Safety demonstrated with Abbott's temafloxacin DRUG REACTIONS 'This summary of the extensive safety analysis of the phase I, II and III trials of temfloxacin [sic] shows that it has a high degree of safety and that it was at least as safe as the quinolone and non-quinolone comparators,' Temafloxacin, a quinolone antibacterial, has been recently introduced by Abbott Laboratories. Data from 675 patients entered in phase I trials of temafloxacin (572 receiving temafloxacin), and 4633 patients entered in phase II and III trials (2602 receiving temafloxacin) were analysed. No significant difference in the frequency of adverse effects was observed between temafloxacin, placebo and other quinolone and nonquinolone antibacterials tested. No drug interaction between temafloxacin and theophylline was observed, but antacids significantly reduced gastric temafloxacin absorption. GI adverse effects were the most commonly reported adverse effects of temafloxacin. The rate of these adverse effects increased with increasing dose and renal dysfunction. Norrby SR, Pernet AG. Assessment of adverse events during drug development: experience with temafloxacin. Journal of Antimicrobial \ Chemotherapy 28 (Suppl. C): 111-119. Dec 1991 "" Editorial comment: FDA approral was granted for Abbott's temafloxacin (,()mn£flox,) on Jan 30 this year. Temafloxacin has already been approved in 8 countries and is marketed as Teflox' in the UK, as Temaflox' in Italy and as Temac' in Sweden. Temafloxacin is indicated in the treatment of pneumonia. bronchitis. prostatitis. urinary tract infections and skin infections. Temafloxacin is the only quinolone which has been approved without the need for a warning regarding interactions with theophylline. If results from Abbott's tema/loxacin-cafJeine interaction study and those of a proposed interaction study with sucralfate are favourable, then this will endorse a favourable drug interaction profile for temafloxacin. ISSN 0156·2703/92/0222-0019/$100/0 © Adis Inlemational Ltd 19 INPHARMA® 22 Feb 1992

Safety demonstrated with Abbott’s temafloxacin

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Safety demonstrated with Abbott's temafloxacin

DRUG REACTIONS

'This summary of the extensive safety analysis of the phase I, II and III trials of temfloxacin [sic] shows that it has a high degree of safety and that it was at least as safe as the quinolone and non-quinolone comparators,' Temafloxacin, a quinolone antibacterial, has been recently introduced by Abbott Laboratories.

Data from 675 patients entered in phase I trials of temafloxacin (572 receiving temafloxacin), and 4633 patients entered in phase II and III trials (2602 receiving temafloxacin) were analysed. No significant difference in the frequency of adverse effects was observed between temafloxacin, placebo and other quinolone and nonquinolone antibacterials tested. No drug interaction between temafloxacin and theophylline was observed, but antacids significantly reduced gastric temafloxacin absorption.

GI adverse effects were the most commonly reported adverse effects of temafloxacin. The rate of these adverse effects increased with increasing dose and renal dysfunction. Norrby SR, Pernet AG. Assessment of adverse events during drug development: experience with temafloxacin. Journal of Antimicrobial \ Chemotherapy 28 (Suppl. C): 111-119. Dec 1991 ""

~ Editorial comment: FDA approral was granted for Abbott's temafloxacin (,()mn£flox,) on Jan 30 this year. Temafloxacin has already been approved in 8 countries and is marketed as Teflox' in the UK, as Temaflox' in Italy and as Temac' in Sweden. Temafloxacin is indicated in the treatment of pneumonia. bronchitis. prostatitis. urinary tract infections and skin infections.

Temafloxacin is the only quinolone which has been approved without the need for a warning regarding interactions with theophylline. If results from Abbott's tema/loxacin-cafJeine interaction study and those of a proposed interaction study with sucralfate are favourable, then this will endorse a favourable drug interaction profile for temafloxacin.

ISSN 0156·2703/92/0222-0019/$100/0 © Adis Inlemational Ltd

INPHARMA® 22 Feb 1992