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Research Articles |
OBJECTIVE: To compare the bioavailability of three generic brands of carbamazepine tablets with that of a proprietary brand in adult patients with epilepsy. DESIGN: A double-blind, randomized, three-phase crossover study. SETTING: A psychiatric facility. PARTICIPANTS: Eighteen patients with epilepsy who had taken carbamazepine at least 5 months before entering the study. MAIN OUTCOME MEASURES: Ten blood specimens from each patient were collected at steady-state. Plasma concentration of carbamazepine was analyzed for pharmacokinetic parameters such as maximum plasma concentration (Cmax), mean time to reach maximum concentration (tmax), and mean AUC. RESULTS: There were no statistically significant differences in these parameters among four brands of carbamazepine. However, when comparing the 90% CI of AUC of three generic brands with that of the proprietary brand, the AUC of two generic brands lay within a range of 80% to 120%. The effects of gender and each brand of carbamazepine on these pharmacokinetic parameters were also analyzed. Breakthrough seizures occurred even though the plasma concentration of carbamazepine was therapeutic. CONCLUSIONS: The bioavailability of two generic brands of carbamazepine tablets (Carmapine and Carzepine) and the proprietary brand (Tegretol) were equivalent in this sample of adult patients with epilepsy.
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  E. S. Roach The Cost of Gullibility Arch Neurol, November 1, 2009; 66(11): 1418 - 1420. [Full Text] [PDF]
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 M. Van Ameringen, C. Mancini, B. Patterson, and M. Bennett Symptom relapse following switch from Celexa to generic citalopram: an anxiety disorders case series J Psychopharmacol, July 1, 2007; 21(5): 472 - 476. [Abstract] [PDF]
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