Gynecologic and Obstetric Investigation
Original Paper
Tolerability, Safety and Efficacy of Two Formulations of Parlodel® – A Slow Release Oral Form (SRO) versus Registered Parlodel CapsulesBiberoğlu K.a · Atasü T.b · Shabgahi B.a · Kandemir Ö.aaDepartment of Obstetrics and Gynecology, Gazi University Medical School, Ankara, Turkey; bDepartment of Obstetrics and Gynecology, Istanbul University Cerrahpasa Medical School, Istanbul, Turkey
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Article / Publication Details
Received: December 04, 1992
Accepted: May 18, 1993
Published online: March 01, 2010
Issue release date: 1994
Number of Print Pages: 4
Number of Figures: 0
Number of Tables: 0
ISSN: 0378-7346 (Print)
eISSN: 1423-002X (Online)
For additional information: https://www.karger.com/GOI
Abstract
Twenty hyperprolactinemic patients who entered a randomized parallel-group, double-blind, double-dummy study were investigated regarding safety, tolerability and efficacy. Half of the patients received 5 mg Parlodel® SRO plus placebo for Parlodel while the other half received 2.5 mg Parlodel b.i.d. and placebo for Parlodel SRO for a period of 15 days. In the second following period of 15 days, the daily dose was increased to 10 mg Parlodel administered either as a single dose of Parlodel SRO or two doses of Parlodel 5 mg. The plasma prolactin levels, clinical signs and symptoms of hyperprolactinemia, physical examination, blood pressure, heart rate assessments and adverse events were recorded during the study. Complete blood count, blood chemistry and standard ECG were performed before and at the end of treatment. In conclusion, both formulations are equally efficacious, well tolerated and safe. Due to the comfort of once-a-day administration and the excellent compliance, one could recommend to replace the b.i.d. or t.i.d. administration of Parlodel with the once-a-day Parlodel SRO in hyperprolactinemic patients.
© 1994 S. Karger AG, Basel
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Article / Publication Details
Received: December 04, 1992
Accepted: May 18, 1993
Published online: March 01, 2010
Issue release date: 1994
Number of Print Pages: 4
Number of Figures: 0
Number of Tables: 0
ISSN: 0378-7346 (Print)
eISSN: 1423-002X (Online)
For additional information: https://www.karger.com/GOI
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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