Beractant

Identification

Name
Beractant
Accession Number
DB06761
Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Other protein based therapies
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.

Protein chemical formula
Not Available
Protein average weight
Not Available
Sequences
Not Available
Synonyms
Not Available
External IDs
A 60386X / A-60386X / A60386X
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
SurvantaSuspension25 mgEndotrachealAbbvie1993-12-31Not applicableCanada
SurvantaSuspension25 mg/mLEndotrachealAbbvie1991-07-01Not applicableUs
Categories
UNII
S866O45PIG
CAS number
108778-82-1

Pharmacology

Indication

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

Structured Indications
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
Toxicity
Not Available
Affected organisms
Not Available
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
DrugInteractionDrug group
AcebutololAcebutolol may increase the bradycardic activities of Beractant.Approved
AmiodaroneAmiodarone may increase the bradycardic activities of Beractant.Approved, Investigational
AtenololAtenolol may increase the bradycardic activities of Beractant.Approved
BendroflumethiazideBendroflumethiazide may increase the bradycardic activities of Beractant.Approved
BetaxololBetaxolol may increase the bradycardic activities of Beractant.Approved
BisoprololBisoprolol may increase the bradycardic activities of Beractant.Approved
BretyliumBretylium may increase the bradycardic activities of Beractant.Approved
CalfactantCalfactant may increase the bradycardic activities of Beractant.Approved
CarteololCarteolol may increase the bradycardic activities of Beractant.Approved
CarvedilolCarvedilol may increase the bradycardic activities of Beractant.Approved, Investigational
CeritinibBeractant may increase the bradycardic activities of Ceritinib.Approved
ClonidineClonidine may increase the bradycardic activities of Beractant.Approved
CrizotinibBeractant may increase the bradycardic activities of Crizotinib.Approved
DexmedetomidineDexmedetomidine may increase the bradycardic activities of Beractant.Approved, Vet Approved
DigoxinDigoxin may increase the bradycardic activities of Beractant.Approved
DiltiazemDiltiazem may increase the bradycardic activities of Beractant.Approved
DonepezilDonepezil may increase the bradycardic activities of Beractant.Approved
DronedaroneDronedarone may increase the bradycardic activities of Beractant.Approved
EsmololEsmolol may increase the bradycardic activities of Beractant.Approved
FingolimodBeractant may increase the bradycardic activities of Fingolimod.Approved, Investigational
GalantamineGalantamine may increase the bradycardic activities of Beractant.Approved
GuanfacineGuanfacine may increase the bradycardic activities of Beractant.Approved, Investigational
IvabradineBeractant may increase the bradycardic activities of Ivabradine.Approved
LabetalolLabetalol may increase the bradycardic activities of Beractant.Approved
LacosamideBeractant may increase the atrioventricular blocking (AV block) activities of Lacosamide.Approved
LanreotideBeractant may increase the bradycardic activities of Lanreotide.Approved
LevobunololLevobunolol may increase the bradycardic activities of Beractant.Approved
LucinactantLucinactant may increase the bradycardic activities of Beractant.Approved, Investigational
MethyldopaMethyldopa may increase the bradycardic activities of Beractant.Approved
MetipranololMetipranolol may increase the bradycardic activities of Beractant.Approved
MetoprololMetoprolol may increase the bradycardic activities of Beractant.Approved, Investigational
NadololNadolol may increase the bradycardic activities of Beractant.Approved
NebivololNebivolol may increase the bradycardic activities of Beractant.Approved, Investigational
OctreotideOctreotide may increase the bradycardic activities of Beractant.Approved, Investigational
PasireotidePasireotide may increase the bradycardic activities of Beractant.Approved
PenbutololPenbutolol may increase the bradycardic activities of Beractant.Approved, Investigational
PindololPindolol may increase the bradycardic activities of Beractant.Approved
Poractant alfaBeractant may increase the bradycardic activities of Poractant alfa.Approved
PropafenonePropafenone may increase the bradycardic activities of Beractant.Approved
PropranololPropranolol may increase the bradycardic activities of Beractant.Approved, Investigational
RivastigmineRivastigmine may increase the bradycardic activities of Beractant.Approved, Investigational
RuxolitinibRuxolitinib may increase the bradycardic activities of Beractant.Approved
SotalolSotalol may increase the bradycardic activities of Beractant.Approved
SufentanilSufentanil may increase the bradycardic activities of Beractant.Approved, Investigational
TimololTimolol may increase the bradycardic activities of Beractant.Approved
TizanidineTizanidine may increase the bradycardic activities of Beractant.Approved
TofacitinibTofacitinib may increase the bradycardic activities of Beractant.Approved, Investigational
VerapamilVerapamil may increase the bradycardic activities of Beractant.Approved
Food Interactions
Not Available

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]
External Links
KEGG Drug
D03096
PubChem Substance
347910369
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
1, 2Active Not RecruitingTreatmentRespiratory Distress Syndrome, Newborn1
2, 3CompletedTreatmentChronic Lung Disease of Prematurity / Infant, Low Birth Weight / Infant, Small for Gestational Age / Infants, Premature / Newborn Infants1
2, 3Not Yet RecruitingTreatmentRespiratory Distress Syndrome (RDS)1
3TerminatedTreatmentNewborn Infants / Respiratory Distress Syndrome (RDS) / Respiratory Insufficiency1
4CompletedBasic ScienceRespiratory Distress Syndrome (RDS)1
4TerminatedTreatmentPatent Ductus Arteriosus (PDA) / Premature Babies / Respiratory Distress Syndrome (RDS)1
4Unknown StatusPreventionChronic Lung Disease of Prematurity / Respiratory Distress Syndrome (RDS)1
Not AvailableCompletedTreatmentPoor Peripheral Perfusion1
Not AvailableCompletedTreatmentPulmonary Haemorrhage1
Not AvailableWithdrawnTreatmentRespiratory Distress Syndrome (RDS)1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
SuspensionEndotracheal25 mg
SuspensionEndotracheal25 mg/mL
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Taxonomy

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

Drug created on September 14, 2010 10:21 / Updated on December 10, 2017 17:18