title: Effect of antacid medication on the pharmacokinetics of temafloxacin.
abstract: The effect of an antacid drug (Maalox 70) on the pharmacokinetics of temafloxacin was studied in 12 healthy young volunteers. The study was designed as a randomised open 2-period crossover trial in which temafloxacin was administered alone and with Maalox 70. In both treatments, temafloxacin was administered as a single oral 400mg dose on the morning of day 2. In the antacid regimen, 8 doses of Maalox 70 were administered every 2h on day 1, starting at 8am and ending with the last dose at 10pm; 5 doses were given on day 2, at 2.5 and 1h before administration of temafloxacin and 1, 3 and 5h after the temafloxacin dose. With coadministration of Maalox 70, peak plasma temafloxacin concentrations (Cmax) were reduced to 44.6% (+/- 24.5), and AUC(0-infinity) was reduced to 39.8% (+/- 17.4) of the corresponding values obtained when temafloxacin was given alone. Urinary excretion of temafloxacin was reduced to 46.0% (+/- 13.7) of that observed when temafloxacin was administered alone. Time to peak plasma concentration (tmax = 1.8h) was not affected by antacid administration. Comparable or greater antacid-associated reductions in relative bioavailability have been reported for other quinolones. As with other quinolones, the concurrent administration of temafloxacin and antacids should be avoided.
authors.affiliation: IBMP-Institute for Biomedical and Pharmaceutical Research, Nürnberg-Heroldsberg, Germany.
authors.forename: G R
authors.initials: GR
authors.lastname: Granneman
authors.forename: U
authors.initials: U
authors.lastname: Stephan
authors.forename: B
authors.initials: B
authors.lastname: Birner
authors.forename: F
authors.initials: F
authors.lastname: Sörgel
authors.forename: D
authors.initials: D
authors.lastname: Mukherjee
mesh_terms: D000328:Adult; D000863:Antacids / Q000008:administration & dosage / Q000494:pharmacology*; D000890:Anti-Infective Agents / Q000097:blood / Q000493:pharmacokinetics* / Q000652:urine; D004347:Drug Interactions; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D008297:Male; D015363:Quinolones / Q000097:blood / Q000493:pharmacokinetics* / Q000652:urine
chemical_list: D000863:Antacids; D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D015363:Quinolones; C054745:temafloxacin