Usual Pediatric Dose for Respiratory Distress Syndrome

Less than 48 hours of life:

• Prevention of RDS in infants less than 1250 g birth weight: 100 mg/kg birth weight intratracheally, preferably within 15 minutes of birth
• Treatment (rescue) of RDS: 100 mg/kg birth weight intratracheally, preferably by 8 hours of age
• Maintenance dose: Doses of 100 mg/kg birth weight can be repeated every 6 hours
• Maximum dose: Total of 4 doses within 48 hours of life

• This drug significantly reduces the incidence of mortality due to RDS and air leak complications.
• Marked improvements in oxygenation may occur within minutes of administration; monitor frequently and carefully the systemic oxygenation to avoid hyperoxia.
• Stop the dosing procedure if the infant experiences bradycardia or oxygen desaturation; initiate appropriate measures to alleviate the condition, and resume treatment after the infant has stabilized.
• Rales and moist breath sounds can occur transiently after administration.
• If clear-cut signs of airway obstruction are present, endotracheal suctioning or other remedial action may be necessary.

• Prevention of Respiratory Distress Syndrome (RDS): In premature infants less than 1250 g birth weight
• Rescue: Treatment of infants with RDS confirmed by X-ray and requiring mechanical ventilation

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established in patients older than 48 hours of life.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug is for intratracheal administration only.
• It should be administered only by or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants.
• Review audiovisual instructional materials describing dosage and administration procedures before using this drug.
• Each vial of this drug is for single use only; used vials with residual drug should be discarded.

• Leave this drug at room temperature for 20 minutes, or warm in the hand for 8 minutes before administration; artificial warming methods should not be used.
• Discard each vial if not used within 8 hours of rewarming to room temperature; vials should not be returned to the refrigerator once warmed.
• Inspect visually for discoloration prior to administration; some settling may occur during storage, which can be redispersed by gently inverting the vial several times, without shaking

• Respiratory: Arterial or transcutaneous measurement of systemic oxygen and carbon dioxide