Relief of symptoms associated with allergic rhinitis and urticaria. The tablets are indicated for use in adults and adolescents from the age of 12 years, and the oral solution in adults, adolescents and children from the age of 1 year.
Composition:
1 tabl powl. contains 5 mg desloratadine. 1 ml oral solution contains 0.5 mg desloratadine; the solution contains sorbitol.
Action:
Desloratadine is a sedative, long-acting histamine antagonist with selective antagonistic activity towards peripheral H-receptors1. Antiallergic properties of desloratadine include inhibition of the release of pro-inflammatory cytokines (such as IL-4, IL-6, IL-8 and IL-13) from mast cells and basophils, as well as inhibition of P-selectin on the surface of endothelial cells. In patients with allergic rhinitis, desloratadine is effective in relieving symptoms such as sneezing, runny nose and pruritus, as well as eye itching, tearing and redness, and itching of the palate. In patients with urticaria, it reduces the number and size of urticarial lesions and soothes pruritus. Desloratadine practically does not penetrate to o.u.n., thanks to which it does not exert a calming effect, does not cause drowsiness or does not affect psychomotor activity. Desloratadine is rapidly absorbed from the gastrointestinal tract (about 30 min), reaching Cmax after about 3 h. The effect of the drug is maintained for 24 h. Plasma protein binding is 83-87%. T0,5 is 27 hours.
Contraindications:
Hypersensitivity to des loratadine, loratadine or to any of the excipients.
Precautions:
Use with caution in patients with severe renal impairment. In children <2 years, it is particularly difficult to distinguish allergic rhinitis from other forms of rhinitis. The absence of symptoms of upper respiratory tract infection or organic lesions should be considered, as well as the history, physical examination and the results of appropriate laboratory tests and skin tests. About 6% of adults and children aged 2-11 have a phenotype associated with the free metabolism of desloratadine and have a larger exposure. Desloratadine has not been studied in children <2 years of age who have a slower metabolism. The safety of use in children aged 2-11 years who have a slowed metabolism is the same as in children with normal metabolism. The safety and efficacy of oral solution in children <1 year of age have not been established, powl. in children <12 years. The clinical trial experience in the use of desloratadine in children aged 1-11 years and in adolescents aged 12-17 is limited. 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:
The safety of the medicine during pregnancy has not been established, therefore the use of desloratadine during pregnancy should be avoided. The presence of desloratadine has been detected in the body of newborns / infants breastfed by mothers being treated; the effect of desloratadine on newborns / infants is unknown. After considering the benefits of breastfeeding for the baby and the benefits of treatment for the mother, it should be decided whether to discontinue breast-feeding or discontinue desloratadine during treatment.
Side effects:
Common: headache, dry mouth, fatigue, insomnia (in children <2 years), diarrhea (in children <2 years), fever (in children <2 years). Very rare: hallucinations, dizziness, drowsiness, insomnia, hyperactivity, seizures, tachycardia, palpitations, abdominal pain, nausea, vomiting, indigestion, diarrhea, increased liver enzymes, increased bilirubin, hepatitis, muscle pain, hypersensitivity reactions (ie anaphylaxis, angioneurotic edema, dyspnoea, pruritus, rash and urticaria, frequency not known: hypersensitivity to light.
Dosage:
Orally. Adults and adolescents ≥12 years: 5 mg (1 tablet or 10 ml oral solution) once a day.Children 6-11 years: 2.5 mg (5 ml oral solution) once a day; children 1-5 years: 1.25 mg (2.5 ml oral solution) once a day. In the treatment of periodic allergic rhinitis should follow the assessment of the course of the disease in a given patient in the past, discontinue treatment after resolution of the symptoms and resume after their recurrence. In chronic allergic rhinitis, continuous treatment during periods of exposure to the allergen can be used. The drug can be taken regardless of meals.
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