Pseudoephedrine hydrochloride

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Adequacy of study:

disregarded due to major methodological deficiencies

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Original reference not available.

Data source

Reference

Reference Type:

other: Patient information sheet

Title:

Actifed.

Author:

Warner Lambert

Year:

1986

Bibliographic source:

Toxicological properties reported on an information sheet for medical and pharmaceutical personnel.

Materials and methods

Objective of study:

toxicokinetics

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:

Pseudoephedrine was resorbed quickly and completely from the gastrointestinal tract. Plasma peaks have been measured after 2 hours. Plasma half-life time was 5.5 hours if the urine pH was between 5.0 and 7.0. After acidification of urine the excretion will be accelerated whereas alkalisation leeds to a decelerated excretion.

Details on excretion:

Plasma half-life time was 5.5 hours if the urine pH was between 5.0 and 7.0. After acidification of urine the excretion will be accelerated whereas alkalisation leeds to a decelerated excretion.

Metabolite characterisation studies

Metabolites identified:

yes

Details on metabolites:

Pseudoephedrine is partly metabolised in the liver, where N-demethylation may occur. The resulting metabolite has shown to be still active. Excretion of pseudoephedrine and the metabolite occurs by renal excretion, with 55-75% of the dose beeing excreted unchanged.