Class: Pulmonary Surfactants
VA Class: RE900
CAS Number: 108778-82-1
Uses for Beractant
Respiratory Distress Syndrome (RDS)
Beractant Dosage and Administration
Observe clinical status and monitor systemic oxygenation frequently to avoid hyperoxia.1 (See Oxygenation and Lung Compliance under Cautions.)
Following completion of dosing procedure, resume usual ventilator management and clinical care.1 Do not suction airways for 1 hour after dosing unless substantial obstruction occurs.1 (See Experience of Supervising Clinician under Cautions.)
Do not administer doses more frequently than every 6 hours.1
Contains no preservatives; discard unused portion.1
Dosage expressed in terms of phospholipids.1
Each mL of the commercially available formulation contains 25 mg of phospholipids (including 11–15.5 mg disaturated phosphatidylcholine) and <1 mg of surfactant proteins (SP-B, SP-C).1
Prevention of RDSIntratracheal
Administer repeat doses (100 mg/kg of birth weight) if neonate has radiographically confirmed RDS, remains intubated, and requires ≥30% inspired oxygen to maintain a PaO2 ≤80 torr.1
Treatment (Rescue) of RDSIntratracheal
Administer repeat doses (100 mg/kg of birth weight) if neonate remains intubated and requires ≥30% inspired oxygen to maintain a PaO2 ≤80 torr.1
Cautions for Beractant
No known contraindications.1
Experience of Supervising Clinician
Use by or under supervision of clinicians experienced in intubation, ventilatory management, and general care of premature neonates.1
Oxygenation and Lung Compliance
Transient episodes of decreased oxygen saturation reported.1 If this occurs, discontinue administration and initiate appropriate measures to alleviate the condition; following stabilization, resume therapy.1
Use with Investigational Treatments for RDS
Safety and efficacy in conjunction with investigational therapies for RDS (e.g., high-frequency ventilation, extracorporeal membrane oxygenation) not established.1
Not intended for use in adults.1
Not intended for use in adults.1
Safety and efficacy not established in neonates with birth weights <600 g or >1750 g.1
Common Adverse Effects
Transient bradycardia, oxygen desaturation, endotracheal tube reflux, pallor, vasoconstriction, hypotension, endotracheal tube blockage, hypertension, hypocarbia, hypercarbia, apnea.1
Interactions for Beractant
No drug interactions reported.1
No pharmacokinetic studies in humans.1
Improvements in arterial-alveolar oxygen ratio (a/APO2), FiO2, and mean airway pressure (MAP) sustained for 48–72 hours following administration.1
Prior to use, warm at room temperature for up to 24 hours (see Intratracheal Administration under Dosage and Administration); record date and time whenever vial is removed from refrigerator.1
Natural bovine lung extract containing mostly phospholipids and small amounts of neutral lipids, fatty acids, and surfactant-associated proteins (SP-B, SP-C).1
Endogenous pulmonary surfactant reduces alveolar surface tension and increases alveolar stability.1
Advice to Patients
Advise patient’s parent(s) or guardian of risk of bradycardia and decreased oxygen saturation.1
Importance of informing parent(s) or guardian of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
25 mg (of phospholipids) per mL
AHFS DI Essentials. © Copyright, 2004-2016, Selected Revisions May 1, 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. Ross Laboratories. Survanta (beractant) intratracheal suspension prescribing information. Columbus, OH: 2004 May
2. Ross Laboratories. Neonatal respiratory distress syndrome. Columbus, OH: 1991 Mar.
3. Ross Laboratories, Columbus, OH: Personal communication.
4. Whitsett JA, Ohning BL, Ross G et al. Hydrophobic surfactant-associated protein in whole lung surfactant and its importance for biophysical activity in lung surfactant extracts used for replacement therapy. Pediatr Res. 1986; 20:460-7. [PubMed 3754957]
5. Reynolds MS, Wallander KA. Use of surfactant in the prevention and treatment of neonatal respiratory distress syndrome. Clin Pharm. 1989; 8:559-76. [IDIS 257816] [PubMed 2670398]
6. Jobe A, Ikegami M. Surfactant for the treatment of respiratory distress syndrome. Am Rev Respir Dis. 1987; 136:1256-76. [IDIS 236107] [PubMed 3314618]
7. Weaver TE, Whitsett JA. Structure and function of pulmonary surfactant proteins. Semin Perinatol. 1988; 12:213-20. [PubMed 3041604]
8. Chida S, Phelps DS, Cordle C et al. Surfactant-associated proteins in tracheal aspirates of infants with respiratory distress syndrome after surfactant therapy. Am Rev Respir Dis. 1988; 137:943-7. [IDIS 240444] [PubMed 3355003]
9. Taeusch HW, Keough KMW, Williams M et al. Characterization of bovine surfactant for infants with respiratory distress syndrome. Pediatrics. 1986; 77:572-81. [PubMed 3634296]
10. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414), to June 28, 1996. Rockville, MD; 1996 Jul.
11. Anon. Two-year folow-up of infants treated for neonatal respiratory distress syndrome with bovine surfactant. Survanta Multidose Study Group. J Pediatr. 1994; 124:962-7.