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These highlights do not include all the information needed to use LISDEXAMFETAMINE DIMESYLATE CHEWABLE TABLETS safely and effectively. See full prescribing information for LISDEXAMFETAMINE DIMESYLATE CHEWABLE TABLETS. LISDEXAMFETAMINE DIMESYLATE chewable tablets, for oral use, CIIInitial U.S. Approval: 2007
Medication labelWhy this: Advisory · dailymed-prescription
Lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)]. Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)]. Limitations of Use: The use of lisdexamfetamine dimesylate chewable tablets are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)]. Lisdexamfetamine dimesylate are not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate for the treatment of obesity have not been established [see Warnings and Precautions (5.2)]
- generic_name
- lisdexamfetamine dimesylate
- product_names
- lisdexamfetamine dimesylate
- ndc
- 31722-321, 31722-322, 31722-323, 31722-324, 31722-325, 31722-326, 31722-321-01, 31722-322-01, 31722-323-01, 31722-324-01, 31722-325-01, 31722-326-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en