Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-186-5 | CAS number: 53-86-1
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
Pharmacokinetics in humans:
Indomethacin is readily absorbed after oral administration, peak plasma concentrations are attained at about 2 hours. Bioavailability is approximately 100%, protein bindung about 99%. It crosses the placenta and blood-brain barrier. Indomethacin undergoes noteworthy enterohepatic circulation and is eliminated via renal excretion, metabolism and biliary excretion. The mean half life is about 4.5 hours. With a typical therapeutic dose (25 or 50 mg t.id.) steady state plasma concentrations are aboout 1.4 fold of the first dosel In plasma it is found as parent drug, and its desmethyl, desbenzoyl and desmethyldesbenzoyl metabolites (in unconjugated form). About 60% of an oral dose is recovered in urine as drug and metabolites (about 26% as indomethacin and its glucuronide) and 33% is recovered in feces (thereof about 1.5% as indomethacin).
Relative bioavailability is about 20% after dermal administration of an indomethacin solution.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
