Usual Pediatric Dose for Respiratory Distress Syndrome

Treatment of Respiratory Distress Syndrome (RDS):

• Less than 72 hours of life: 107.1 mg/kg (3 mL/kg) birth weight instilled intratracheally every 12 hours for a total of up to 3 doses.
• 72 hour of life or older: Data not available

• Less than 29 weeks of gestational age: 107.1 mg/kg (3 mL/kg) birth weight instilled intratracheally as soon as possible, preferably within 30 minutes after birth. Dose can be repeated every 12 hours for a total of up to 3 doses.
• 29 weeks of gestational age or older: Data not available

• Rapid and substantial increases in blood oxygenation and improved lung compliance often follow instillation of this drug.
• Adjust oxygen therapy and ventilator pressures appropriately.
• Immediate care and stabilization of the premature infant born with hypoxemia and/or bradycardia should precede prophylaxis with this drug.
• Discontinue administration for bradycardia, reflux into the endotracheal tube, airway obstruction, cyanosis, dislodgement of the endotracheal tube, or hypoventilation.
• Endotracheal suctioning or reintubation may be needed when there are signs of airway obstruction.
• Data on the efficacy of this drug are limited to doses of approximately 100 mg phospholipid/kg body weight and up to a total of 4 doses.

• Prophylaxis therapy at birth for premature infants less than 29 weeks of gestational age at significant risk for RDS
• Treatment of infants less than or equal to 72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotracheal intubation

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established in patients older than 72 hours.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For intratracheal administration only, by instillation into the endotracheal tube.
• Administer under the supervision of clinicians experienced in the acute care of newborn infants with respiratory failure who require intubation.
• Gentle swirling or agitation of the vial is often necessary for redispersion. DO NOT SHAKE.
• Warming before administration is not necessary.
• The dose is drawn from the single-use vial using a 20-gauge or larger needle with care to avoid excessive foaming.
• Consult the manufacturer product information for additional administration procedures.

• Significant improvements in fraction of inspired oxygen (FiO2) and mean airway pressure (MAP) during the first 24 to 48 hours following initiation of therapy with this drug have been demonstrated in clinical trials.
• This drug decreases the incidence of RDS, mortality due to RDS, and air leaks associated with RDS.

• Oxygen therapy and ventilator pressure