Desal tab. p / o captivity. 5mg # 30

Release form, composition and packaging

Film-coated tablets of blue color, round, biconvex, engraved with LT" on one side.

1 tab.

desloratadine 5 mg

microcrystalline cellulose - 55 mg, pregelatinized corn starch - 15 mg, mannitol - 22 mg, talc - 2.5 mg, magnesium stearate - 0.5 mg.

The composition of the film shell: blue opadry 03F20404 (hypromellose 6cP - 1.9 mg, titanium dioxide (E171) - 0.61 mg, macrogol 6000 - 0.34 mg, indigo carmine aluminum varnish (E132) - 0.14 mg) - about 3 mg.

10 pieces.

- blisters (1) - cardboard packs.

10 pieces.

- blisters (2) - cardboard packs.

10 pieces.

- blisters (3) - cardboard packs.

pharmachologic effect

Long-acting antihistamine, blocker of peripheral histamine H1 receptors.

Desloratadine 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 pro-inflammatory chemokines, production of superoxide anions by activated polymorphonuclear neutrophils, adhesion and chemotaxis of eosinophils, release of adhesion molecules such as P-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, practically does not have a sedative effect (does not cause drowsiness) and does not affect the speed of psychomotor reactions when taken in recommended doses.

Does not cause prolongation of the QT interval on the ECG.

The action of desloratadine begins within 30 minutes after ingestion and lasts for 24 hours.

Pharmacokinetics

Suction

After taking the drug inside, desloratadine is well absorbed from the gastrointestinal tract.

It is determined in blood plasma after 30 minutes, and Cmax is reached after approximately 3 hours. There were no clinically significant changes in the concentration of desloratadine in blood plasma with repeated administration of ketoconazole and erythromycin.

The bioavailability of desloratadine is dose proportional with a dose ranging from 5 mg to 20 mg.

Distribution

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 are no signs of clinically significant cumulation of desloratadine.

The degree of desloratadine cumulation is consistent with the T1 / 2 value and the frequency of its use 1 time / day.

The AUC and Cmax values ��in children were similar to those in adults who received 5 mg of desloratadine.

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

Does not penetrate the BBB.

Metabolism

The enzymes responsible for the metabolism of desloratadine are not yet known, so interactions with some drugs cannot be completely ruled out.

It is not an inhibitor of 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, which is then glucuronized.

Withdrawal

The terminal phase T1 / 2 is about 27 hours. Desloratadine is excreted from the body in the form of a glucuronide compound and in small amounts unchanged (with urine - less than 2% and through the intestines - less than 7%).

Indications for use

To relieve or eliminate symptoms:

- allergic rhinitis (sneezing, nasal congestion, rhinorrhea, itchy nose, itchy palate, itching and redness of the eyes, watery eyes)

- urticaria (itching, rash).

Contraindications for use

- pregnancy

- the period of breastfeeding

Name ENG

DESAL

Clinical and pharmacological group

Blocker of histamine H1 receptors.

Antiallergic drug

ATX code

Desloratadine

Dosage

5mg

Structure

1 tablet contains desloratadine 5 mg

auxiliary substances: microcrystalline cellulose, pregelatinized corn starch, mannitol, talc, magnesium stearate.

Indications

To relieve or eliminate symptoms:

allergic rhinitis (sneezing, nasal congestion, rhinorrhea, itchy nose, itchy palate, itchy and red eyes, watery eyes)

urticaria (itching, rash).

Contraindications

hypersensitivity to the active or any auxiliary substance of the drug

pregnancy

period of breastfeeding

age up to 12 years (efficacy and safety have not been established)

The drug should be used with caution in severe renal failure.

Storage conditions and periods

In a dry, dark place at a temperature not exceeding 25 degrees.

Expiration date: 2 years

INN / Active ingredient

desloratadine

Specifications

Category

Allergy

Scope of the drug

Leather

Release form

Tablet

Manufacturer country

Malta

Package quantity, pcs

thirty

Scope of application

Allergology

Minimum age from

12 years

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Actavis

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

730

Dosage (volume) of the substance in the preparation

desloratadine 5 mg

Package weight, g

15

Mode of application

:

Inside, regardless of the meal.

Adults and adolescents (12 years and older) - 5 mg (1 tablet) 1 time per day.

Pharmaco-therapeutic group

:

Antiallergic agent - H1-histamine receptor blocker

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