Ország: Indonézia
Nyelv: indonéz
Forrás: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
FEXOFENADINE HYDROCHLORIDE
AVENTIS PHARMA - Indonesia
FEXOFENADINE HYDROCHLORIDE
60 MG
TABLET SALUT SELAPUT
DUS, 1 BLISTER @ 10 TABLET SALUT SELAPUT
AVENTIS PHARMA - Indonesia
2021-10-21
FEXOFENADINE HCL ® 60 mg DESCRIPTION Fexofenadine hydrochloride, the active ingredient of TELFAST 60 mg, is a histamine H1-receptor antagonist with the chemical name (+)-4-[1-hydroxy-4-[4-(hydroxydiphe- n y l - m e t h y l ) - 1 - p i p e r i d i n y l ] - b u t y l ] - a,a-dimethyl benzeneacetic acid hydrochlo- ride, it has the following chemical structure: The molecular weight is 538.13 and the empirical formula is C32H39NO4.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 hydrochlo- ride is a racemate and exists as a zwitterion in aqueous media at physiological pH. TELFAST 60 mg is formulated as tablet for oral administration. Each film coated tablet contains 60 mg Fexofenadine Hydrochloride and the following excipients: croscarmellose sodium, pregelatinized maize starch, microcrystalline cellulose, magnesium stearate, and purified water. The coated tablet shell is made from hydroxypropyl methylcel- lulose E-15, hydroxypropyl methylcellulose E-5, povidone, titanium dioxide (E171), colloidal anhydrous silica, macrogol 400, pink iron oxide blend, yellow iron oxide blend and purified water. CLINICAL PHARMACOLOGY Mechanism of action Fexofenadine, a metabolite of terfenadine, is an antihistamine with selective peripheral H1-receptor antagonist activity. Fexofenadine inhibited antigen-induced bronchospasm in sensitized guinea pigs and histamine release from peritoneal mast cells in rats. In laboratory animals, no anticholinergic or alpha1-adrenergic receptor blocking effects were observed. Moreover, no sedative or other central nervous system effects were observed. Radiolabeled tissue distribution studies in rats indicated that fexofenadine does not cross the blood-brain barrier. Pharmacokinetics Fexofenadine Hydrochloride was rapidly absorbed following oral administration of a single dose of two 60 mg tablet to healthy male volunteers with a mean time to maximum p Olvassa el a teljes dokumentumot