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

tablet shell: Opadry blue (lactose monohydrate, hypromellose, titanium dioxide, macrogol, blue lacquer aluminum) 6 mg Opadry Clear (hypromellose, macrogol) 0.6 mg 0.005 mg Carnauba wax, beeswax white 0.005 mg.

Description:

Round, biconvex blue pills. On one side of the tablet stamping method is applied trademark Schering-Plow a stylized letters SP.

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 allergic inflammation reactions, including the release of pro-inflammatory cytokines, including interleukins IL-4, IL-6, IL-8, IL-13, release of pro-inflammatory chemokinesRANTES), 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 the Erius® drug starts within 30 minutes after taking inside 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 blood-brain barrier. 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 of CYP3A4 and CYP2D6 and is not a substrate or an 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 through the intestine (<7%). Half-life is 20-30 hours (on average - 27 hours).

Indications:

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

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

Contraindications:

- PExcess sensitivity to any of the substances that make up the drug;

- Pregnancy and lactation;

- age up to 12 years.

Carefully:Severe kidney failure.

Pregnancy and lactation:

The use of the drug in pregnancy is contraindicated due to the lack of clinical data on the safety of the use of the drug Erius® during pregnancy.

Desloratadine, the active substance, is excreted in breast milk, so the use of the drug Erius® during breastfeeding is contraindicated.

Dosing and Administration:

For oral administration. The tablet should be swallowed whole, not liquid, and washed down with water. The drug should be taken regularly at the same time of the day, regardless of the time of ingestion.

Adults and teenagers from 12 years old - 1 tablet (5 mg) once a day.

Side effects:

Increased fatigue (in 1.2% of cases), dry mouth (0.8%), headache (0,6%).

Very rarely, the following side effects were noted: tachycardia, palpitation, increased activity of liver enzymes, increased bilirubin concentrations, allergic reactions, including anaphylaxis and rash.

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 doses up to 20 mg for 14 days was not accompaniedstatistically or clinically relevant changes in the cardiovascular system. In a clinical pharmacological study, the use of desloratadine at a dose of 45 mg per day (9 times as high as recommended) for 10 days did not cause lengthening of the interval QT and was not accompanied by the appearance of serious side effects.

Treatment

Inadvertently ingesting a large amount of the drug is necessary immediately consult a doctor. Recommended gastric lavage, reception of activated charcoal; if necessary, symptomatic therapy. Desloratadine not is excreted during 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:

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:

At the recommended dose, Erius® does not affect the ability to drive vehicles or operate machinery.

Form release / dosage:

Tablets, film-coated, 5 mg.

Packaging:

For 1, 2, 3, 5, 7 or 10 tablets in a blister of PVC and aluminum foil.

For 1, 2, 3, 5, 9 or 10 blisters, together with instructions for use in a cardboard bundle.

Storage conditions:

At temperatures not higher than 30 ° C, out of reach of children.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:П N014704 / 02

Date of registration:06.08.2010

The owner of the registration certificate:Schering-Plau N. Labo.Schering-Plau N. Labo. Belgium

Manufacturer: & nbsp

SCHERING-PLOUGH LABO, N.V. Belgium

Representation: & nbspMSD Pharmaceuticals Ltd.MSD Pharmaceuticals Ltd.

Information update date: & nbsp03.01.2016

Illustrated instructions

Instructions

Erius® (Aerius®)