J Clin Pharmacol
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Population pharmacokinetics of lamotrigine adjunctive therapy in adults with epilepsy

TH Grasela, J Fiedler-Kelly, E Cox, GP Womble, ME Risner, and C Chen

Plasma concentrations of lamotrigine, an antiepileptic drug obtained in three adult controlled clinical trials conducted in the United States were pooled and analyzed using NONMEM, a population pharmacokinetic computer program, to facilitate development of dosing guidelines. A total of 2,407 lamotrigine plasma concentrations from 527 patients with epilepsy were analyzed. Regression equations for oral clearance were developed as a function of body size, age (18-64 years), gender, race, and use of concomitant antiepileptic drugs. The population mean apparent oral clearance of lamotrigine in adult patients receiving one concomitant enzyme-inducing antiepileptic drug and not valproic acid was estimated to be 1 mL/min/kg. Gender and age did not affect clearance significantly. On average, clearance was reduced by 25% in non-whites and increased by 13% in patients receiving more than one concomitant enzyme-inducing antiepileptic agent. Lamotrigine did not influence the disposition of phenytoin or carbamazepine. Dosing adjustments for lamotrigine in patients receiving concomitant enzyme-inducing antiepileptic drugs and not valproic acid should not be necessary for age, gender, or the number of concomitant enzyme-inducing antiepileptic drugs. Lamotrigine does not influence the dosing requirements for phenytoin or carbamazepine.
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B. Punyawudho, R. E. Ramsay, F. M. Macias, A. J. Rowan, J. F. Collins, R. C. Brundage, and A. K. Birnbaum
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[Abstract] [Full Text] [PDF]

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H. Zhou
Population-based assessments of clinical drug-drug interactions: qualitative indices or quantitative measures?
J. Clin. Pharmacol., November 1, 2006; 46(11): 1268 - 1289.
[Abstract] [Full Text] [PDF]


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