Ezlor Solution Tablets 5mg #10

Instruction for Ezlor Solution Tablets

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Pharmacodynamics

H1-histamine receptor blocker (long-acting). It is the primary active metabolite of loratadine. Inhibits the cascade of allergic inflammation, including - the release of inflammatory cytokines including the interleukins IL-4, IL-6, IL-8, IL-13, the release of proinflammatory chemokines (RANTES), the production of superoxide anion by activated polymorphonuclear neutrophils adhesion and chemotaxis 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 anti-exudative action, reduces capillary permeability, prevents the development of tissue edema, and smooth muscle spasm.
Ezlor Solution Tablets 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 in the recommended therapeutic dose, there was no prolongation of the QT interval on the ECG.
The action of the drug begins within 30 minutes after ingestion and lasts for 24 hours.

Pharmacokinetics

Suction

After taking Ezlor Solution Tablets inside desloratadine is well absorbed from the gastrointestinal tract, while the detected concentration of desloratadine in the blood plasma is reached within 30 minutes, and the maximum concentration is 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 cumulation of desloratadine is not observed. Simultaneous ingestion of food or simultaneous consumption of grapefruit juice does not affect the distribution of desloratadine (when taken in 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, coupled with the 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 part of the ingested dose is excreted by the kidneys (<2%) and through the intestines (<7%). The half-life is 20-30 hours (on average, 27 hours).

Indications for use

    allergic rhinitis (elimination or relief of sneezing, nasal congestion, discharge of mucus from the nose, itching of the nose, itching of the palate, itching and redness of the eyes, tearing);
    urticaria (reduction or elimination of pruritus, rash).

Contraindications for Ezlor Solution Tablets

    Hypersensitivity to desloratadine, other components of the drug or to loratadine,
    pregnancy and breastfeeding,
    children up to 1 year
    phenylketonuria.
With care: severe renal failure.

Use during pregnancy and during breastfeeding

The use of Ezlor Solution Tablets 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 the use of the drug during breastfeeding is contraindicated.

Dosage and administration

Inside, regardless of meal times. The tablet must be dissolved in a small amount of water (10-50 ml or ¼ cup), before use, the solution must be mixed.
Adults and adolescents aged 12 years and older - 1 tablet (5 mg) 1 time per day.
Children from 6 to 12 years old - 1 tablet (2.5 mg) 1 time per day.
For children from 1 to 6 years old, take ½ tablet (1.25 mg - ½ tablet at a dose of 2.5 mg) once a day.
In case of seasonal (intermittent) allergic rhinitis (if symptoms persist for less than 4 days per week or less than 4 weeks per year), the course of the disease should be assessed. With the disappearance of symptoms, taking Ezlor Solution Tablets should be stopped, with the reappearance of symptoms, the drug should be resumed. For year-round (persistent) allergic rhinitis (if symptoms persist for more than 4 days a week or more than 4 weeks a year), the drug should be taken during the entire period of allergen exposure.
To determine the duration of drug therapy, it is necessary to consult with your doctor.

Side effect of Ezlor Solution Tablets

The frequency 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 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 (according to the available data it is not possible to determine the frequency).
On the part of the immune system: very rarely - itching, rash, including urticaria, angioedema, dyspnea, anaphylaxis.
From the side of the central nervous system: often - headache, insomnia (in children under 2 years old); very rarely - dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions, hallucinations.
Since the cardiovascular system: very rarely - tachycardia, palpitations, prolongation of the QT interval.
On the part of the gastrointestinal tract: often - dry mouth, diarrhea (in children under 2 years old); 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.
On the part of the skin and subcutaneous tissues: very rarely - photosensitization.
Other: often - increased fatigue, fever (in children under 2 years old); frequency is unknown - asthenia.

Post-registration period

Children: frequency is unknown - prolongation of the QT interval, arrhythmia, bradycardia.
If any of the side effects indicated in the instruction are aggravated, or you have noticed any other side effects that are not indicated in the instruction, inform your doctor.

Overdose

Symptoms: taking a dose that is 5 times the recommended one did not lead to the appearance of any symptoms. In clinical studies, daily use of desloratadine in a dose of up to 20 mg for 14 days in adults and adolescents was not accompanied by statistically or clinically significant changes in the cardiovascular system. In a clinical 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 a prolongation of the QT interval and was not accompanied by serious side effects.
Treatment: in case of accidental ingestion of a large amount of Ezlor Solution Tablets - gastric lavage, taking activated charcoal; if necessary, symptomatic therapy. Desloratadine is not excreted by hemodialysis, the effectiveness of peritoneal dialysis has not been established.

Interaction with other drugs

No interactions with other drugs were found in studies with azithromycin, ketoconazole, erythromytion, fluoxetine and cimetidine.
Simultaneous consumption of food or consumption of grapefruit juice does not affect the effectiveness of Ezlor Solution Tablets. Desloratadine does not increase the effect of alcohol on the central nervous system, however, during post-registration use, cases of intolerance to alcohol and alcohol intoxication were reported. Therefore, desloratadine along with alcohol should be used with caution. Studies on the interaction with other drugs were conducted only in adult patients.

special instructions

Studies on the effectiveness of desloratadine in rhinitis infectious etiology has not been conducted.
Influence on ability to driving of the car and control of mechanisms
In the recommended dose, Ezlor Solution Tablets does not affect the ability to drive vehicles or control mechanisms.
The potential for side effects such as dizziness and drowsiness should be taken into account. When the described adverse events should refrain from performing these activities.

Release form

Dispersible tablets 2.5 mg and 5 mg.
On 10, 20 or 30 tablets in a blister strip packaging from a film of a polyvinyl chloride and aluminum foil printed lacquered.
10, 20, 30, 40, 50 or 100 tablets in cans of polyethylene terephthalate for drugs or polypropylene for drugs, sealed with high-pressure polyethylene lids with first opening control, or polypropylene lids with a push-turn system, or lids from polyethylene of low pressure with control of the first opening.
One can or 1, 2, 3, 4, 5 or 10 blister packs together with the instructions for use are placed in a carton (pack).
Completion of 2 or 3 cardboard packaging (packs) in group packaging (shipping container) of cardboard for consumer packaging is allowed.

Storage conditions

At a temperature not higher than 25 ° C.
Keep out of the reach of children.
Shelf life - 3 years. Do not use after expiration date.

Terms of sell

You don't need a prescription to buy Ezlor Solution Tablets.