Ibuprofen

Ibuprofen Lysine is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. The clinical trial was conducted among infants with an asymptomatic PDA. However, the consequences beyond 8 weeks after treatment have not been evaluated, therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA. Ibuprofen Lysine is a nonsteroidal anti-inflammatory drug indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management is ineffective.

The mechanism of action through which ibuprofen causes closure of a patent ductus arteriosus (PDA) in neonates is not known. In adults, ibuprofen is an inhibitor of prostaglandin synthesis.

A course of therapy is three doses administered I.V. An initial dose of 10 mg/kg (based on birth weight) is followed by two doses of 5 mg/kg each, after 24 and 48 hours. Do not administer if anuria or marked oliguria (<0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose

Ibuprofen Lysine is contraindicated in: Preterm infants with proven or suspected infection that is untreated, Preterm infants with congenital heart disease in whom patency of the PDA is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta), Preterm infants who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding, Preterm infants with thrombocytopenia, Preterm infants with coagulation defects, Preterm infants with or who are suspected of having necrotizing enterocolitis, Preterm infants with significant impairment of renal function.

Ibuprofen Lysine has not been assessed for neurodevelopmental outcome and growth. Ibuprofen Lysine may alter the usual signs of infection. Ibuprofen Lysine can inhibit platelet aggregation, and has been shown to prolong bleeding time in normal adult subjects. Ibuprofen has been shown to displace bilirubin from albumin binding-sites. Ibuprofen Lysine should be administered carefully to avoid extravascular injection or leakage. Ibuprofen Lysine may cause serious skin reactions

Most common adverse reactions (≥10%) are sepsis, anemia, intraventricular bleeding, apnea, gastrointestinal disorders, impaired renal function, respiratory infection, skin lesions, hypoglycemia, hypocalcemia, respiratory failure.

Diuretics: Ibuprofen may reduce the effect of diuretics, diuretics can increase the risk of nephrotoxicity of NSAIDs in dehydrated patients. Monitor renal function in patients receiving concomitant diuretics. Amikacin: Ibuprofen may decrease the clearance of amikacin. Diuretics: Increased risk of renal dysfunction.

Store at 20 – 25°C (68 – 77°F), excursions permitted 15 – 30°C (59 – 86°F). Protect from light. Store vials in carton until contents have been used.