Eden

General characteristics. Structure:

Active ingredient: desloratadine;

1 ml of syrup contains a dezloratadin in terms of 100% substance of 0,5 mg;

excipients: sorbite (Е 420); sucrose; dinatrium phosphate dodecahydrate; Natrium benzoicum (Е 211); dinatrium эдетат; propylene glycol; citric acid, monohydrate; yellow decline of FCF (E 110); the water purified.

Pharmacological properties:

Dezloratadin is the selection blocker peripheral histamine

H1 receptors of long action. Inhibits the cascade of reactions of an allergic inflammation, including:
release of pro-inflammatory cytokines, including interleykina of IL-4, IL-6, IL-8, IL-13;
release of pro-inflammatory chemokines, such as RANTES;
products of superoxidic anions the activated polymorphonuclear neutrophils;
adhesion and chemotaxis of eosinophils;
allocation of molecules of adhesion, such as R-selectin;
IgE - the mediated release of a histamine, D2 prostaglandin and C4 leukotriene.

Dezloratadin is primary active metabolite of a loratadin. Dezloratadin has antihistaminic, antiallergic and antiinflammatory effect.

Drug does not get through a blood-brain barrier. Does not influence cardiovascular system, does not cause lengthening of an interval of QT on an ECG. Does not influence the central nervous system, does not slow down the speed of psychomotor reactions, does not render sedation.

Prevents development and facilitates the course of allergic reactions, possesses antipruritic and anti-exudative action (reduces permeability of capillaries, edematization of fabrics, a spasm of smooth muscles warns).

Drug is quickly and easily soaked up at intake, absorption of a dezloratadin is not influenced by age of the patient and meal. Dezloratadin define in a blood plasma for 30 minutes after his reception. The maximum concentration in a blood plasma is reached 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 mg to 20 mg. Dezloratadin moderately (83 - 87%) contacts proteins of a blood plasma.

Results of researches showed that дезлоратадин CYP3A4 or CYP2D6 does not oppress and is not substrate or inhibitor of the R-glycoprotein.

Food (fat high-calorific breakfast) or grapefruit juice do not influence distribution of a dezloratadin.

Indications to use:

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

Route of administration and doses:

Drug is accepted inside irrespective of meal.

Children:
aged from 6 months up to 11 months: on 2 ml of syrup (1 mg of a dezloratadin) of 1 times a day;
aged from 1 year up to 5 years: on 2,5 ml of syrup (1,25 mg of a dezloratadin) of 1 times a day;
aged from 6 up to 11 years: on 5 ml of syrup (2,5 mg of a dezloratadin) of 1 times a day.

Adults and teenagers are more senior than 12 years: on 10 ml of syrup (5 mg of a dezloratadin) of 1 times a day. For a drug dosing it is recommended to use the portioning device (a spoon or a glass) with the corresponding divisions.

Duration of treatment depends on weight and the course of a disease.

Treatment of intermittent allergic rhinitis is carried out taking into account data of the anamnesis of a disease of the patient and can be stopped after disappearance of symptoms and is resumed at their emergence. Continuous treatment can be recommended to patients with persistent allergic rhinitis throughout the period of contact with allergen.

Features of use:

The Eden does not strengthen such effects of alcohol as disturbance of psychomotor function and drowsiness.

Use during pregnancy or feeding by a breast. Safety of use of drug for pregnant women is not established therefore it is not recommended to appoint it during pregnancy. Dezloratadin gets into breast milk. In need of use of drug it is necessary to stop feeding by a breast.

Ability to influence speed of response at control of motor transport or work with other mechanisms. Dezloratadin in therapeutic doses does not influence ability to manage motor transport or to work with other mechanisms.

Children. Efficiency and safety of use of syrup the Eden to children aged up to 6 months are finally not studied therefore patients of this age category are not recommended to apply it.

Side effects:

Usually syrup of a dezloratadin is well transferred, but in isolated cases emergence of side effects is possible: increased fatigue, dryness in a mouth, a headache. Tachycardia, a heart consciousness, increase in activity of liver enzymes, increase in level of bilirubin, diarrhea, an abdominal pain, nausea, vomiting, dyspepsia, development of hepatitis, a psychomotor hyperactivity are in some cases possible.

In isolated cases – hypersensitivity reactions (including an acute anaphylaxis, a Quincke's disease, an itch and a small tortoiseshell).

Interaction with other medicines:

Clinically significant changes in plasma concentration of a dezloratadin at numerous combined use together with ketokonazoly, erythromycin, azithromycin, flyuoksetiny, Cimetidinum it was revealed not. Because the enzyme which is responsible for metabolism of a dezloratadin is not established, the possibility of interaction with other medicines completely cannot be excluded.

Contraindications:

Hypersensitivity to active agent or to any component of drug, children's age up to 6 months.

Overdose:

At accidental intake of a large amount of drug the gastric lavage, reception of absorbent carbon is recommended; if necessary – symptomatic therapy. Dezloratadin is not brought by a hemodialysis, efficiency of its removal by means of peritoneal dialysis is not established.

Storage conditions:

Period of validity 2 years. A period of validity after opening of a bottle of 90 days. Not to use drug after the termination of the period of validity specified on packaging. To store at a temperature not above 30 °C. To store in the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

On 60 ml or 100 ml in a bottle together with the spoon dosing and the dosing glass enclosed in a pack.