Discovery Laboratories, Inc. is a specialty biotechnology company focused on advancing a new standard in respiratory critical care.
- Mar 16, 2015
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Nov 12, 2013
Nov 11, 2013
- SURFAXIN® (lucinactant) Intratracheal Suspension is approved by the U.S. Food and Drug Administration (FDA) for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for developing RDS.
IMPORTANT SAFETY INFORMATION
SURFAXIN® (lucinactant) Intratracheal Suspension is intended for intratracheal use only. The administration of exogenous surfactants, including SURFAXIN®, can rapidly affect oxygenation and lung compliance. SURFAXIN® should be administered only by clinicians trained and experienced with intubation, ventilator management, and general care of premature infants in a highly supervised clinical setting. Infants receiving SURFAXIN® should receive frequent clinical assessments so that oxygen and ventilatory support can be modified to respond to changes in respiratory status.
Most common adverse reactions associated with the use of SURFAXIN® are endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for dose interruption. During SURFAXIN® administration, if bradycardia, oxygen desaturation, endotracheal tube reflux, or airway obstruction occurs, administration should be interrupted and the infant’s clinical condition assessed and stabilized. Overall, the incidence of administration-related adverse events did not appear to be associated with an increased incidence of serious complications or mortality relative to the comparator surfactants.
SURFAXIN®is not indicated for use in acute respiratory distress syndrome (ARDS).
- For Full Prescribing Information please click here.