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
Condition | Modality | Targets | Highest Phase | Product |
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Primary | EXOSURF NEONATAL Approved UseRespiratory 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 Date1990 |
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NCI_THESAURUS |
C83486
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FDA ORPHAN DRUG |
87994
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WHO-ATC |
R05CA01
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FDA ORPHAN DRUG |
14886
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CFR |
21 CFR 310.201
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FDA ORPHAN DRUG |
68492
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WHO-VATC |
QR05CA01
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DB06439
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Tyloxapol
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DTXSID30179950
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ACTIVE MOIETY