Discovery Laboratories, Inc.

Discovery Laboratories, Inc. Drugs

• Surfaxin
  

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  Surfaxin

  

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  For intratracheal administration only.

  SURFAXIN should be administered by or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants.

  2.1 Dosing

  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) 600-649     3.5     950-999     5.5 650-699     3.8     1000-1049     5.8 700-749     4.1     1050-1099     6.1 750-799     4.4     1100-1149     6.4 800-849     4.6     1150-1199     6.7 850-899     4.9     1200-1250     7.0 900-949     5.2                      

  2.2 Directions for Use

  Preparation

  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.

  Administration

  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.

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