Lordestin tab. p / o film. 5mg # 30

Release form, composition and packaging

Film-coated tablets, yellow, round, biconvex

at the break - white or almost white.

1 tab.

desloratadine hemisulfate 5.788 mg,

- which corresponds to the content of desloratadine 5 mg

microcrystalline cellulose, calcium hydrogen phosphate dihydrate, pregelatinized starch, colloidal silicon dioxide, magnesium stearate.

Film casing: opadry AMB yellow 80W22099 (polyvinyl alcohol partially hydrolyzed, titanium dioxide, talc, soy lecithin, aluminum varnish based on quinoline yellow dye, xanthan gum, iron oxide yellow, aluminum varnish based on indigo carmine dye).

10 pieces.

- contour cell packaging (1) - cardboard packs.

10 pieces.

- contour cell packages (3) - cardboard packs.

pharmachologic effect

Long-acting antihistamine. It is the primary active metabolite of loratadine. Inhibits the cascade of reactions of allergic inflammation, incl. - release of pro-inflammatory cytokines, including interleukins IL-4, IL-6, IL-8, IL-13, release of proinflammatory chemokines (RANTES), production of superoxide anions by activated polymorphonuclear neutrophils, adhesion and chemotaxis of eosinophils, release of such molecules as adhesion 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 anti-exudative effect, reduces capillary permeability, prevents the development of tissue edema and smooth muscle spasm.

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.

In clinical and pharmacological studies of the use of desloratadine in the recommended therapeutic dose, there was no prolongation of the QT interval on the ECG.

The action of the drug Lordestin begins within 30 minutes after ingestion and lasts for 24 hours.

Pharmacokinetics

Suction

Desloratadine is well absorbed in the digestive tract.

Determined in blood plasma 30 minutes after ingestion.

Cmax in blood plasma is reached, on average, 3 hours after administration.

Distribution

Does not penetrate the BBB.

Plasma protein binding 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 was no clinically significant cumulation of the drug.

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

Metabolism

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

It is extensively metabolized in the liver by hydroxylation to form 3-OH-desloratadine, combined with glucuronide.

Withdrawal

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

T1 / 2 is 20-30 hours (on average - 27 hours).

Indications for use

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

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

Contraindications for use

- hypersensitivity to desloratadine, other components of the drug, peanuts, soybean oil or loratadine

- pregnancy

- the period of breastfeeding

- children under 12 years old.

Precautions: severe renal impairment.

Dosage regimen

Inside.

For adults and children 12 years and older, the drug is prescribed in a dose of 5 mg (1 tab.) 1 time / day.

The drug is recommended to be taken at the same time of day, regardless of the meal, with a small amount

Name ENG

LORDESTIN

Clinical and pharmacological group

Blocker of histamine H1 receptors.

Antiallergic drug

ATX code

Desloratadine

Dosage

5mg

Structure

Active ingredient: desloratadine hemisulfate 5.788 (equivalent to 5 mg desloratadine)

Excipients: MCC - 39 mg

calcium hydrogen phosphate dihydrate - 46.712 mg

pregelatinized starch - 7 mg

colloidal silicon dioxide (aerosil) - 0.5 mg

magnesium stearate - 1 mg

Film casing: Opadry AMB yellow 80W22099 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, talc, lecithin, aluminum varnish based on quinoline yellow dye, xanthan gum, iron oxide yellow, aluminum varnish based on indigo carmine dye)

Indications

Seasonal allergic rhinitis, chronic idiopathic urticaria.

Contraindications

Pregnancy, lactation, children under 2 years of age, hypersensitivity to desloratadine.

INN / Active ingredient

Desloratadine

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 4 years

Specifications

Category

Allergy

Scope of the drug

General

Release form

Tablet

Manufacturer country

Russia

Package quantity, pcs

thirty

Minimum age from

12 years

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Gedeon richter

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

Expiration date in days

1460

The target audience

Children

Package weight, g

ten

Mode of application

:

Inside, swallowing whole, without chewing.

The drug is recommended to be taken at the same time of day, regardless of food intake, with a small amount of water.

Adults and adolescents aged 12 years and older - the drug is prescribed once a day at a dose of 5 mg (1 tablet).

With chronic renal failure and liver failure - correction of the dosage regimen is required - the initial dose of 5 mg is recommended to be taken every other day (according to pharmacokinetics).

There are no dosage recommendations in children with CRF and hepatic impairment (due to insufficient data).

Pharmaco-therapeutic group

:

Antiallergic agent - H1-histamine receptor blocker

Dosage (volume) of the substance in the preparation

:

desloratadine hemisulfate 5.788 (equivalent to 5 mg desloratadine)

Information on technical characteristics, delivery set, country of manufacture