Ezlor solyushn dispersing tablets tab. 5mg 10 pc

Description

Composition
Active substance:
Desloratadine – 5.0 mg
Excipients:
calcium hydrogen phosphate dihydrate – 170.0 mg; Microcrystalline cellulose – 50.0 mg; Sodium carboxymethyl – 6.0 mg; Aspartame – 5.0 mg; Magnesium stearate – 2.4 mg; Colloidal silicon dioxide – 1.6 mg.
Description:
Oval biconvex, white or nearly white with Valium.
Product form:
Dispersible tablets 5 mg.
10 tablets in blisters of PVC film and aluminum foil printed patent.
Or
10 tablets in banks for polyethylene terephthalate or polypropylene drugs for medicines, caps of the capped high-pressure polyethylene having a first opening control, or polypropylene caps System “push-turn” or caps of high density polyethylene with a first control opening.
One bank 1 or contour cell package together with instructions for use placed in a cardboard box (pack).
Equipment is allowed to 2 or 3 cartons (packs) in multipacks (transportation) of paperboard for consumer packaging.
Contraindications
– Hypersensitivity to desloratadine, other ingredients, or to loratadine,
– pregnancy and lactation,
– Children up to age 1 year,
– phenylketonuria.
Precautions: severe renal insufficiency.
Dosage
5 mg
Indications
– allergic rhinitis (elimination or relief of sneezing, nasal congestion, discharge of mucus from the nose,
itchy nose, itching palate, itching and redness of the eyes, tearing);
– urticaria (reduction or elimination of itching, rashes).
Interaction with other drugs
Interactions with other drugs have been identified in studies with azithromycin, ketoconazole, eritromitsionom, fluoxetine and cimetidine.
Simultaneous eating or drinking grapefruit juice does not affect the efficacy of the drug. Desloratadine does not increase the effect of alcohol on the central nervous system, however, during the post-marketing use of cases of intolerance to alcohol and intoxication have been reported. Therefore, desloratadine with alcohol should be used with caution. on interaction studies with other medicinal products were conducted only in adult patients.
Overdose
Symptoms: receiving doses higher than the recommended 5 times, does not cause any symptoms. In clinical trials, daily use in adults and adolescents desloratadine at a dose of 20 mg for 14 days is not associated with a statistically or clinically significant changes of the cardio – vascular system. At clinical-pharmacological study of desloratadine in a dose of 45 mg per day (at 9 times higher than the recommended) for 10 days did not cause QT interval elongation and not accompanied by the appearance of serious side effects.
Treatment: Accidental ingestion of large amounts of drug – gastric lavage, administration of activated charcoal; if necessary – symptomatic therapy. Desloratadine does not appear in hemodialysis, peritoneal dialysis efficacy has not been established.
pharmachologic effect
Pharmacological group:
antiallergic agent – H1 – histamine receptor blocker.
Pharmacodynamics:
Blocker H1 – histamine receptors (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 , selection 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 allergic reactions,
and protivoekssudativnoe has antipruritic effect, reduces the permeability of the capillaries,
prevents the development of edema, smooth muscle spasm.
The drug has no effect on the central nervous system with practically no sedative effect (does not cause drowsiness) and does not affect the speed of psychomotor reactions. At clinical-pharmacological studies of desloratadine in recommended therapeutic dose were observed lengthening QT interval on the electrocardiogram.
The action of the drug starts within 30 minutes after ingestion and continues for 24 hours.
Pharmacokinetics:
Suction
After taking the drug inside desloratadine well absorbed from the gastrointestinal tract, thus defined desloratadine plasma concentrations are reached within 30 minutes, and the maximum concentration – about 3 hours.
Distribution
desloratadine Binding to plasma proteins is 83-87%. In the application for adults and adolescents over 14 days in a dose of 5 mg to 20 mg of 1 time / day. clinically significant accumulation of desloratadine is not marked. Simultaneous food intake or simultaneous use of grapefruit juice does not affect the distribution of desloratadine (when receiving a dose of 7.5 mg 1 time / day). It does not cross the blood-brain barrier.
Metabolism
It undergoes extensive metabolism in the liver by hydroxylation to form 3-OH-desloratadine connected to glucuronide. Not an inhibitor of isozyme CYP3A4 and CYP2D6, and is not a substrate or inhibitor of P-glycoprotein.
breeding
Only a small part of an oral dose is excreted by the kidneys (
Pregnancy and breast-feeding
Use of the drug is contraindicated in pregnancy due to the lack of clinical data on the safety of its use during pregnancy.
Desloratadine is excreted in breast milk, therefore the use of the drug during breast-feeding is contraindicated.
Conditions of supply of pharmacies
Without a prescription.
side effects
The frequency of side effects is classified according to the recommendations of the World Health Organization: very often – at least 10%; often – at least – 1% but less than 10%; infrequently – at least 0.1% but less than 1%; rarely – at least 0.01% but less than 0.1%; very rarely – less than 0.01%; frequency is not known (from the available data to determine the frequency is not possible).
Immune system: very rarely – itching, skin rashes, including urticaria, angioedema, dyspnea, and anaphylaxis.
Central nervous system: often – headache, insomnia (in children younger than 2 years); very rarely – dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures, hallucinations.
With the cardiovascular system: very rarely – tachycardia, palpitations, lengthening the interval QT.
Gastro-intestinal tract: often – dry mouth, diarrhea (in children younger than 2 years); very rarely – nausea, vomiting, dyspepsia, diarrhea, abdominal pain, increased activity of “liver” enzymes, increased bilirubin, hepatitis.
On the part of the musculoskeletal system and connective tissue disorders: very rarely – myalgia.
Skin and subcutaneous tissue disorders: very rarely – photosensitivity.
Other: often – fatigue, fever (in children younger than 2 years); the frequency is unknown – asthenia.
Post-registration period
Children: the frequency is unknown – lengthening the interval QT, an arrhythmia, bradycardia.
If any of these instructions side effects are compounded, or if you notice any other side effects not mentioned in the instructions, tell your doctor.
special instructions
Research on the effectiveness of desloratadine in rhinitis infectious etiology have been conducted.
Effects on ability to drive a car, and management mechanisms
At the recommended dose of the drug does not affect the ability to drive vehicles and management mechanisms.
It should take into account the potential for the development of side effects such as dizziness and somnolence. When the described adverse events should refrain from carrying out these activities.
Storage conditions
At temperatures above 25 ° C.
Keep out of the reach of children.
Dosing and Administration
Inside, regardless of mealtime. A tablet to be dissolved in a small amount of water (10-50 ml or 1/4 cup) before use is necessary to mix the solution.
Adults and adolescents aged 12 years – 1 tablet (5 mg), 1 per day.
Children 6 to 12 years – 1 tablet (2.5 mg), 1 time per day.
Babies from 1 to 6 years – 1/2 tablet (1.25 mg – 1/2 tablet dosage 2.5 mg), 1 time per day.
By seasonal (intermittent) allergic rhinitis (with symptoms lasting less than 4 days per week or at least 4 weeks in a year) should be evaluated for the disease. With the disappearance of the symptoms, the drug should be discontinued at the re-emergence of symptoms the drug should be resumed. In year-round (persistent) allergic rhinitis (with symptoms lasting more than 4 days per week, or up to 4 weeks in a year), medication must be taken over the entire period of allergen exposure.
To determine the duration of drug therapy should consult with a physician.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist