lisdexamfetamine dimesylate 10 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 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 : • 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 )
mylan pharmaceuticals inc.
CAPSULE PURPLE Mylan LE 10
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
LISDEXAMFETAMINE Dimesylate capsules are available containing 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg or 70 mg of
LISDEXAMFETAMINE dimesylate. The 10 mg capsules are hard-shell gelatin capsules with a purple opaque cap and purple opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 10 in black ink on cap and body. They are available as follows: NDC 0378-6854-77 bottles of 90 capsules The 20 mg capsules are hard-shell gelatin capsules with an ivory opaque cap and ivory opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 20 in black ink on cap and body. They are available as follows: NDC 0378-6855-77 bottles of 90 capsules The 30 mg capsules are hard-shell gelatin capsules with an orange opaque cap and white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 30 in black ink on cap and body. They are available as follows: NDC 0378-6856-77 bottles of 90 capsules The 40 mg capsules are hard-shell gelatin capsules with a green opaque cap and white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 40 in black ink on cap and body. They are available as follows: NDC 0378-6857-77 bottles of 90 capsules The 50 mg capsules are hard-shell gelatin capsules with a blue opaque cap and white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 50 in black ink on cap and body. They are available as follows: NDC 0378-6858-77 bottles of 90 capsules The 60 mg capsules are hard-shell gelatin capsules with a blue opaque cap and blue opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 60 in black ink on cap and body. They are available as follows: NDC 0378-6859-77 bottles of 90 capsules The 70 mg capsules are hard-shell gelatin capsules with an orange opaque cap and blue opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 70 in black ink on cap and body. They are available as follows: NDC 0378-6860-77 bottles of 90 capsules 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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