Relief of symptoms associated with: allergic rhinitis, urticaria.
Composition:
1 tabl coated contains 5 mg of desloratadine. 1 ml oral solution contains 0.5 mg desloratadine; sol. 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 des loratadine, any of the excipients or to loratadine.
Precautions:
The drug should be used with caution in case of severe renal failure. The safety and efficacy of oral solution in infants up to 1 year of age have not been established, powl. in children <12 years. Desloratadine has not been studied in children <2 years of age who have a slower metabolism. The safety of desloratadine in children from 2 to 11 years of age who have a slowed metabolism is the same as in children with normal metabolism. Due to the content of sorbitol, the oral solution should not be used in patients with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.
Pregnancy and lactation:
It is not recommended to take the drug during pregnancy (no safety was established) and during breastfeeding. Desloratadine is excreted in breast milk.
Side effects:
The most common side effects in adults and adolescents were: tiredness, dry mouth and headaches. In children the most common were: diarrhea, fever and insomnia. Other side effects observed very rarely after the medicine are: 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).
Dosage:
Orally. Adults and adolescents ≥12 years: 1 tabl. or 10 ml of solution once a day. Children 6-11 years: 5 ml of solution once a day; 1-5 years: 2.5 ml of solution once a day. There is insufficient clinical data on the efficacy of desloratadine in adolescents from 12 to 17 years of age. Periodic allergic rhinitis (symptoms occur less than 4 days per 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 or more per week and for more than 4 weeks), the patient may be advised to continue treatment during periods of exposure to the allergen. The drug can be taken regardless of meals.
(C)
