Pharmacokinetic drug interactions between clobazam and drugs metabolized by cytochrome P450 isoenzymes

Pharmacotherapy

Volumn 32, Issue 4, 2012, Pages 340-353

  Walzer, Mark ^a   Bekersky, Ihor ^a   Blum, Robert A ^b   Tolbert, Dwain ^a  

^a LUNDBECK RESEARCH USA   (United States)

^b Buffalo Clinical Research Center LLC   (United States)

Author keywords

Clobazam; CYP; Cytochrome P450; Drug interactions

Indexed keywords

CAFFEINE; CARBAMAZEPINE; CLOBAZAM; CYTOCHROME P450 1A2; CYTOCHROME P450 2C19; CYTOCHROME P450 2C9; CYTOCHROME P450 2D6; CYTOCHROME P450 3A4; CYTOCHROME P450 ISOENZYME; DEXTROMETHORPHAN; FELBAMATE; KETOCONAZOLE; LAMOTRIGINE; MIDAZOLAM; NORCLOBAZAM; OMEPRAZOLE; OXCARBAZEPINE; PHENOBARBITAL; PHENYTOIN; TOLBUTAMIDE; VALPROIC ACID; ANTICONVULSIVE AGENT; ANTIDIABETIC AGENT; BENZODIAZEPINE DERIVATIVE; CENTRAL STIMULANT AGENT; CYTOCHROME P450; HYPNOTIC SEDATIVE AGENT; ISOENZYME; TRIAZINE DERIVATIVE;

ABNORMAL DREAMING; ADULT; AGED; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; CHILD; CLINICAL RESEARCH; CONTROLLED STUDY; DECREASED APPETITE; DIZZINESS; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG ELIMINATION; DRUG ERUPTION; DRUG EXPOSURE; DRUG HALF LIFE; DRUG MEGADOSE; DRUG METABOLISM; DRUG POTENTIATION; DRUG SAFETY; DYSGEUSIA; ENZYME INHIBITION; ENZYME SUBSTRATE; FEMALE; GASTROINTESTINAL SYMPTOM; HEADACHE; HUMAN; IRRITABILITY; LENNOX GASTAUT SYNDROME; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; PRESCHOOL CHILD; RHINOPHARYNGITIS; SIDE EFFECT; SINGLE DRUG DOSE; SOMNOLENCE; STEADY STATE; TIME TO MAXIMUM PLASMA CONCENTRATION; VOMITING; ADOLESCENT; CLINICAL TRIAL; DRUG INTERACTION; METABOLISM; MIDDLE AGED; PHARMACOKINETICS; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL; PROSPECTIVE STUDY; STATISTICAL MODEL;

ADOLESCENT; ADULT; ANTICONVULSANTS; AREA UNDER CURVE; BENZODIAZEPINES; CAFFEINE; CENTRAL NERVOUS SYSTEM STIMULANTS; CLINICAL TRIALS, PHASE I AS TOPIC; CYTOCHROME P-450 ENZYME SYSTEM; DEXTROMETHORPHAN; DRUG INTERACTIONS; FEMALE; HUMANS; HYPNOTICS AND SEDATIVES; HYPOGLYCEMIC AGENTS; ISOENZYMES; MALE; MIDAZOLAM; MIDDLE AGED; MODELS, STATISTICAL; PHARMACOKINETICS; PROSPECTIVE STUDIES; TOLBUTAMIDE; TRIAZINES; VALPROIC ACID; YOUNG ADULT;

EID: 84864096509     PISSN: 02770008     EISSN: None     Source Type: Journal    
DOI: 10.1002/j.1875-9114.2012.01028.x     Document Type: Article

References (31)

1. Gastaut H. Exceptional and unrecognized antiepileptic properties of a commercial anxiolytic: clobazam. Concours Med 1978;100:3697-702.
2. Fielding S, Hoffmann I. Pharmacology of anti-Anxiety drugs with special reference to clobazam. Br J Clin Pharmacol 1979;7(suppl 1):7S-15S.
3. Gastaut H, Low MD. Antiepileptic properties of clobazam, a 1-5 benzodiazepine, in man. Epilepsia 1979;20:437-46.
4. Shovron S. The antiepileptic drugs. In: Shovron S, ed. Handbook of epilepsy treatment, 3rd ed. West Sussex, UK: John Wiley & Sons, Ltd., 2010:171-4.
5. Schmidt D, Wilensky AJ. Benzodiazepines. In: Engel J Jr, Pedley TA, eds. Epilepsy, a comprehensive textbook, vol. II, 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins, 2008:1531-41.
6. de Wildt SN, Kearns GL, Leeder JS, van den Anker JN. Cytochrome P450 3A: ontogeny and drug disposition. Clin Pharmacokinet 1999;37:485-505.
7. Giraud C, Tran A, Rey E, Vincent J, Tréluyer JM, Pons G. In vitro characterization of clobazam metabolism by recombinant cytochrome P450 enzymes: importance of CYP2C19. Drug Metab Dispos 2004;32:1279-86.
8. Volz M, Christ O, Kellner HM, et al. Kinetics and metabolism of clobazam in animals and man. Br J Clin Pharmacol 1979;7 (suppl 1):41S-50S.
9. Meldrum BS, Croucher MJ. Anticonvulsant action of clobazam and desmethylclobazam in reflex epilepsy in rodents and baboons. Drug Dev Res Suppl 1982;1:33-8.
10. Haigh JR, Pullar T, Gent JP, Dailley C, Feely M. N-desmethylclobazam: a possible alternative to clobazam in the treatment of refractory epilepsy? Br J Clin Pharmacol 1987;23:213-8.
11. Data on file, Lunbeck Inc., Deerfield, IL, 2010.
12. Food and Drug Administration. Draft guidance for industry: drug interaction studies-study design, data analysis, and implications for dosing and labeling, September 2006. Available from www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatory-Information/Guidances/ucm072101.pdf. Accessed January 18, 2011.
13. Nallani SC, Glauser TA, Hariparsad N, et al. Dose-dependent induction of Cytochrome P450 (CYP) 3A4 and activation of Pregnane X receptor by topiramate. Epilepisa 2003;44:1521-8.
14. Kosaki K, Tamura K, Sato R, Samejima H, Tanigawara Y, Takahashi T. A major influence of CYP2C19 genotype on the steady-state concentration of N-desmethylclobazam. Brain Dev 2004;26:530-4.
15. Bardy AH, Seppälä T, Salokorpi T, Granström ML, Santavuori P. Monitoring of concentrations of clobazam and norclobazam in serum and saliva of children with epilepsy. Brain Dev 1991;13:174-9.
16. Sennoune S, Mesdjian E, Bonneton J, Genton P, Dravet C, Roger J. Interactions between clobazam and standard antiepileptic drugs in patients with epilepsy. Ther Drug Monit 1992;14:269-74.
17. Theis JG, Koren G, Daneman R, et al. Interactions of clobazam with conventional antiepileptics in children. J Child Neurol 1997;12:208-13.
18. Contin M, Riva R, Albani F, Baruzzi AA. Effect of felbamate on clobazam and its metabolite kinetics in patients with epilepsy. Ther Drug Monit 1999;21:604-8.
19. Giraud C, Treluyer JM, Rey E, et al. In vitro and in vivo inhibitory effect of stiripentol on clobazam metabolism. Drug Metab Dispos 2006;34:608-11.
20. Conry JA, Ng YT, Paolicchi JM, et al. Clobazam in the treatment of Lennox-Gastaut syndrome. Epilepsia 2009;50:1158-66.
21. Ng YT, Conry JA, Drummond R, Stolle J, Weinberg M., on behalf of the OV-1012 study investigators. Randomized, phase III study results of clobazam in Lennox-Gastaut syndrome. Neurology 2011;77:1473-81.
22. Venkatakrishnan K, von Moltke LL, Greenblatt DJ. Effects of the antifungal agents on oxidative drug metabolism: clinical relevance. Clin Pharmacokinet 2000;38:111-80.
23. Ko JW, Sukhova N, Thacker D, Chen P, Flockhart DA. Evaluation of omeprazole and lansoprazole as inhibitors of cytochrome P450 isoforms. Drug Metab Dispos 1997;25:853-62.
24. Gugler R, Jensen JC. Omeprazole inhibits oxidative drug metabolism. Studies with diazepam and phenytoin in vivo and 7-ethoxycoumarin in vitro. Gastroenterology 1985;89:1235-41.
25. Andersson T, Andrén K, Cederberg C, Edvardsson G, Heggelund A, Lundborg P. Effect of omeprazole and cimetidine on plasma diazepam levels. Eur J Clin Pharmacol 1990;39:51-4.
26. Andersson T, Cederberg C, Edvardsson G, Heggelund A, Lundborg P. Effect of omeprazole treatment on diazepam plasma levels in slow versus normal rapid metabolizers of omeprazole. Clin Pharmacol Ther 1990;47:79-85.
27. Omeprazole (Prilosec®) product prescribing information. Wilmington, DE: AstraZeneca Pharmaceuticals LP, 2010.
28. Neafsey P, Ginsberg G, Hattis D, Sonawane B. Genetic polymorphism in cytochrome P450 2D6 (CYP2D6): population distribution of CYP2D6 activity. J Toxicol Environ Health B Crit Rev 2009;12:334-61.
29. Bun H, Monjanel-Mouterde S, Noel F, Durand A, Cano JP. Effects of age and antiepileptic drugs on plasma levels and kinetics of clobazam and N-desmethylclobazam. Pharmacol Toxicol 1990;67:136-40.
30. Weintraub D, Buchsbaum R, Resor SR Jr, Hirsch LJ. Effect of antiepileptic drug comedication on lamotrigine clearance. Arch Neurol 2005;62:1432-6.
31. Reimers A, Skogvoll E, Sund JK, Spigset O. Lamotrigine in children and adolescents: the impact of age on its serum concentrations and on the extent of drug interactions. Eur J Clin Pharmacol 2007;63:687-92