Class: Lung surfactant
- Suspension, intratracheal 35 mg phospholipids/mL suspended in sodium chloride 0.9% solution and 0.65 mg proteins. With 26 mg phosphatidylcholine, of which 16 mg is disaturated phosphatidylcholine. Also includes 0.26 mg of SP-B.
Extract of natural surfactant from calf lungs that restores lung surfactant in premature infants with lung surfactant deficiency causing respiratory distress syndrome (RDS).
Indications and Usage
RDS in premature infants younger than 29 wk of gestational age at high risk for RDS and for the treatment rescue of premature infants younger than 72 h of age who develop RDS and require endotracheal intubation.
None well documented.
Dosage and AdministrationNewborn Infants
Intratracheal 3 mL/kg body weight at birth. Dose may be repeated every 12 h for total of 3 doses.
- Discard any unused drug after opening.
- For intratracheal administration only. Administer through an endotracheal tube. Draw dose into a syringe from the single-use vial using a 20-gauge or larger needle; avoid excessive shaking and foaming.
- Do not shake, dilute, or sonicate. If settling has occurred, swirl or roll gently.
- Visible flecks in the suspension and foaming at the surface are normal and warming before administration is not necessary.
- Before administration, ensure proper placement and patency of endotracheal tube. If suctioning is required, be sure patient is adequately oxygenated and stabilized before administering.
- Administer calfactant via the intratracheal route through a side-port adapter into the endotracheal tube. Two qualified medical professionals experienced in the care of high-risk infants should facilitate the dosing: one to instill the calfactant and the other to monitor the patient and assist in positioning. After each aliquot is instilled, position the infant on the right or left side to facilitate distribution.
- Calfactant also can be administered through a 5 French feeding catheter inserted into the endotracheal tube with the tip above the carina. Do not instill into the main stem bronchus. Attach the catheter to syringe. Fill with medication and discard any excess through catheter to ensure the total dose to be given remains in syringe. Instill the total dose in 4 equal aliquots with the catheter removed between each of the instillations and mechanical ventilation resumed for 30 sec to 2 min. Administer each of the aliquots in 1 of 4 different positions (eg, prone, supine, right, left lateral) to facilitate even distribution of the surfactant. Continue the procedure until the total dose is achieved.
- Avoid suctioning patient for 1 h after administration unless airway obstruction is present.
Refrigerate (36° to 46°F) and protect from light. Unopened, unused vials that have been warmed to room temperature can be returned to refrigerator within 24 h for future use. Avoid repeated warming.
None well documented.
Laboratory Test Interactions
None well documented.
Cyanosis; airway obstruction.
Reflux of surfactant into endotracheal tube; requirement for manual ventilation; reintubation.
Monitor lung sounds carefully for any changes (eg, moist rales).Oxygen therapy/Ventilatory support
Calfactant can rapidly improve oxygenation and lung compliance; monitor patients carefully so that oxygen therapy and ventilatory support can be modified in response to changes in respiratory status. Monitor respiratory and oxygen status closely following administration and adjust oxygen therapy and ventilator pressures appropriately.Oxygen and carbon dioxide levels
Continually monitor oxygen and carbon dioxide levels. If oxygen saturation decreases or bradycardia develops, discontinue administration until the infant is stabilized.
Administer calfactant intratracheally through an endotracheal tube and only in an acute care unit organized, staffed, equipped, and experienced with intubation, ventilation management, and general care of newborns with, or at risk for, RDS. During administration of calfactant liquid suspension into the airway, monitor the infant for bradycardia, reflux of calfactant into the endotracheal tube, airway obstruction, cyanosis, dislodgment of the endotracheal tube, or hypoventilation. If any of these events occur, interrupt administration and stabilize the infant's condition using appropriate interventions before resuming administration.
If any of the following situations occur while administering calfactant, interrupt administration and stabilize the infant's condition before resuming administration: bradycardia; reflux of calfactant into endotracheal tube; airway obstruction; cyanosis; hypoventilation; dislodgment of endotracheal tube.
Be prepared for possible endotracheal suctioning or reintubation if signs of airway obstruction are present during administration.
Overloading of the lungs with isotonic solution.
- Provide family with patient information leaflet.
- Offer frequent updates to the parents and other family members on the infant's condition.
- Encourage whole family participation in the infant's care whenever possible.
- Provide emotional support.
- Make appropriate referrals to hospital services and support groups.
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