Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DESLORATADINE
MERCK SHARP & DOHME PHARMA - Indonesia
DESLORATADINE
5 MG
TABLET SALUT SELAPUT
DUS, 2 BLISTER @ 15 TABLET SALUT SELAPUT
SCHERING PLOUGH LABO N.V. - Belgium
2018-05-23
Proposed PI ver.2 (Versus PI 07/08 LRN: 034117-DL-TB-PIPB 1 AERIUS ® DESLORATADINE FILM COATED TABLETS DESCRIPTION: AERIUS (desloratadine) Film coated Tablets are light blue, round, film coated tablets containing 5 mg desloratadine, an antihistamine, to be administered orally. It also contains the following excipients: dibasic calcium phosphate dihydrate USP, microcrystalline cellulose NF, corn starch NF, talc USP, carnauba wax NF, white wax NF, coating material consisting of lactose monohydrate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and FD&C Blue # 2 Aluminum Lake. Desloratadine is a white to off-white powder that is slightly soluble in water, but very soluble in ethanol and propylene glycol. It has an empirical formula: C 19 H 19 ClN 2 and a molecular weight of 310.8. The chemical name is 8-chloro- 6,11-dihydro-11-(4-piperdinylidene)-5 H -benzo[5,6]cyclohepta[1,2- b ]pyridine and has the following structure : CLINICAL PHARMACOLOGY: MECHANISM OF ACTION: Desloratadine is a longacting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. Receptor binding data indicates that at a concentration of 2 – 3 ng/mL (7 nanomolar), DISETUJUI OLEH BPOM : 26/12/2021 EREG10037312100311 Proposed PI ver.2 (Versus PI 07/08 LRN: 034117-DL-TB-PIPB 2 desloratadine shows significant interaction with the human histamine H 1 - receptor. Desloratadine inhibited histamine release from human mast cells in vitro . Results of a radiolabeled tissue distribution study in rats and a radioligand H 1 - receptor binding study in guinea pigs showed that desloratadine did not readily cross the blood brain barrier. The clinical significance of this finding is unknown. PHARMACOKINETICS: ABSORPTION: Following oral administration of desloratadine 5 mg once daily for 10 days to normal healthy volunteers, the mean time to maximum plasma concentrations (T max ) occurred at approximately 3 hours post dose and mean steady state peak plasma concentrations (C max ) and area under the concen Baca dokumen lengkapnya