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FACTIVE (GEMIFLOXACIN MESYLATE) TABLETS: DRUG INTERACTIONS
Administration of repeat doses of Factive (Gemifloxacin Mesylate) pills had no effect on the repeat dose pharmacokinetics of theophylline, digoxin or an ethinylestradiol / levonorgestrol oral contraceptive product in healthy subjects.
Concomitant administration of Factive and cimetidine, omeprazole, calcium carbonate, or an estrogen / progesterone oral contraceptive produced minor changes in the pharmacokinetics of gemifloxacin, which were considered to be without clinical significance.
Concomitant administration of Gemifloxacin (Factive) pills with probenecid resulted in a 45% increase in systemic exposure to gemifloxacin.
This medicine had no significant effect on the anticoagulant effect of warfarin in healthy subjects on stable warfarin therapy. However, post-marketing reports of increases in the INR, or PT, and/or clinical episodes of bleeding in patients have been noted with the use of quinolones, including Factive, and warfarin, or its derivatives. In addition, infectious disease and its accompanying inflammatory process, age and general status of the patient are risk factors for increased anticoagulation activity. Therefore, the PT, INR or other suitable coagulation test should be closely monitored if a quinolone antimicrobial, including Gemifloxacin Mesylate (Factive) pills, is administered concomitantly with warfarin or its derivatives.
Quinolones form chelates with alkaline earth and transition metals. The absorption of oral gemifloxacin is significantly reduced by the concomitant administration of an antacid containing aluminum and magnesium. Magnesium- and/or aluminum-containing antacids, products containing ferrous sulfate (iron), multivitamin preparations containing zinc or other metal cations, or Videx (Didanosine) chewable/buffered tablets or the pediatric powder for oral solution should not be taken within 3 hours before or 2 hours after Factive. Sucralfate should not be taken within 2 hours of Factive (Gemifloxacin).
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Factive prescribing information