No

Lung Surfactant

Prevention and treatment of respiratory distress syndrome (RDS) in premature infants

Rescue therapy: Treatment of infants with RDS confirmed by x-ray and requiring mechanical ventilation (administer as soon as possible - within 8 hours of age)

Rapidly affects oxygenation and lung compliance and should be restricted to a highly supervised use in a clinical setting with immediate availability of clinicians experienced with intubation and ventilatory management of premature infants. If transient episodes of bradycardia and decreased oxygen saturation occur, discontinue the dosing procedure and initiate measures to alleviate the condition; produces rapid improvements in lung oxygenation and compliance that may require immediate reductions in ventilator settings and FiO₂.

During the dosing procedure:

1% to 10%: Respiratory: Oxygen desaturation

<1%:

Cardiovascular: Vasoconstriction, hypotension, hypertension, pallor

Respiratory: Endotracheal tube blockage, hypocarbia, hypercarbia, apnea, pulmonary air leaks, pulmonary interstitial emphysema

Miscellaneous: Increased probability of post-treatment nosocomial sepsis

No data reported

Refrigerate; protect from light, prior to administration warm by standing at room temperature for 20 minutes or held in hand for 8 minutes; artificial warming methods should not be used; unused, unopened vials warmed to room temperature may be returned to the refrigerator within 8 hours of warming only once

Replaces deficient or ineffective endogenous lung surfactant in neonates with respiratory distress syndrome (RDS) or in neonates at risk of developing RDS. Surfactant prevents the alveoli from collapsing during expiration by lowering surface tension between air and alveolar surfaces.

Alveolar clearance is rapid

Prophylactic treatment: Administer 100 mg phospholipids (4 mL/kg) intratracheal as soon as possible; as many as 4 doses may be administered during the first 48 hours of life, no more frequently than 6 hours apart. The need for additional doses is determined by evidence of continuing respiratory distress; if the infant is still intubated and requiring at least 30% inspired oxygen to maintain a PaO₂ less than or equal to 80 torr.

Rescue treatment: Administer 100 mg phospholipids (4 mL/kg) as soon as the diagnosis of RDS is made; may repeat if needed, no more frequently than every 6 hours to a maximum of 4 doses

For intratracheal administration only. Suction infant prior to administration; inspect solution to verify complete mixing of the suspension. Administer intratracheally by instillation through a 5-French end-hole catheter inserted into the infant's endotracheal tube. Administer the dose in four 1 mL/kg aliquots. Each quarter-dose is instilled over 2-3 seconds; each quarter-dose is administered with the infant in a different position; slightly downward inclination with head turned to the right, then repeat with head turned to the left; then slightly upward inclination with head turned to the right, then repeat with head turned to the left.

Continuous EKG and transcutaneous O₂ saturation should be monitored during administration; frequent arterial blood gases are necessary to prevent postdosing hyperoxia and hypocarbia

None reported

None reported

No information available to require special precautions

No effects or complications reported

Do not shake; if settling occurs during storage, swirl gently

Suspension: 200 mg (8 mL)