"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
TPN is an intravenous"...
NeoProfen Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
NeoProfen (ibuprofen lysine) Injection is a nonsteroidal anti-inflammatory drug (NSAID) used to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. Common side effects include rapid heart rate, cardiac failure, abdominal distension, gastroesophageal reflux, gastritis, intestinal obstruction, inguinal hernia, injection site reactions, cholestasis, various infections, feeding problems, convulsions, jaundice, hypotension, low white blood cell counts, low platelet count, and high blood sugar.
A course of therapy of NeoProfen is three doses administered intravenously. An initial dose of 10 mg per kilogram is followed by two doses of 5 mg per kilogram each, after 24 and 48 hours. All doses should be based on birth weight. NeoProfen may interact with other drugs. Tell your doctor all medications and supplements your child uses. NeoProfen is usually used in infants and is unlikely to be used in pregnant or breastfeeding women; consult your doctor if you have questions.
Our NeoProfen (ibuprofen lysine) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
NeoProfen FDA Prescribing Information: Side Effects
Clinical Trials Experience
The most frequently reported adverse events with NeoProfen were as shown in Table 1.
Table 1: Adverse Events within 30 Days of Therapy in
the Multicenter Study*
|Adverse Event||% Incidence|
|Intraventricular Hemorrhage, Grades ½||15||13|
|Intraventricular Hemorrhage, Grades 3/4||15||10|
|Intraventricular Hemorrhage, All Grades||29||24|
|Gastrointestinal Disorders non-Necrotizing Enterocolitis||22||18|
|Total Renal Events**||21||15|
|Renal Insufficiency, Impairment||6||4|
|Urine Output Reduced||3||1|
|Blood Creatinine Increased||3||1|
|Blood Urea Increased with Hematuria||1||1|
|Blood Urea Increased||7||4|
|Urinary Tract Infection||9||4|
|* Within 30 days of therapy,
with an event rate greater on NeoProfen than on placebo, and greater than 2
events on NeoProfen.
** A given subject may have experienced more than one specific event within these adverse event categories. Only the most severe grade of IVH counted for a given subject.
Compared to placebo, there was a small decrease in urinary output in the ibuprofen group on days 2-6 of life, with a compensatory increase in urine output on day 9. In other studies, adverse events classified as renal insufficiency including oliguria, elevated BUN, elevated creatinine, or renal failure were reported in ibuprofen treated infants.
Additional Adverse Events
The adverse events reported in the multicenter study and of unknown association include tachycardia, cardiac failure, abdominal distension, gastroesophageal reflux, gastritis, ileus, inguinal hernia, injection site reactions, cholestasis, various infections, feeding problems, convulsions, jaundice, hypotension, and various laboratory abnormalities including neutropenia, thrombocytopenia, and hyperglycemia.
The following adverse reactions have been identified from spontaneous post-marketing reports or published literature: gastrointestinal perforation and necrotizing enterocolitis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency, or establish a causal relationship to drug exposure.
Read the entire FDA prescribing information for NeoProfen (Ibuprofen Lysine Injection)
Additional NeoProfen Information
- NeoProfen Drug Interactions Center: ibuprofen lysine (pf) iv
- NeoProfen Side Effects Center
- NeoProfen FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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