FDA Okays Injectable Ibuprofen
By Todd Neale, Staff Writer, MedPage Today
Published: June 12, 2009
LITTLE FALLS, N.J., June 12 -- The FDA has approved an intravenous form of ibuprofen -- to be marketed under the name Caldolor -- for the relief of pain and fever.
The IV form will be available for use in hospitals only and will be administered in 400 and 800 mg doses over 30 minutes every six hours for acute pain.
For fever, it will be administered in the 400-mg dose over 30 minutes, followed by 400 mg every four to six hours or 100 to 200 mg every four hours, according to the FDA.
In phase III trials, hospitalized patients who received IV ibuprofen had a significant reduction in the intensity of postsurgical pain and were less likely to request morphine, said Cumberland Pharmaceuticals, the drug's maker.
In patients with fever, there were significant reductions in temperature compared with placebo, the company said.
The most common adverse events in the trial were nausea, flatulence, vomiting, and headache, but the IV form has also been associated with high blood pressure and serious skin and allergic reactions, according to the FDA.
The agency said the drug should be used with caution in patients with congestive heart failure and renal impairment, those at risk for blood clots, and those who have a prior history of ulcers or gastrointestinal bleeding.
"Injectable ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are promising pain management options," said Bob Rappaport, M.D., of the FDA's Center for Drug Evaluation and Research. "An injectable ibuprofen product can provide patients with relief from pain and fever when they cannot take oral products."
Cumberland said it expects the drug to be available later this year