Effect of carbamazepine on the pharmacokinetics of paliperidone extended-release tablets at steady-state

Clinical Pharmacology in Drug Development

Volumn 3, Issue 5, 2014, Pages 371-377

  Kerbusch Herben, Virginie ^a   Cleton, Adriaan ^a   Berwaerts, Joris ^a   Vandebosch, An ^a   Remmerie, Bart ^a  

^a JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

Antipsychotics; Carbamazepine; Drug interaction; P glycoprotein; Paliperidone

Indexed keywords

CARBAMAZEPINE; MULTIDRUG RESISTANCE PROTEIN; PALIPERIDONE; ABC TRANSPORTER SUBFAMILY B; ABCB1 PROTEIN, HUMAN; NEUROLEPTIC AGENT; TRANQUILIZER;

ADULT; ADVERSE OUTCOME; AREA UNDER THE CURVE; ARTICLE; BIPOLAR I DISORDER; CONTROLLED STUDY; CREATININE CLEARANCE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EFFECT; DRUG EXCRETION; DRUG RELEASE; DRUG SAFETY; DRUG TOLERABILITY; DRUG URINE LEVEL; EXTRAPYRAMIDAL SYNDROME; FEMALE; HEADACHE; HUMAN; KIDNEY CLEARANCE; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MIDDLE AGED; OPEN STUDY; REPEATED DRUG DOSE; SCHIZOPHRENIA; STEADY STATE; TIME TO MAXIMUM PLASMA CONCENTRATION; YOUNG ADULT; BIPOLAR DISORDER; BLOOD; BULGARIA; CLINICAL TRIAL; CROATIA; DELAYED RELEASE FORMULATION; DRUG ADMINISTRATION; DRUG EFFECTS; DRUG FORMULATION; DRUG INTERACTION; INTESTINE ABSORPTION; METABOLIC CLEARANCE RATE; METABOLISM; MULTICENTER STUDY; PSYCHOLOGY; TREATMENT OUTCOME; URINARY EXCRETION;

ADULT; ANTIMANIC AGENTS; ANTIPSYCHOTIC AGENTS; AREA UNDER CURVE; ATP BINDING CASSETTE TRANSPORTER, SUB-FAMILY B; BIPOLAR DISORDER; BULGARIA; CARBAMAZEPINE; CROATIA; DELAYED-ACTION PREPARATIONS; DRUG ADMINISTRATION SCHEDULE; DRUG COMPOUNDING; DRUG INTERACTIONS; FEMALE; HUMANS; INTESTINAL ABSORPTION; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; PALIPERIDONE PALMITATE; RENAL ELIMINATION; SCHIZOPHRENIA; SCHIZOPHRENIC PSYCHOLOGY; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84908544886     PISSN: 2160763X     EISSN: 21607648     Source Type: Journal    
DOI: 10.1002/cpdd.122     Document Type: Article

References (26)

1. Fowler JA, Bettinger TL, Argo TR. Paliperidone extended-release tablets for the acute and maintenance treatment of schizophrenia. Clin Ther. 2008; 30:231-248.
2. Spina E, Crupi R. Safety and efficacy of paliperidone extended-release in acute and maintenance treatment of schizophrenia. J Cent Nerv Syst Dis. 2011; 3:27-41.
3. Greil W, Ludwig-Mayerhofer W, Erazo N, et al. Lithium vs carbamazepine in the maintenance treatment of schizoaffective disorder: a randomised study. Eur Arch Psychiatry Clin Neurosci. 1997; 247:42-50.
4. Greil W, Ludwig-Mayerhofer W, Erazo N, et al. Lithium versus carbamazepine in the maintenance treatment of bipolar disorders-a randomised study. J Affect Disord. 1997; 43:151-161.
5. Okuma T, Yamashita I, Takahashi R, et al. A double-blind study of adjunctive carbamazepine versus placebo on excited states of schizophrenic and schizoaffective disorders. Acta Psychiatr Scand. 1989; 80:250-259.
6. Simhandl C, Meszaros K, Denk E, Thau K, Topitz A. Adjunctive carbamazepine or lithium carbonate in therapy-resistant chronic schizophrenia. Can J Psychiatry. 1996; 41:317.
7. Citrome L, Macher JP, Salazar DE, Mallikaarjun S, Boulton DW. Pharmacokinetics of aripiprazole and concomitant carbamazepine. J Clin Psychopharmacol. 2007; 27:279-283.
8. Grimm SW, Richtand NM, Winter HR, Stams KR, Reele SB. Effects of cytochrome P450 3A modulators ketoconazole and carbamazepine on quetiapine pharmacokinetics. Br J Clin Pharmacol. 2006; 61:58-69.
9. Lucas RA, Gilfillan DJ, Bergstrom RF. A pharmacokinetic interaction between carbamazepine and olanzapine: observations on possible mechanism. Eur J Clin Pharmacol. 1998; 54:639-643.
10. Miceli JJ, Anziano RJ, Robarge L, Hansen RA, Laurent A. The effect of carbamazepine on the steady-state pharmacokinetics of ziprasidone in healthy volunteers. Br J Clin Pharmacol. 2000; 49(Suppl 1):65S-70S.
11. Ono S, Mihara K, Suzuki A, et al. Significant pharmacokinetic interaction between risperidone and carbamazepine: its relationship with CYP2D6 genotypes. Psychopharmacology (Berl). 2002; 162:50-54.
12. Vermeir M, Naessens I, Remmerie B, et al. Absorption, metabolism, and excretion of paliperidone, a new monoaminergic antagonist, in humans. Drug Metab Dispos. 2008; 36:769-779.
13. Remmerie BM, Sips LL, de Vries R, et al. Validated method for the determination of risperidone and 9-hydroxyrisperidone in human plasma by liquid chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2003; 783:461-472.
14. De Meulder M, Remmerie B, de Vries R, et al. Validated LC-MS/MS method for the determination of risperidone and the enantiomers of 9-hydroxyrisperidone in human plasma and urine. J. Chromatogr B Analyt Technol Biomed Life Sci. 2008; 870:8-16. doi: 10.1016/j.jchromb.2008.1004.1041
15. Thyssen A, Cleton A, Talluri K, et al. No pharmacokinetic interaction between paliperidone extended-release tablets and trimethoprim in healthy subjects. Hum Psychopharmacol. 2009; 24:532-539.
16. Larkin JG, McLellan A, Munday A, et al. A double-blind comparison of conventional and controlled-release carbamazepine in healthy subjects. Br J Clin Pharmacol. 1989; 27:313-322.
17. McMillin GA, Juenke JM, Tso G, Dasgupta A. Estimation of carbamazepine and carbamazepine-10, 11-epoxide concentrations in plasma using mathematical equations generated with two carbamazepine immunoassays. Am J Clin Pathol. 2010; 133:728-736.
18. Yasui-Furukori N, Kubo K, Ishioka M, Tsuchimine S, Inoue Y. Interaction between paliperidone and carbamazepine. Ther Drug Monit. 2013; 35:649-652.
19. Annaert P, Steemans K, Mannens G. In vitro study on transepithelial transport of the psychotropic compound paliperidone (PAL) across Caco-2 monolayers. European ISSX Meeting at the Pharmaceutical Sciences Fair and Exhibition, Nice, France. 2005.
20. Giessmann T, May K, Modess C, et al. Carbamazepine regulates intestinal P-glycoprotein and multidrug resistance protein MRP2 and influences disposition of talinolol in humans. Clin Pharmacol Ther. 2004; 76:192-200.
21. Bialer M, Doose DR, Murthy B, et al. Pharmacokinetic interactions of topiramate. Clin Pharmacokinet. 2004; 43:763-780.
22. Drescher S, Glaeser H, Murdter T, et al. P-glycoprotein-mediated intestinal and biliary digoxin transport in humans. Clin Pharmacol Ther. 2003; 73:223-231.
23. Greiner B, Eichelbaum M, Fritz P, et al. The role of intestinal P-glycoprotein in the interaction of digoxin and rifampin. J Clin Invest. 1999; 104:147-153.
24. Westphal K, Weinbrenner A, Zschiesche M, et al. Induction of P-glycoprotein by rifampin increases intestinal secretion of talinolol in human beings: a new type of drug/drug interaction. Clin Pharmacol Ther. 2000; 68:345-355.
25. Kirschbaum KM, Henken S, Hiemke C, Schmitt U. Pharmacodynamic consequences of P-glycoprotein-dependent pharmacokinetics of risperidone and haloperidol in mice. Behav Brain Res. 2008; 188:298-303.
26. Owen A, Goldring C, Morgan P, Park BK, Pirmohamed M. Induction of P-glycoprotein in lymphocytes by carbamazepine and rifampicin: the role of nuclear hormone response elements. Br J Clin Pharmacol. 2006; 62:237-242.