"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
The following signs and symptoms have occurred in individuals (not necessarily in premature infants) following an overdose of oral ibuprofen: breathing difficulties, coma, drowsiness, irregular heartbeat, kidney failure, low blood pressure, seizures, and vomiting. There are no specific measures to treat acute overdosage with NeoProfen. The patient should be followed for several days because gastrointestinal ulceration and hemorrhage may occur.
NeoProfen 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 active intracranial hemorrhage or gastrointestinal bleeding;
- Preterm infants with thrombocytopenia;
- Preterm infants with coagulation defects;
- Preterm infants with or who are suspected of having necrotizing enterocolitis;
- Preterm infants with significant impairment of renal function.
Last reviewed on RxList: 12/12/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional NeoProfen Information
- NeoProfen Drug Interactions Center: ibuprofen lysine (pf) iv
- NeoProfen Side Effects Center
- NeoProfen FDA Approved Prescribing Information including Dosage
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