NeoProfen
SIDE EFFECTS
The most frequently reported adverse events with NeoProfen were as shown in Table 2.
| Table 2. Adverse Events within 30 Days of Therapy in the Multicenter Study* | ||
| NeoProfen | ||
| Sepsis | 43 | 37 |
| Anemia | 32 | 25 |
| Total Bleeding** | 32 | 29 |
| Intraventricular Hemorrhage, Grades 1/2 | 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 than2 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.
DRUG INTERACTIONS
Drug interactions of NeoProfen in neonates have not been assessed.
Generic Name: Ibuprofen Lysine Injection
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