Symptomatic treatment of allergic rhinitis (including chronic allergic rhinitis) and urticaria. The tablets are intended for use in adults and adolescents aged> 12 years; oral solution - in children from 2 to 11 years old.
Composition:
1 tabl contains 10 mg of rupatadine (as fumarate); Table. contain lactose. 1 ml oral solution contains 1 mg of rupatadine (as fumarate); sol. contains sucrose and methyl parahydroxybenzoate.
Action:
Antihistamine - a long-acting histamine antagonist with selective antagonism on peripheral H-receptors1. Some metabolites (desloratadine and its hydroxylated metabolite) retain antihistamine activity and may partly contribute to the overall effectiveness of the drug. Rupatadine in high concentration has the properties of inhibiting mast cell degranulation, induced by immunological and non-immunological stimuli, as well as inhibiting the release of cytokines, especially TNFα by human mast cells and monocytes. After oral administration it is quickly absorbed. In 98.5-99% it is bound to plasma proteins. It is almost completely metabolised (mainly with the participation of CYP3A4) into active and inactive metabolites and excreted in faeces (60.9%) and urine (34.6%), in the form of metabolites. Medium T0,5 in the elimination phase of rupatadine in children aged 2-5 years is 15.9 h, and in children 6-11 years - 12.3 h and it is longer than observed after administration of the drug in the form of tablets in adults and adolescents.
Contraindications:
Hypersensitivity to rupatadine or to any of the excipients.
Precautions:
Rupatadine tablets are not recommended for use in children <12 years of age. In children from 2 to 11 years of age, rupatinid should be used in the form of an oral solution. Rupatadine is not recommended for children <2 years of age (safety and efficacy have not been established). It is not recommended for patients with impaired renal or hepatic function (no clinical experience). Use with caution in patients with established prolongation of QT interval, with decompensated hypokalemia, with conditions predisposing to arrhythmia (such as: clinically significant bradycardia, acute myocardial ischemia), in elderly (≥ 65 years). There is a risk of CYP3A4 mediated interactions - use caution. Due to the lactose content, tablets should not be used in patients with galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose. Due to the sucrose content of the oral solution, do not use in patients with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency. The oral solution contains methyl parahydroxybenzoate, which may cause allergic reactions (possible late-type reactions).
Pregnancy and lactation:
Data from a limited number of pregnant uses do not indicate a deleterious effect of rupatadine on pregnancy or on the health of the fetus and / or newborn, however, for caution, it is recommended that rupatadine be avoided during pregnancy. Rupatadine is excreted in milk in animals; it is not known whether it is excreted in human milk - a decision should be made whether to discontinue breast-feeding or discontinue rupatadine taking into account the benefits of breastfeeding for the baby and the benefits of treatment for the woman.
Orally.Adults and adolescents> 12 years: 10 mg (1 tablet) once a day.Children (2-11 years): mc. ≥25 kg: 5 mg (5 ml solution) once a day; mc ≥ 10 kg and <25 kg: 2.5 mg (2.5 ml solution) once a day. The drug can be taken with or without food.
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