Registration Dossier
Registration Dossier
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EC number: 201-740-9 | CAS number: 87-33-2
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
After oral administration of both single and repeated doses (15, 30, 60 and 120 mg four times daily) of ISDN, peak serum levels are observed after 0.5 to 1 hours. Oral bioavailability ranges from 22% to 59%; it may be affected by food (reduced absorption); multiple-dose studies of ingested ISDN have shown progressive increases in bioavailability during chronic administration.
Protein binding is minimal. In humans the volume of distribution ranges from 48 to 473 liters (2 -4 L/kg). ISDN is metabolized to isosorbide-5-mononitrate and to isosorbide-2-mononitrate. The excretion is mainly renal (80% to 90% of the administered dose): the majority is excreted as conjugated metabolites within 24 hours . Total body clearance is 2 -4 liters/minute. During chronic administration, clearance decreased with increasing dose. The elimination half-life after oral administration is 4 hours.The daily dose-free interval is at least 14 hours due to the half-lives of ISDN and its active metabolites.
Key value for chemical safety assessment
Additional information
After oral administration of both single and repeated doses (15, 30, 60 and 120 mg four times daily) of ISDN, peak serum levels are observed after 0.5 to 1 hours. Oral bioavailability ranges from 22% to 59%; it may be affected by food (reduced absorption); multiple-dose studies of ingested ISDN have shown progressive increases in bioavailability during chronic administration.
Protein binding is minimal. In humans the volume of distribution ranges from 48 to 473 liters (2 -4 L/kg). ISDN is metabolized to isosorbide-5-mononitrate and to isosorbide-2-mononitrate. The excretion is mainly renal (80% to 90% of the administered dose): the majority is excreted as conjugated metabolites within 24 hours . Total body clearance is 2 -4 liters/minute. During chronic administration, clearance decreased with increasing dose. The elimination half-life after oral administration is 4 hours.The daily dose-free interval is at least 14 hours due to the half-lives of ISDN and its active metabolites.
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