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Prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS and for the treatment ( "rescue " �) of premature infants who develop RDS
Prophylaxis: Therapy at birth with calfactant is indicated for premature infants <29 weeks of gestational age at significant risk for RDS. Should be administered as soon as possible, preferably within 30 minutes after birth.
Treatment: For infants ≤72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotracheal intubation.
There are no contraindications listed in the manufacturers labeling.
Prevention or treatment of RDS in premature infants: Endotracheal administration only: Each dose is 3 mL/kg body weight at birth; should be administered every 12 hours for a total of up to 3 doses
No dosage adjustment provided in manufacturer 's labeling.
No dosage adjustment provided in manufacturer 's labeling.
Should be administered intratracheally through an endotracheal tube. Dose is drawn into a syringe from the single-use vial using a 20-gauge or larger needle with care taken to avoid excessive foaming. Dose should be administered in 2 or 4 equal aliquots. After each aliquot is instilled, the infant should be positioned with either the right or the left side dependent. Administration is made while ventilation is continued over 20-30 breaths for each aliquot, with small bursts timed only during the inspiratory cycles. A pause followed by evaluation of the respiratory status and repositioning should separate the aliquots. Do not dilute or sonicate.
Gentle swirling or agitation of the vial of suspension is often necessary for redispersion. Do not shake. Visible flecks of the suspension and foaming under the surface are normal. Calfactant should be stored upright (3 mL vial) and under refrigeration at 2 � �C to 8 � �C (36 � �F to 46 � �F); protect from light; document date and time removed from refrigeration. Warming before administration is not necessary. Unopened and unused vials of calfactant that have been warmed to room temperature can be returned to refrigeration storage within 24 hours for future use. Repeated warming to room temperature should be avoided. Each single-use vial should be entered only once and the vial with any unused material should be discarded after the initial entry.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Inhalation:
Infasurf: 35 mg phospholipids and 0.7 mg protein per mL (3 mL, 6 mL)
Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Monitor therapy
Bretylium: May enhance the bradycardic effect of Bradycardia-Causing Agents. Bretylium may also enhance atrioventricular (AV) blockade in patients receiving AV blocking agents. Monitor therapy
Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Avoid combination
Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Monitor therapy
Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Monitor therapy
Ruxolitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Management: Ruxolitinib Canadian product labeling recommends avoiding use with bradycardia-causing agents to the extent possible. Monitor therapy
Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Monitor therapy
Following administration, patients should be carefully monitored so that oxygen therapy and ventilatory support can be modified in response to changes in respiratory status.
>10%
Cardiovascular: Bradycardia (34%)
Gastrointestinal: Endotracheal tube reflux (21%)
Respiratory: Cyanosis (65%), airway obstruction (39%)
Miscellaneous: Mechanical ventilation (16%; manual ventilation required)
1% to 10%:
Miscellaneous: Endotracheal intubation (3%; reintubation needed)
Concerns related to adverse effects:
- Transient adverse effects: Transient episodes of bradycardia, decreased oxygen saturation, endotracheal tube blockage or reflux of calfactant into endotracheal tube may occur. Discontinue dosing procedure and initiate measures to alleviate the condition; may reinstitute after the patient is stable.
Other warnings/precautions:
- Administration: For intratracheal administration only.
- Monitoring: Produces rapid improvements in lung oxygenation and compliance that may require frequent adjustments to oxygen delivery and ventilator settings.
- Trained personnel: Rapidly affects oxygenation and lung compliance; restrict use to a highly-supervised clinical setting with immediate availability of clinicians experienced in intubation and ventilatory management of premature infants.
Endogenous lung surfactant is essential for effective ventilation because it modifies alveolar surface tension, thereby stabilizing the alveoli. Lung surfactant deficiency is the cause of respiratory distress syndrome (RDS) in premature infants and lung surfactant restores surface activity to the lungs of these infants.
- Discuss specific use of drug and side effects with caregiver as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Have caregiver report immediately to prescriber difficulty breathing, blue or gray skin color, bradycardia, or cough (HCAHPS).
- Educate caregiver about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Caregiver should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.