Usual Pediatric Dose for Respiratory Distress Syndrome

Less than 48 hours of life:

• 174 mg/kg (5.8 mL/kg) birth weight instilled intratracheally no more often than every 6 hours for a total of up to 4 doses in the first 48 hours of life.

• Data not available

• No information is available on doses greater than 5.8 mL per kg birth weight, the effects of more than 4 doses, or dosing more frequently than every 6 hours.
• Discontinue administration for bradycardia, oxygen desaturation, reflux of drug into the endotracheal tube (ETT), and airway/ETT obstruction. The clinical condition of the infant should be assessed and stabilized.
• Suctioning of the ETT or reintubation may be required if airway obstruction persists or is severe. After the patient is stable, dosing may proceed with appropriate monitoring.

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.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For intratracheal administration only.
• Administer 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.
• The endotracheal tube may be suctioned before administering this drug.
• The infant should be allowed to stabilize before proceeding with dosing.
• Consult the manufacturer product information for additional administration recommendations.

• Before use, warm the vial for 15 minutes in a preheated dry block heater.
• If not used immediately after warming, store protected from light (i.e., in the carton) at room temperature for up to 2 hours. Do not return this drug to the refrigerator after warming.
• Discard the product if not used within 2 hours of warming. Vials are for single use only.
• The manufacturer product information should be consulted.

• Oxygen and ventilatory support; adjust as needed to respond to changes in respiratory status.