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Fluoxetine resulted in a modest (30%) increase in alprazolam concentrations. CYP3A4 inducers would be expected to decrease plasma alprazolam concentrations. Following administration of carbamazepine 300 mg/day for 10 days, oral clearance of alprazolam was increased from 0.90 mL/min/kg to 2.13 mL/min/kg.

In the sponsor's proposed labeling, it is stated that alprazolam can produce additive CNS depressant effects when co-administered with other psychotropic medications, anticonvulsants, hydrocodone compound antihistaminics, ethanol and other drugs which themselves produce CNS depression. The steady state plasma concentrations of imipramine and desipramine have been reported to be increased an average of 31% and 20%, respectively, by the concomitant administration of XANAX tablets in doses up to 4 hydrocodone compound mg/day. The clinical significance of these changes is unknown. In addition, it is stated that drugs which inhibit the cytochrome P450 3A metabolic pathway may have a profound effect on the clearance of alprazolam. Based on clinical diug interaction studies, caution is recommended for co-administration of alprazolam with the following medications: diltiazem, isoniazid, macrolide antibiotics such as erythromycin and clarithromycin, and grapefruit juice. Data from in vitro studies of alprazolam suggest a possible drug interaction with alprazolam for the following: sertraline and parox etine. Co-administration of oral contraceptives hydrocodone compound increased the maximum plasma concentration of alprazolam by 18%, decreased clearance by 22%, and increased half-life by 29%.

Data from in vitro studies of benzodiazepines other than alprazolam suggest possible drug interactions with the following: ergotamine, cyclosporine, amiodarone, nicardipine, and nifedipine. Caution is recommended during the co-admiinistration of'any of these with alprazolam.

Pharmacodynamics hydrocodone compound in Humans The pharmacodynamics of the extended release formulation of alprazolam were examined in several studies of normal volunteers, using psychomotor and cognitive performance tests, sedation scores, and paradigms of abuse liability. Single doses of XR tablets 6 mg, compared to dosing with alprazolam IR 1.5 mg QID, resulted in significantly greater maximal sedation and decrements in performance in Study R/2002/0002. However, with single doses of alprazolam XR 3 mg and alprazolam IR 1.5 mg BID, the results were comparable. After single doses of XR tablets, acute tolerance developed to these psychomotor effects. Similarly, chronic tolerance to these effects developed.

Comparing multiple dose administration of the XR and IR formulations, the pharmacodynamic profiles are similar regarding psychomotor performance and sedation. On the PCAG sedation scale comparing various benzodiazepines, alprazolam IR and diazepam had the highest scores at one hour. Alprazolam IR and clonazepam scores both peaked at 2 hours, and the score for alprazolam XR peaked at 4 hours.

All active treatments were more sedating than placebo at 3, 4, and 5 hours. In quantitative EEG studies, both XR and IR administration, compared to placebo, resulted in significan t differences in the percentage of beta-wave activity. However, at steady state, no prescription phentermine overnight there were no significant differences in EEG effects between the two alprazolam formulations. Overall Data Data reviewed included those from 37 (13 Phase D/m & 24 Phase I) studies submitted in NDA 21,434.



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