Erius pills 5 mg 10 pcs.
International non-proprietary name- desloratadine
Dosage Form- film-coated pills
CompositionActive ingredient: desloratadine 5 mg.
Excipients: calcium hydrophosphate dihydrate 53 mg, microcrystalline cellulose 28 mg, corn starch 11 mg, talc 3 mg.
Tablet shell: opadry blue (lactose monohydrate, hypromellose, titanium dioxide, macrogol, aluminum blue varnish) 6 mg, opadry transparent (hypromellose, macrogol) 0.6 mg, carnauba wax 0.005 mg, beeswax white 0.005 mg.
DescriptionRound biconvex pills of blue color. On one side of the tablet, the Schering-Plow trademark in the form of SP stylized letters is applied by embossing.
Pharmacotherapeutic groupAntiallergic - H 1 -histamine receptor blocker.
PharmacodynamicsAntihistamine drug long-acting. It is the primary active metabolite of loratadine. Inhibits the cascade of allergic inflammation, including - the release of pro-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, spasm
The drug has no effect on the central nervous system, almost does not have a sedative effect (does not cause drowsiness) and does not affect the speed of psychomotor reactions. Does not cause lengthening of the QT interval on the ECG.
The effect of the drug Erius begins within 30 minutes after ingestion and lasts for 24 hours.
PharmacokineticsDesloratadine is well absorbed in the gastrointestinal tract. Determined in blood plasma 30 minutes after ingestion. The maximum concentration is reached on average 3 hours after ingestion. Does not penetrate the blood-brain barrier.
Communication with 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 per day, there is no clinically significant cumulation of the drug. Simultaneous ingestion of food or grapefruit juice does not affect the distribution of desloratadine when used at a dose of 7.5 mg 1 time per day.
Desloratadine is not a CYP3A4 and CYP2D6 inhibitor and is not a substrate or P-glycoprotein inhibitor. It is extensively metabolized in the liver by hydroxylation to form 3-OH-desloratadine, coupled with the glucuronide.
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 in the nose, itching of the palate, itching and redness of the eyes, watering eyes);
- urticaria (reduction or elimination of pruritus, rash).
Contraindications hypersensitivity to any of the substances that make up the drug,
pregnancy and lactation,
Age up to 12 years.
severe renal failure.
Use during pregnancy and lactationThe use of the drug in pregnancy is contraindicated due to the lack of clinical data on the safety of the drug Erius during pregnancy.
Desloratadine, the active substance, is excreted in breast milk, so the use of the drug Erius during breastfeeding is contraindicated.
Dosage and administrationFor oral administration. The tablet should be swallowed whole, without chewing, and drink water. The drug is preferably taken regularly at the same time of day, regardless of the time of the meal.
Adults and teenagers from 12 years old - 1 tablet (5 mg) 1 time per day.
OverdoseSymptoms Reception of the dose, which exceeds the recommended 5 times, did not lead to the appearance of any symptoms. During clinical trials, 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 prolongation of the QT interval and was not accompanied by the appearance of serious side effects.
Treatment. In case of accidental ingestion of a large amount of the drug should immediately consult a doctor.Recommended gastric lavage, taking activated charcoal; if necessary, symptomatic therapy. Desloratadine is not excreted by hemodialysis, the effectiveness of peritoneal dialysis has not been established.
Side effectFatigue (1.2% of cases), dry mouth (0.8%), headache (0.6%).
The following side effects were very rarely observed: tachycardia, palpitations, increased activity of liver enzymes, increased bilirubin concentration, allergic reactions, including anaphylaxis and rash.
Interaction with other drugs was not detected.
Eating does not affect the effectiveness of the drug. Erius does not increase the effect of alcohol on the central nervous system.
special instructionsResearch on the effectiveness of the drug Erius in rhinitis infectious etiology was not conducted.
Influence on ability to drive motor transport and control mechanismsIn the recommended dose, Erius does not affect the ability to drive vehicles or control mechanisms.
Release formpills, film coated, 5 mg. On 1, 2, 3, 5, 7 or 10 pills in the blister from PVC and aluminum foil. On 1, 2, 3, 5, 9 or 10 blisters together with the application instruction in a cardboard pack.
Storage conditionsAt a temperature not higher than 30 ° C, out of the reach of children.
Shelf life2 years. Do not use after expiration date.
It is a pharmaceutical drug. Use only as directed by your doctor.