desloratadine Canon tab. p / o captivity. 5mg # 10

Release form, composition and packaging

Film-coated tablets of white or almost white color, round, biconvex

on a cross section almost white or white with a creamy or white with a pinkish tinge.

1 tab.

desloratadine 5 mg

calcium hydrogen phosphate dihydrate 61.7 mg, povidone 6.8 mg, calcium stearate 0.7 mg, croscarmellose sodium 4.8 mg, microcrystalline cellulose 41 mg.

The composition of the film shell: Opadray II white 4 mg, including: polyvinyl alcohol 1.88 mg, macrogol 0.94 mg, talc 0.7 mg, titanium dioxide 0.48 mg.

7 pcs.

- contoured cell packages (aluminum / PVC) (1) - cardboard packs.

7 pcs.

- contour cell packages (aluminum / PVC) (2) - cardboard packs.

7 pcs.

- contour cell packages (aluminum / PVC) (3) - cardboard packs.

10 pieces.

- contoured cell packages (aluminum / PVC) (1) - cardboard packs.

10 pieces.

- contour cell packages (aluminum / PVC) (2) - cardboard packs.

10 pieces.

- contour cell packages (aluminum / PVC) (3) - cardboard packs.

30 pcs.

- contoured cell packages (aluminum / PVC) (1) - cardboard packs.

30 pcs.

- contour cell packages (aluminum / PVC) (2) - cardboard packs.

pharmachologic effect

Blocker of histamine H1-receptors (long-acting).

It is the primary active metabolite of loratadine.

Inhibits the release of histamine and leukotriene C4 from mast cells.

Prevents the development and facilitates the course of allergic reactions.

It has antiallergic, antipruritic and antiexudative effect.

Reduces capillary permeability, prevents the development of tissue edema, relieves spasm of smooth muscles.

It practically does not have a sedative effect and, when taken in a dose of 7.5 mg, does not affect the speed of psychomotor reactions.

In comparative studies of desloratadine and loratadine, there were no qualitative or quantitative differences in the toxicity of the two drugs in comparable doses (taking into account the concentration of desloratadine).

Pharmacokinetics

After oral administration, it begins to be determined in plasma after 30 minutes.

Food has no effect on distribution.

Bioavailability is dose proportional, ranging from 5 mg to 20 mg.

Plasma protein binding is 83-87%.

After a single dose of 5 mg or 7.5 mg, Cmax is reached after 2-6 hours (on average, after 3 hours).

Does not penetrate the BBB.

It is extensively metabolized in the liver by hydroxylation to form 3-OH-desloratadine, combined with glucuronide, only a small part of the dose taken orally is excreted by the kidneys (< 2%) and with feces (< 7%).

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

When using desloratadine at a dose of 5 mg to 20 mg 1 time / day for 14 days, there were no signs of clinically significant cumulation.

Indications for use

Seasonal allergic rhinitis, chronic idiopathic urticaria.

Contraindications for use

Phenylketonuria, pregnancy, lactation, children under 1 year of age, hypersensitivity to desloratadine.

Dosage regimen

Adults and adolescents aged 12 years and older are prescribed orally, regardless of food intake, at a dose of 5 mg / day.

Children aged 1 to 5 years - 1.25 mg 1 time / day, aged 6 to 11 years - 2.5 mg 1 time / day.

Side effect

From the nervous system: headache, hallucinations, psychomotor hyperreactivity, convulsions.

From the digestive system: dry mouth, hepatitis.

Others: photosensitivity, myalgia, shortness of breath, feeling tired.

Drug interactions

The study of interaction with ketoconazole and erythromycin revealed no clinically significant changes.

Does not affect the effects of ethanol.

Application during pregnancy and lactation

Desloratadine is contraindicated during pregnancy and lactation (breastfeeding).

special instructions

Desloratadine is prescribed with caution in severe renal failure.

Effect on driving ability

Name ENG

DESLORATADINE CANON

Clinical and pharmacological group

Blocker of histamine H1 receptors.

Antiallergic drug

ATX code

Desloratadine

Dosage

5mg

Structure

1 tab .: - desloratadine 5 mg

excipients: calcium hydrogen phosphate dihydrate 61.7 mg

povidone 6.8 mg

calcium stearate 0.7 mg

croscarmellose sodium (primellose) 4.8 mg

microcrystalline cellulose 41 mg

composition of the film shell: Opadray II white 4 mg, including: polyvinyl alcohol 1.88 mg, macrogol (polyethylene glycol 3350) 0.94 mg, talc 0.7 mg, titanium dioxide 0.48 mg.

Indications

allergic rhinitis (eliminating or relieving sneezing, nasal congestion, nasal mucus, itchy nose, itchy palate, itchy and red eyes, watery eyes)

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

INN / Active ingredient

desloratadine

Contraindications

hypersensitivity to any of the substances that make up the drug

- pregnancy and lactation

- age up to 12 years.

Precautions: severe chronic renal failure.

Storage conditions and periods

At a temperature not exceeding 25 degrees, in the original packaging.

Expiration date: 2 years

Specifications

Category

Allergy

Scope of the drug

Leather

Release form

Tablet

Manufacturer country

Russia

Package quantity, pcs

ten

Minimum age from

12 years

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Kanonpharma Production CJSC

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

desloratadine 5 mg

Expiration date in days

730

Package weight, g

thirty

Mode of application

:

Inside, regardless of food intake, adults and adolescents from 12 years old, 1 tablet per day.

The tablet should be swallowed whole with water.

Pharmaco-therapeutic group

:

Antiallergic agent - H1-histamine receptor blocker

Information on technical characteristics, delivery set, country of manufacture