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Any suggestions regarding resources discussing the pharmacokinetics of
Clonazepam. For exapmle, when does the plasma level peak and at what
level ng/ml? What are the therepeutic and toxic ranges? How about a
single dose of 4mg versus a steady state? The manufacturer itself
(Roche) seems to equivocate on these issues in it's own literature.
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[I've made a small start on an eBook version of the PharmPK archives, =
iBook and pdf format. Comments, suggestions welcome. Probably more work =
than worth. Let me know. Last two entries on my eBooks page, =
http;//www.pharmpk.com/MyeBooks.html - db]
The following message was posted to: PharmPK
from Goodman and Gilmans appendix: (an excellent starting point for PK
info)
Metabolized by CYP3A. Range of Cmax values following a single 2-mg IV
dose (model-fitted for bolus dose) or mean following a 2-mg oral dose
(tablet) given to healthy adults. Most patients, including children
whose seizures are controlled by clonazepam have steady-state =
concentrations
of 5-70 ng/mL. However, patients who do not respond and those with side
effects achieve similar levels.
Reference: Berlin A, et al. Pharmacokinetics of the anticonvulsant drug
clonazepam evaluated
from single oral and intravenous doses and by repeated oral
administration. Eur J Clin
Pharmacol, 1975, 9:155-159.
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Dear Mr Matt Lehrer,
Please find below the Public Assessment Reports and Scientific Articles
which will answer your queries regarding Clonazepam.
1. MHRA's Public Assessment Report, Decentralized Procedure, Clonazepam,
UK/H/1890/01-02/DC, UK License no. PL 20620/0045-6, NRIM Limited.
=
http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con09115=
7.pdf
2. MHRA's Public Assessment Report, Decentralized Procedure, Clonazepam,
UK/H/2487/001-02/DC, UK License no. PL 00427/0157-8, Rosemont
Pharmaceuticals Limited.
=
http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con14359=
2.pdf
3. Crevoisier C, Delisle MC, Joseph I, Foletti G.Comparative single-dose
pharmacokinetics of clonazepam following intravenous, intramuscular and
oral administration to healthy volunteers.=20
Eur Neurol. 2003;49(3):173-7.
4. BL Chauhan, SP Sane, SN Revankar, L Rammamurthy, B Doshi, AD Bhatt,
VR Bhate, RD Kulkarni, Comparative Bioavailability Study of Clonazepam
After Oral Administration of Two Tablet Formulations.=20
=
http://www.japi.org/october2000/s-Comparative%20Bioavailability%20Study%20=
of%20Clonazepam%20After%20Oral%20Administration%20of%20Two%20Tablet%20Form=
ulations.htm
5. MedSafe Datasheet, Paxam (Clonazepam 0.5 mg and 2.0 mg tablets)
http://www.medsafe.govt.nz/profs/datasheet/p/Paxamtab.pdf
Regards,
Dr.S.Gunasakaran, MD
Head - Clinical Research & Medical Affairs,
Azidus Clinical Research Organization, India
Global Moderator - ClinicalResearchForum
www.clinicalresearchsociety.org
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