Beractant is a pulmonary surfactant used for the treatment of Respiratory Distress Syndrome (RDS) in premature infants. Considered a natural source of surfactant as it is made from bovine lung extract, beractant contains a mixture of phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins such as SP-B and SP-C. The final composition provides 25 mg/mL phospholipids (including 11.0-15.5 mg/mL disaturated phosphatidylcholine), 0.5-1.75 mg/mL triglycerides, 1.4-3.5 mg/mL free fatty acids, and less than 1.0 mg/mL protein. It is suspended in 0.9% sodium chloride solution, and heat-sterilized.
In anticipation of birth, endogenous lung surfactant is produced to lower the surface tension on alveolar surfaces and to stabilize the alveoli against collapse at resting transpulmonary pressures. However, in Respiratory Distress Syndrome, developmental deficiency of surfactant results collapse of the alveoli causing fast breathing, increased heart rate, apoxia, and sometimes death. Administration of lung surfactant remains the cornerstone of therapy in this condition that is currently the leading cause of death in preterm infants. In comparison to synthetic forms of surfacant, natural forms such as Beractant have been found to have a reduced incidence of pneumothorax and reduced mortality.
|Protein chemical formula||Not Available|
|Protein average weight||Not Available|
|External IDs||A 60386X / A-60386X / A60386X|
|Product Ingredients||Not Available|
|Approved Prescription Products|
|Approved Generic Prescription Products||Not Available|
|Approved Over the Counter Products||Not Available|
|Unapproved/Other Products||Not Available|
|International Brands||Not Available|
|Brand mixtures||Not Available|
Beractant is indicated for prevention and treatment of Respiratory Distress Syndrome (RDS) in premature infants.
In vitro, Beractant reproducibly lowers minimum surface tension to less than 8 dynes/cm as measured by the pulsating bubble surfactometer and Wilhelmy Surface Balance. In situ, it restores pulmonary compliance to excised rat lungs artificially made surfactant-deficient. In vivo, single doses improve lung pressure-volume measurements, lung compliance, and oxygenation in premature rabbits and sheep.
|Mechanism of action|
Beractant replenishes lung surfactant and restores surface activity to the lungs by lowering surface tension on alveolar surfaces during respiration and stabilizing the alveoli against collapse at resting transpulmonary pressures.
Beractant is administered directly to the target organ, the lungs, where biophysical effects occur at the alveolar surface.
|Volume of distribution||Not Available|
|Protein binding||Not Available|
In surfactant-deficient premature rabbits and lambs, alveolar clearance of radio-labelled lipid components of beractant is rapid. Most of the dose becomes lung-associated within hours of administration, and the lipids enter endogenous surfactant pathways of reutilization and recycling. Limited animal experiments have not found effects of beractant on endogenous surfactant metabolism.
|Route of elimination||Not Available|
|Half life||Not Available|
|Affected organisms||Not Available|
|Pharmacogenomic Effects/ADRs||Not Available|
|Food Interactions||Not Available|
|Synthesis Reference||Not Available|
|ATC Codes||Not Available|
|AHFS Codes||Not Available|
|PDB Entries||Not Available|
|FDA label||Download (3.16 MB)|
|Experimental Properties||Not Available|
|Super Class||Organic Acids|
|Class||Carboxylic Acids and Derivatives|
|Sub Class||Amino Acids, Peptides, and Analogues|
|Alternative Parents||Not Available|
|Molecular Framework||Not Available|
|External Descriptors||Not Available|