Home » Drug Information » FDA Approved Drugs » 1998
Medical Areas: Pediatrics/Neonatology | Pulmonary/Respiratory Diseases
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved July 1998.
Treatment Area: Respiratory Distress Syndrome (RDS)
Infasurf is indicated for the 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. Infasurf decreases the incidence of RDS, mortality due to RDS
and air leaks associated with RDS.
Infasurf therapy is intended for infants greater than or equal
to 72 hours of age with RDS and requiring endotracheal
The efficacy of Infasurf was demonstrated in two multiple-dose
controlled clinical trials involving approximately 2,000 infants
treated with Infasurf (approximately 100mg phospholipid/kg) or
Exosurf Neonatal. In addition, two controlled trials of Infasurf
versus Survanta and four uncontrolled trials were conducted that
involved approximately 15,500 patients treated with Infasurf.
The most common side effects occurring with Infasurf were:
cyanosis, airway obstruction, bradycardia, reflux of surfactant
into the endotracheal tube, requirement for manual vantilation and
reintubation. These events were generally transient and not
associated with serious complications or death.