the product in the database has an inactive status
indications:
Relief of symptoms associated with allergic rhinitis and urticaria.
Composition:
1 tabl contains 5 mg desloratadine. 1 ml oral solution contains 0.5 mg desloratadine; the solution contains sorbitol.
Action:
Antihistamine - an H receptor antagonist1. Desloratadine is a sedative, long-acting histamine antagonist that has selective antagonistic activity on peripheral H-receptors1. After oral administration, desloratadine selectively inhibits peripheral histamine H receptors1because it does not penetrate to o.u.n. researchin vitro demonstrated the antiallergic properties of desloratadine. These include the inhibition of the release of human basal cells / leukocytes of basophilic inflammatory cytokines, such as IL-4, IL-6, IL-8 and IL-13, as well as the inhibition of adhesion of the P-selectin molecule on the surface of endothelial cells. The clinical significance of these observations has not yet been confirmed. Plasma concentrations of desloratadine can be determined within 30 min after administration. The drug is well absorbed and the maximum concentration is reached after approx. 3 hours. T0,5 in the phase of elimination is about 27 h. The degree of accumulation of desloratadine was adequate to its T0,5 and frequency of administration - once a day. The bioavailability of desloratadine was dose proportional in the range of 5-20 mg. The drug is moderately bound to plasma proteins (83-87%). There is no evidence of a clinically relevant accumulation of desloratadine administered once daily (doses of 5-20 mg) for 14 days. The enzyme responsible for the metabolism of desloratadine has not yet been identified, therefore interaction with other drugs can not be ruled out. Desloratadine does not inhibit CYP3A4in vivoand the research carried outin vitro indicate that the drug does not inhibit CYP2D6 and is neither a substrate nor an inhibitor of P-glycoproteins.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients, or to loratadine.
Precautions:
The preparation should be used with caution in case of severe renal failure. The efficacy and safety of the tablet formulation has not been established in children under 12 years of age. The efficacy and safety of the oral solution formulation has not been established in children under one year of age. It is particularly difficult to distinguish allergic rhinitis from other forms of rhinitis in children under the age of 2 years. The lack of symptoms of upper respiratory tract infection or organic lesions as well as history, physical examination and appropriate laboratory tests and skin tests should be taken into account. Most cases of rhinitis in children under 2 years of age are caused by infection and there is no data on the treatment of infectious rhinitis with the preparation. About 6% of adults and children aged 2-11 years have a phenotypically slowed down metabolism of desloratadine and are exposed to greater exposure. The safety of using desloratadine in children aged 2-11 years who have a slowed metabolism is the same as in children with normal metabolism. Desloratadine has not been studied in children <2 years of age who have a slower metabolism. The tablets contain lactose - they should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose. The oral solution contains sorbitol - should not be used in patients with rare hereditary fructose intolerance, glucose-galactose malabsorption or sucrose isomaltase deficiency.
Pregnancy and lactation:
The safety of the preparation during pregnancy has not been established - use is not recommended. The medicine is excreted in breast milk - it is not recommended during breastfeeding.
Side effects:
In adults and adolescents the most common are fatigue (1.2%), dry mouth (0.8%) and headache (0.6%). Side effects observed very rarely on the market after introduction of the drug: hallucinations, dizziness, drowsiness, insomnia, psychomotor agitation, convulsions, tachycardia, palpitations, abdominal pain, nausea, vomiting, indigestion, diarrhea, increased liver enzymes, increased bilirubin, hepatitis, muscle pain, hypersensitivity reactions (such as anaphylaxis, angioneurotic edema, dyspnoea, pruritus, rash and urticaria). The overall number of adverse events in children 2-11 years was similar in the desloratadine and placebo groups. In infants and children aged 6-23 monthsthe most frequent adverse events reported more frequently than in the placebo group were diarrhea (3.7%), fever (2.3%) and insomnia (2.3%). In additional studies carried out in the group of children aged 6-11 years, taking a single dose of 2.5 mg desloratadine oral solution, no adverse events were reported.
Dosage:
Orally.tablets. Adults and youth from 12 years: 1 tabl. once a day, regardless of the meal.Oral solution. Adults and adolescents from 12 years: 10 ml (5 mg) once a day. Children 6-11 years: 5 ml (2.5 mg) once a day. Children 1-5 years: 2.5 ml (1.25 mg) once a day. The preparation can be taken regardless of the meal. Periodic allergic rhinitis (symptoms occur less than 4 days in a week or less than 4 weeks) should be treated taking into account the patient's medical history. Treatment should be discontinued after symptoms have resolved and resumed at the time they recur. In chronic allergic rhinitis (symptoms occur for 4 days in a week or more and for more than 4 weeks), the patient may be advised to continue treatment during the period of exposure to the allergen.
(C)
