| Autor: |
Sramek, J.J., Anand, R., Hartman, R.D., Schran, H.F., Hourani, J., Barto, S., Wardle, T.S., Shiovitz, T.M., Cutler, N.R. |
| Předmět: |
|
| Zdroj: |
Clinical Drug Investigation; 1999, Vol. 17 Issue 1, p51-58, 8p |
| Abstrakt: |
Objective: This inpatient, randomised, three-way crossover study evaluated the steady-state pharmacokinetics and tolerability of generic clozapine (Creighton) versus Clozaril (Novartis brand of clozapine) in patients with schizophrenia. Setting: Patients were hospitalised throughout the study. Patients: Thirty patients meeting DSM-III-R criteria for a diagnosis of schizophrenia participated in this study. Design: Clozaril was titrated over 5 days from 12.5 to 75mg twice daily, after which patients received all of the following 1-week regimens in random order: Clozaril - one 100mg tablet twice daily; clozapine - four 25mg tablets twice daily; and clozapine - one 100mg tablet twice daily. Main Outcome Measures and Results: Both the 25 and 100mg dose forms of clozapine were bioequivalent to Clozaril 100mg, justifying their interchangeability; mean area under the concentration-time curve (AUC) values were 2683 ± 1613, 2781 ± 1775, and 2547 ± 1429 µg/L·h, respectively. The most common adverse events were dizziness and asthenia. Tolerability findings between groups were comparable, although a high incidence (20%) of symptomatic orthostatic hypotension during the initial titration of Clozaril emphasised the need for careful monitoring, even in the target patient population. Conclusions: The results of this study demonstrated that the 25 and 100mg dose forms of generic clozapine and Clozaril 100mg are bioequivalent, which should ensure comparable efficacy and tolerability with the clinical use of either product. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
|
