Active substances: Norfloxacin
It licensed use in acute and chronic complicated kidney infections has been withdrawn as a result. CHMP stated that doctors should not prescribe oral norfloxacin for complicated pyelonephritis and should consider switching patients already taking oral norfloxacin for this type of infection to an alternative antibiotic.
Contraindications As noted above, under licensed use, norfloxacin is also now considered to be contraindicated for the treatment of certain sexually transmitted diseases by some experts due to bacterial resistance.
Patients taking any of these drugs concomitantly with norfloxacin should be carefully monitored.
Pregnancy Norfloxacin has been reported to rapidly cross the blood-placenta and blood-milk barrier, and is extensively distributed into the fetal tissues. For this reason norfloxacin and other fluoroquinolones are contraindicated during pregnancy due to the risk of spontaneous abortions and birth defects.
The manufacturer only recommends use of norfloxacin during pregnancy when benefit outweighs risk. Ciprofloxacin is being licensed for the treatment of Complicated Urinary Tract Infections and Pyelonephritis due to Escherichia coli and Inhalational Anthrax post-exposure and levofloxacin was recently licensed for the treatment of Inhalational Anthrax post-exposure.
However, the Fluoroquinolones are licensed to treat lower respiratory infections in children with cystic fibrosis in the UK. Adverse effects In general, fluoroquinolones are well tolerated, with most side-effects being mild to moderate.
The overall rate of adverse events in patients treated with fluoroquinolones is roughly similar to that seen in patients treated with other antibiotic classes. Centers for Disease Control study found patients treated with fluoroquinolones experienced adverse events severe enough to lead to an emergency department visit more frequently than those treated with cephalosporins or macrolides, but less frequently than those treated with penicillins, clindamycin, sulfonamides, or vancomycin.
Among these, tendon problems and exacerbation of the symptoms of the neurological disorder myasthenia gravis are the subject of "black box" warnings in the United States. Younger people typically experience good recovery, but permanent disability is possible, and is more likely in older patients.
Simultaneous use of corticosteroids is present in almost one-third of quinolone-associated tendon rupture.
Fluoroquinoline treatment is associated with risk that is similar to or less than that associated with broad spectrum cephalosporins.
Therefore, cyclosporine serum levels should be monitored and appropriate cyclosporine dosage adjustments made when these drugs are used concomitantly.
The primary end point was prevention of TD during 14 days of treatment measured by time to first unformed stool. Concomitant medications other than those listed above were permitted. Before the study began, individuals attended an orientation that included instructions on how to avoid diarrhea.
Clinical evaluations were conducted at screening ie, baseline, during treatment day 8, and at the end of the study day 15, 16, or 17.
Participants recorded the number of formed and unformed stools passed and enteric symptoms experienced on daily diary cards for the duration of the study.
Individuals who withdrew from the study prematurely because of diarrhea or requested rescue medication were considered cases of TD. All participants supplied a stool sample at the end of the study regardless of TD acquisition.
Individuals who developed TD during the treatment period discontinued the study medication and received rescue antibiotic therapy with levofloxacin, ciprofloxacin, or azithromycin.
All individuals provided written informed consent.