On June 11, 2009, the FDA approved Caldolor, which is the first injectable form of the common pain medication, Ibuprofen. Ibuprofen is used to treat fever and pain.

Caldolor will be available only for hospital use. It is approved to be administered in 400 mg to 800 mg doses, over 30 minutes, every 6 hours for acute pain. To treat fever, the drug is approved in a 400 mg dose administered over 30 minutes, followed by 400 mg every 4 to 6 hours, or 100-200 mg every 4 hours, as necessary.

Injectable ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are promising pain management options,” said Bob Rappaport, M.D., director, Division of Anesthesia, Analgesia and Rheumatology Drug Products in the FDA’s Center for Drug Evaluation and Research. “But until now there were only oral forms of most NSAIDs. An injectable ibuprofen product can provide patients with relief from pain and fever when they cannot take oral products.”

In a study done using Caldolor, 319 women who had undergone an elective abdominal hysterectomy were less likely to request morphine for pain when Caldolor was administered.
Caldolor should be used with caution in patients with congestive heart failure, kidney impairment, risk of blood clots, and those who have a prior history of ulcers or gastrointestinal bleeding. When used in such patients, attention to using the lowest effective dose for the shortest time period is important to reduce the risk of serious adverse events. The drug has also been associated with high blood pressure, serious skin reactions, and serious allergic reactions.

The most common adverse reactions reported were nausea, flatulence, vomiting, and headache.

Labels: Caldolor, FDA, Ibuprofen, medicine