Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DESLORATADINE
ORGANON PHARMA INDONESIA TBK - Indonesia
DESLORATADINE
0.5 MG
SIRUP
DUS, 1 BOTOL @ 60 ML
SCHERING-PLOUGH LABO NV - Belgium
2021-08-05
AERIUS SYRUP Desloratadine DESCRIPTION: Each 1 ml of syrup contains 0.5 mg of desloratadine. PHARMACOLOGICAL PROPERTIES Pharmacodynamic properties Pharmacotherapeutic group: antihistamines – H 1 antagonist, ATC code : R06A X27 Desloratadine is a non-sedating, long acting histamine antagonist with selective peripheral H 1 - receptors antagonist activity. After oral administration desloratadine selectively blocks peripheral histamine H 1 -receptors because the substance is excluded from entry to the central nervous system. Desloratadine has demonstrated antiallergic properties from in vitro studies. These include inhibiting the release of proinflammatory cytokines such as IL-4, IL-6, IL-8, and IL-13 from human mast cells/basophils, as well as inhibition of the expression of the adhesion molecule P-selectin on endothelial cells. The clinical relevance of these observations remains to be confirmed. Efficacy of Aerius syrup has not been investigated in separate paediatric trials. Safety of Aerius syrup was demonstrated in three-paediatric trials. Children ages 1 through 11 years of age who were candidates for antihistamine therapy received a daily dose of 1.25 mg (1-5 years of age) and 2.5 mg (6 through 11 years of age). Treatment was well tolerated as documented by clinical laboratory tests, vital signs, and ECG interval data, including QTc. When given at the recommended doses, the plasma concentration of desloratadine (see Pharmacokinetic properties) was comparable in the paediatric and adult populations. Thus, since the course of SAR/CIU and the profile of desloratadine are similar in adults and paediatric patients, desloratadine efficacy data in adults can be extrapolated to the paediatric population. In a multiple dose clinical trial, in adults and adolescents, in which up to 20 mg of desloratadine was administered daily for 14 days, no statistically or clinically relevant cardiovascular effect was observed. In a clinical pharmacology trial, in adults and adolescents, in which desloratadine was administered Baca dokumen lengkapnya