NEOPROFEN Dosage & Rx Info | Uses, Side Effects

Neoprofen Generic Name & Formulations

Legal Class

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

Recordati Rare Diseases, Inc.

Generic Availability

YES

Mechanism of Action

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

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 15mins. Initially 10mg/kg, then two doses of 5mg/kg each, after 24 and 48hrs. 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. Discontinue at the first sign of skin rash or any other hypersensitivity.

Neoprofen Pharmacokinetics

Metabolism

Hepatic (CYP2C9).

Elimination

Renal (~80%), fecal.

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; serious skin reactions (eg, exfoliative dermatitis, SJS, TEN, AGEP).

Neoprofen Clinical Trials

See Literature

Neoprofen Note