Caldolor Is First Approved Injected Ibuprofen
For hospital patients who can't take oral drug
FRIDAY, June 12, 2009 (HealthDay News) -- Caldolor, the first injected form of ibuprofen, has been approved by the U.S. Food and Drug Administration to treat pain and fever, the agency said in a news release.
The drug will be available only for hospital use in 400 milligram to 800 milligram doses, depending on whether the patient has acute pain or fever. It's particularly useful for patients who cannot take ibuprofen in its oral form, the agency said.
Clinical testing involving 319 women who had undergone an elective hysterectomy found they were much less likely to ask for morphine if given Caldolor. Nausea, flatulence, vomiting and headache were the most common adverse reactions.
The drug is produced by Tennessee-based Cumberland Pharmaceuticals Inc.
The FDA has more about this approval.