Relief of symptoms associated with allergic rhinitis, urticaria.
Composition:
1 tabl 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 inhibiting the release of cytokines inducing an inflammatory response (i.e., IL-4, IL-6, IL-8 and IL-13) from human mast cells and basophils, as well as inhibiting the expression of P-selectin on the surface of endothelial cells. In patients with allergic rhinitis, desloratadine is effective in relieving symptoms such as sneezing, pruritus, nasal discharge, as well as itching, tearing and redness of the eyes and pruritis. 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:
The drug should be used with caution in case of severe renal failure. The efficacy and safety of the drug in the form of in children under 12 years of age and in the form of oral solution in children in the 1st year. It is particularly difficult to distinguish allergic rhinitis from other forms of rhinitis in children under 2 years of age. 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 considered. Approx. 6% of adults and children between the ages of 2 and 11 years have a phenotypically slowed down metabolism of desloratadine and are exposed to greater exposure. The safety of desloratadine in children from 2 to 11 years of age who have a slow metabolism is the same as in children with normal metabolism. The effects of desloratadine in children under 2 years of age who have slowed down metabolism have not been studied. Oral solution contains sorbitol - patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this form of the drug.
Pregnancy and lactation:
It is not recommended during pregnancy (no safety is established). In animal studies, desloratadine was not teratogenic. Desloratadine is excreted in breast milk, therefore it is not recommended for breast-feeding women.
Side effects:
In adults and adolescents, the most common side effects were: tiredness, dry mouth, headache; in infants and children from 6 to 23 months: diarrhea, fever, insomnia. Other side effects observed very rarely after marketing: hallucinations, dizziness, drowsiness, insomnia, psychomotor agitation, convulsions, tachycardia, palpitations, abdominal pain, nausea, vomiting, indigestion, diarrhea, increased liver enzymes, increased bilirubin in the blood, hepatitis, muscle pain, hypersensitivity reactions (including anaphylaxis, angioneurotic edema, dyspnoea, pruritus, rash, urticaria).
Dosage:
Orally. Adults and adolescents ≥12 years: 5 mg (1 tablet or 10 ml) once a day. Children 6-11 years: 2.5 mg oral solution (5 ml) once a day; 1-5 years: 1.25 mg oral solution (2.5 ml) once a day. 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 longer than 4 weeks), the patient may be advised to continue treatment during the period of exposure to the allergen. The drug can be taken regardless of the meal.
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