Lisdexamfetamine dimesylate capsules

1 INDICATIONS AND USAGE Lisdexamfetamine dimesylate capsules 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 capsules is 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 capsules 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 capsules for the treatment of obesity have not been established [see Warnings and Precautions ( 5.2 )]. Lisdexamfetamine dimesylate capsules are a central nervous system (CNS) stimulant indicated for the treatment of ( 1 ): • Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older • Moderate to severe binge eating disorder (BED) in adults Limitations of Use: • The use of lisdexamfetamine dimesylate capsules is 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 ( 5.5 , 8.4 ) • Lisdexamfetamine dimesylate capsules are not indicated 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 capsules for the treatment of obesity have not been established ( 5.2 )