(ber AKT ant)
- Bovine Lung Surfactant
- Natural Lung Surfactant
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Survanta: Phospholipids 25 mg/mL (4 mL, 8 mL)
Brand Names: U.S.
- Lung Surfactant
Replaces deficient or ineffective endogenous lung surfactant in neonates with respiratory distress syndrome (RDS) or in neonates at risk of developing RDS. Surfactant prevents the alveoli from collapsing during expiration by lowering surface tension between air and alveolar surfaces.
Clearance: Alveolar clearance is rapid
Use: Labeled Indications
Prevention and treatment of respiratory distress syndrome (RDS) in premature infants
Prophylactic therapy: Body weight <1250 g in infants at risk for developing, or with evidence of, surfactant deficiency (administer within 15 minutes of birth)
Rescue therapy: Treatment of infants with RDS confirmed by x-ray and requiring mechanical ventilation (administer as soon as possible - within 8 hours of age)
There are no contraindications listed within the FDA-approved labeling
Respiratory distress treatment: Premature infants:
Prophylactic treatment: Endotracheal: Administer 4 mL/kg (100 mg phospholipids/kg) as soon as possible; as many as 4 doses may be administered during the first 48 hours of life, no more frequently than 6 hours apart. The need for additional doses is determined by evidence of continuing respiratory distress; if the infant is still intubated and requiring at least 30% inspired oxygen to maintain a PaO2 ≤80 torr.
Rescue treatment: Endotracheal: Administer 4 mL/kg (100 mg phospholipids/kg) as soon as the diagnosis of RDS is made; may repeat if needed, no more frequently than every 6 hours to a maximum of 4 doses
Dosing: Renal Impairment
No dosage adjustment provided in manufacturer’s labeling.
Dosing: Hepatic Impairment
No dosage adjustment provided in manufacturer’s labeling.
For endotracheal administration only
Suction infant prior to administration. Inspect solution to verify complete mixing of the suspension (may swirl gently, but DO NOT SHAKE). Do not filter dose and avoid shaking.
Administer endotracheally by instillation through a 5-French end-hole catheter inserted into the infant's endotracheal tube.
Administer the dose in four 1 mL/kg aliquots. Each quarter-dose is instilled over 2-3 seconds followed by at least 30 seconds of manual ventilation or until stable; each quarter-dose is administered with the infant in a different position. Slightly downward inclination with head turned to the right, then repeat with head turned to the left; then slightly upward inclination with head turned to the right, then repeat with head turned to the left. Following administration of one full dose, withhold suctioning for 1 hour unless signs of significant airway obstruction.
Refrigerate; protect from light. Prior to administration, warm by standing at room temperature for 20 minutes or held in hand for 8 minutes. Artificial warming methods should not be used. Unused, unopened vials warmed to room temperature may be returned to the refrigerator within 24 hours of warming only once.
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
Frequency not defined. The following occurred during the dosing procedure:
>10%: Cardiovascular: Bradycardia (transient)
1% to 10%: Respiratory: Oxygen desaturation
<1% (Limited to important or life-threatening): Apnea, hypercapnia, hypertension, hypotension, increased susceptibility to infection (post-treatment nosocomial sepsis), obstruction of endotracheal tube, pulmonary air leak, pulmonary interstitial emphysema, vasoconstriction
Concerns related to adverse effects:
• Transient adverse effects: Transient episodes of bradycardia and decreased oxygen saturation occur. Discontinue dosing procedure and initiate measures to alleviate the condition; may reinstitute after the patient is stable.
• Administration: For endotracheal 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.
Continuous ECG and transcutaneous O2 saturation should be monitored during administration; frequent arterial blood gases are necessary to prevent postdosing hyperoxia and hypocarbia
Beractant is only indicated for use in premature infants.
• Discuss specific use of drug and side effects with patient 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 patient report immediately to prescriber difficulty breathing, 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.