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Pronunciation: EYE-bue-PROE-fen lye-SEEN
Class: Patent ductus arteriosus agent
- Solution for injection 17.1 mg/mL
Mechanism by which ibuprofen closes patent ductus arteriosus (PDA) is not known.
In adults, ibuprofen is a prostaglandin synthesis inhibitor.
Population Vd of racemic ibuprofen for premature infants at birth is 320 mL/kg.
Metabolism in premature infants has not been studied.
Excretion in premature infants has not been studied. The t ½ in infants is more than 10 times longer than in adults. Interindividual variability in Cl and Vd are 55% and 14%, respectively.
Indications and Usage
Closure of PDA in premature infants weighing between 500 and 1,500 g, who are more than 32 wk gestational age.
Preterm infants with 1) proven or suspected infection that is untreated; 2) congenital heart disease in whom patency of the PDA is necessary for satisfactory pulmonary or systemic blood flow (eg, pulmonary atresia); 3) thrombocytopenia; 4) coagulation defects; 5) suspected necrotizing enterocolitis; 6) significant renal function impairment; or 7) bleeding, especially those with active intracranial hemorrhage or GI bleeding.
Dosage and AdministrationInfants
IV A course of therapy is 3 doses. The initial dose of 10 mg/kg is followed by 2 doses of 5 mg/kg after 24 and 48 h.
- Base dosage on birth weight.
- If anuria or marked oliguria (urinary output less than 0.6 mL/kg/h) is evident at the time of the scheduled second or third dose, do not give an additional dose until laboratory studies indicate that renal function has returned to normal.
- If ductus arteriosus closes or is significantly reduced in size after completion of first course of treatment, no further doses are necessary.
- If, during continued medical management, the ductus arteriosus fails to close or reopens, a second course of treatment, alternative pharmacological therapy, or surgery may be necessary.
- Inspect the product visually for particulate matter and discoloration prior to administration.
- Dilute the medication to an appropriate volume with dextrose or saline.
- Prepare the infusion for administration within 30 min of administration and infuse continuously over 15 min.
- Administer via the IV port nearest to the insertion site.
- Because the product contains no preservative, discard any remaining solution after the first withdrawal from the vial.
- Do not administer in the same IV line with TPN.
- Interrupt TPN for a 15-min period prior to and after drug administration.
- Maintain line patency with dextrose or saline.
Store at 68° to 77°F. Protect from light. Store vials in carton until contents have been used.
None well documented in neonates.
Laboratory Test Interactions
None well documented.
Cardiac failure, hypotension, tachycardia.
Skin lesion/irritation (16%).
Nonnecrotizing enterocolitis (22%); abdominal distension, gastritis, gastroesophageal reflux, ileus.
UTI (9%); renal function impairment (6%); reduced urine output (3%); hematuria, renal failure (1%).
Anemia (32%); intraventricular hemorrhage (IVH) grades 1/2, IVH grades 3/4 (15%); other bleeding (6%); neutropenia, thrombocytopenia.
Hypernatremia, increased blood urea (7%); increased blood creatinine (3%).
Hypocalcemia, hypoglycemia (12%); hyperglycemia.
Apnea (28%); respiratory tract infection (19%); respiratory failure (10%); atelectasis (4%).
Sepsis (43%); adrenal insufficiency (7%); edema (4%); feeding problems, infections, inguinal hernia.
Because ibuprofen may displace bilirubin from albumin-binding sites, use with caution in infants with elevated total bilirubin.
Because the solution may be irritating to tissue, administer carefully to avoid extravascular injection or leaking.
Signs of infection may be altered; use the drug with extra care in presence of controlled infection and in infants at risk of infection.
May inhibit platelet aggregation and prolong bleeding time.
Breathing difficulties, coma, drowsiness, irregular heartbeat, kidney failure, low BP, seizures, vomiting.
Copyright © 2009 Wolters Kluwer Health.