EXOSURF NEONATAL (colfosceril palmitate, cetyl alcohol, tyloxapol) for
Intratracheal Suspension is a protein-free synthetic lung surfactant stored
under vacuum as a sterile lyophilized powder. EXOSURF NEONATAL is reconstituted
with preservative-free Sterile Water for Injection prior to administration
by intratracheal instillation. Each 10-mL vial contains 108 mg colfosceril
palmitate, commonly known as dipalmitoylphosphatidylcholine (DPPC), 12
mg cetyl alcohol, 8 mg tyloxapol, and 47 mg sodium chloride. Sodium hydroxide
or hydrochloric acid may have been added to adjust pH. When reconstituted
with 8 mL Sterile Water for Injection, the EXOSURF NEONATAL suspension
contains 13.5 mg/mL colfosceril palmitate, 1.5 mg/mL cetyl alcohol, and
1 mg/mL tyloxapol in 0.1 N NaCl. The suspension appears milky white with
a pH of 5 to 7 and an osmolality of 185 mOsm/kg.
The chemical names of the components of EXOSURF NEONATAL are as follows:
hydroxide inner salt,4-oxide
The molecular formula is CH3(CH2)14CH2OH.
4-(1,1,3,3-tetramethylbutyl)phenol polymer with formaldehyde and oxirane