Classifications: lung surfactant; Therapeutic: lung surfactant
Pregnancy Category: Not applicable
108 mg powder for injection
Synthetic lung surfactant. Endogenous pulmonary surfactant lowers surface tension on alveolar surfaces during respiration
and stabilizes the alveoli against collapse at resting pressures. Colfosceril lowers minimum surface tension on alveolar
surfaces and restores pulmonary compliance and oxygenation in premature infants.
Helps to reverse the effects of the deficiency of surfactant that causes respiratory distress syndrome (RDS) in premature
Prophylactic treatment of infants with birth weights <1350 g who are at risk of developing RDS. Prophylactic therapy of
infants with birth weights >1350 g who show evidence of pulmonary immaturity.
Rescue treatment of infants with established RDS; RDS in adults.
Infants who have major congenital abnormalities or who are suspected of having congenital infections.
Route & Dosage
Infant: Intratracheal 3 doses of 5 mL/kg are recommended, with the first dose being given as soon as possible after birth and repeat doses 12
and 24 h later to infants who remain on mechanical ventilation
Infant: Intratracheal 2 doses of 5 mL/kg are recommended, the first dose being initiated as soon as the diagnosis of RDS is confirmed and the
second 12 h later in infants remaining on mechanical ventilation
- Reconstitute immediately before use if possible. Use only supplied diluent for reconstitution.
- Reconstitute as follows: (1) withdraw diluent with 1819-gauge needle attached to 1012-mL syringe; (2) inject
into vial by allowing vacuum to draw diluent in; (3) do not withdraw needle and aspirate as much of solution as possible
back into syringe; (4) maintain vacuum and quickly release plunger. Repeat steps 3 and 4 three or four times to ensure adequate
- Reconstituted drug is a milky white suspension. Gently shake if needed to resuspend it.
- Withdraw entire ordered dose into syringe while maintaining vacuum in vial.
- Before administration of drug, ensure that endotracheal tube tip is in the trachea.
- Before administration of drug, the infant should be suctioned. If possible, avoid suctioning for 2 h after drug administration.
- Drug is administered without interrupting mechanical ventilation. Use side port on the endotracheal tube adaptor.
- Administer dose in halves, each half over 12 min. Give first half dose with head in midline position; then turn head
and torso to the right. Wait 30 s; then return to midline position for second half dose. Give each dose in short bursts timed
with inspiration. After second half dose, turn head and torso to left for 30 s; then return to midline.
- Slow or stop drug administration and adjust ventilator rate or FIO2 if any of the following occur: heart rate decreases, infant becomes dusky or agitated, or O2 saturation drops.
- Store at 15°30° C (59°86° F) in a dry place. Reconstituted solution is stable for 12 h.
INCOMPATIBILITIES Solution/additive: Do not mix any antibiotics with surfactant; this may inactivate surfactant.
Adverse Effects (≥1%)CV:
Bradycardia, tachycardia. Respiratory:
Decreased oxygen saturation, mucous plugging, apnea, pulmonary
No clinically significant interactions established.
Absorbed from the alveolus into lung tissue
At least 7 d. Distribution:
Distributes uniformly to all lobes of the lung, distal airways, and alveolar
Recycled and metabolized exclusively in the lungs. Half-Life:
Assessment & Drug Effects
- During administration of drug, continuous ECG and transcutaneous monitoring are required. Also monitor chest expansion and
- Monitor pulmonary function during administration. Rapid changes may require immediate adjustment of peak inspiratory pressure,
ventilator rate, or FIO2.
- Monitor continuously for 30 min following administration. Frequent arterial blood gas sampling is required to prevent hyperoxia