Erius with swelling

Excipients: propylene glycol, sorbitol (liquid,noncrystallizing), citric acid anhydrous, sodium citrate dihydrate, sodium benzoate, disodium edetate, sucrose, flavor no. 15864, dye yellow No. 6 (E110), purified water.

60 ml - bottles of dark glass (1) complete with a dosage spoon, graduated to 2.5 ml and 5 ml - packs of cardboard.
120 ml - bottles of dark glass (1) complete with a dosage spoon, graduated to 2.5 ml and 5 ml - packs of cardboard.

An antihistamine long-acting drug, a blocker of peripheral histamine H1 receptors. Desloratadine is the primary active metabolite of loratadine. Inhibits a cascade of reactions of allergic inflammation, incl. release of pro-inflammatory cytokines, including interleukins IL-4, IL-6, IL-8, IL-13, release of pro-inflammatory chemokines, production of superoxide anions by activated polymorphonuclear neutrophils, adhesion and chemotaxis of eosinophils, isolation of adhesion molecules such as P-selectin, IgE- mediated release of histamine, prostaglandin D2 and leukotriene C4. Thus, it prevents the development andfacilitates the course of allergic reactions, has antipruritic and antiexudative action, reduces permeability of capillaries, prevents the development of edema of tissues, spasm of smooth muscles.

The drug has no effect on the central nervous system, has almost no sedative effect (does not cause drowsiness) and does not affect the rate of psychomotor reactions.

Does not cause an extension of the QT interval on the ECG.

The action of Erius begins within 30 minutes after ingestion and lasts for 24 hours.

After taking the drug inward desloratadine is well absorbed from the digestive tract, while the determined concentrations of desloratadine in the blood plasma are reached within 30 minutes, and Cmax - After about 3 hours.

The binding of desloratadine to plasma proteinsis 83-87%. When used in adults and adolescents for 14 days at a dose of 5 mg to 20 mg 1 time / day, no signs of a clinically significant cumulation of desloratadine have been detected. Simultaneous food intake or simultaneous consumption of grapefruit juice does not affect the distribution of desloratadine (when taken at a dose of 7.5 mg 1 time / day). Does not penetrate the BBB.

Exposed to intensive metabolism byhydroxylation to form 3-OH-desloratadine coupled to glucuronide. It is not an inhibitor of CYP3A4 and CYP2D6 and is not a substrate or an inhibitor of P-glycoprotein.

Desloratadine is excreted from the body in the form of a glucuronide compound and in a small amount (less than 2% with urine and less than 7% with feces) unchanged.

T1/2 averages 27 hours (20-30 hours).

- allergic rhinitis (elimination or relief of sneezing, nasal congestion, discharge of mucus from the nose, itching of the nose, itching of the palate, itching and redness of the eyes, lachrymation);

- urticaria (reduction or elimination of itching, rash).

- lactation (breastfeeding);

- age to 1 year (for syrup);

- age up to 12 years (for coated tablets);

Hereditary transmitted diseases(intolerance to fructose, impaired absorption of glucose / galactose, or insufficiency of sucrose / isomaltase in the body) due to the presence of sucrose and sorbitol in the syrup;

- Hypersensitivity to the components of the drug.

FROM caution It is necessary to apply the drug for renal failure of severe degree.

Adults and adolescents aged 12 years and over prescribe 5 mg 1 time / day, regardless of food intake, preferably at the same time of day.

The tablet should be swallowed whole, not liquid, squeezed with a small amount of water.

Children aged 1 to 5 years Assign to 1.25 mg (2.5 ml of syrup) 1 time / day; children aged 6 to 11 years - 2.5 mg (5 ml of syrup) 1 time / day; Adults and teenagers over 12 years of age - 5 mg (10 ml of syrup) 1 time / day.

Syrup is taken orally, regardless of food intake, with a small amount of water.

Symptoms: taking a dose that exceeds the recommended dose by a factor of 5 did not lead to any symptoms.

During clinical trials, dailythe use of desloratadine in adults and adolescents at a dose of up to 20 mg for 14 days was not accompanied by statistically or clinically significant changes in the cardiovascular system. In a clinical pharmacological study, the use of desloratadine at a dose of 45 mg / day (9 times higher than recommended) for 10 days did not cause prolongation of the QT interval and was not accompanied by serious side effects.

Treatment: with the occasional ingestion of large quantitiespreparation - gastric lavage, reception of activated charcoal; if necessary, symptomatic therapy. Desloratadine is not excreted in hemodialysis, the effectiveness of peritoneal dialysis is not established.

Clinically significant interaction with other drugs has not been identified.

Erius does not increase the effects of ethanol on the central nervous system.

Eating does not affect the effectiveness of the drug.

The use of the drug in pregnancy is not recommended due to the lack of clinical data on the safety of its use in this period.

Desloratadine is excreted in breast milk, so the use of Erius during breastfeeding is not recommended.

When using the drug, there was increased fatigue (1.2%), dry mouth (0.8%), headache (0.6%).

From the cardiovascular system: very rarely - tachycardia, palpitations.

From the digestive system: very rarely - increased activity of liver enzymes, increased bilirubin concentration.

Allergic reactions: very rarely - anaphylaxis, rash.

In children under 2 years of age with the application of Eriusthe following undesirable events were observed, the frequency of which was slightly higher than with placebo: diarrhea, fever, insomnia.

In children aged 2 to 11 years with the use of Erius, the incidence of side effects was the same as with placebo.

Adults and adolescents (12 years and older) withapplication of Erius the following undesirable phenomena were observed, the frequency of which was slightly higher than with the placebo: increased fatigue, dry mouth, headache.

When using the drug in adults and adolescents at a recommended dose of 5 mg / day, the incidence of drowsiness was not higher than with placebo.

Very rarely, the following side effects were noted.

From the side of the central nervous system: dizziness, drowsiness.

From the cardiovascular system: tachycardia, palpitations.

From the digestive system: abdominal pain, nausea, vomiting, dyspepsia, diarrhea, increased bilirubin, hepatic enzymes in the blood serum.

Allergic reactions: anaphylaxis, angioedema, itching, rash, urticaria.

Terms and conditions of storage

The drug should be stored out of reach of children at a temperature of no higher than 30 ° C. Shelf life - 2 years.

Effectiveness and safety of Erius application in the form of syrup children under the age of 1 year not installed.

In most cases, rhinitis children under 2 years has an infectious nature. There were no studies of the efficacy of Erius in rhinitis of infectious etiology.

Differential diagnosis between allergicrhinitis and rhinitis of a different origin in children under 2 years of age presents certain difficulties. When conducting a differential diagnosis, attention should be paid to the presence or absence of foci of infection or structural anomalies of the upper respiratory tract, to conduct a careful history, examination, as well as appropriate laboratory tests and skin tests.

Influence on the ability to drive and drive machinery

In the recommended dose, Erius does not affect the ability to drive vehicles or control mechanisms.

In case of violations of kidney function

FROM caution It is necessary to apply the drug for renal failure of severe degree.

Application in childhood

Effectiveness and safety of Erius application in the form of syrup children under the age of 1 year not installed.

Contraindicated in infants under 1 year (syrup), under the age of 12 years (film-coated tablets).

In most cases, rhinitis children under 2 years has an infectious nature. There were no studies of the efficacy of Erius in rhinitis of infectious etiology.

Differential diagnosis between allergicrhinitis and rhinitis of a different origin in children under 2 years of age presents certain difficulties. When conducting a differential diagnosis, attention should be paid to the presence or absence of foci of infection or structural anomalies of the upper respiratory tract, to conduct a careful history, examination, as well as appropriate laboratory tests and skin tests.

Conditions of leave from pharmacies

The drug is approved for use as a means of OTC.