ERIUS 5MG PILLS

Trade name of the drug - Erius®

International non-proprietary name - Desloratadine

Dosage Form - film-coated tablets

Composition

Active substance: desloratadine 5 mg.

Excipients: Calcium hydrophosphate dihydrate 53 mg, cellulose

microcrystalline 28 mg, corn starch 11 mg, talc 3 mg.

Tablet shell: opadry blue (lactose monohydrate, hypromellose, titanium

dioxide, macrogol, aluminum blue varnish) 6 mg, opadry transparent (hypromellose,

macrogol) 0.6 mg, carnauba wax 0.005 mg, beeswax white 0.005 mg.

Description

Round biconvex pills of blue color. On the one hand pill method

The stamping of the Schering-Plow trademark in the form of stylized letters SP.

Pharmacotherapeutic group

Antiallergic - H1-histamine receptor blocker.

Pharmacological properties

Pharmacodynamics

Antihistamine drug long-acting. Is the primary active

metabolite of loratadine. Inhibits a cascade of allergic inflammation reactions, including

including the release of pro-inflammatory cytokines, including IL-4 interleukins,

IL-6, IL-8, IL-13, release of proinflammatory chemokines (RANTES),

production of superoxide anions by activated polymorphonuclear

neutrophils, adhesion and eosinophil chemotaxis, the release of adhesion molecules such as

P-selectin, IgE-mediated release of histamine, prostaglandin D2 and

leukotriene C4. Thus, it prevents the development and facilitates the course of allergic reactions, has antipruritic and anti-exudative action,

reduces capillary permeability, prevents the development of tissue edema, spasm

smooth muscle.

The drug has no effect on the central nervous system, almost no

has a sedative effect (does not cause drowsiness) and does not affect the speed

psychomotor reactions. Does not cause lengthening of the QT interval on the ECG.

The effect of the drug Erius® begins within 30 minutes after taking

inside and lasts for 24 hours.

Pharmacokinetics

Desloratadine is well absorbed in the gastrointestinal tract. Determined in plasma

blood 30 minutes after ingestion. The maximum concentration is reached in

on average 3 hours after ingestion. Does not penetrate the blood-brain barrier.

Communication with plasma proteins is 83-87%. When used in adults and adolescents in

for 14 days at a dose of 5 mg to 20 mg 1 time per day of clinically significant cumulation

drug is not marked. Simultaneous ingestion of food or grapefruit juice is not

affects the distribution of desloratadine when used at a dose of 7.5 mg 1 time per day.

Desloratadine is not a CYP3A4 and CYP2D6 inhibitor and is not a substrate or

an inhibitor of P-glycoprotein.Intensively metabolized in the liver by

hydroxylation to form 3-OH-desloratadine, coupled with a glucuronide.

Only a small part of the ingested dose is eliminated by the kidneys (<2%) and after

intestine (<7%). The half-life is 20-30 hours (on average, 27 hours).

Indications for use

- 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, watery eyes);

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

Contraindications

• hypersensitivity to any of the substances that make up the drug,
• pregnancy and lactation,
• age up to 12 years.

Carefully

• severe renal failure.

Application ____________ during pregnancy and lactation

The use of the drug during pregnancy is contraindicated due to the lack

clinical data on the safety of the drug Erius® in

gestation time.

Desloratadine, the active substance, is excreted in breast milk; therefore,

Erius® drug during breastfeeding is contraindicated.

Dosage and administration

For oral administration. The pill should be swallowed whole, not chewed, and drink

water The drug is preferably taken regularly at the same time of day, regardless

from the time of eating.

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

Overdose

Symptoms Receiving a dose exceeding the recommended 5 times, did not lead to

the appearance of any symptoms. During clinical trials daily

use in adults and adolescents desloratadine in a dose of up to 20 mg for 14 days not

accompanied by statistically or clinically significant changes from

of cardio-vascular system. In the clinical and pharmacological study the use of

desloratadine at a dose of 45 mg per day (9 times higher than recommended) for 10 days is not

caused a prolongation of the QT interval and was not accompanied by the appearance of serious side effects.

effects.

Treatment. In case of accidental ingestion of large quantities of the drug must

Seek immediate medical attention. Recommended gastric lavage, taking

activated carbon; if necessary, symptomatic therapy. Desloratadine not

displayed during hemodialysis, the effectiveness of peritoneal dialysis has not been established.

Side effect

Fatigue (1.2% of cases), dry mouth (0.8%), headache

(0,6 %).

The following side effects were very rare: tachycardia, palpitations,

increased activity of liver enzymes, increasing the concentration of bilirubin,

allergic reactions, including anaphylaxis and rashes.

Interaction with other drugs

Interaction with other drugs was not detected. Meal not

affects the effectiveness of the drug. Erius® does not enhance the effect of alcohol

on the central nervous system.

special instructions

Research on the effectiveness of the drug Erius® in rhinitis infectious

etiology was not carried out.

Influence on ability to drive motor transport and control mechanisms

At the recommended dose, Erius® does not affect the ability to drive motor vehicles.

funds or management mechanisms.

Release form

Tablets, film coated, 5 mg. 1, 2, 3, 5, 7 or 10 pills in a blister

PVC and aluminum foil. Through 1, 2, 3, 5, 9 or 10 blisters along with instructions for

application in a carton box.

Storage conditions

At a temperature not higher than 30 ° C, out of the reach of children.

Shelf life

2 years. Do not use after expiration date.

Vacation conditions

Over the counter.