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Description
Round 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.
Active ingredients
Desloratadine
Release form
Pills
Composition
Active 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.
Pharmacological effect
Antihistamine 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, and smooth muscle 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.
Pharmacokinetics
Desloratadine 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
- 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.
Precautionary measures
- severe renal failure.
Use during pregnancy and lactation
The use of the drug during 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 Erius® medicine during breastfeeding is contraindicated.
Dosage and administration
For 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.
Side effects
Fatigue (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.
Overdose
Symptoms 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 carbon; if necessary, symptomatic therapy. Desloratadine is not excreted by hemodialysis, the effectiveness of peritoneal dialysis has not been established.
Interaction with other drugs
Interaction with other drugs was not detected. Eating does not affect the effectiveness of the drug. Erius® does not enhance the effect of alcohol on the central nervous system.
special instructions
Research on the effectiveness of the drug Erius® in rhinitis infectious etiology has not been conducted. Effects on the ability to drive vehicles and control mechanisms: In the recommended dose, Erius® does not affect the ability to drive vehicles or control mechanisms.
Storage conditions
At a temperature not higher than 30 ° C, in the reach of children.