FDA Okays Injectable Ibuprofen

By H Bomber · Jun 15, 2009 · ·
  1. H Bomber
    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


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  1. RedCamaro87
    swim was actually given this in the er room for swims kidney stone pain, it was a miracle
  2. H Bomber
    Swim bets it was, ibuprofen is a non-narcotic miracle drug for pain, and the notion of having it available in a form which can bypass the GI tract, thereby eliminating its worst side effects (stomach bleeding and what not) is fantastic. Swim is glad to hear from someone who has had experience with it in its recently approved form.
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