Ezlor Solution Tablets, 5 mg 10 pcs

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Indications

– Allergic rhinitis (elimination or relief of sneezing, nasal congestion, nasal mucus, itching of the nose, itching of the palate, itching and redness of the eyes, watery eyes);

– urticaria (reduction or elimination of skin itching, rash).

Pharmacological effect

H1-histamine receptor blocker (long-acting). It is the primary active metabolite of loratadine. Inhibits the cascade of allergic inflammation reactions, including the release of anti-inflammatory cytokines, including interleukins IL-4, IL-6, IL-8, IL-13, the release of proinflammatory chemokines (RANTES), the production of superoxide anions by activated polymorphonuclear neutrophils, the adhesion and chemotaxis of eosinophils, the release of adhesion molecules such as P-selectin, IgE-mediated release of histamine, prostaglandin D2 and leukotriene C4.

Thus, it prevents the development and facilitates the course of allergic reactions, has antipruritic and antiexudative effects, reduces capillary permeability, and prevents the development of tissue edema and smooth muscle spasm.

The drug has no effect on the central nervous system, has virtually 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 at the recommended therapeutic dose, there was no prolongation of the QT interval on the ECG.

The effect of the drug begins within 30 minutes after ingestion and continues for 24 hours.

Pharmacokinetics:

Suction

After taking the drug orally, desloratadine is well absorbed from the gastrointestinal tract, with detectable concentrations of desloratadine in the blood plasma achieved within 30 minutes, and the maximum concentration after approximately 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 1 time / day. There is no clinically significant accumulation of desloratadine. Simultaneous food intake or simultaneous consumption of 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 blood-brain barrier.

Metabolism

It is extensively metabolized in the liver by hydroxylation to form 3-OH-desloratadine combined with a glucuronide. It is not an inhibitor of CYP3A4 and CYP2D6 isoenzymes and is not a substrate or inhibitor of P-glycoprotein.

Removal

Only a small portion of the oral dose is excreted by the kidneys (<2%) and intestines (<7%). The half-life is 20-30 hours (on average 27 hours).

Special instructions

There have been no studies of the effectiveness of desloratadine in rhinitis of infectious etiology.
Impact on the ability to drive vehicles. Wed and fur.:

At the recommended dose, the drug does not affect the ability to drive vehicles or operate machinery.

The potential for side effects such as dizziness and drowsiness should be taken into account. If the described adverse events occur, you should refrain from performing these activities.

Active ingredient

Desloratadine

Composition

Active substance:

desloratadine – 5.0 mg.

Excipients:

calcium hydrogen phosphate dihydrate – 170.0 mg;

microcrystalline cellulose – 50.0 mg;

sodium carboxymethyl starch – 6.0 mg;

aspartame – 5.0 mg;

magnesium stearate – 2.4 mg;

colloidal silicon dioxide – 1.6 mg.

Pregnancy

The use of the drug during 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 use of the drug during breastfeeding is contraindicated.

Contraindications

– Hypersensitivity to desloratadine, other components of the drug or to loratadine,

– pregnancy and breastfeeding period,

– children under 1 year of age,

– phenylketonuria.

With caution:

Severe renal failure.

Side Effects

The incidence of side effects is classified according to the recommendations of the World Health Organization: very often – at least 10%; often – no less than 1%, but less than 10%; infrequently – not less than 0.1%, but less than 1%; rarely – not less than 0.01%, but less than 0.1%; very rarely – less than 0.01%; frequency is unknown (it is not possible to determine the frequency based on available data).

From the immune system: very rarely – itching, rash, including urticaria, angioedema, dyspnea, anaphylaxis.

From the central nervous system: often – headache, insomnia (in children under 2 years of age); very rarely – dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions, hallucinations.

From the cardiovascular system: very rarely – tachycardia, palpitations, prolongation of the QT interval.

From the gastrointestinal tract: often – dry mouth, diarrhea (in children under 2 years of age); very rarely – nausea, vomiting, dyspepsia, diarrhea, abdominal pain, increased activity of liver enzymes, increased bilirubin concentration, hepatitis.

From the musculoskeletal system and connective tissue: very rarely – myalgia.

From the skin and subcutaneous tissues: very rarely – photosensitivity.

Other: often – increased fatigue, fever (in children under 2 years of age); frequency unknown – asthenia.

Post-registration period

Children: frequency unknown – QT interval prolongation, arrhythmia, bradycardia.

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Interactions with other drugs were not detected in studies with azithromycin, ketoconazole, erythromycin, fluoxetine and cimetidine. Simultaneous ingestion of food or consumption of grapefruit juice does not affect the effectiveness of the drug.

Desloratadine does not enhance the effects of alcohol on the central nervous system; however, cases of alcohol intolerance and alcohol intoxication have been reported during post-marketing use. Therefore, desloratadine is one

Overdose

Symptoms: Taking a dose 5 times the recommended dose did not result in any symptoms. In clinical studies, 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.

In a clinical and pharmacological study, 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: in case of accidental ingestion of a large amount of the drug – gastric lavage, intake of activated charcoal; if necessary, symptomatic therapy. Desloratadine is not eliminated by hemodialysis; the effectiveness of peritoneal dialysis has not been established.

Storage conditions

In a place protected from light at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life

3 years. Do not use after expiration date.

Manufacturer

Ozon, Russia