País: Malasia
Idioma: inglés
Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PSEUDOEPHEDRINE HYDROCHLORIDE; FEXOFENADINE HCL
DKSH MALAYSIA SDN BHD
PSEUDOEPHEDRINE HYDROCHLORIDE; FEXOFENADINE HCL
50 Tablet Tablets; 10 Tablet Tablets; 100 Tablet Tablets; 20 Tablet Tablets; 30 Tablet Tablets
Opella Healthcare International SAS
SA/551685 --,--,-- Effects on Steady-State Fexofenadine Pharmacokinetics After 7 Days of Co-Administration with Fexofenadine Hydrochloride 120 mg Every 12 Hours (Two times the recommended twice daily dose) in Healthy Volunteers (n=24) Concomitant Drug Erythromycin (500 mg every 8 hrs) Ketoconazole (400 mg once daily) C max. SS (Peak plasma concentration) + 82% + 135% AUC ss (0-12h) (Extent of systemicexposure) + 109% + 164% DESCRIPTION TELFAST-D (fexofenadine hydrochloride and pseudoephedrine hydrochloride) Extended-Release Tablets for oral administration contain 60 mg fexofenadine hydrochloride for immediate release and 120 mg pseudoephedrine hydrochloride for extended release. Tablets also contain as excipients: microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, magnesium stearate, carnauba wax, stearic acid, silicon dioxide, hydropropylmethyl cellulose and polyethylene glycol. Fexofenadine hydrochloride, one of the active ingredients of TELFAST-D, is a histamine H1-receptor antagonist with the chemical name (±)-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1 -piperidinyl]-butyl]-α, α-dimethyl benzeneacetic acid hydrochloride and the following chemical structure: The molecular weight is 538.13 and the empirical formula is C 32 H 39 NO 4 •HCl. Fexofenadine hydrochloride is a white to off-white crystalline powder. It is freely soluble in methanol and ethanol, slightly soluble in chloroform and water, and insoluble in hexane. Fexofenadine hydrochloride is a racemate and exists as a zwitterion in aqueous media at physiological pH. Pseudoephedrine hydrochloride, the other active ingredient of TELFAST-D, is an adrenergic (vasoconstrictor) agent with the chemical name [S-(R*,R*)]-α-[1-(methylamino)ethyl]-benzeneme thanol hydrochloride and the following chemical structure: The molecular weight is 201.70. The molecular formula is C 10 H 15 NO•HCl. Pseudoephedrine hydrochloride occurs as fine, white to off-white crystals or powder, having a faint characteristic odor. It is very soluble in water Leer el documento completo