Formulary Drug Reviews

INDICATIONS AND BACKGROUND Ibuprofen lysine is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1,500 g who are no more than 32 weeks gestational age when usual medical management (fluid restriction, diuretics, respiratory support, etc.) is ineffective. Indomethacin injection is indicated for the treatment of PDA in premature infants weighing between 500 and 1,750 g when, after 48 hours, usual medical management is ineffective. PDA commonly occurs in premature infants with respiratory distress syndrome; 31% of infants weighing between 501 and 1,500 g have PDA. When substantial leftto-right shunting occurs through the ductus there is an increased risk of intraventricular hemorrhage, necrotizing enterocolitis, bronchopulmonary dysplasia, and death. Previously, intravenous (IV) indomethacin was the only pharmacologic therapy available for the treatment of PDA. However, indomethacin can adversely affect renal, GI, and cerebral perfusion and may cause complications such as transient or permanent renal dysfunction, necrotizing enterocolitis, GI hemorrhage, and reduced cerebral intracellular oxygenation. IV ibuprofen is an alternative to IV indomethacin. In animal models, ibuprofen closed the ductus without affecting basal cerebral blood flow and intestinal or renal hemodynamics during positivepressure ventilation.