Structure and form of release

Active ingredient: desloratadine;

Structure

• 1 tablet supports a dezloratadin in terms of 100% anhydrous substance of 5 mg;
• additional substances: calcium hydrophosphate dihydrate, cellulose microcrystalline, lactoses monohydrate, starch corn, gipromelloza, calcium stearate, Opadry II 85F 30571 Blue (ferrous oxide red (E 172), polyvinyl alcohol, polyvinyl alcohol (E 132), polyethyleneglycol).

release Form

Tablet, coated.

Pharmacological properties

Pharmacodynamics. Dezloratadin - not sedative antihistaminic medicine of long action having selection antagonistic action on peripheral h1-receptors. After oral introduction dezloratadin selectively blocks peripheral histamine h1-receptors.

In the researches in vitro on cells of an endothelium the antiallergenic properties. It was shown by oppression of discharge of anti-inflammatory cytokines, such as interleukin (IL)-4,-6,-8 and-13, from mastocytes/basophiles of the person and also oppression of an expression of molecules of adhesion, such as R-selectin.

Results of numerous researches demonstrate to what, except antihistaminic activity, dezloratadin has antiallergic and anti-inflammatory effect. Dezloratadin does not cause changes from a cardiovascular system, does not get into central nervous system and does not influence psychomotor function.

At patients with allergic rhinitis dezloratadin such symptoms as sneezing, discharges from a nose and naggers and also the irritation of eyes, dacryagogue and reddening, an itch of the sky effectively eliminates. Dezloratadin effectively controls symptoms during 24 h

Pharmacokinetics. Concentration of a dezloratadin in blood plasma can be defined in 30 min. after introduction. Dezloratadin is well absorbed, the C _max is reached approximately in 3 h; T _½ ≈27 h. Extent of cumulation of a dezloratadin corresponded to its T _½ (≈27 h) and the frequency of reception of 1 times in day. The bioavailability of a dezloratadin was proportional to a dose in the range from 5 to 20 mg. Dezloratadin moderately contacts proteins of blood plasma (83–87%). At application 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 medicine it is not revealed.

Food (fat high-calorific breakfast) does not influence pharmacokinetics of a dezloratadin. It is also established that grapefruit juice does not influence pharmacokinetics of a dezloratadin.

Indication

Elimination of the symptoms connected with allergic rhinitis (sneezing, discharges from a nose, an itch, hypostasis and congestion of a nose, an itch and reddening of eyes, dacryagogue, an itch in the field of the sky and cough), a small tortoiseshell (itch, rash).

Use

to Adults and children aged from 12 years medicine appoint in a dose 5 mg (1 tablet) of 1 times a day irrespective of meal. time of day is regularly recommended to take the medicament in one and too. whole needs to swallow of a tablet, without chewing and washing down with a small amount of water. duration of treatment depends on weight and a course of the disease.

taking into account data of an anemnez: to stop after disappearance of symptoms and to renew after their repeated emergence. In 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.

Contraindication

Hypersensitivity to active agent or to any component of medicine, or to a loratadin.

Side effects

Usually dezloratadin it is well transferred, but emergence of side effects is sometimes possible.

Mental disorders: hallucinations.

from nervous system: headache, dizziness, drowsiness, insomnia, psychomotor hyperactivity, spasms.

from heart: tachycardia, strong heartbeat.

from a digestive tract: dryness in a mouth, diarrhea, an abdominal pain, nausea, vomiting, dyspepsia.

from a gepatobiliarny system: increase in activity of liver enzymes, increase in level of bilirubin, hepatitis.

from a skeletal and muscular system and connective tissue: myalgia.

General violations: reactions of hypersensitivity (including an anaphylaxis, a Quincke's disease, an asthma, the naggers, rash and a small tortoiseshell), increased fatigue.

Special instructions

At patients with a renal failure of high degree administration of medicament the Eden should be carried out under control of the doctor. patients with rare hereditary manifestations of intolerance of a galactose, insufficiency of lactase or a sprue of glucose and a galactose should not take this drug.

Dezloratadin did not show to

teratogenecity in researches on animals.

Safety of use of medicine during pregnancy is not established to

therefore application of the Eden during this period is not recommended.

Dezloratadin gets into breast milk therefore use of the medicine Eden is not recommended to women who nurse.

Children

by

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Drivers

Influence of a dezloratidin on ability to steer motor transport or other mechanisms is not revealed

. However patients should inform that very seldom some people test drowsiness that can affect their ability to drive the car and a difficult technique.

by

Interaction

Clinically significant changes of concentration of medicine in blood plasma at the numerous combined application with ketokonazoly, erythromycin, azithromycin, fluoxetine, Cimetidinum it is not revealed. because the enzyme which is responsible for metabolism of a dezloratadin is not established, interaction probability with other medicines completely cannot be excluded.

In kliniko-pharmacological researches dezloratadin which was accepted together with alcohol did not strengthen negative effect of ethanol on psychomotor function.

Overdose

in case of overdose needs to take standard measures for removal of not absorbed active agent. the symptomatic and supporting treatment is recommended. in clinical trials where dezloratadin entered in doses 45 mg (by 9 times exceeding recommended), clinically significant undesirable reactions were not observed. dezloratadin it is not removed by a hemodialysis; the possibility of its removal at peritoneal dialysis is not established.

Storage conditions

In original packing at a temperature not above 25 °C.