Erius - instructions for use, dose, side effects, contraindications

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

Description:

Transparent orange liquid.

Pharmacotherapeutic group:antiallergic agent - H1-histamine receptor blocker

ATX: & nbsp

R.06.A.X Other antihistamines for systemic use

R.06.A.X.27 Desloratadine

Pharmacodynamics:

Antihistamine is a long-acting drug. It is the primary active metabolite of loratadine. Inhibits the cascade of reactions of allergic inflammation, including the release of pro-inflammatory cytokines, including interleukins IL-4, IL-6, IL-8, IL-13, release of pro-inflammatory chemokines (RANTES), the production of superoxide anions by activated polymorphonuclear neutrophils, the adhesion and chemotaxis of eosinophils, the release 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 antiexcudative 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 practically no sedative effect (does not cause drowsiness) and does not affect the rate of psychomotor reactions. Does not cause lengthening of the interval QT on the ECG.

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

Pharmacokinetics:

Desloratadine is well absorbed in the gastrointestinal tract. It is determined in the blood plasma 30 minutes after ingestion. The maximum concentration is achieved on average 3 hours after administration. Does not penetrate the BBB. The connection with plasma proteins is 83-87%. When used in adults and adolescents for 14 days at a dose of 5 mg to 20 mg once a day, there is no clinically significant cumulation of the drug. Simultaneous intake of food or grapefruit juice does not affect the distribution of desloratadine when administered at a dose of 7.5 mg 1 time per day. Desloratadine is not an inhibitor CYP3A4 and CYP2D6 and is not a substrate or inhibitor of P-glycoprotein. Intensively metabolized in the liver by hydroxylation to form 3-OH-desloratadine, combined with glucuronide. Only a small part of the dose taken internally is excreted by the kidneys (<2%) and with caloric masses (<7%). The half-life is 20-30 hours (on the average - 27 hours).

Indications:

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

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

Contraindications:

- Hypersensitivity to desloratadine, other components of the drug or loratadine;

- pregnancy and the period of breastfeeding;

- Children's age up to 6 months;

- hereditary peregiven diseases: fructose intolerance, impaired absorption of glucose-galactose, or insufficiency of sucrose-isomaltase in the body (due to the presence of sucrose and sorbitol in the composition).

Carefully:

Severe kidney failure.

Pregnancy and lactation:

The use of the drug in pregnant women is not recommended due to the lack of clinical data on the safety of Erius® during pregnancy.

Desloratadine is excreted in human milk, therefore it is not recommended to use Eryus® during breast-feeding.

Dosing and Administration:

Inside, regardless of the time of intake, drink a little water.

Children aged 6 to 12 months - 1 mg (2 ml of syrup) 1 time per day.

Children aged 1 to 5 years - 1,25 mg (2.5 ml syrup) 1 time per day.

Children aged 6 to 11 years - 2.5 mg (5 ml of syrup) 1 time per day.

Adults and teenagers from 12 years old - 5 mg (10 ml of syrup) 1 time per day.

Side effects:

In children under 2 years of age the following undesirable events were observed, the frequency of which was slightly higher than with placebo (≥1 / 100 to <1/10): diarrhea (3.7% of cases), fever (2.3%), insomnia (2 , 3%).

Children aged 2 to 11 years When using the drug Erius® Syrup, the incidence of side effects was the same as with placebo.

In adults and adolescents (12 years and older) the incidence of side effects was slightly higher compared with placebo (> 1/100 to <1/10), of which the most common were: increased fatigue (1.2%), dry mouth (0.8%), headache ( 0.6%).

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

Among the very rare side effects (<1/10 000) are the following:

from the nervous system: hallucinations, dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions;

from the liver and bile ducts: increased activity of liver enzymes, increased concentrations of bilirubin, hepatitis;

from the digestive system: abdominal pain, nausea, vomiting, indigestion, diarrhea;

from the cardiovascular system: tachycardia, palpitations;

from the musculoskeletal system: myalgia;

allergic reactions: anaphylaxis, angioedema, dyspnea, pruritus, rash, including urticaria.

From the skin and subcutaneous tissues photosensitivity is possible.

Overdose:

Symptoms. Taking a dose that exceeds the recommended dose by 5 times did not lead to any symptoms. In clinical trials, the daily 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 the clinico-pharmacological study, the use of desloratadine at a dose of 45 mg / day (9 times higher than recommended) for 10 days did not cause lengthening of the interval QT and was not accompanied by the appearance of serious side effects.

Treatment. If you ingest large amounts of the drug, you should immediately consult a doctor. Recommended gastric lavage, reception of activated charcoal; if necessary, symptomatic therapy. Desloratadine is not excreted in hemodialysis, the effectiveness of peritoneal dialysis is not established.

Interaction:

Interaction with other drugs has not been identified. Eating does not affect the effectiveness of the drug.

Erius® does not enhance the effect of alcohol on the central nervous system.

Special instructions:

Pediatric Use

The efficacy and safety of the use of the Erius® Syrup drug in children under 6 months of age has not been established.

There were no studies of the efficacy of the Erius® drug in rhinitis of infectious etiology.

Effect on the ability to drive transp. cf. and fur:

Consideration should be given to the potential for the development of side effects such as dizziness and drowsiness. When these undesirable phenomena appear, one should refrain from performing these activities.

Form release / dosage:

Syrup, 0.5 mg / ml.

Packaging:

30, 50, 60, 100, 120, 150, 225 or 300 ml of syrup in dark glass bottles, sealed with polypropylene screw stoppers with polyethylene gaskets that have a childproof protection device.

For 1 bottle complete with a dosage spoon of transparent plastic or a syringe, graduated to measure the required amount of syrup, along with instructions for use in a cardboard bundle.

Storage conditions:

At a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:П N014704 / 01

Date of registration:10.08.2010 / 05.10.2015

The owner of the registration certificate:BAYER, AO BAYER, AO Russia

Manufacturer: & nbsp

SCHERING-PLOUGH LABO, N.V. Belgium

Representation: & nbspBAYER, AOBAYER, AO

Information update date: & nbsp03.01.2016

Illustrated instructions

Instructions

Erius® (Aerius®)