Paroxetine mesylate: comparable to paroxetine hydrochloride?

Abstract:

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.

authors

Pae CU,Misra A,Ham BJ,Han C,Patkar AA,Masand PS

doi

10.1517/14656560903451708

subject

Has Abstract

pub_date

2010-02-01 00:00:00

pages

185-93

issue

2

eissn

1465-6566

issn

1744-7666

journal_volume

11

pub_type

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