|
Additional Info DRUG ABUSE AND DEPENDENCE Controlled Substance Class Olanzapine is not a controlled substance.
Physical and Psychological Dependence In studies prospectively designed to assess abuse and dependence potential, olanzapine was shown to have acute depressive CNS effects but little or no potential of abuse or physical dependence in rats administered oral doses up to 15 times the maximum recommended human daily dose (20 mg) and rhesus monkeys administered oral doses up to 8 times the maximum recommended human daily dose on a mg/ m 2 basis. Text Continues Below

Olanzapine has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic, and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/ or abused once marketed. Consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of olanzapine (e. g., development of tolerance, increases in dose, drug-seeking behavior).
|