The Food and Drug Administration (FDA) has approved updated labeling for Caldolor® (ibuprofen injection) to include new clinical trial data related to preoperative administration for pain management.

Caldolor, a nonsteroidal anti-inflammatory drug, may now be administered just prior to surgery in order to reduce postoperative pain. Caldolor is indicated for use in adults and pediatric patients 6 months and older for the management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics. It is also approved for the reduction of fever.

The updated labeling is based on data from a randomized, double-blind, placebo-controlled study evaluating orthopedic surgical pain. The study included 185 patients who were randomly assigned to receive either Caldolor 800mg or placebo intravenously every 6 hours (started preoperatively), in addition to morphine administered on an as-needed basis. Findings showed a statistically significantly greater reduction in pain intensity over 24 hours postoperatively for Caldolor-treated patients compared with those who received placebo. 

Caldolor is supplied in ready-to-use premixed bags containing 800mg of ibuprofen in a 200mL low sodium formulation for injection. It is also available in 800mg/8mL single-dose vials for dilution.

“Before the pandemic began, healthcare systems across the country were in the midst of a public health mission to control surgical pain while decreasing opioid consumption,” said A.J. Kazimi, chief executive officer of Cumberland Pharmaceuticals Inc. “We feel confident that this important development provides additional insights into how intravenous ibuprofen can help healthcare professionals and patients as elective surgeries resume.”

References

  1. Caldolor® now FDA approved for pre-operative administration. News release. Cumberland Pharmaceuticals Inc. November 29, 2021. Accessed November 30, 2021. https://www.prnewswire.com/news-releases/caldolor-now-fda-approved-for-pre-operative-administration-301433207.html
  2. Caldolor. Package insert. Cumberland Pharmaceuticals Inc.; 2021. Accessed November 29, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022348s021lbl.pdf.