 tablet) once a day regardless of food intake. the drug is recommended to be taken regularly at the same time of day. the tablet is swallowed whole without chewing and washed down with a small amount of water. the duration of treatment depends on the severity and course of the disease.

Treatment for 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 anemesis data: stop after the symptoms disappear and resume after their re-occurrence. With persistent allergic rhinitis (the presence of symptoms more than 4 days a week or more than 4 weeks), it is necessary to continue treatment during the entire period of contact with the allergen.

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

Desloratadine is usually well tolerated, but side effects can sometimes occur.

Mental disorders: hallucinations.

From the nervous system: headache, dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions.

From the side of the heart: tachycardia, strong heartbeat.

Gastrointestinal tract: dry mouth, diarrhea, abdominal pain, nausea, vomiting, dyspepsia.

From the hepatobiliary system: increased activity of liver enzymes, increased bilirubin level, hepatitis.

From the musculoskeletal system and connective tissue: myalgia.

General disorders: hypersensitivity reactions (including anaphylaxis, angioedema, shortness of breath, itching, rash and urticaria), increased fatigue.

Patients with severe renal insufficiency should take the drug under the supervision of a doctor. patients with rare hereditary manifestations of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not take this drug.

Clinically significant changes in the concentration of the drug in the blood plasma during repeated simultaneous use with ketoconazole, erythromycin, azithromycin, fluoxetine, cimetidine were not detected. due to the fact that the enzyme responsible for the metabolism of desloratadine has not been established, the possibility of interaction with other medicinal products cannot be completely excluded.

In clinical and pharmacological studies, desloratadine, which was taken together with alcohol, did not increase the negative effect of ethanol on psychomotor function.

In case of overdose, it is necessary to apply standard measures to remove the unabsorbed active substance. symptomatic and supportive treatment is recommended. in clinical studies, where desloratadine was administered in doses of 45 mg (9 times higher than recommended), clinically significant adverse reactions were not observed. desloratadine is not removed by hemodialysis; the possibility of its removal during peritoneal dialysis has not been established.

In the original packaging at a temperature not higher than 25 °C.