edoc

Safety, tolerability and pharmacokinetics of intravaginal pentamycin

Frey Tirri, B. and Bitzer, J. and Geudelin, B. and Drewe, J.. (2010) Safety, tolerability and pharmacokinetics of intravaginal pentamycin. Chemotherapy, 56 (3). pp. 190-196.

[img]
Preview
PDF - Published Version
123Kb

Official URL: http://edoc.unibas.ch/dok/A5840268

Downloads: Statistics Overview

Abstract

BACKGROUND/AIMS: Intravaginal pentamycin is a polyene macrolide with a broad spectrum of antimicrobial activity and is effective in various forms of infectious vaginitis. We evaluated the safety, tolerability and pharmacokinetics of escalating doses of this product. METHODS: Nineteen healthy volunteers were randomized to receive double blind one of five doses of intravaginal pentamycin (3, 10, 30, 60 or 100 mg) or the corresponding dose of pentamycin vehicle daily for 6 days. Patients with symptomatic vaginitis received a single dose of 60 (n = 6) or 100 mg (n = 6) of intravaginal pentamycin. Safety and tolerability parameters were monitored throughout the study. Plasma concentrations of pentamycin were measured daily in the healthy volunteers and on the day of drug application in the patients. RESULTS: The most frequently reported adverse events were mild or moderate vaginal discharge and mild symptoms of vaginal irritation (mainly pruritus or burning sensation), which also occurred in women who applied the vehicle. No patient with symptomatic vaginitis reported treatment-related adverse events. The plasma levels of pentamycin were below the quantification limit in all samples. CONCLUSION: Intravaginal pentamycin does not cause adverse reactions compared with vehicle and is not absorbed through the intact or the inflamed vagina.
Faculties and Departments:03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Klinische Pharmakologie > Klinische Pharmakologie (Krähenbühl)
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Klinische Pharmakologie > Klinische Pharmakologie (Krähenbühl)
03 Faculty of Medicine > Bereich Spezialfächer (Klinik) > Ehemalige Einheiten Spezialfächer (Klinik) > Geburtshilfliche und Gynäkologische Psychosomatik (Bitzer)
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Spezialfächer (Klinik) > Ehemalige Einheiten Spezialfächer (Klinik) > Geburtshilfliche und Gynäkologische Psychosomatik (Bitzer)
03 Faculty of Medicine > Departement Biomedizin > Former Units at DBM > Clinical Pharmacology (Drewe)
UniBasel Contributors:Drewe, Jürgen and Bitzer, Johannes
Item Type:Article, refereed
Article Subtype:Research Article
Bibsysno:Link to catalogue
Publisher:Karger
ISSN:0009-3157
e-ISSN:1421-9794
Note:Publication type according to Uni Basel Research Database: Journal article
Language:English
Related URLs:
Identification Number:
Last Modified:25 Oct 2017 08:27
Deposited On:08 Nov 2012 16:21

Repository Staff Only: item control page