Zodak Express - tablets 7 pcs., levocetirizine, anti-allergy medicine

Oblong biconvex film-coated tablets, white or almost white, with an e" engraving on one side.

Pharmacodynamics

Levocetirizine, the active substance of the drug, is the R-enantiomer of cetirizine, a powerful and selective histamine antagonist that blocks H 1 -histamine receptors.

Levocetirizine affects the histamine-dependent stage of allergic reactions, and also reduces the migration of eosinophils, reduces vascular permeability, and limits the release of inflammatory mediators.

Levocetirizine prevents the development and facilitates the course of allergic reactions, has an anti-exudative, antipruritic effect, practically does not have an anticholinergic and antiserotonin effect.

In therapeutic doses, it practically does not have a sedative effect.

After oral administration, the antiallergic effect of levocetirizine continues for 24 hours.

Pharmacokinetics

The pharmacokinetic parameters of levocetirizine vary linearly and practically do not differ from the pharmacokinetics of cetirizine.

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 (C max) in the blood plasma is reached after 0.9 hours and is 270 ng / ml, after repeated administration at a dose of 5 mg - 308 ng / ml.

Equilibrium concentration is reached after 2 days.

Distribution

Levocetirizine is 90% bound to blood plasma proteins.

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

Bioavailability reaches 100%.

Metabolism

In small amounts (< 14%), levocetirizine 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 insignificant metabolism and the lack of metabolic potential, the interaction of levocetirizine with other drugs appears to be

unlikely.

Withdrawal

In adults, the half-life (T 1/2) is 7.9 ± 1.9 h

in young children, T 1/2 is shortened.

In adults, 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.

Name ENG

ZODAC

Clinical and pharmacological group

Blocker of histamine H1 receptors.

Antiallergic drug

ATX code

R06AE09

Dosage

levocetirizine dihydrochloride - 5.00 mg.

Structure

1 tablet contains:

Active ingredient: levocetirizine dihydrochloride - 5.00 mg.

Excipients: core: lactose monohydrate, cellulose

microcrystalline, sodium carboxymethyl starch, colloidal silicon dioxide,

magnesium stearate

film shell: hypromellose 2910/5, macrogol - 6000, talc, titanium

E171 dioxide.

Indications

Treating symptoms of perennial (persistent) and seasonal

(intermittent) allergic rhinitis and allergic conjunctivitis,

such as itching, sneezing, nasal congestion, rhinorrhea, lacrimation, flushing

conjunctiva

- hay fever (hay fever)

- urticaria (including chronic idiopathic urticaria)

- other allergic dermatoses, accompanied by itching and rashes.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 3 years

INN / Active ingredient

levocetirizine dihydrochloride

Contraindications

Hypersensitivity to levocetirizine, cetirizine, hydroxyzine, and others

derivatives of piperazine or to any of the auxiliary components of the drug

- end-stage renal failure (CC less than 10 ml / min)

4

- age up to 6 years (for this dosage form)

- congenital galactose intolerance, lactase deficiency or malabsorption

glucose - galactose (due to the content of lactose in the preparation).

Specifications

Category

Allergy

Scope of the drug

Respiratory system

Release form

Tablet

Manufacturer country

Czech

Package quantity, pcs

7

Scope of application

Allergology

Minimum age from

6 years

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Zentiva

The amount of the dosage form in the primary package

7 pcs.

Primary packaging type

Blister

Type of consumer packaging

Pack of cardboard

Anatomical and therapeutic characteristics

R06AE09 Levocetirizine

Dosage form

Film-coated tablets

The target audience

Children

Dosage (volume) of the substance in the preparation

cetirizine dihydrochloride 5 mg

Expiration date in days

1095

Package weight, g

twenty

Mode of application

:

The tablet should be taken orally without chewing and drinking a liquid, regardless of

eating.

It is recommended to take the daily dose at one time.

Adults, adolescents and children over 6 years old

The recommended daily dose is 5 mg (1 tablet).

If after treatment there is no improvement or new symptoms appear,

it is necessary to consult a doctor.

Use the drug only according to the route of administration and in those doses that

specified in the instructions.

If necessary, please consult

doctor before using the drug.

Elderly patients

In elderly patients with moderate renal impairment and

dose adjustment is recommended for severe renal impairment (see "Patients

with impaired renal function ").

Patients with impaired renal function

When prescribing the drug to patients with impaired renal function in the case when

alternative treatment cannot be prescribed, the dose should be adjusted to

depending on the CC value, since levocetirizine is excreted from the body in

mainly by the kidneys.

Pharmaco-therapeutic group

:

Antiallergic agent - H1-histamine receptor blocker

Information on technical characteristics, delivery set, country of manufacture "