Universal reference book for medicines
Name of the drug: DESLORATADIN (DESLORATADINE)

Active substance: desloratadine

Type: The blocker of histamine H 1 -receptors.
Anti-allergic drug
Manufacturer: ВЕРТЕКС (Russia)
Composition, form of production and packaging
?
The tablets covered with a film cover of blue color, round, biconcave; the core is white or almost white in cross section.
1 tab.

desloratadine 5 mg

Excipients: calcium hydrophosphate dihydrate - 53 mg, microcrystalline cellulose - 27.5 mg, corn starch - 11 mg, talc - 2.5 mg, magnesium stearate - 1 mg.

The composition of the film shell: dry film-coating mixture (polyvinyl alcohol 40%, titanium dioxide 22.1%, macragol 3350 (polyethylene glycol 3350) 20.2%, talc 14.8%, aluminum dye based on indigo carmine dye 2.8%, iron oxide yellow (iron oxide) - 0.1%) - 3 mg.

10 pieces.
- packings of cellular contour (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

H 1 -gistamine receptor blocker long-acting.
It is the primary active metabolite of loratadip. Inhibits the cascade of the reaction of allergic inflammation, including the release of pro-inflammatory cytokines, including interleukins IL-4. IL-6. IL-8, IL-13. release of pro-inflammatory chemokines (RANTES). production of superoxide anions by activated polymorphonuclear neutrophils, adhesion and chemotaxis of eosinophils, isolation of adhesion molecules such as P-selectin, IgE-mediated release of histamine, prostaglandin D2 and leukotriene C4. Thus, it prevents development and facilitates the course of allergic reactions, has antipruritic and antiexcudative action, reduces permeability of capillaries, prevents the development of edema of tissues, spasm of smooth muscles.
The drug has no effect on the central nervous system, has almost no sedative effect (does not cause drowsiness) and does not affect the rate of psychomotor reactions.Does not cause prolongation of the QT interval on the electrocardiogram (ECG).

The action of the drug 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, with defined concentrations of desloratadine in the blood plasma reached within 30 minutes, and the maximum concentration - after about 3 hours.

Distribution

The binding of desloratadine to plasma proteins is 83-87%.
When used in adults and adolescents for 14 days at a dose of 5 mg to 20 mg once a day, there is no clinically significant cumulation of the drug. Simultaneous food intake or simultaneous use of grapefruit juice does not affect the bioavailability and distribution of desloratadine (when taken at a dose of 7.5 mg 1 time per day). Does not penetrate the blood-brain barrier.
Metabolism

It is subjected to intensive metabolism in the liver by hydroxylation with the formation of 3-OH-desloratadine, combined with glucuroid.
Desloratadine is not an inhibitor of the isoenzymes CYP3A4 and CYP2D6 and is not a substrate or inhibitor of P-glycoinothein.
Excretion

It is excreted from the body in the form of a glucuronide compound.
In small amounts in unchanged form is excreted by the kidneys (<2%) and through the intestine (<7%). The half-life period is 20-30 hours (on average - 27 hours).
INDICATIONS

- allergic rhinitis (elimination or relief of sneezing, nasal congestion, discharge of mucus from the nose, itching in the nose, itching of the palate, itching and redness of the eyes, lachrymation);

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

DOSING MODE

Inside.
The tablet should be swallowed whole, not liquid, squeezed with a small amount of water.
The drug should be taken at the same time of the day, regardless of the time you take it.

Adults and adolescents from 12 years - 1 tablet (5 mg) 1 time per day.
The duration of therapy depends on the duration of the symptomatology.
In seasonal (intermittent) allergic rhinitis (the presence of symptoms lasting less than 4 days a week or a total duration of less than 4 weeks per year) and urticaria, it is necessary to evaluate the course of the disease.
With the disappearance of symptoms, taking the drug should be discontinued, with the repeated appearance of symptoms, the drug should be resumed.
With year-round (persistent) allergic rhinitis (the presence of symptoms lasting more than 4 days a week or their total duration of more than 4 weeks per year) treatment can continue throughout the exposure period of allergens.

To determine the duration of therapy, the drug should be consulted with your doctor.

SIDE EFFECT

The incidence of adverse events is classified according to the recommendations of the World Health Organization:

Often - ?
1/10 (> 10%):
often - from?
1/100 to <1/10 (> 1% and <10%);
infrequently - from?
1/1000 to <1/100 (> 0.1% and <1%);
rarely - from?
1/10000 to <1/1000 (> 0.01% and <0.1%);
very rarely - <1/10000 (<0.01%).

From the immune system

Very rarely - anaphylaxis, angioneurotic edema, shortness of breath, itching, rash, including hives.

Violations from the central nervous system

Infrequent - a headache.

Very rarely - dizziness, drowsiness, insomnia, psychomotor hyperactivity, hallucinations, convulsions.

Disorders from the cardiovascular system

Very rarely - tachycardia, a feeling of palpitations.

Disorders from the digestive system

Infrequent - dry mouth.

Very rarely - abdominal pain, nausea, vomiting, dyspepsia, diarrhea, hepatitis.

From the side of the musculoskeletal system

Very rarely - myalgia.

Laboratory indicators

Very rarely - increased activity of "liver" enzymes, an increase in the concentration of bilirubin.

Other

Often - increased fatigue.

Very rarely - pharyngitis, dysmenorrhea.

CONTRAINDICATIONS

- Hypersensitivity to any of the components that make up the drug, and loratadine;

- Pregnancy and the period of breastfeeding;

- age up to 12 years.

With caution: with severe kidney failure.

PREGNANCY AND LACTATION

The use of the drug in pregnancy is contraindicated due to the lack of clinical data on the safety of its use during pregnancy.
Desloratadine is excreted in breast milk, so the use of the drug during breastfeeding is contraindicated.
APPLICATION FOR FUNCTIONS OF THE LIVER

With caution in severe kidney failure.

APPLICATION FOR CHILDREN

Contraindicated for children under 12 years.

SPECIAL INSTRUCTIONS

Studies of the effectiveness of desloratadine in rhinitis of infectious etiology were not conducted.

Impact on the ability to drive vehicles and mechanisms

When desloratadine was taken in the recommended dose, adverse effects on the management of vehicles and mechanisms were not noted.

However, in rare cases, some patients take drowsiness and dizziness when taking the medication, which can affect the ability to drive vehicles and work with mechanisms.

OVERDOSE

Symptoms

Taking a dose that exceeds the recommended dose by 5 times did not lead to any symptoms.
Daily use of desloratadine in adults and adolescents at a dose of up to 20 mg for 14 days was not accompanied by statistically or clinically significant changes in the cardiovascular system. The use of desloratadine at a dose of 45 mg per day (9 times higher than recommended) for 10 days did not cause prolongation of the QT interval and was not accompanied by serious side effects.
Treatment

If you ingest large amounts of the drug, you should immediately consult a doctor.
Recommended gastric lavage, the reception of activated charcoal, if necessary - symptomatic therapy. Desloratadine is not excreted in hemodialysis, the efficacy of yertpsal dialysis is not established.
DRUG INTERACTION

Interactions with other drugs have not been identified in studies with azithromycin, ketoconazole.
erythromycin, fluoxetine and cimetidine.
Eating does not affect the effectiveness of the drug.

Desloratadine does not enhance the effect of alcohol on the central nervous system.

TERMS OF RELEASE FROM PHARMACY

Without recipe.

TERMS AND CONDITIONS OF STORAGE

In the dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children. Shelf life - 3 years.
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