Patent ductus arteriosus (PDA), Analgesic, Antipyretic,

Analgesic, Nonopioid; Anti-inflammatory Agent; Antipyretic; Nonsteroidal Anti-inflammatory Drug (NSAID)

Maximum effect:
Antipyretic: 2 to 4 hours

Distribution:
1. Vd:
IV: Pediatric patients 6 months to <2 years: 0.31 L/kg
Pediatric patients 2 to 16 years: 0.23 L/kg
2. Protein binding: >99% ; Premature infants: ~95%

Metabolism:
Hepatic via oxidation

Half-life elimination: IV:
Pediatric patients: 6 months to <2 years: 1.8 hours
2 to 16 years: ~1.5 hours
Adults: 2.22 to 2.44 hours

Hypersensitivity to ibuprofen (eg, anaphylactic reactions, serious skin reactions) or any component of the formulation; history of asthma, urticaria, or allergic-type reaction to aspirin or other NSAIDs; aspirin triad (eg, bronchial asthma, aspirin intolerance, rhinitis); use in the setting of coronary artery bypass graft (CABG) surgery

Fetal risk cannot be ruled out. [MDX]

Infant risk cannot be ruled out. [MDX]

Common(>10%):
Dermatologic: Skin irritation (?16%), skin lesion (?16%)
Endocrine & metabolic: Hypocalcemia (12%), hypoglycemia (12%)
Gastrointestinal: Enterocolitis (22%)
Hematologic & oncologic: Anemia (32%), hemorrhage (32%; primarily intraventricular)
Infection: Sepsis (43%)
Nervous system: Intraventricular hemorrhage (29%)
Respiratory: Apnea (28%), respiratory tract infection (19%)

1% to 10%:
Cardiovascular: Edema (4%)
Endocrine & metabolic: Adrenocortical insufficiency (7%), hypernatremia (7%)
Genitourinary: Decreased urine output (3%), urinary tract infection (9%)
Renal: Increased blood urea nitrogen (7%), increased serum creatinine (3%), renal insufficiency (6%)
Respiratory: Atelectasis (4%), respiratory failure (10%)

Dosage is recommended in Ibuprofen.
Patent ductus arteriosus (PDA), treatment:
Standard-dose therapy: Preterm neonates:
IV: Initial dose: 10 mg/kg, followed by 2 doses of 5 mg/kg/dose at 24 and 48 hours after the initial dose.
A second course of treatment, alternative pharmacologic therapy, or surgery may be needed if the ductus arteriosus fails to close or reopens following the initial course of therapy.

Analgesic:
IV: Patients should be well hydrated prior to administration.
Infants ≥6 months and Children <12 years: IV: 10 mg/kg/dose (maximum dose: 400 mg/dose) every 4 to 6 hours as needed; maximum daily dose: 40 mg/kg/day or 2,400 mg/day, whichever is less.Children >12 years and Adolescents <17 years: IV: 400 mg every 4 to 6 hours as needed; maximum daily dose: 2,400 mg/day.
Adolescents >18 years: IV: 400 to 800 mg every 6 hours as needed; maximum daily dose: 3,200 mg/day.

Antipyretic:
Infants ≥6 months and Children <12 years: IV: 10 mg/kg/dose (maximum dose: 400 mg/dose) every 4 to 6 hours as needed; maximum daily dose: 40 mg/kg/day or 2,400 mg/day, whichever is less.
Children >12 years and Adolescents <17 years: IV: 400 mg every 4 to 6 hours as needed; maximum daily dose: 2,400 mg/day.
Adolescents >18 years: IV: Initial dose: 400 mg once, followed by 400 mg every 4 to 6 hours or 100 to 200 mg every 4 hours as needed; maximum daily dose: 3,200 mg/day.

Pediatric: KDIGO 2013:
eGFR 30 to <60 mL/minute/1.73 m2: Avoid use in patients with intercurrent disease that increases risk of acute kidney injury.
eGFR <30 mL/minute/1.73 m2: Avoid use.

Adult:
CrCl ?60 mL/minute: No dosage adjustment necessary.
CrCl >30 to <60 mL/minute: No dosage adjustment necessary. Use of analgesics other than nonsteroidal anti-inflammatory drugs may be preferred.
If necessary, use the lowest effective dose for the shortest duration possible; avoid in patients at high risk for acute kidney injury (ie, volume depleted, hypotensive, elderly, or taking concurrent nephrotoxic medications)
CrCl ? 30 mL/minute: Avoid use due to increased risk of acute kidney injury.

Hemodialysis, intermittent (thrice weekly):
Not significantly dialyzable: No dosage adjustment necessary. Avoid use in patients with residual kidney function.

Peritoneal dialysis:
No dosage adjustment necessary. Avoid use in patients with residual kidney function.

CRRT:
Avoid use.

PIRRT (eg, sustained, low-efficiency diafiltration):
Avoid use.

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution to avoid adverse effects and discontinue if hepatic function worsens.

Store intact vials and ready-to-use bags at 20°C to 25°C
Excursions permitted to 15°C to 30°C