Allerway tab. p / o film. 5 mg # 10

Structure

Each film-coated tablet contains:

active substance: levocetirizine dihydrochloride 5.00 mg

excipients: lactose monohydrate 88.00 mg

microcrystalline cellulose 34.10 mg

colloidal silicon dioxide 1.60 mg

magnesium stearate 1.30 mg

film sheath: Opadry white OY 58900 (hypromellose (5 cP) 62.5%, titanium dioxide (E171) 31.25%, macrogol-400 6.25%) 3.25 mg.

pharmachologic effect

Pharmacotherapeutic group: antiallergic agent - H1-histamine receptor blocker.

ATX code: R06AE09

Pharmacological properties

Pharmacodynamics

Levocetirizine (R), an enantiomer of cetirizine, is an inhibitor of peripheral H1-histamine receptors.

Levocetirizine has a pronounced antihistamine and antiallergic effect.

It affects the histamine-dependent phase of an allergic reaction, reduces the migration of eosinophils, reduces the permeability of the vascular wall and limits the release of inflammatory mediators.

Levocetirizine prevents the development and facilitates the course of allergic reactions, has antipruritic and antiexudative effects.

Virtually no effect on cholinergic and serotonin receptors, in therapeutic doses does not have a sedative effect.

Pharmacokinetics

The pharmacokinetics of levocetirizine changes linearly.

Suction

After oral administration, the drug is rapidly and completely absorbed from the gastrointestinal tract.

Food intake does not affect the completeness of absorption, although its rate decreases.

In adults, after a single dose of the drug in a therapeutic dose (5 mg), the maximum concentration (Cmax) in the blood plasma is 270 ng / ml and is reached after 0.9 hours, after repeated administration at a dose of 5 mg - 308 ng / ml.

Equilibrium plasma concentration (Css) is reached after 2 days.

Distribution

Levocetirizine is 90% bound to blood plasma proteins.

The volume of distribution (Vd) is 0.4 l / kg.

Bioavailability reaches 100%.

Metabolism

Less than 14% of the drug is metabolized in the body by N- and O-dealkylation (in contrast to other antagonists of H1-histamine receptors, which are metabolized in the liver by the cytochrome system) to form a pharmacologically inactive metabolite.

Due to the limited metabolism and lack of metabolic inhibitory activity, the interaction of levocetirizine at the metabolic level with other substances is unlikely.

Withdrawal

In adults, the half-life (T1 / 2) is 7.9 ± 1.9 hours, the total clearance is 0.63 ml / min / kg.

About 85.4% of the taken dose of the drug is excreted by the kidneys unchanged by glomerular filtration and tubular secretion

about 12.9% - through the intestines.

Features of pharmacokinetics in selected patients

Patients with impaired renal function

In patients with renal insufficiency (creatinine clearance (CC) < 40 ml / min), drug clearance decreases and T1 / 2 is lengthened.

In patients on hemodialysis, the total clearance is reduced by 80%, which requires a change in the dosage regimen.

Less than 10% of levocetirizine is removed during a standard 4-hour hemodialysis procedure.

Indications

Allerway, film-coated tablets, 5 mg is indicated in adults and children from 6 years of age and older with:

treating symptoms of allergic rhinitis, including perennial (persistent) and seasonal (intermittent) allergic rhinitis, and allergic conjunctivitis, such as itching, sneezing, nasal congestion, rhinorrhea, watery eyes, conjunctival hyperemia

hay fever (hay fever)

urticaria

other allergic dermatoses, accompanied by itching and rashes.

Contraindications

Hypersensitivity to the active substance, cetirizine, hydroxyzine, any piperazine derivative or to any excipient of the drug.

Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Terminal stage by

Name ENG

ALLERWAY

Clinical and pharmacological group

Blocker of histamine H1 receptors.

Antiallergic drug

ATX code

Levocetirizine

Dosage

5mg

Structure

Each film-coated tablet contains: active ingredient: levocetirizine dihydrochloride 5.00 mg

excipients: lactose monohydrate 88.00 mg

microcrystalline cellulose 34.10 mg

colloidal silicon dioxide 1.60 mg

magnesium stearate 1.30 mg

film sheath: Opadry white OY 58900 (hypromellose (5 cP) 62.5%, titanium dioxide (E171) 31.25%, macrogol-400 6.25%) 3.25 mg.

Indications

treating symptoms of allergic rhinitis, including perennial (persistent) and seasonal (intermittent) allergic rhinitis, and allergic conjunctivitis such as pruritus, sneezing, nasal congestion, rhinorrhea, lacrimation, conjunctival hyperemia

pollinosis (hay fever)

hives

Quincke's edema

other allergic dermatoses, accompanied by itching and rashes.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 2 years

INN / Active ingredient

levocetirizine

Contraindications

Severe renal failure (CC below 10 ml / min)

children under 2 years of age

hypersensitivity to levocetirizine.

Specifications

Category

Allergy

Scope of the medicinal product

General

Release form

Tablet

Manufacturer country

India

Package quantity, pcs

ten

Scope of application

Allergology

Minimum age from

6 years

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Dr.

Reddy's

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

R06AE09 Levocetirizine

Dosage form

Film-coated tablets

Dosage (volume) of the substance in the preparation

1 tab .: levocetirizine dihydrochloride 5 mg

Expiration date in days

730

The target audience

Children

Package weight, g

twenty

Mode of application

:

The tablet should be taken orally, without chewing and with a liquid, regardless of the meal. < br> Adults and children over 6 years old < br> The daily dose is 5 mg (1 tablet) once. < br> Duration of taking the drug < br> In the treatment of seasonal (intermittent) rhinitis (the presence of symptoms less than 4 days a week or their total duration is less than 4 weeks), the duration of treatment depends on the duration of the symptoms treatment can be stopped when symptoms disappear and resumed when symptoms appear. < br> In the treatment of perennial (persistent) allergic rhinitis (symptoms of more than 4 days a week and their total duration of more than 4 weeks), treatment can be continued during the entire period of exposure to allergens. < br> The doctor sets the course of treatment for pollinosis.

Pharmaco-therapeutic group

:

Antiallergic agent - H1-histamine receptor blocker

Information on technical characteristics, delivery set, country of manufacture