Trade Names:Neoprofen- 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.
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.
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.
Store at 68° to 77°F. Protect from light. Store vials in carton until contents have been used.
None well documented in neonates.
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.
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