Ezlor tab. p / o captivity. 5mg # 10

General description:

antiallergic agent - H1-histamine receptor blocker.

Release form:

Film-coated tablets 5 mg.

On 10 tablets in a blister strip packaging from a film of polyvinyl chloride and printed aluminum foil varnished.

Dosage form

Cylindrical biconvex tablets, film-coated white or almost white, two layers are visible on the fracture - a white or almost white core and a film shell.

Structure

One tablet contains the active substance: desloratadine - 5.0 mg.

Excipients (core): lactose monohydrate (milk sugar) - 70.0 mg

microcrystalline cellulose - 12.1 mg

povidone (polyvinylpyrrolidone) - 3.0 mg

magnesium stearate - 0.9 mg

croscarmellose sodium - 4.0 mg.

Excipients (shell): opadry II 85F48105 White - 3.0 mg, incl.

(polyvinyl alcohol - 1.407 mg macrogol 3350 - 0.708 mg talc - 0.522 mg titanium dioxide - 0.363 mg).

pharmachologic effect

H1-histamine receptor blocker (long-acting). It is the primary active metabolite of loratadine. Inhibits the cascade of reactions of allergic inflammation, including the release of anti-inflammatory cytokines, including interleukins IL-4, IL-6, IL-8, IL-13, the release of proinflammatory chemokines (RANTES), the production of superoxide anions by activated polymorphonuclear neutrophils, eutrophil adhesion and erosion , 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 an antipruritic and antiexudative effect, reduces capillary permeability, prevents the development of tissue edema, 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 speed of psychomotor reactions. Does not cause prolongation of the QT interval on the ECG. The effect of the drug begins within 30 minutes after ingestion and continues for 24 hours.

Pharmacokinetics

Suction

After taking the drug inside, desloratadine is well absorbed from the gastrointestinal tract, while the detectable concentrations of desloratadine in the blood plasma are reached within 30 minutes, and the maximum concentration after about 3 hours.

Distribution

Plasma protein binding of desloratadine is 83-87%.

When used in adults and adolescents for 14 days at a dose of 5 mg to 20 mg 1 time / day.

there is no clinically significant cumulation of desloratadine.

Simultaneous food intake or the simultaneous use of grapefruit juice does not affect the distribution of desloratadine (when taken in a dose of 7.5 mg 1 time / day).

Does not penetrate the blood-brain barrier.

Metabolism

It undergoes intensive metabolism in the liver by hydroxylation to form 3-OH-desloratadine, combined with glucuronide.

It is not an inhibitor of CYP3A4 and CYP2D6 isoenzymes and is not a substrate or inhibitor of P-glycoprotein.

Withdrawal

Only a small fraction of the oral dose is excreted by the kidneys (< 2%) and through the intestines (< 7%).

The half-life is 20-30 hours (on average, 27 hours).

Side effects

The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - at least 10%

often - not less than -1%, but less than 10% infrequently - not less than 0.1%, but less than 1%

rarely - not less than 0.01%), but less than 0.1%

very rarely - less than 0.01%.

From the immune system: very rarely - rash, including urticaria, angioedema, urticaria, dyspnea, anaphylactic shock.

From the side of the central nervous system: infrequently - headache, very rarely - dizziness, drowsiness, insomnia, psychomotor hyperactivity, seizures

Name ENG

EZLOR

Clinical and pharmacological group

Blocker of histamine H1 receptors.

Antiallergic drug

ATX code

Desloratadine

Dosage

5mg

Structure

One tablet contains the active substance: desloratadine - 5.0 mg.

Excipients (core): lactose monohydrate (milk sugar) - 70.0 mg

microcrystalline cellulose - 12.1 mg

povidone (polyvinylpyrrolidone) - 3.0 mg

magnesium stearate - 0.9 mg

croscarmellose sodium - 4.0 mg.

Excipients (shell): opadry II 85F48105 White - 3.0 mg, incl.

(polyvinyl alcohol - 1.407 mg macrogol 3350 - 0.708 mg talc - 0.522 mg titanium dioxide - 0.363 mg).

Indications

allergic rhinitis (elimination or relief of sneezing, nasal congestion, nasal mucus discharge, itching in the nose, itchy palate, itchy and red eyes, watery eyes)

urticaria (reduction or elimination of itching, rash).

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 3 years

INN / Active ingredient

desloratadine

Contraindications

Hypersensitivity to any of the components that make up the drug - age up to 12 years, - lactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

WITH CAUTION: severe renal failure.

Specifications

Category

Allergy

Scope of the drug

General

Release form

Tablet

Manufacturer country

Russia

Package quantity, pcs

ten

Scope of application

Allergology

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Ozone OOO

The amount of the dosage form in the primary package

10 pieces.

Primary packaging type

Blister

Type of consumer packaging

Pack of cardboard

Anatomical and therapeutic characteristics

R06AX27 Desloratadine

Dosage form

Film-coated tablets

Dosage (volume) of the substance in the preparation

5 mg

The target audience

Children

Expiration date in days

1095

Package weight, g

ten

Mode of application

:

The tablet should be swallowed whole, without chewing, with a little water. < br> It is advisable to take the drug at the same time of day, regardless of the time of the meal.

Adults and adolescents over the age of 12 years - 1 tablet (5 mg) 1 time per day. < br>

Pharmaco-therapeutic group

:

Antiallergic agent - H1-histamine receptor blocker

Information on technical characteristics, delivery set, country of manufacture