U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS
Tyloxapol is a nonionic liquid polymer of the alkyl aryl polyether alcohol type that is used as a surfactant to aid liquefaction and removal of mucopurulent (containing mucus and pus) bronchopulmonary secretions. Tyloxapol is also used as a detergent, dispersing agent, encapsulating agent and a hydroxy radical scavenger. Tyloxapol has been used as a mucolytic agent for over 50 years and has proven to be well tolerated during this time. Tyloxapol influences the respiratory system by the following four different action mechanisms: secretolytic action, reduction of surface tension, dissolution of coatings and down-regulation of inflammation. Several studies have shown that small quantities of Tyloxapol applied as an aerosol liquefy sputum. The viscosity of sputum is reduced by 10% to 20% according to rotational viscosimetry measurements. Tyloxapol also penetrates the mucous wall and dissolves viscous and dried secretions, thus enabling increased ciliary activity in the respiratory tract. Although the mechanism of Tyloxapol has been well described, and there is a long-standing basis for its clinical usefulness, there are almost no randomized, double-blind, placebo-controlled trials available that demonstrate the superiority of Tyloxapol vs. saline. Side-effects in the form of hypersensitivity reactions have only occurred very rarely.

Approval Year

Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
EXOSURF NEONATAL

Approved Use

Respiratory distress syndrome, neonatal (prophylaxis and treatment)—Colfosceril, cetyl alcohol, and tyloxapol combination is indicated for the prophylactic treatment of infants with birth weights of less than 1350 grams who are at risk of developing respiratory distress syndrome (RDS) and of infants with birth weights greater than 1350 grams who show evidence of pulmonary immaturity. {01} {24} {26} —Colfosceril, cetyl alcohol, and tyloxapol combination is also indicated for rescue treatment of infants who have developed RDS. {21} Infants considered for rescue treatment with this medication should be on mechanical ventilation, and have a diagnosis of RDS based on the presence of respiratory distress that is not due to causes other than RDS (as shown by clinical and laboratory assessments) and on chest radiographic findings consistent with the diagnosis of RDS.

Launch Date

1990
PubMed

PubMed

TitleDatePubMed
Synthetic surfactant for respiratory distress syndrome in preterm infants.
2000
Name Type Language
TYLOXAPOL
II   INN   JAN   MART.   MI   ORANGE BOOK   USAN   USP   USP-RS   VANDF   WHO-DD  
USAN   INN  
Official Name English
tyloxapol [INN]
Common Name English
TYLOXAPOL [JAN]
Common Name English
TYLOXAPOL COMPONENT OF EXOSURF NEONATAL
Common Name English
TYLOXAPOL [VANDF]
Common Name English
TYLOXAPOL [USP MONOGRAPH]
Common Name English
SUPERINONE
Brand Name English
TYLOXAPOL [USP-RS]
Common Name English
EXOSURF NEONATAL COMPONENT TYLOXAPOL
Common Name English
TYLOXAPOL [MI]
Common Name English
TACHOLIQUINE
Brand Name English
ALEVAIRE
Brand Name English
TYLOXAPOL [ORANGE BOOK]
Common Name English
TYLOXAPOL [MART.]
Common Name English
NSC-90255
Code English
TYLOXAPOL [USAN]
Common Name English
TYLOXAPOL [II]
Common Name English
Tyloxapol [WHO-DD]
Common Name English
Classification Tree Code System Code
NCI_THESAURUS C83486
Created by admin on Fri Dec 15 22:13:26 GMT 2023 , Edited by admin on Fri Dec 15 22:13:26 GMT 2023
FDA ORPHAN DRUG 87994
Created by admin on Fri Dec 15 22:13:26 GMT 2023 , Edited by admin on Fri Dec 15 22:13:26 GMT 2023
WHO-ATC R05CA01
Created by admin on Fri Dec 15 22:13:26 GMT 2023 , Edited by admin on Fri Dec 15 22:13:26 GMT 2023
FDA ORPHAN DRUG 14886
Created by admin on Fri Dec 15 22:13:26 GMT 2023 , Edited by admin on Fri Dec 15 22:13:26 GMT 2023
CFR 21 CFR 310.201
Created by admin on Fri Dec 15 22:13:26 GMT 2023 , Edited by admin on Fri Dec 15 22:13:26 GMT 2023
FDA ORPHAN DRUG 68492
Created by admin on Fri Dec 15 22:13:26 GMT 2023 , Edited by admin on Fri Dec 15 22:13:26 GMT 2023
WHO-VATC QR05CA01
Created by admin on Fri Dec 15 22:13:26 GMT 2023 , Edited by admin on Fri Dec 15 22:13:26 GMT 2023
Code System Code Type Description
RS_ITEM_NUM
1704003
Created by admin on Fri Dec 15 22:13:26 GMT 2023 , Edited by admin on Fri Dec 15 22:13:26 GMT 2023
PRIMARY
RXCUI
38998
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PRIMARY RxNorm
MERCK INDEX
m11284
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PRIMARY Merck Index
INN
1435
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PRIMARY
CAS
25301-02-4
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PRIMARY
SMS_ID
100000084780
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PRIMARY
MESH
C016811
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PRIMARY
ChEMBL
CHEMBL1201548
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PRIMARY
EVMPD
SUB05015MIG
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PRIMARY
DAILYMED
Y27PUL9H56
Created by admin on Fri Dec 15 22:13:26 GMT 2023 , Edited by admin on Fri Dec 15 22:13:26 GMT 2023
PRIMARY
NSC
90255
Created by admin on Fri Dec 15 22:13:26 GMT 2023 , Edited by admin on Fri Dec 15 22:13:26 GMT 2023
PRIMARY
FDA UNII
Y27PUL9H56
Created by admin on Fri Dec 15 22:13:26 GMT 2023 , Edited by admin on Fri Dec 15 22:13:26 GMT 2023
PRIMARY
CHEBI
141517
Created by admin on Fri Dec 15 22:13:26 GMT 2023 , Edited by admin on Fri Dec 15 22:13:26 GMT 2023
PRIMARY
DRUG CENTRAL
4738
Created by admin on Fri Dec 15 22:13:26 GMT 2023 , Edited by admin on Fri Dec 15 22:13:26 GMT 2023
PRIMARY
NCI_THESAURUS
C80949
Created by admin on Fri Dec 15 22:13:26 GMT 2023 , Edited by admin on Fri Dec 15 22:13:26 GMT 2023
PRIMARY
DRUG BANK
DB06439
Created by admin on Fri Dec 15 22:13:26 GMT 2023 , Edited by admin on Fri Dec 15 22:13:26 GMT 2023
PRIMARY
WIKIPEDIA
Tyloxapol
Created by admin on Fri Dec 15 22:13:26 GMT 2023 , Edited by admin on Fri Dec 15 22:13:26 GMT 2023
PRIMARY
EPA CompTox
DTXSID30179950
Created by admin on Fri Dec 15 22:13:26 GMT 2023 , Edited by admin on Fri Dec 15 22:13:26 GMT 2023
PRIMARY
Display Structure of TYLOXAPOL