Eden (tablets)

General characteristics. Structure:

Active ingredient: desloratadine;

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

excipients: calcium hydrophosphate dihydrate, cellulose microcrystallic, lactoses monohydrate, starch corn, gipromeloza, magnesium stearate, Opadry II 85F 30571 Blue (ferrous oxide red (Е 172), polyvinyl alcohol, titanium dioxide (Е 171), talc, indigo carmine (Е 132), polyethyleneglycol).

Pharmacological properties:

Dezloratadin – not sedative antihistaminic drug of long action having the selection antagonistic action on peripheral H1 receptors. After peroral introduction дезлоратадин selectively blocks peripheral histamine H1 receptors.

In the researches invitro дезлоратадин showed the antiallergenic properties on endothelium cells. It was shown by oppression of release of antiinflammatory cytokines, such as IL-4, IL-6, IL-8 and IL-13, from mastocytes/basophiles of the person, and also oppression of an expression of molecules of adhesion, such as R-selectin.

Numerous researches showed what, except antihistaminic activity, дезлоратадин has antiallergic and antiinflammatory effect. Dezloratadin does not cause changes from cardiovascular system, does not get into the central nervous system and does not influence psychomotor function.

At patients with allergic rhinitis дезлоратадин effectively eliminates such symptoms as sneezing, allocations from a nose and an itch, and also irritation of eyes, dacryagogue and reddening, a sky itch. Dezloratadin effectively controls symptoms within 24 hours.

Concentration of a dezloratadin in a blood plasma can be defined in 30 minutes after introduction. Dezloratadin is well absorbed, the maximum concentration is reached approximately in 3 hours; the elimination half-life makes about 27 hours. Extent of cumulation of a dezloratadin answered its elimination half-life (about 27 hours) and frequency of reception of 1 times a day. Bioavailability of a dezloratadin was proportional to a dose in the range from 5 to 20 mg. Dezloratadin moderately contacts proteins of plasma (83-87%). At use of a dose of a dezloratadin (from 5 to 20 mg) once a day within 14 days of signs of clinically significant cumulation of drug 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.

Indications to use:

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

Route of administration and doses:

To adults and children from 12 years drug is appointed in a dose of 5 mg (1 tablet) of 1 times a day, irrespective of meal. Drug is recommended to accept regularly in one and too time of day. Whole needs to swallow of a tablet, without chewing, washing down with a small amount of water. Duration of treatment depends on weight and the course of a disease.

Treatment 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 an anemnez: 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:

Use during pregnancy or feeding by a breast.

Dezloratadin did not show teratogenecity in researches on animals. Safety of use of drug during pregnancy is not established therefore Edem's use during pregnancy is not recommended.

Dezloratadin gets into breast milk therefore Edem's use is not recommended to the women nursing.

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

Patients should be informed that seldom or never some people feel drowsiness, dizziness that can influence their ability to drive the car and a difficult technique.

Children.

Efficiency and safety of use of the tablets Eden are not established to children up to 12 years.

Side effects:

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

Mental disorders: hallucinations.

From a nervous system: headache, dizziness, drowsiness, sleeplessness, psychomotor hyperactivity, spasms.

From heart: tachycardia, strong heartbeat.

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

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

From skeletal and muscular system and connecting fabric: mialgiya.

General disturbances: hypersensitivity reactions (including an anaphylaxis, a Quincke's disease, an asthma, an itch, rashes and a small tortoiseshell), increased fatigue.

Interaction with other medicines:

Clinically significant changes in plasma concentration of drug at numerous sharing 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 probability of interaction with other medicines completely cannot be excluded.

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

Contraindications:

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

Appropriate security measures at use

 

At patients with a renal failure of high degree administration of drug we Go it is necessary to carry 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 accept this drug.

Overdose:

In case of overdose to apply standard measures to removal of not absorbed active agent. The symptomatic and supporting treatment is recommended. In clinical trials where дезлоратадин it was entered in doses of 45 mg (which by 9 times exceeded recommended), clinically significant undesirable reactions were not observed. Dezloratadin is not brought by a hemodialysis; the possibility of its removal at peritoneal dialysis is not established.

Storage conditions:

Period of validity 3 years. Not to use drug after the termination of the period of validity specified on packaging. To store in original packaging at a temperature not above 25 °C. To store in the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

On 10 or 30 tablets in the blister. On 1 blister in a pack.