The Food and Drug Administration (FDA) has approved Caldolor (ibuprofen; Cumberland Pharmaceuticals) Injection for the treatment of pediatric patients 6 months of age and older. Caldolor is the first and only injectable non-steroidal anti-inflammatory drug (NSAID) approved for use in pediatric patients.
Pediatric approval was granted based on safety and efficacy data from clinical trials in hospitalized febrile children and in children undergoing tonsillectomy surgery. In the fever study, a statistically significant greater reduction in temperature was seen in pediatric patients given Caldolor versus acetaminophen; 74% of patients treated with Caldolor became afebrile by the end of the first dosing interval.
The most common side effects in children were infusion site pain, vomiting, nausea, anemia and headache. Caldolor must be diluted before administration.
In 2009, the FDA first approved Caldolor for adults in the management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics, as well as for the reduction of fever. Pediatric data was submitted to the FDA as part of a post-marketing commitment.
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