"The U.S. Food and Drug Administration today approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transpla"...
SURFAXIN® (lucinactant) 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 only.
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 6 hours.
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.
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 dosing.
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 respiratory status.
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 18976
Last reviewed on RxList: 3/16/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Surfaxin Information
Report Problems to the Food and Drug Administration
Find out what women really need.