Abstract
Cyclooxygenase inhibitors have proven efficacy in the treatment of patent ductus arteriosus (PDA). Intravenous indomethacin has been the only approved treatment for PDA available in the United States for the past 20 years. The armamentarium has recently been expanded with the approval of intravenous ibuprofen lysine in 2006. Ibuprofen lysine has been used for years in Europe, and the author reviews the extensive published literature. This review addresses common questions about ibuprofen lysine, summarizes the available literature, and discusses the data submitted to the Food and Drug Administration (FDA) in support of its approval. Three major trials served as the approval basis for the safety and efficacy of ibuprofen lysine. The author has summarized these studies and, where appropriate, presents pooled results from additional analyses that have not been previously published. Many practical questions regarding the drug, including dosing, administration, and storage are addressed. The results of recently completed but unpublished tests on stability and compatibility with commonly used drugs in the neonatal setting are also reviewed. Ibuprofen lysine now represents an alternative pharmacological option to surgery for the treatment of PDA.