Beractant

Identification

Name
Beractant
Accession Number
DB06761
Description

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.

Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Other protein based therapies
Protein Chemical Formula
Not Available
Protein Average Weight
Not Available
Sequences
Not Available
Synonyms
Not Available
External IDs
  • A 60386X
  • A-60386X
  • A60386X

Pharmacology

Indication

Beractant is indicated for prevention and treatment of Respiratory Distress Syndrome (RDS) in premature infants.

Associated Conditions
Contraindications & Blackbox Warnings
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Pharmacodynamics

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.

Absorption

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
Metabolism

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
Clearance
Not Available
Adverse Effects
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Toxicity
Not Available
Affected organisms
Not Available
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
AcebutololAcebutolol may increase the bradycardic activities of Beractant.
AlfentanilAlfentanil may increase the bradycardic activities of Beractant.
AmiodaroneAmiodarone may increase the bradycardic activities of Beractant.
AmlodipineAmlodipine may increase the bradycardic activities of Beractant.
AtenololAtenolol may increase the bradycardic activities of Beractant.
BendroflumethiazideBendroflumethiazide may increase the bradycardic activities of Beractant.
BepridilBepridil may increase the bradycardic activities of Beractant.
BetaxololBetaxolol may increase the bradycardic activities of Beractant.
BisoprololBisoprolol may increase the bradycardic activities of Beractant.
BretyliumBretylium may increase the bradycardic activities of Beractant.
Additional Data Available
  • Extended Description
    Extended Description

    Extended description of the mechanism of action and particular properties of each drug interaction.

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  • Severity
    Severity

    A severity rating for each drug interaction, from minor to major.

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  • Evidence Level
    Evidence Level

    A rating for the strength of the evidence supporting each drug interaction.

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  • Action
    Action

    An effect category for each drug interaction. Know how this interaction affects the subject drug.

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Food Interactions
Not Available

Products

Active Moieties
NameKindUNIICASInChI Key
CalfactantunknownQ4K217VGA9183325-78-2Not applicable
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
SurvantaSuspension25 mg/1mLEndotrachealAbbVie Inc.1991-07-01Not applicableUS flag
SurvantaSuspension25 mgEndotrachealAbbvie1993-12-31Not applicableCanada flag
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Categories

Drug Categories
Chemical TaxonomyProvided by Classyfire
Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available

Chemical Identifiers

UNII
S866O45PIG
CAS number
108778-82-1

References

General References
  1. Bayat S, Porra L, Broche L, Albu G, Malaspinas I, Doras C, Strengell S, Petak F, Habre W: Effect of surfactant on regional lung function in an experimental model of respiratory distress syndrome in rabbit. J Appl Physiol (1985). 2015 Aug 1;119(3):290-8. doi: 10.1152/japplphysiol.00047.2015. Epub 2015 May 21. [PubMed:25997942]
  2. Speer CP, Sweet DG, Halliday HL: Surfactant therapy: past, present and future. Early Hum Dev. 2013 Jun;89 Suppl 1:S22-4. doi: 10.1016/S0378-3782(13)70008-2. [PubMed:23809343]
  3. Halliday HL: History of surfactant from 1980. Biol Neonate. 2005;87(4):317-22. Epub 2005 Jun 1. [PubMed:15985754]
KEGG Drug
D03096
PubChem Substance
347910369
RxNav
46967
ChEMBL
CHEMBL1201624
RxList
RxList Drug Page
Drugs.com
Drugs.com Drug Page
Wikipedia
Beractant
AHFS Codes
  • 48:36.00 — Pulmonary Surfactants
FDA label
Download (3.16 MB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedBasic ScienceRespiratory Distress Syndrome1
4CompletedTreatmentRespiratory Distress Syndrome, Newborn / Respiratory Failure1
4TerminatedTreatmentInfants, Premature / Patent Ductus Arteriosus (PDA) / Respiratory Distress Syndrome1
4Unknown StatusPreventionChronic Lung Disease of Prematurity / Respiratory Distress Syndrome1
3TerminatedTreatmentNewborn Infants / Respiratory Distress Syndrome / Respiratory Insufficiency1
2, 3CompletedTreatmentChronic Lung Disease of Prematurity / Infant, Low Birth Weight / Infant, Small for Gestational Age / Infants, Premature / Newborn Infants1
2, 3CompletedTreatmentRespiratory Distress Syndrome1
2, 3Unknown StatusTreatmentRespiratory Distress Syndrome1
1, 2Active Not RecruitingTreatmentRespiratory Distress Syndrome, Newborn1
Not AvailableCompletedTreatmentPoor Peripheral Perfusion1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
SuspensionEndotracheal80 MG/ML
SuspensionEndotracheal100 mg/4mL
SuspensionEndotracheal200 mg/8mL
SuspensionEndotracheal25 mg/1mL
SuspensionEndotracheal25 mg
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Drug created on September 14, 2010 10:21 / Updated on October 25, 2020 09:16

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