Pantoprazole does not interact with the pharmacokinetics of carbamazepine

Int J Clin Pharmacol Ther. 1998 Oct;36(10):521-4.


Objective: Pantoprazole is a H+/K+-ATPase inhibitor with a minimized potential of interaction with the cytochrome P450 system. Imidazole derivatives such as cimetidine and omeprazole have been shown to markedly interact with carbamazepine, a major anticonvulsant with a narrow therapeutic range. Therefore, the influence of steady-state pantoprazole on the pharmacokinetics of carbamazepine was investigated.

Subjects and methods: N = 20 healthy volunteers (12 male/8 female) completed a double-blind, placebo-controlled, randomized crossover study. During the test period they received 40 mg pantoprazole p.o. once daily for 11 days and concomitantly a single oral dose of 400 mg carbamazepine on day 5. In the reference period placebo was administered instead of pantoprazole.

Results: Serum concentrations of carbamazepine and its active metabolite carbamazepine-10,11-epoxide were measured until day 11. Geometric means of AUC (extent characteristic) and Cmax/AUC (rate characteristic) of carbamazepine were 292 and 287 mgxh/l, and 0.0150 and 0.0144 l/h (reference and test), respectively. Point estimates and 90% confidence intervals of the ratios were 0.98 (0.95, 1.01) for AUC, and 0.96 (0.92, 1.00) for Cmax/AUC, respectively. Since the 90% confidence intervals of the primary characteristics, AUC and Cmax/AUC were entirely within the predefined equivalence range of 0.80 - 1.25, lack of interaction of pantoprazole with the pharmacokinetics of carbamazepine was demonstrated. Equivalence was also demonstrated for carbamazepine-10,11-epoxide using the characteristics AUC and Cmax.

Conclusion: No dose adjustment of carbamazepine is therefore required during concomitant treatment with pantoprazole.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Adult
  • Anticonvulsants / adverse effects
  • Anticonvulsants / pharmacokinetics*
  • Area Under Curve
  • Benzimidazoles / adverse effects
  • Benzimidazoles / pharmacology*
  • Biotransformation
  • Carbamazepine / adverse effects
  • Carbamazepine / pharmacokinetics*
  • Cross-Over Studies
  • Double-Blind Method
  • Drug Interactions
  • Enzyme Inhibitors / adverse effects
  • Enzyme Inhibitors / pharmacology*
  • Female
  • Humans
  • Male
  • Omeprazole / analogs & derivatives
  • Pantoprazole
  • Proton Pump Inhibitors*
  • Sulfoxides / adverse effects
  • Sulfoxides / pharmacology*


  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Anticonvulsants
  • Benzimidazoles
  • Enzyme Inhibitors
  • Proton Pump Inhibitors
  • Sulfoxides
  • Carbamazepine
  • Pantoprazole
  • Omeprazole