Paroxetine mesylate: comparable to paroxetine hydrochloride?

Published

Journal Article (Review)

IMPORTANCE OF THE FIELD: Currently available small case reports clearly propose that existing regulatory procedures to approve generic versions only require essential bioequivalence, have limitations and fail to meet stricter scientific and clinical demands. AREAS COVERED IN THIS REVIEW: Data indicate that paroxetine mesylate has some potential differences in bio- and clinical equivalence compared with paroxetine hydrochloride, although it has not been fully and sufficiently investigated in well-designed clinical trials. Data available now regarding safety, tolerability, efficacy and practical issues dealing with debates between generic and brand-name products paroxetine mesylate and paroxetine hydrochloride are presented in the review. WHAT THE READER WILL GAIN: Preclinical and clinical data are reviewed, and clinical issues relating to use of generic version versus original product are comprehensively discussed; tips for the clinician in clinical practice are also provided. TAKE HOME MESSAGE: Potential differences in efficacy and safety but also reduction in the use of health care and in pharmacy cost should be considered when choosing the generic version or the original product based on the clear benefit-risk ratio in patients.

Full Text

Duke Authors

Cited Authors

  • Pae, C-U; Misra, A; Ham, B-J; Han, C; Patkar, AA; Masand, PS

Published Date

  • February 2010

Published In

Volume / Issue

  • 11 / 2

Start / End Page

  • 185 - 193

PubMed ID

  • 20088740

Pubmed Central ID

  • 20088740

Electronic International Standard Serial Number (EISSN)

  • 1744-7666

International Standard Serial Number (ISSN)

  • 1465-6566

Digital Object Identifier (DOI)

  • 10.1517/14656560903451708

Language

  • eng