Table of Contents
Clinical Overview Omeprazole Magnesium (Prilosec 1 TM) June 21, 2002
Initial Proposed Indications for OTC Omeprazole Mg
Conclusions of First Advisory Committee
Pharmacological Characteristics of Omeprazole-Mg
The increase of acid suppression over consecutive daily doses may reinforce continuous unsupervised usage by consumers seeking optimal relief of chronic heartburn
Overview of Presentation
Omeprazole-Mg Safety Profile Toxicity of Short-Term Exposure
Drug-Drug Interactions
Safety Issues of Long-term OTC Exposure
Potential for Long-term OTC Usage
Currently Proposed Indications
Efficacy Studies
Study Results
Influence of Baseline Heartburn Frequency on Responses
Conclusions
GERD*
Characterization of Study Patients
Actual Use Study
Cautions Listed in Proposed Labeling
Issues to Resolve
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