Usual Pediatric Dose for Respiratory Distress Syndrome

Initial dose: 200 mg/kg (2.5 mL/kg) birth weight intratracheally as 1 or 2 aliquots depending upon the instillation procedure
Maintenance dose: Up to two additional doses of 100 mg/kg (1.25 mL/kg) birth weight at about 12-hour intervals in infants who remain intubated and in whom RDS is considered responsible for their persisting or deteriorating respiratory status.
Maximum dose: Total of 400 mg/kg (5 mL/kg) [initial and up to two repeat doses]

Comments:

• The first dose should be given as soon as possible, no more than 15 hours after diagnosing of RDS.
• This drug reduces mortality and pneumothoraces associated with RDS.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established in full term infants or older pediatric patients.

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.
• Assure proper placement and patency of the endotracheal tube before administering this drug.
• At the discretion of the clinician, the endotracheal tube may be suctioned before administering this drug; allow the infant to stabilize before proceeding with dosing.

• By intratracheal instillation in two divided aliquots through a 5 French end-hole catheter after briefly disconnecting the endotracheal tube from the ventilator.
• By a single aliquot through the secondary lumen of a dual lumen endotracheal tube without interrupting mechanical ventilation.

• Remove the suspension from the refrigerator and slowly warm the vial to room temperature before use.
• Inspect visually for discoloration prior to administration. The suspension should be white to creamy white; discard the vial if the suspension is discolored.
• Gently turn the vial upside-down, in order to obtain a uniform suspension; do not shake.
• Unopened, unused suspension vials that have warmed to room temperature can be returned to refrigerated storage within 24 hours for future use. Suspension should not be warmed to room temperature and return to refrigerated storage more than once. Protect from light.

• There is no controlled experience on the effects of doses other than the recommended, dosing more frequently than every 12 hours, or initiating therapy more than 15 hours after diagnosing RDS.
• Adequate data are not available on the use of this drug in conjunction with experimental therapies of RDS (e.g., high-frequency ventilation or extracorporeal membrane oxygenation).