FDA Safety Page

Lotrisone: What is correct route of administration?

The Food & Drug Administration would like to alert healthcare providers to a packaging configuration for Lotrisone Lotion that has resulted in patients using the product in their eyes or ears rather than topically on their skin. Lotrisone (betamethasone dipropionate and clotrimazole) Lotion, manufactured by Schering, was approved on Dec. 8, 2000, under NDA 02-010, for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum. Since 2001, the FDA has received four reports of medication errors involving the use of Lotrisone Lotion by an inappropriate route of administration. Three of the cases involve individuals who inadvertently administered Lotrisone Lotion by the ophthalmic route rather than the intended topical route of administration because the shape of the Lotrisone Lotion resembled an eyedropper. A fourth case identifies an individual who administered Lotrisone Lotion to the ear, for an ear infection. Fortunately, none of these patients sustained permanent injuries, but all experienced some level of discomfort requiring medical attention.

Two factors need to be included for consideration by healthcare practitioners and consumers alike when prescribing or receiving Lotrisone Lotion. The first involves the packaging of the drug product. Both 10-mL (professional sample) and 30-mL sizes of Lotrisone Lotion are packaged in containers that resemble ophthalmic, otic, and nasal drug products. Additionally, the size and shape of the plastic dispenser tip (see photo) promotes the use of Lotrisone Lotion to routes (i.e., eyes, ears, nose) that would normally not be easily accessible if the tip were blunted or flat. Each of the above reports identified an individual who mistakenly administered the product by an unintended route of administration because the tip resembles a "dropper."

The second factor contributing to these medication errors involves the presentation of the current labels and labeling. The printed labels do not prominently indicate that the product is "FOR TOPICAL USE ONLY," and the size and number of words grouped together obscure the warning. A more prominently displayed warning statement, using lay terminology, might help prevent these errors. While the FDA is working with the manufacturer on labeling and packaging changes to minimize potential user error and maximize patient safety, consider the following suggestions until new labels and labeling are available:

• Counsel healthcare providers who dispense this product (pharmacists and physicians who sample it) and patients who receive it on its proper use, including the correct route of administration and the potential for confusion.

• Advise patients using otic or ophthalmic preparations to store this product where it is unlikely to be confused with the other products.

Circle or otherwise highlight the "FOR TOPICAL USE ONLY" statement on the product package and container if possible.

By Jinhee Jahng, Pharm.D. and Carol Holquist, R.Ph.

Jinhee Jahng, Pharm.D., is Safety Evaluator and Carol Holquist, R.Ph., is the Director of the Division of Medication Errors and Technical Support, Office of Drug Safety, at the Food & Drug Administration.

 

Carol Holquist. Lotrisone: What is correct route of administration? Drug Topics Jul. 12, 2004;148:62.