Aerius syrup instuction for use

You can buy Aerius syrup here

Clinical and pharmacological group

The blocker of histamine H1 receptors. Anti-allergic drug

Form of release, composition and packaging

Orange syrup, transparent.
1 ml desloratadine (micronized) 500 μg
Auxiliary substances: propylene glycol 100 mg, sorbitol 150 mg, citric acid 500 μg, sodium citrate dihydrate 1.26 mg, sodium benzoate 1 mg, disodium edetate 250 μg, sucrose 490 mg, flavor No. 15864 750 μg, dye sunset sunset yellow - 23 mcg, purified water - up to 1 ml.
60 ml - bottles of dark glass (1) complete with a dosage spoon, graduated to 2.5 ml - packs of cardboard.

pharmachologic effect

Antihistamine is a 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 development and facilitates 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 the preparation of Eryus begins within 30 minutes after ingestion and lasts for 24 hours.

Pharmacokinetics

Suction
After taking the drug inside desloratadine is well absorbed from the gastrointestinal tract, with determined concentrations of desloratadine in the blood plasma reached within 30 minutes, and Cmax - after about 3 hours.
Distribution
The binding of desloratadine to plasma proteins is 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.
Metabolism
Exposed to intensive metabolism by hydroxylation to form 3-OH-desloratadine, coupled with glucuronide. It is not an inhibitor of CYP3A4 and CYP2D6 and is not a substrate or an inhibitor of P-glycoprotein.
Excretion
Desloratadine is excreted from the body in the form of a glucuronide compound, and only a small part is excreted by the kidneys (<2%) and through the intestine (<7%) unchanged.
T1 / 2 averages 27 hours.

Indications

- 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).

Contraindications

- Pregnancy;
- lactation (breastfeeding);
- age to 1 year (for syrup);
- age up to 12 years (for coated tablets);
- hereditary transmitted diseases (fructose intolerance, impaired glucose / galactose absorption or sugarase / isomaltase insufficiency in the body) due to the presence of sucrose and sorbitol in the syrup;
- Hypersensitivity to the components of the drug.
With caution should be used in patients with severe renal failure.

Dosage

Syrup
Children aged 1 to 5 years are prescribed 1.25 mg (2.5 ml syrup) 1 time / day; children aged 6 to 11 years - 2.5 mg (5 ml syrup) 1 time / day; adults and teenagers over 12 years - 5 mg (10 ml of syrup) 1 time / day.
Syrup is taken orally, regardless of food intake, with a small amount of water.

Side effects

Syrup
In children under 2 years of age, the following adverse events were observed with the use of the Erius preparation, the frequency of which was slightly higher than in placebo (≥1 / 100 to <1/10): diarrhea (3.7%), body temperature increase (2.3% ), insomnia (2.3%).
In children aged 2 to 11 years with the use of Erius, the incidence of side effects was the same as with placebo.
In adults and adolescents aged 12 years and older with the use of the Erius preparation, the incidence of side effects was slightly higher compared with placebo (≥1 / 100 to <1/10), the most frequent of which were fatigue, dry mouth, headache .
When using Aerius in adults and adolescents at a recommended dose of 5 mg / day, the incidence of drowsiness was not higher than with placebo.
Very rarely (<1/10 000), the following side effects were noted.
From the side of the central nervous system: dizziness, drowsiness.
From the cardiovascular system: tachycardia, palpitations.
On the part of the digestive system: abdominal pain, nausea, vomiting, dyspepsia, diarrhea, increased bilirubin, hepatic enzymes in the blood serum.
Allergic reactions: anaphylaxis, angioedema, itching, rash, urticaria.

Overdose

Symptoms: taking a dose that exceeds the recommended dose 5 times did not lead to any symptoms.
In clinical trials, the daily use of desloratadine in adults and adolescents at doses 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 a large amount of the drug - gastric lavage, the reception of activated charcoal; if necessary, symptomatic therapy. Desloratadine is not excreted in hemodialysis, the effectiveness of peritoneal dialysis is not established.

Drug Interactions

In studies, no interaction with azithromycin, ketoconazole, erythromycin, fluoxetine, and cimetidine has been identified.
Aerius does not increase the effects of ethanol on the central nervous system.
Eating does not affect the effectiveness of the drug.

special instructions

There were no studies of the efficacy of Erius in rhinitis of infectious etiology.
Use in Pediatrics
The effectiveness and safety of Erius in the form of syrup in children under the age of 1 year is not established.
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.

Pregnancy and lactemia

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.

Application in childhood

The effectiveness and safety of Erius application in the form of syrup in children under the age of 1 year is not established.
Contraindicated at the age of up to 1 year (for syrup), at the age of 12 years (for coated tablets).
In most cases, rhinitis in children under 2 years of age is of an infectious nature. There were no studies of the efficacy of Erius in rhinitis of infectious etiology.
Differential diagnosis between allergic rhinitis and rhinitis of a different origin in children under 2 years of age presents certain difficulties. When making 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.

In case of violations of kidney function

With caution should be used in patients with severe renal failure.

Conditions of leave from pharmacies

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

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.