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FDA Approves Injectable Form of Ibuprofen
The U.S. Food and Drug Administration today approved Caldolor, the first
injectable dosage form of the common pain medication ibuprofen, to treat pain
and fever.
"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.”
Caldolor will be available for hospital use only. 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.
In a clinical trial of 319 women who had undergone an elective abdominal
hysterectomy, patients were less likely to request morphine for pain on an
as-needed basis when administered Caldolor.
Caldolor should be used with caution in patients with congestive heart
failure, kidney impairment, at 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 in the controlled clinical trials
were nausea, flatulence, vomiting, and headache.
Caldolor is manufactured by Cumberland Pharmaceuticals Inc., Nashville,
Tenn.
