Intratracheal Suspension is indicated for the prevention of respiratory
distress syndrome (RDS) in premature infants at high risk for RDS. SURFAXIN
reduces the incidence of RDS at 24 hours and mortality due to RDS.
DOSAGE AND ADMINISTRATION
For intratracheal administration
SURFAXIN should be administered by
or under the supervision of clinicians experienced in intubation, ventilator
management, and general care of premature infants.
The recommended dose of SURFAXIN
is 5.8 mL per kg birth weight. Up to 4 doses of SURFAXIN can be administered in
the first 48 hours of life. Doses should be given no more frequently than every
No information is available on
doses greater than 5.8 mL per kg birth weight, the effects of more than 4
doses, or dosing more frequently than every 6 hours.
Dosage may be determined from
Table 1: Dosing Chart
|Birth Weight (g)
||Total Dose (mL)
||Birth Weight (g)
||Total Dose (mL)
Directions for Use
Before use, warm the vial for 15
minutes in a preheated dry block heater set at 44°C (111°F). After warming, shake
the vial vigorously until SURFAXIN is a uniform and free-flowing suspension. The
temperature of the product will be approximately 37°C (99°F) or less after the
product is drawn into a syringe for administration.
For each vial of SURFAXIN that is
warmed, record the date and time of warming in the space provided on the
carton. If not used immediately after warming, SURFAXIN can be stored protected
from light (i.e., in the carton) at room temperature for up to 2 hours. Do not
return SURFAXIN to the refrigerator after warming. Discard the product if not
used within 2 hours of warming. Vials are for single use only. Discard any
unused portion of SURFAXIN.
Visually inspect SURFAXIN before
use. After being warmed and vigorously shaken, SURFAXIN should be free-flowing
and opaque white to off-white. Use aseptic technique to slowly draw up the
appropriate amount of SURFAXIN into a single, appropriately sized syringe,
depending on the total dose volume, using a 16- or 18-gauge needle.
Before administering SURFAXIN,
assure proper placement and patency of the endotracheal tube. At the discretion
of the clinician, the endotracheal tube may be suctioned before administering
SURFAXIN. The infant should be allowed to stabilize before proceeding with
Position the infant in the right
lateral decubitus position with head and thorax inclined upward 30°. Attach the
syringe containing SURFAXIN to a 5-French end-hole catheter. Thread the
catheter through a Bodai valve or equivalent device that allows maintenance of
positive end-expiratory pressure and then advance the tip of the catheter into
the endotracheal tube. Position the catheter such that its tip is slightly
distal to the end of the endotracheal tube.
Each SURFAXIN dose should be
delivered in 4 aliquots. Instill the first aliquot of the dose (one-quarter of
the total volume) as a bolus while continuing positive pressure mechanical
ventilation and maintaining positive end-expiratory pressure of 4 to 5 cm H2O.
Ventilator settings may be adjusted at the discretion of the clinician to
maintain appropriate oxygenation and ventilation. Ventilate until the
infant is stable, that is, has an oxygen saturation of at least 90% and a heart
rate greater than 120 beats per minute. Repeat the procedure with the infant in
the left decubitus position while maintaining adequate positive pressure
ventilation. Repeat the procedure with the infant in the right, then left
decubitus position to deliver a total of 4 aliquots. A pause should separate
administration of the aliquots to allow for an evaluation of the infant's
After instillation of the last aliquot, remove the catheter
and resume usual ventilator management and critical care while keeping the head
of the infant's bed elevated at least 10 degrees for at least 1-2 hours. Do not
suction the infant during the first hour after dosing unless signs of
significant airway obstruction occur.
Use the same technique for additional doses, if indicated.
Dosage Forms And Strengths
8.5 mL suspension in a glass vial. Each mL contains 30 mg
phospholipids [22.50 mg dipalmitoylphosphatidylcholine (DPPC) and 7.50 mg
palmitoyloleoylphosphatidylglycerol, sodium salt (POPG, Na)], 4.05 mg palmitic
acid (PA), and 0.862 mg sinapultide.
Storage And Handling
SURFAXIN (lucinactant) Intratracheal Suspension is supplied
sterile in single-use, rubber-stoppered, clear glass vials containing 8.5 mL of
white suspension (NDC 68628-500-31). One vial per carton.
Store SURFAXIN in a refrigerator at 2° to 8°C (36° to 46°F)
and protect from light until ready for use. Do not freeze. Vials are for single
use only. Discard any unused portion of SURFAXIN. Discard warmed vials of
SURFAXIN if not used within 2 hours of warming [see Directions for Use].
Manufactured by Discovery Laboratories, Inc. Warrington, PA