Indications for: SURVANTA
Prevention and treatment of respiratory distress syndrome (RDS) in premature infants.
See literature for dosing chart, administration, and additional support procedures. 100mg of phospholipids (4mL)/kg birth weight per dose, by intratracheal administration; max 4 doses, at 6-hr intervals in the first 48hrs after birth. Rescue: give 1st dose as soon as possible after infant is placed on mechanical ventilation for treatment of RDS. Prevention: give 1st dose as soon as possible after birth, preferably within 15 mins. Avoid suctioning for 1 hour after treatment, unless significant airway obstruction occurs. Retreatment is determined by continued respiratory distress. Get radiographic confirmation of RDS in those infants given preventative dose before giving additional doses.
Interrupt dosing if bradycardia or oxygen desaturation occurs; treat; resume after stabilization. Monitor oxygenation, carbon dioxide, and clinical condition frequently and carefully.
Dosing procedure reactions including oxygen desaturation and bradycardia, rales, moist breath sounds, sepsis, intracranial hemorrhage.
Drug for neonatal respiratory distress syndrome
Beractant, also known by the trade name of Survanta, is a modified bovinepulmonary surfactant containing bovine lung extract (phospholipids, neutral lipids, fatty acids, and bovine surfactant proteins), to which synthetic DPPC, tripalmitin and palmitic acid are added. The composition provides 25 mg/mL phospholipids, 0.5 to 1.75 mg/mL triglycerides, 1.4 to 3.5 mg/mL free fatty acids, and <1.0 mg/mL total surfactant proteins. As an intratracheal suspension, it can be used for the prevention and treatment of neonatal respiratory distress syndrome. Survanta is manufactured by Abbvie.
Beraksurf is generic form of Survanta (Beractant) which is manufacturing by Tekzima.
- ^Moya FR, Gadzinowski J, Bancalari E, Salinas V, Kopelman B, Bancalari A, et al. (April 2005). "A multicenter, randomized, masked, comparison trial of lucinactant, colfosceril palmitate, and beractant for the prevention of respiratory distress syndrome among very preterm infants". Pediatrics. 115 (4): 1018–29. doi:10.1542/peds.2004-2183. PMID 15805380. S2CID 40458323.
- ^Lotze A, Mitchell BR, Bulas DI, Zola EM, Shalwitz RA, Gunkel JH (January 1998). "Multicenter study of surfactant (beractant) use in the treatment of term infants with severe respiratory failure. Survanta in Term Infants Study Group". The Journal of Pediatrics. 132 (1): 40–7. doi:10.1016/S0022-3476(98)70482-2. PMID 9469998.
- "Beractant". Drug Information Portal. U.S. National Library of Medicine.
Pulmonary surfactant (medication)
Pulmonary surfactant is used as a medication to treat and prevent respiratory distress syndrome in newborn babies.
Prevention is generally done in babies born at a gestational age of less than 32 weeks. It is given by the endotracheal tube. Onset of effects is rapid. A number of doses may be needed.
Side effects may include slow heart rate and low oxygen levels. Its use is also linked with intracranial bleeding. Pulmonary surfactant may be isolated from the lungs of cows or pigs or made artificially.
Pulmonary surfactant was discovered in the 1950s and a manufactured version was approved for medical use in the United States in 1990. It is on the World Health Organization's List of Essential Medicines.
Pulmonary surfactant is used to treat and prevent respiratory distress syndrome in newborn babies. Prevention is generally done in babies born less than 32 weeks gestational age. Tentative evidence supports use in drowning.
See also: Pulmonary surfactant § composition
There are a number of types of pulmonary surfactants available. Like their natural counterparts, pulmonary surfactant preparations consist of phospholipids (mainly DPPC) combined with spreading agents such as SP-B and SP-C.
Synthetic pulmonary surfactants:
- Colfosceril palmitate (Exosurf) - a mixture of DPPC with hexadecanol and tyloxapol added as spreading agents
- Pumactant (Artificial Lung Expanding Compound or ALEC) - a mixture of DPPC and PG
- Lucinactant (KL-4) - composed of DPPC, palmitoyl-oleoyl phosphatidylglycerol, and palmitic acid, combined with a 21 amino acid synthetic peptide (sinapultide) that mimics the C-terminal helical domain of SP-B.
- Venticute - DPPC, PG, palmitic acid and recombinant SP-C
- Lucinactant (trade name Surfaxin) is a liquid medication that contains DPPC, POPG as the sodium salt, and palmitic acid.
Animal derived surfactants:
- (Alveofact) - extracted from cow lung lavage fluid, manufacturing by Boehringer Ingelheim
- (Survanta) - extracted from minced cow lung with additional DPPC, palmitic acid and tripalmitin, manufacturing by Abbvie
- (Beraksurf) - extracted from minced cow lung with additional DPPC, palmitic acid and tripalmitin, manufacturing by Tekzima
- Calfactant (Infasurf) - extracted from calf lung lavage fluid
- Poractant alfa (Curosurf) - extracted from material derived from minced pig lung
Researcher John Clements identified surfactants and their role in the 1950s. Mary Ellen Avery soon after showed that the lungs of premature infants couldn't produce surfactants.
Exosurf, Curosurf, Infasurf, and Survanta were the initial surfactants FDA approved for use in the U.S.
In 2012, the US FDA approved an additional synthetic surfactant, lucinactant (Surfaxin).
- ^ abcdefghBritish national formulary : BNF 69 (69 ed.). British Medical Association. 2015. p. 217. ISBN .
- ^ abFanaroff, Avroy A.; Fanaroff, Jonathan M. (2013). Klaus and Fanaroff's Care of the High-Risk Neonate, Expert Consult - Online and Print,6: Klaus and Fanaroff's Care of the High-Risk Neonate. Elsevier Health Sciences. p. 252. ISBN . Archived from the original on 2017-01-09.
- ^ abLantos, John D.; Meadow, William L. (2006). Neonatal Bioethics: The Moral Challenges of Medical Innovation. JHU Press. pp. 54–56. ISBN . Archived from the original on 2017-01-09.
- ^Slonim, Anthony D.; Pollack, Murray M. (2006). Pediatric Critical Care Medicine. Lippincott Williams & Wilkins. pp. 724–725. ISBN . Archived from the original on 2017-01-09.
- ^World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
- ^Brady, Bill; Charlton, Nathan P.; Lawner, Benjamin J.; Sutherland, Sara F. (2012). Cardiac Arrest, An Issue of Emergency Medicine Clinics. Elsevier Health Sciences. p. 175. ISBN . Archived from the original on 2017-01-09.
- ^Nkadi, Paul O.; Merritt, T. Allen; Pillers, De-Ann M. (2009). "An overview of pulmonary surfactant in the neonate: Genetics, metabolism, and the role of surfactant in health and disease". Molecular Genetics and Metabolism. 97 (2): 95–101. doi:10.1016/j.ymgme.2009.01.015. ISSN 1096-7192. PMC 2880575. PMID 19299177.
- ^"KL4 Surfactant Technology - Windtree Therapeutics, Inc". Windtree Therapeutics, Inc. Archived from the original on July 29, 2018. Retrieved 29 November 2017.
- ^Palca, Joe (3 August 2015). "How A Scientist's Slick Discovery Helped Save Preemies' Lives". NPR. Archived from the original on 3 August 2015. Retrieved 3 August 2015.
- ^Taeusch, H William; Lu, Karen; Ramierez-Schrempp, Daniela (2002). "Improving pulmonary surfactants"(PDF). Acta Pharmacologica Sinica. 23 Suppl: 11–5. Archived(PDF) from the original on 2015-03-01.
- "Poractant alfa". Drug Information Portal. U.S. National Library of Medicine.
- "Beractant". Drug Information Portal. U.S. National Library of Medicine.
- "Calfactant". Drug Information Portal. U.S. National Library of Medicine.
Jonathan M. Klein, MD
Peer Review Status: Internally Peer Reviewed
A. Treatment of intubated infants on 30% or more oxygen whose clinical presentation and chest x-ray are consistent with RDS.
B. Prophylactic administration may be considered in infants < 26 weeks EGA.
C. Secondary surfactant dysfunction, inactivation or post surfactant slump.
|Premature infants with RDS < 700 g||Survanta|
|Premature infants with RDS > 700 g||Curosurf|
|Premature infants unresponsive to 2 doses of Survanta||Infasurf|
|Premature infants unresponsive to 2 doses of Curosurf||Infasurf|
|Premature infants with inactivation, dysfunction or post surfactant slump||Infasurf|
|Term infants with surfactant inactivation or dysfunction||Infasurf|
Etiology of surfactant inactivation or dysfunction: pulmonary hemorrhage, sepsis, pneumonia, meconium aspiration, and post surfactant slump.
Surfactant replacement therapy for RDS - Early rescue therapy should be practiced: First dose needs to be given as soon as diagnosis of RDS is made. RDS in a premature infant is defined as respiratory distress requiring more than 30% oxygen delivered by positive pressure using either Nasal CPAP or an ET Tube with a chest radiograph that has diffuse infiltrates with a ground glass granular appearance with air bronchograms. Ideally the dose should be given within 1 hr of birth but definitely before 2 hours of age. A repeat dose should be given within 4 - 12 hours if the patient is still intubated and requiring more than 30 to 40% oxygen.
Prophylactic therapy (before chest radiograph) can be considered in patients with respiratory distress who are intubated and are < 26 weeks gestation.
|Survanta||4 ml/kg in 4 aliquots, repeat dose as needed if responsive|
|Infasurf||3 ml/kg in 2 aliquots, repeat dose as needed, (use of "drip dosing on HFOV" discuss with staff/fellow)|
|Curosurf||2.5 ml/kg in 2 aliquots, repeat dose (1.25 ml/kg) as needed, (use of "in and out therapy" - rapid extubation after one dose, discuss with staff/fellow)|
Subsequent doses are generally withheld if the infant requires less than 30% oxygen. The technical details of administration are discussed in the package insert and in the NICU Nursing Protocols on administration.
Ventilator Management: A blood gas should be checked within 15 - 20 minutes of the dose and the ventilator settings should be weaned appropriately to minimize the risk of a pneumothorax. A chest radiograph should be checked both 1 hour and 4 - 6 hours after the initial dose to avoid hyperinflation.
Surveillance after administration
The clinical response is unpredictable. Lung compliance usually improves, sometimes quite rapidly. Blood gases should be monitored frequently, and the ventilator should be adjusted to keep the PCO2 above 40. Occasionally, gas exchange deteriorates after surfactant administration, requiring a temporary increase in settings to facilitate spreading or suctioning if the ET tube is becoming obstructed. In either case, close surveillance of chest wall movement and frequent monitoring of blood gases, especially during the first 3 hours after dosing, will minimize the complications of either volutrauma or atelectasis.
- Prophylactic vs Rescue - Dunn et al, Pediatrics 1991;87:377, Kendig et al. N Engl J Med 1991;324:865, Osiris Exosurf Trial - Lancet 1992
- Surfactant Inactivation – Hall et al, Am Rev Respir Dis, 1992;145:24, Seeger et al, Eur Respir J, 1993:6:971
- Survanta vs Infasurf - Bloom et al, Pediatrics 1997;100:31
- Survanta vs Curosurf - Ramanathan et al, Am J Perinatal 2004;21:109
- Term Infants - Findlay et al, Pediatrics 1996;97:48. Lotze et al, J Pediatr 1998;132:40
- Post Surfactant Slump - Katz and Klein, Journal of Perinatology 2006;26:414
Generic name surfactant
.Evaluating Surfactants – A Pharmacy Perspective
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