Drug Safety-related Labeling Changes (SrLC)

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NEOPROFEN (NDA-021903)

(IBUPROFEN LYSINE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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10/16/2017 (SUPPL-10)

Approved Drug Label (PDF)

7 Drug Interactions

(Additions and/or revisions are underlined)

  • 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.

8 Use in Specific Populations

8.4 Pediatric Use

(Newly added subsection)

Safety and effectiveness have only been established in premature infants.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions are underlined)

Infection

NeoProfen may alter signs of infection. Patients’ caregivers should be informed to monitor the infant for any signs of infection.

Platelet Aggregation

Patients’ caregivers should be informed that like other NSAIDS, NeoProfen can inhibit clot formation therefore their infant should be monitored for any signs of bleeding.

Administration

Patients’ caregivers should be informed that the infants’ skin and tissues should be monitored as leakage from administration may be irritating to tissue.

01/13/2016 (SUPPL-9)

Approved Drug Label (PDF)

6 Adverse Reactions

Post marketing Experience

*added term Pulmonary hypertension

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

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