Halcion An Independent Assessment of Safety and Efficacy Data (1997) / Chapter Skim
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Appendix B: Summary Tables of Literature Reviewed for Safety of Halcion
Appendix B: Summary Tables of Literature Reviewed for Safety of Halcion
Pages 123-142
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From page 123... ...
B Summary Tables of Literature Reviewed for Safely of Halcion B-l Evaluation of Comparability, Pharmacokinetics, and Pharmacodynamic Interactions of Halcion, 124 B-2 Results of In Vitro Binding Studies: Displacement of Flunitrazepam in the Human Cortex, 127 B-3 Displacement of t3H] FlumazeniT in Rats as Determined by In Vivo Autoradiography, 128 B-4 Relative Lipophilicity of Benzodiazepines, 129 B-5 IOM Summary of Studies Investigating Possible Unique Amnestic Effects of Halcion, 130 B-6 IOM Summary of Studies Investigating Possible Unique Anxiogenic Effects During Administration of Halcion, arid Anxiogenic or Insomnia-Promoting Effects with Withdrawal, 133 B-7 IOM Summary of Studies Investigating Possible Unique Ataxic or Dyscoordination Effects of HaTcion, ~ 37 B-S IOM Summary of Studies Investigating Possible Unique Disinhibiting Effects of Halcion, 138 B-9 IOM Summary of Studies Investigating Possible Unique Psychotigenic, Confusion, or Dissociation-Generating Effects of HaTcion, 139 B-10 IOM Summary of Studies Investigating Other Possible Adverse Events related to Halcion, 140 123
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APPENDIX B 127 TABLE B-2 Results of Tn Vitro Binding Studies: Displacement of Flunitrazepam in the Human Cortex Drug K (37°C) nMa t~,2 off (min~b Ratio to Ka HalcionC Halcion 0.5 + 0.01 5.3 Alpha-hydroxy- 2.2 + 0.06 triazolam 4 Clonazepam 2.2 + 0.2 3.4 4 Lorazepam 3.8 + 0.2 8 Midazolam 4.9 + 0.07 10 Diazepam 9.8 + 0.7 20 Desmethyldiazepam 48 + 2 96 Alprazolam 10.6 + 0.4 3.4 21 Oxazepam 39 + 3 78 Flurazepam 51 + 2 4.6 102 Desalkylflurazepam 8.2 + 0.3 16 Quazepam 58 + 4 116 Desalkylflurazepam 8.2 + 0.3 16 Temazepam 66 + 1 132 Chlordiazepoxide 694 + 8 >103 aRatio of Ka of drug to Ka of Halcion.
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Ratio Halcion 0.7 + 0.1 1 0.1 + 0.8 1 0.5 + 0.08 1.0 Clonazepam 0.3 + 0.07 0.04 0.3 + 0.08 3 0.3 + 0.07 0.6 Lorazepam 0.8 + 0.3 1.1 1.0 + 0.3 10 0.4 + 0.09 0.8 Alprazolam 3.9 + 1.2 5.6 1.9 + 0.4 19 3.4 + 0.9 6.8 Zopiclone 6.6 + 1.1 9.4 5.7 + 0.5 57 4.7 + 0.7 9.4 Zolpidem 7.0 + 1.6 10.0 13.4 + 2.8 134 6.8 + 1.0 13.6 Diazepam 10.9 + 0.5 15.6 7.4 + 0.6 74 10.6 + 0.5 21.2 NOTE: ICso is the 50% inhibitory concentration. SOURCE: Sanger and Benavides (1993~.
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are ~C50/i + S/K~, where IC50 is the 50% inhibitory concentration and S is the flunitrazepam concentration. c In minutes.
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130 o .~ o Cal 4 C)
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132 s .~ s _ cat ~ a ·..
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134 x .~ o a: so C)
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137 o .~ Cal Cal o Cal Cal as ran o .~ Cal o o C)
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141 _ ~ ~ a ~ a C ' e ° C ~, Dy o ~j ~ E ' j° s , ~ i ~ a== ~ ~ ' ~ .: ~ ~o o Cut Cd ~.
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142 s .~ s o to ~¢ V, o o o .~ a V)
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