Generic Name and Formulations:

Ibuprofen lysine 10mg/mL; soln for IV infusion after dilution; preservative-free.

Company:

Recordati Rare Diseases, Inc.
Indications for NEOPROFEN:

To close clinically significant patent ductus arteriosis (PDA) in premature infants weighing between 500–1500g who are no more than 32 weeks gestational age when usual management is ineffective.

Adult:

Not applicable.

Children:

Give by IV infusion over 15 minutes. Initially 10mg/kg, then two doses of 5mg/kg each, after 24 and 48 hours. Withhold second or third dose if anuria or marked oliguria is evident; do not give additional doses until renal function has returned to normal. If ductus arteriosis closes or is significantly reduced in size after completion of first course, no further doses are necessary. If ductus arteriosis fails to close or reopens, second course, alternative pharmacological therapy, or surgery may be necessary.

Contraindications:

Proven or suspected infection that is untreated. Congenital heart disease in whom patency of the PDA is necessary for satisfactory pulmonary or systemic blood flow. Bleeding, esp. active intracranial hemorrhage or GI bleeding. Thrombocytopenia. Coagulation defects. Necrotizing enterocolitis. Significant renal impairment.

Warnings/Precautions:

May alter usual signs of infection. May prolong bleeding time. Elevated total bilirubin. Avoid extravasation.

Pharmacological Class:

NSAID.

Adverse Reactions:

Sepsis, anemia, intraventricular bleeding, apnea, GI disorders, impaired renal function, respiratory infection, skin lesions, hypoglycemia, hypocalcemia, respiratory failure.

How Supplied:

Single-use vials (2mL)—3