Depomed, Inc., has received the FDA’s approval of ciprofloxacin HCl (Proquin™ XR), a once-daily, extended-release formulation for the treatment of uncomplicated bacterial urinary tract infections (UTIs). UTIs are frequently caused by Escherichia coli and are typically treated with antibiotics.
This is the first version of ciprofloxacin for which nausea and diarrhea are listed as “uncommon” adverse events in its label rather than “common” adverse events. As a class of compounds, fluoroquinolones and ciprofloxacin are cited in the literature as a cause of nausea and diarrhea; these side effects are reportedly the most frequent reason that patients discontinue ciprofloxacin treatment.
The drug is gradually released over six hours. The extended-release formula avoids the “dumping” of large quantities of the drug into the intestinal system, where it can cause side effects or interactions with gastrointestinal drugs.