lisdexamfetamine dimesylate 20 mg
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: Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older [see 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 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: Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older. (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)
amneal pharmaceuticals llc
CAPSULE YELLOW AN 23
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
LISDEXAMFETAMINE dimesylate capsules, 20 mg are supplied as beige body/beige cap, imprinted with AN 23. They are available as follows: Bottles of 90: NDC 65162-023-09
LISDEXAMFETAMINE dimesylate capsules, 30 mg are supplied as white body/orange cap, imprinted with AN 24. They are available as follows: Bottles of 90: NDC 65162-024-09
LISDEXAMFETAMINE dimesylate capsules, 40 mg are supplied as white body/sea green cap, imprinted with AN 25. They are available as follows: Bottles of 90: NDC 65162-025-09
LISDEXAMFETAMINE dimesylate capsules, 50 mg are supplied as white body/dark blue cap, imprinted with AN 26. They are available as follows: Bottles of 90: NDC 65162-026-09
LISDEXAMFETAMINE dimesylate capsules, 60 mg are supplied as light blue body/light blue cap, imprinted with AN 27. They are available as follows: Bottles of 90: NDC 65162-027-09
LISDEXAMFETAMINE dimesylate capsules, 70 mg are supplied as blue body/orange cap, imprinted with AN 28. They are available as follows: Bottles of 90: NDC 65162-028-09 16.2 Storage and Handling Dispense in a tight, light-resistant container as defined in the USP. Store at room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° to 86 ° F) [see USP Controlled Room Temperature].
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