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| Clinical data | |
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| Trade names | Factive |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a604014 |
| License data | |
| Routes of administration | By mouth |
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| Pharmacokinetic data | |
| Bioavailability | 71% |
| Protein binding | 60–70% |
| Metabolism | Limited metabolism by the liver to minor metabolites |
| Excretion | Feces (61%); urine (36%) |
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| Chemical and physical data | |
| Formula | C18H20FN5O4 |
| Molar mass | 389.387 g·mol−1 |
| 3D model (JSmol) | |
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Gemifloxacin mesylate, sold under the brand nameFactive among others, is abroad-spectrumquinolone antibacterial agent used in the treatment of acute bacterial exacerbation of chronicbronchitis and mild-to-moderatepneumonia. It is takenby mouth. Vansen Pharma Inc. licensed the active ingredient from LG Life Sciences of Korea.[citation needed]
Gemifloxacin is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
Gemifloxacin has been shown to be active against most strains of the following microorganisms:
includingmulti-drug resistantStreptococcus pneumoniae (MDRSP). MDRSP includes isolates previously known as PRSP (penicillin-resistantStreptococcus pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin, 2nd generationcephalosporins, e.g.,cefuroxime,macrolides,tetracyclines andtrimethoprim/sulfamethoxazole.
Fluoroquinolones are generally well tolerated with most side effects being mild and serious adverse effects being rarely.[2][3] Some of the serious adverse effects which occur more commonly withfluoroquinolones than with other antibiotic drug classes include CNS and tendon toxicity.[2][4] The currently marketed quinolones have safety profiles similar to that of other antimicrobial classes.[2]
The serious events may occur with therapeutic or with acute overdose. At therapeutic doses they include: central nervous system toxicity,cardiovascular toxicity, tendon / articular toxicity, and rarely hepatic toxicity.[5] Events that may occur in acute overdose are rare and include: renal failure and seizure.[5] Children and the elderly are at greater risk.[2][4] Tendon damage may manifest during, as well as up to a year after fluoroquinolone therapy.[6]
The FDA added aboxed warnings on all fluoroquinolones about the possible toxic effects of fluoroquinolones on tendons.[7]
In August 2013, the FDA issued a Safety Announcement where they described that they are requiring the medication guides and drug labels for allfluoroquinolones to be updated and better describe the risk forperipheral neuropathy.[8] The peripheral neuropathy may occur very quickly, and may be irreversible. This warning applies to fluoroquinolones taken by mouth and injection, but does not apply to fluoroquinolones taken topically.
A study showed that gemifloxacin possess anti-metastatic activities againstbreast cancer in vitro and in vivo (in mice).[9]
