No

Lung Surfactant

Prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS and for the treatment ("rescue") of premature infants who develop RDS

Treatment: For infants less than or equal to 72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotracheal intubation.

For intratracheal administration only; the administration of exogenous surfactants often rapidly improves oxygenation and lung compliance. Transient episodes of cyanosis, bradycardia, reflux of surfactant into the endotracheal tube, and airway obstruction were observed more frequently among infants treated with calfactant in clinical trials.

Cardiovascular: Bradycardia (34%), cyanosis (65%)

Respiratory: Airway obstruction (39%), reflux (21%), requirement for manual ventilation (16%), reintubation (1% to 10%)

There have been no known reports of overdosage. While there are no known adverse effects of excess lung surfactant, overdoses would result in overloading the lungs with an isotonic solution. Ventilation should be supported until clearance of the liquid is accomplished.

Gently swirling or agitation of the vial of suspension is often necessary for redispersion. Do not shake. Visible flecks of the suspension and foaming at the surface are normal. Calfactant should be stored at refrigeration (2°C to 8°C/36°F to 46°F). Warming before administration is not necessary. Unopened and unused vials of calfactant that have been warmed to room temperature can be returned to the refrigeration storage within 24 hours for future use. Repeated warming to room temperature should be avoided. Each single-use vial should be entered only once and the vial with any unused material should be discarded after the initial entry.

Endogenous lung surfactant is essential for effective ventilation because it modifies alveolar surface tension, thereby stabilizing the alveoli. Lung surfactant deficiency is the cause of respiratory distress syndrome (RDS) in premature infants and lung surfactant restores surface activity to the lungs of these infants.

No human studies of absorption, biotransformation, or excretion of calfactant have been performed

Intratracheal administration only: Each dose is 3 mL/kg body weight at birth; should be administered every 12 hours for a total of up to 3 doses

Gentle swirling or agitation of the vial is often necessary for redispersion as injection suspension settles during storage; do not shake; visible flecks in the suspension and foaming at the surface are normal; does not require reconstitution; do not dilute or sonicate

Following administration, patients should be carefully monitored so that oxygen therapy and ventilatory support can be modified in response to changes in respiratory status

None reported

None reported

No information available to require special precautions

No effects or complications reported

Suspension, intratracheal: 6 mL

Bloom BT, Kattwinkel J, Hall RT, et al, "Comparison of Infasurf® (Calf Lung Surfactant Extract) to Survanta® (Beractant) in the Treatment and Prevention of Respiratory Distress Syndrome," Pediatrics, 1997, 100(1):31-8.

Hudak ML, Martin DJ, Egan EA, et al, "A Multicenter Randomized Masked Comparison Trail of Synthetic Surfactant Versus Calf Lung Surfactant Extract in the Prevention of Neonatal Respiratory Distress Syndrome," Pediatrics, 1997, 100(1):39-50.