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Tapentadol PreReview Report WHO(Tapentadol PreReview报告的人)
Tapentadol
Pre-Review Report
Expert Committee on Drug Dependence
Thirty-fifth Meeting
Hammamet, Tunisia, 4-8 June 2012
35th ECDD (2012) Agenda item 5.2 Tapentadol
2
35th ECDD (2012) Agenda item 5.2 Tapentadol
Acknowledgements
This report has been drafted under the responsibility of the WHO Secretariat, Essential Medicines
and Health Products, Medicines Access and Rational Use Unit. The WHO Secretariat would like
to thank Dr Ellen Walker, USA for literature review and drafting this pre-review report.
3
35th ECDD (2012) Agenda item 5.2 Tapentadol
Contents
SUMMARY 6
1. Substance identification 7
A. International Nonproprietary Name (INN) 7
B. Chemical Abstract Service (CAS) Registry Number 7
C. Other Names 7
D. Trade Names (hydrochloride salt) 7
E. Physical properties 7
F. WHO Review History 7
2. Chemistry 7
A. Chemical Name 7
C. Chemical Structure 7
C. Stereoisomers 8
D. Synthesis 8
E. Chemical description 8
F. Chemical properties 8
G. Chemical identification 8
3. Ease of convertibility into controlled substances 9
4. General pharmacology 9
4.1. Pharmacodynamics 9
4.2. Routes of administration and dosage 10
4.3. Pharmacokinetics 11
5. Toxicology 11
6. Adverse reactions in humans 12
7. Dependence potential 13
8. Abuse potential 13
9. Therapeutic applications and extent of therapeutic use and epidemiology of medical use 14
10. Listing on the WHO Model List of Essential
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