Label Changes for:
Adderall XR (dextroamphetamine mixed salts of a single-entity amphetamine product) Capsules
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2010
- Proton Pump Inhibitors (PPIs) PPIs act on proton pumps by blocking acid production, thereby reducing gastric acidity. When ADDERALL XR (20 mg single-dose) was administered concomitantly with the proton pump inhibitor, omeprazole (40 mg once daily for 14 days), the median Tmax of d-amphetamine was decreased by 1.25 hours (from 4 to 2.75 hours), and the median Tmax of l-amphetamine was decreased by 2.5 hours (from 5.5 to 3 hours), compared to ADDERALL XR administered alone. The AUC and Cmax of each moiety were unaffected. Therefore, co-administration of ADDERALL XR and proton pump inhibitors should be monitored for changes in clinical effect.