IBUPROFEN LYSINE

and Bioavailability Studies The pharmacokinetic data were obtained from 54 Ibuprofen Lysine Injection-treated premature infants included in a double-blind, placebo-controlled, randomized, multicenter study. Infants were less than 30 weeks gestational age, weighed between 500 and 1000 g, and exhibited asymptomatic PDA with evidence of echocardiographic documentation of ductal shunting. Dosing was initially 10 mg/kg followed by 5 mg/kg at 24 and 48 hours. The population average clearance and volum...

In a double-blind, multicenter clinical study premature infants of birth weight between 500 and 1000 g, less than 30 weeks post-conceptional age, and with echocardiographic evidence of a PDA were randomized to placebo or Ibuprofen Lysine Injection. These infants were asymptomatic from their PDA at the time of enrollment. The primary efficacy parameter was the need for rescue therapy (indomethacin, open-label ibuprofen, or surgery) to treat a hemodynamically significant PDA by study day 14. An infant was rescued if there was clinical evidence of a hemodynamically significant PDA that was echoca...

Most common adverse reactions (≥10%) are sepsis, anemia, intraventricular bleeding, apnea, gastrointestinal disorders, impaired renal function, respiratory infection, skin lesions, hypoglycemia, hypocalcemia, respiratory failure. (6) To report SUSPECTED ADVERSE REACTIONS, contact XGen Pharmaceuticals DJB Inc. at 1-866-390-4411, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The most frequently reported adverse events with Ibuprofen Lysine Injection were as shown...

Ibuprofen Lysine Injection 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 ...

Ibuprofen Lysine Injection has not been assessed for neurodevelopmental outcome and growth (5.1) Ibuprofen Lysine Injection may alter the usual signs of infection (5.2) Ibuprofen Lysine Injection can inhibit platelet aggregation, and has been shown to prolong bleeding time in normal adult subjects (5.3) Ibuprofen has been shown to displace bilirubin from albumin binding-sites (5.4) Ibuprofen Lysine Injection should be administered carefully to avoid extravascular injection or leakage (5.5) Ibupr...

7 DRUG INTERACTIONS 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. ( 7 )