DERANI [Desloratadine] 5 mg Film-coated tablets

DERANI

instructions for the medical use of the medicinal product

Tradename

Derani, Дерани

International non-proprietary name or generic name

Desloratadine, Дезлоратадин

Composition

Each film-coated tablet contains:

Active substance: desloratadine 5 mg.

Excipients: Avicel-102, Avicel-200, talc, magnesium stearate.

Dosage form

Tablets.

Pharmacotherapeutic group

Antiallergic agent - H1-histamine receptor blocker.

Pharmacological properties

Pharmacodynamics

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 smooth muscle spasm. 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 achieved after 2-6 hours (on average, after 3 hours). Does not penetrate the BBB. It is extensively metabolized in the liver by hydroxylation with the formation of 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

Symptomatic therapy of seasonal and perennial allergic rhinitis, chronic idiopathic urticaria.

Contraindications

Hypersensitivity to desloratadine, children under 1 year of age.

Method of administration and dosage

Inside, regardless of food intake, with a small amount of liquid.

Adults and adolescents aged 12 years and older 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.

Special instructions and precautions

It is prescribed with caution in severe renal failure.

Influence on the ability to drive vehicles and mechanisms

No adverse effects on driving or complex technical devices were noted.

Application during pregnancy and during breastfeeding

Contraindicated for use during pregnancy and during breastfeeding.

Interaction with other medicinal products

With repeated co-administration of desloratadine with ketoconazole, erythromycin, azithromycin, fluoxetine and cimetidine, clinically significant changes in the concentration of desloratadine in plasma were not revealed. Simultaneous food intake does not affect the distribution of desloratadine in the body.

Side effect

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

From the digestive system: dry mouth, hepatitis.

Others: photosensitivity, myalgia, shortness of breath, fatigue.

If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.

Overdose

Symptoms: increased severity of adverse reactions.

Treatment: gastric lavage, symptomatic and supportive therapy. Hemodialysis is ineffective.

Storage conditions

Store in a dry and cool place, at a temperature not exceeding 30°C.

Keep out of the reach of children!

Shelf life

2 years. Do not use after the expiration date printed on the package.

Vacation conditions

Dispensed by prescription.

Release form

10 tablets in aluminum foil blister. 1 blister with instructions for use in a cardboard box.

Manufacturer

The holder of trade mark and Marketing Authorization is

“LIVE MEDICINE LIMITED”, GREAT BRITAIN.