Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
AVENTIS PHARMA - Indonesia
FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
60.00 MG /120.00 MG
TABLET PELEPASAN LAMBAT
DUS, 10 BLISTER @ 10 TABLET PELEPASAN LAMBAT
AVENTIS PHARMA - Indonesia
2020-10-29
absolute bioavailability of fexofenadine hydrochloride has not been established, it is unknown if the fecal component is unabsorbed drug or the result of biliary excreation. The pharmacokinetics of fexofenadine hydrochloride in seasonal allergic rhinitis patients was similar to those in healthy subjects. Peak fexofenadine plasma concentrations were similar between adolescent (12–16 years of age) and adult patients. Fexofenadine is 60% to 70% bound to plasma proteins, primarily albumin and α 1-acid glycoprotein. Pseudoephedrine has been shown to have a mean elimination half-life of 4–6 hours, which is dependent on urine pH. The elimination half-life is decreased at urine pH lower than 6 and may be increased at urine pH higher than 8. The biovailability of fexofenadine hydrochloride and pseudoephedrine hydrochloride from TELFAST-PLUS Extended-Release Tablets is similar to that achieved with separate administration of the components. Co-administration of fexofenadine and pseudoephedrine does not significantly affect the biovailability of either component. Fexofenadine hydrochloride was rapidly absorbed following single-dose administration of the 60-mg fexofenadine hydrocloride/120 mg pseudoephedrine hydrochloride tablet with median time to mean maximum fexofenadine plasma concentration of 191 ng/mL occurring 2 hours post-dose. Pseudoephedrine hydrochloride produced a mean single-dose pseudoephedrine peak plasma concentration of 206 ng/mL, which occurred 6 hours postdose. Following multiple dosing to steady-state, a fexofenadine peak concentration of 255 ng/mL was observed 2 hours postdose. Following multiple dosing to steady-state, a pseudoephedrine peak concentration of 411 ng/mL was observed 5 hours postdose. Co-administration of TELFAST-PLUS with a high fat meal decreased fexofenadine plasma concentrations C max (-46%) and AUC (-42%). Time to maximum concen-tration (T max ) was delayed by 50%. The rate or extent of pseudoephedrine absorption was not affected by food. It is recommended that the administration Baca dokumen lengkapnya