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Neoprofen Generic Name & Formulations
Legal Class
Rx
General Description
Ibuprofen lysine 10mg/mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
NSAID.
How Supplied
Single-use vials (2mL)—3
Manufacturer
Generic Availability
YES
Neoprofen Indications
Indications
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.
Neoprofen Dosage and Administration
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.
Neoprofen Contraindications
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.
Neoprofen Boxed Warnings
Not Applicable
Neoprofen Warnings/Precautions
Warnings/Precautions
May alter usual signs of infection. May prolong bleeding time. Elevated total bilirubin. Avoid extravasation.
Neoprofen Pharmacokinetics
See Literature
Neoprofen Interactions
Interactions
May potentiate amikacin. May antagonize diuretics. Monitor renal function when concomitant diuretics.
Neoprofen Adverse Reactions
Adverse Reactions
Sepsis, anemia, intraventricular bleeding, apnea, GI disorders, impaired renal function, respiratory infection, skin lesions, hypoglycemia, hypocalcemia, respiratory failure.
Neoprofen Clinical Trials
See Literature
Neoprofen Note
Not Applicable
Neoprofen Patient Counseling
See Literature
