Relief of symptoms associated with allergic rhinitis and urticaria.
Composition:
1 tabl contains 5 mg desloratadine. The drug contains sunset yellow.
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, loratadine or any of the excipients.
Precautions:
Caution should be exercised in patients with severe renal impairment. The efficacy and safety of desloratadine in the form of in children under 12 years. The drug contains an orange yellow, which can cause allergic reactions.
Pregnancy and lactation:
The use of the drug during pregnancy is not recommended (safety not established). In animal studies, desloratadine was not teratogenic. Desloratadine is excreted in breast milk - breast-feeding is not recommended.
Side effects:
The most common symptoms were fatigue, dry mouth and headache. Very rare: 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 (anaphylaxis, angioneurotic edema, dyspnoea, pruritus, rash and urticaria).
Dosage:
Orally. Adults and adolescents (> 12 years old): 1 tabl. once a day regardless of the meal. 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 and treatment should be discontinued after the symptoms have resolved and resumed when they recur. In chronic allergic rhinitis (symptoms occur for 4 days or more per week and longer than 4 weeks), the patient may be advised to continue treatment during the period of exposure to the allergen.
(C)
