Eridez

General characteristics. Structure:

Active ingredient: desloratadine; 1 tablet contains dezloratadina5 mg;

excipients: a mannitol (Е 421), starch corn, the hydroxypropyl cellulose low-replaced, talc, calcium phosphate, a gipromelloz (gidroksipropilmetiltsellyuloz), titanium dioxide (Е 171), propylene glycol, ferrous oxide red (Е 172), ferrous oxide yellow (Е 172).

Pharmacological properties:

Dezloratadin is the selection blocker peripheral histamine H1 receptors, does not cause sedation. Dezloratadin is primary active metabolite of a loratadin. After oral administration дезлоратадин selectively blocks peripheral H1-histamine receptors and does not get through a blood-brain barrier.

Except anti-histamine activity, дезлоратадин has antiallergic and antiinflammatory effect. Dezloratadin suppresses the cascade of various reactions which are the cornerstone of development of an allergic inflammation namely:
• release of pro-inflammatory cytokines, including IL-4, IL-6, IL-8, IL-13;
• release of pro-inflammatory chemokines, such as RANTES;
• products of superoxidic anion the activated polymorphonuclear neutrophils;
• adhesion and chemotaxis of eosinophils;
• expression of molecules of adhesion, such as R-selectin;
• IgE-dependent allocation of a histamine, D2 prostaglandin and C4 leukotriene;
• an acute allergic bronchospasm in researches on animals.

Dezloratadin does not get through a blood-brain barrier, does not influence psychomotor function at reception of a dose to 7,5 mg.

Dezloratadin begins to be defined in plasma within 30 min. after reception. The maximum concentration of a dezloratadin in plasma is reached on average in 3 hours, the elimination half-life averages 27 hours. Extent of cumulation of a dezloratadin corresponds to its elimination half-life (about 27 hours) and frequency rates of use (1 times a day). Bioavailability of a dezloratadin is proportional to a dose in the range from 5 to 20 mg. Dezloratadin moderately (83-87%) contacts proteins of plasma. At use of a dezloratadin in a dose from 5 to 20 mg of 1 times a day within 14 days of signs of clinically significant cumulation of drug it is not revealed.

The food (fat high-calorific breakfast) or grapefruit juice does not influence distribution of a dezloratadin.

Indications to use:

For bystry elimination of allergic symptoms, including a pollinosis and allergic rhinitis (such as sneezing, allocations of a nose, an itch, hypostasis and a congestion of a nose, and also an itch, dacryagogue and reddening of eyes, an itch in the field of the sky and cough), for elimination of the symptoms connected with a small tortoiseshell, an itch, a rash.

Route of administration and doses:

Eridez is intended for oral administration. Adults and children are more senior than 12 years accept on      1 tablet (5 mg) once a day, irrespective of meal. It is necessary to swallow of a tablet entirely, washing down with water. Eridez it is desirable to accept regularly, in same it is a high time days.

Duration of treatment is defined by weight and the course of a disease.

Therapy of intermittent allergic rhinitis (existence of symptoms less than 4 days a week or less than 4 weeks) needs to be carried out taking into account data of the anamnesis: to stop after disappearance of symptoms and to renew after their repeated emergence.
At persistent allergic rhinitis (existence 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 allergen.

Features of use:

With care appoint to patients with a renal and liver failure. Dezloratadin does not strengthen such effects of alcohol as disturbance of psychomotor function and drowsiness. Results of psychomotor tests significantly did not differ at the patients receiving дезлоратадин and placebo separately or together with alcohol.

Use during pregnancy or feeding by a breast.

Safety of use of Eridez for pregnant women is not established therefore it is not recommended to appoint it during pregnancy. Dezloratadin gets into breast milk therefore women should not appoint drug during feeding a breast.

Ability to influence speed of response at control of motor transport or work with other mechanisms.

Influence of a dezloratadin on driving or work with difficult technical devices was not noted.

Children.

Efficiency and safety of a dezloratadin in the form of tablets at children up to 12 years was not investigated.

Side effects:

At drug use increased fatigue, dryness in a mouth, a headache were the frequent undesirable phenomena.

It was very seldom reported about hypersensitivity reaction (including an anaphylaxis and rash), tachycardia, heartbeat, a psychomotor hyperactivity, spasms, increase in activity of liver enzymes, increase in level of bilirubin, development of hepatitis.

In case of any undesirable phenomena the patient needs to consult to the doctor.

Interaction with other medicines:

If you accept any other medicines, surely report about it to the doctor.

Clinically significant changes in plasma concentration of a dezloratadin at numerous combined use with ketokonazoly, erythromycin, azithromycin, fluoxetine, Cimetidinum it was revealed not. Because the enzyme which is responsible for metabolism of a dezloratadin unspecified, interaction with other medicines completely it is impossible to exclude.

Contraindications:

Hypersensitivity to a dezloratadin or a loratadin, pregnancy, the feeding period a breast, children up to 12 years (for this dosage form).

Overdose:

At accidental reception of high doses of Eridez strengthening of side effects – fatigue, dryness in a mouth, a headache, tachycardia is possible.

Treatment. Gastric lavage, reception of absorbent carbon, symptomatic therapy. Dezloratadin does not leave at a hemodialysis; efficiency of peritoneal dialysis is not established.

Storage conditions:

Period of validity. 3 years from the date of production of in bulk. Do not use drug after the termination of a period of validity. To store in the place, unavailable to children, in original packaging at a temperature not over 25 ºС.

Issue conditions:

Without recipe

Packaging:

On 10 tablets in a blister strip packaging; on 1 blister strip packaging in a pack.