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NeoProfen

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NeoProfen

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
(Adverse Reactions)

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
NeoProfen Placebo
Sepsis 43 37
Anemia 32 25
Total Bleeding** 32 29
  Intraventricular Hemorrhage, Grades ½ 15 13
  Intraventricular Hemorrhage, Grades 3/4 15 10
  Other Bleeding 6 13
Intraventricular Hemorrhage, All Grades 29 24
Apnea 28 26
Gastrointestinal Disorders non-Necrotizing Enterocolitis 22 18
Total Renal Events** 21 15
  Renal Failure 1 3
  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
Respiratory Infection 19 13
Skin Lesion/Irritation 16 6
Hypoglycemia 12 6
Hypocalcemia 12 9
Respiratory Failure 10 4
Urinary Tract Infection 9 4
Adrenal Insufficiency 7 1
Hypernatremia 7 4
Edema 4 0
Atelectasis 4 1
* 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.

Renal Function

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.

Post-marketing Experience

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) »

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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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