Pediatric News - Cipro
(ciprofloxacin, Bayer Pharmaceuticals)
The Food and Drug Administration approved ciprofloxacin for patients aged 1-17 years to treat complicated urinary tract infections and pyelonephritis caused by Escherichia coli (not as first-line therapy).
* Recommended Dosage: For complicated urinary tract infections (UTIs) or pyelonephritis, the intravenous dosage is 6 mg/kg to 10 mg/kg up to a maximum of 400 mg per dose, every 8 hours. The oral tablet or suspension dosage is 10 mg/kg to 20 mg/kg up to a maximum of 750 mg per dose, every 12 hours. Maximum doses should not be exceeded, even in patients weighing more than 51 kg.
Related Results
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* Special Considerations: Although ciprofloxacin was effective in clinical trials, it is not a first-line treatment for pediatric patients. In studies, there was an increased incidence of adverse events compared with controls, including joint and surrounding tissue effects that included arthralgia, abnormal gait, joint sprains, myalgia, and bone pain.
Ciprofloxacin should only be used for the FDA-approved indications in pediatric patients, according to the labeling.
* Comment: Researchers in clinical trials compared 337 pediatric patients taking intravenous and/or oral ciprofloxacin with 352 patients taking a cephalosporin for complicated UTIs or pyelonephritis. The mean age was 6 years, and mean duration of therapy was 11 days. The ciprofloxacin group experienced a 95.7% clinical response, vs. 92.6% for the cephalosporin group at 5-9 days post treatment. Also, 84.4% of the ciprofloxacin group experienced bacteriologic eradication, compared with 78.3% of the cephalosporin group.
“This approval signals a major change in the status of ciprofloxacin and other quinolones. Historically, this class of antibiotics has not been approved in children due to concerns about arthropathies, which have occurred in all animal species tested,” Dr. John V. Williams of the department of pediatric infectious diseases at Vanderbilt Children’s Hospital, Nashville, Tenn., said in an interview. “This approval opens the door to new, wider use of a potent class of antimicrobials in children, with the potential attendant risks and benefits.”
The usual indication for ciprofloxacin is a child with infections caused by Pseudomonas or other highly resistant bacteria, Dr. Williams said. “These urinary tract infections usually occur in children with chronic, recurrent UTI due to either urinary reflux or structural abnormalities of the urinary tract.”
“I would consider joint problems as a potential adverse effect to be discussed with the patient and their family and watched for, like any other potential side effect,” said Dr. Williams, who does not have a conflict of interest regarding Cipro or Bayer Pharmaceuticals Corp.
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