ibuprofen lysine [IV]

Adult Dosing

N/A

Pediatric Dosing

Clousure of patent ductus arteriosus (PDA)

10 mg/kg (birth weight) IV, followed by two 5 mg/kg doses, after 24 and 48 hours, for a total of three doses

Notes:

If closure or size reduction of ductus is seen after completion of first course, no further doses are necessary
If ductus ductus arteriosus remains open after the first course, a second course may given, or alternative pharmacological therapy or surgery may be considered

[Outline]

Indications ⬆ ⬇

Clousure of a clinically significant patent ductus arteriosus (PDA) in premature infants (32 weeks gestational age) weighing between 500 and 1500 grams refractory to regular medical management

Contraindications ⬆ ⬇

Hypersensitivity to any of the ingredients of the product
Pretem infants with proven or suspected untreated infection
Pretem infants with congenital heart disease requiring patency of the PDA for satisfactory pulmonary or systemic circulation
Pretem infants with impaired renal function
Pretem infants with thrombocytopenia, coagulation abnormalities, or bleeding
Pretem infants with proven or suspected necrotizing enterocolitis

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Anuria or marked oliguria (<0.6 mL/kg/hr): Withhold therapy until renal function normalizes

Hepatic Dose Adjustment

Warnings/Precautions ⬆ ⬇

Ibuprofen has not been evaluated in infants beyond 36 weeks post-conceptual age, hence its effect on neurodevelopmental outcome and growth, and diseases of prematurity is not clearly known
Ibuprofen may mask typical signs of infection. Physicians must use the drug cautiously in patients with controlled infection and in infants at risk of infection
Ibuprofen is a platelet aggregation inhibitor. Preterm infants should be monitored for signs of bleeding
Ibuprofen can prolong bleeding time, The effect is more prominent in patients with underlying hemostatic defects
Ibuprofen should be used cautiously in patients with elevated total bilirubin, due to its tendency to displace bilirubin from albumin binding-sites
Extravascular injection or leakage should be avoided during administration, as tissue irritation may occur

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:N/A

Breastfeeding: N/A

Adverse Reactions ⬆ ⬇

CV: Intraventricular hemorrhage, tachycardia, cardiac failure, hypotension
CNS: Convulsions
GI: Non-necrotizing enterocolitis, abdominal distension, gastroesophageal reflux, gastritis, ileus, feeding problems, inguinal hernia
GU: Renal Failure, renal insufficiency/impairment, decresed renal output, hematuria, urinary tract infection, thrombocytopenia
HEMA: Anemia, bleeding, ventricular hemorrhage
METABOLIC: Hypoglycemia, hypocalcemia, hypernatremia, hyperglycemia
DERM: Skin Lesion/irritation
RESP: Apnea, respiratory infection, respiratory Failure, atelectasis
LABTESTS: Elevated blood creatinine, elevated blood urea, neutropenia
HEPA: Cholestasis, jaundice
LOCAL: Injection site reactions
MISC: Edema, sepsis, infections

Clinical Pharmacology ⬆ ⬇

NSAID; The exact machanism of action for closure of a patent ductus arteriosus in neonates not known. Inhibits prostaglandin synthesis in adults
Metabolism in neonates is unknown. Metabolized by liver in adults; CYP2C9
Excertion in neonates is unknown. Primarily excreted in urine in adults (10-15% unchanged)
Half-life: Unknown in neonates; 2-4 hours in adults

Brands and Availability ⬆ ⬇