Practitioners' Reporting News

Practitioners' Concerns Prompt Cipro Oral Suspension Labeling Change

Issued March 16, 2000

Cipro® Oral Suspension (ciprofloxacin hydrochloride) has been the focus of several reports received by the USP Practitioners' Reporting NetworkSM (USP PRN®). Specifically, pharmacists have expressed concern about the product's packaging and labeling. The product consists of two separate bottles; the active ingredient, ciprofloxacin microcapsules in one bottle and a milky suspension as the diluent in another. Prior to dispensing, the microcapsules must be added to the diluent to create the oral suspension. The diluent bottle has two labels: The top label is informational and includes directions for mixing; it is removed prior to dispensing. The second label identifies the oral suspension after the medication is mixed. One pharmacist remarked that it is difficult to determine if the microcapsules have been added to the bottle of diluent because of the diluent suspension's milky appearance. Another pharmacist, citing the diluent’s milky appearance described an actual episode where the diluent alone was dispensed to the patient.

Cipro Oral Suspension is available in 5% (5g ciprofloxacin in 100 mL) and 10% (10 g ciprofloxacin in 100 mL) strengths. One of the pharmacists reported that the product's labeling in grams/100 mL, rather than milligrams/mL, could provoke dosing errors. Usually, ciprofloxacin is ordered in milligrams; representation of the product in terms of the gram measurement may cause calculation errors when determining the volume of the ordered dose.

USP PRN reports and other similar complaints received by Bayer prompted the company to change the product's labeling.  The FDA has approved the new labeling and new batches will reflect these changes including the strength in milligrams/mL on the box and clearer labeling of the diluent bottle.

This manufacturer's response to these practitioners' concerns is an example of changes that can occur when vigilant health care professionals take time to report their observations. Product concerns may be reported online or by calling toll free 800-4-USP PRN (800-487-7776).

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The USP Medication Errors Reporting Program is presented in cooperation with the Institute for Safe Medication Practices.


Readers are advised that official USP cautions and warnings for drugs appear in the USP–NF or USP DI. Unless otherwise indicated, any advice or opinions expressed herein reflect solely the judgment of USP staff. Such statements are intended for further consideration and evaluation and may or may not be applicable to a particular practice. The USP Medication Errors Reporting Program is presented in cooperation with the Institute for Safe Medication Practices.