Ezlor Solution pills dispersible pills 5mg, 10pcs

Composition

Active ingredient:  

desloratadine – 5.0 mg.

Auxiliary substances:  

calcium hydrophosphate 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

Pharmacological action

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

Thus, it prevents the development and facilitates the course of allergic reactions, has an antipruritic and anti-exudative effect, reduces capillary permeability, prevents the development of tissue edema, smooth muscle spasm.

The drug does not affect the central nervous system, has almost 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 oral use, desloratadine is well absorbed from the gastrointestinal tract, while detectable plasma concentrations of desloratadine are reached within 30 minutes, and the maximum concentration is reached 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, clinically significant accumulation of desloratadine is not observed. 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). It does not cross the blood-brain barrier.

Metabolism

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

Deduction

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

Indications

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

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

Contraindications

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

– pregnancy and lactation,

– 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 – not less than 1% but < 10%; infrequently – no more than 0.1% but < 1%; rarely – not less than 0.01%, but less than 0.1%; very rarely – less than 0.01%; frequency unknown (according to available data to determine the frequency is not possible).

From the immune system:  very rarely-itching, rash, including urticaria, angioedema, dyspnoea, 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, palpitation, 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.

Musculoskeletal and connective tissue disorders:  very rarely – myalgia.

Skin and subcutaneous tissue disorders:  very rarely – photosensitization.

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

Post-marketing period

Children: frequency unknown-prolongation of the QT interval, arrhythmia, bradycardia.

If any of the side effects listed 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 food intake or consumption of grapefruit juice does not affect the effectiveness of the drug. Desloratadine does not enhance the effect of alcohol on the central nervous system, however, cases of alcohol intolerance and intoxication have been reported during post-marketing use. Therefore, desloratadine concomitantly with alcohol should be used with caution. Interaction studies with other drugs were conducted only in adult patients.

How to take, course of use and dosage

Inside, regardless of the meal time. The tablet should be dissolved in a small amount of water (10-50 ml or ¼ cup), the solution should be mixed before use.

Adults and adolescents over the age of 12 years – 1 tablet (5 mg) 1 time a day.

Children from 6 to 12 years – 1 tablet (2.5 mg) 1 time a day.

Children from 1 year to 6 years – ½ tablet (1.25 mg – ½ tablet with a dosage of 2.5 mg) 1 time a day.

For seasonal (intermittent) allergic rhinitis (with symptoms lasting less than 4 days a week or less than 4 weeks a year), it is necessary to assess the course of the disease. If symptoms disappear, the drug should be discontinued, and if symptoms reappear, the drug should be resumed.

In case of year-round (persistent) allergic rhinitis (if there are symptoms lasting more than 4 days a week or more than 4 weeks a year), the drug should be taken during the entire period of exposure to the allergen.

To determine the duration of therapy with the drug, it is necessary to consult with your doctor.

Overdose

Symptoms:  taking a dose exceeding the recommended 5 times did not lead to 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, taking activated charcoal; if necessary – symptomatic therapy. Desloratadine is not eliminated by hemodialysis, and the effectiveness of peritoneal dialysis has not been established.

Special instructions

Studies of the effectiveness of desloratadine in rhinitis of infectious etiology have not been conducted. Influence on the ability to drive vehicles and fur. :

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

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 types of activities.

Storage conditions

Store in a dark place at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf

life is 3 years. Do not use after the expiration date.

Active ingredient

Desloratadine

Dosage form

Tablets

Purpose

For adults and Children over 6 years of age

Indications

Diathesis, Dermatitis, Allergy, Allergic Conjunctivitis, Pollinosis, Allergic Rhinitis, Urticaria