A quinolone - It is used to treat certain kinds of bacterial infections
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Special Alerts:
[Posted 07/08/2008] FDA notified healthcare professionals that a BOXED WARNING and Medication Guide are to be added to the prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use.
Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug. Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Fluoroquinolone, http://www.fda.gov/cder/drug/infopage/fluoroquinolones/default.htm, http://www.fda.gov/cder/drug/InfoSheets/HCP/fluoroquinolonesHCP.htm and http://www.fda.gov/bbs/topics/NEWS/2008/NEW01858.html.
Treatment of uncomplicated UTIs (including cystitis) caused by susceptible Citrobacter freundii, Enterobacter aerogenes, E. cloacae, Escherichia coli, Klebsiella pneumoniae, Morganella morganii†, Proteus mirabilis, P. vulgaris, Providencia rettgeri†, Pseudomonas aeruginosa, or Serratia marcescens†. Also used for treatment of uncomplicated UTIs caused by susceptible Staphylococcus aureus, S. epidermidis, S. saprophyticus, or Streptococcus agalactiae (group B streptococci), or Enterococcus faecalis.
Treatment of complicated UTIs caused by susceptible E. coli, K. pneumoniae, P. mirabilis, Ps. aeruginosa, S. marcescens, or E. faecalis.
Treatment of prostatitis caused by E. coli.
Usually reserved for treatment of complicated UTIs, especially those caused by multidrug-resistant bacteria; generally not recommended for uncomplicated UTIs (e.g., acute cystitis) unless more commonly employed urinary anti-infectives are contraindicated or not tolerated.
GI Infections
Treatment of gastroenteritis† caused by susceptible enterotoxigenic E. coli, Aeromonas hydrophila, Plesiomonas shigelloides, Salmonella, or Shigella (including Sh. boydii, Sh. dysenteriae, Sh. flexneri, Sh. sonnei).
Treatment of cholera†, including infections caused by Vibrio cholerae serotypes 01 or 0139. Tetracyclines generally are drugs of choice when an anti-infective is indicated as an adjunct to fluid and electrolyte replacement; alternative agents for V. cholerae resistant to tetracyclines include co-trimoxazole, fluoroquinolones, or furazolidone.
Treatment of travelers’ diarrhea†. Replacement therapy with oral fluids and electrolytes may be sufficient for mild to moderate disease. Generally self-limited and may resolve within 3–4 days without anti-infective treatment; if diarrhea is moderate or severe, persists for >3 days, or is associated with fever or bloody stools, short-term (1–3 days) anti-infective treatment may be indicated. Fluoroquinolones (ciprofloxacin, levofloxacin, norfloxacin, ofloxacin) usually drugs of choice when treatment, including self-treatment, is indicated. Azithromycin is a treatment alternative for those who should not receive fluoroquinolones (e.g., children, pregnant women) and may be a drug of choice for travelers in areas with a high prevalence of fluoroquinolone-resistant Campylobacter (e.g., Thailand, India) or those who have not responded after 48 hours of fluoroquinolone treatment. Rifaximin is another alternative for treatment of travelers' diarrhea caused by noninvasive E. coli.
Prevention of travelers’ diarrhea† in individuals traveling for relatively short periods to areas where enterotoxigenic E. coli and other causative bacterial pathogens (e.g., Shigella) are known to be susceptible to the drug. CDC and others do not recommend anti-infective prophylaxis in most individuals traveling to areas of risk; the principal preventive measures are prudent dietary practices. If anti-infective prophylaxis is used (e.g., in immunocompromised individuals such as those with HIV infection), a fluoroquinolone (ciprofloxacin, levofloxacin, ofloxacin, norfloxacin) is recommended for nonpregnant adults, although the increasing incidence of quinolone resistance in pathogens that cause travelers' diarrhea (e.g., Campylobacter) should be considered.
Gonorrhea and Associated Infections
Has been used for treatment of uncomplicated urethral, endocervical, or rectal† gonorrhea caused by susceptible Neisseria gonorrhoeae.
Although fluoroquinolones (ciprofloxacin, levofloxacin, ofloxacin) were previously considered drugs of choice for treatment of uncomplicated gonorrhea, CDC currently states that fluoroquinolones should not be used for treatment of gonorrhea or any associated infections involving N. gonorrhoeae (e.g., pelvic inflammatory disease [PID], epididymitis).
Quinolone-resistant N. gonorrhoeae (QRNG) has been reported with increasing frequency worldwide and is widespread in the US. (See Resistance in Neisseria gonorrhoeae under Cautions.)
For treatment of uncomplicated cervical, urethral, or rectal gonorrhea, CDC and others recommend IM ceftriaxone or oral cefixime; IM ceftriaxone is drug of choice for pharyngeal infections.
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