lisdexamfetamine dimesylate 30 mg
1 INDICATIONS AND USAGE Lisdexamfetamine dimesylate capsules and 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: 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 is 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 )] . Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets 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 is 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 for the treatment of obesity have not been established ( 5.2 )
Sun Pharmaceutical Industries, Inc.
TRIANGLE WHITE 30 S85
30 S85 TRIANGLE WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Information for
LISDEXAMFETAMINE DIMESYLATE capsules:
LISDEXAMFETAMINE DIMESYLATE capsules 10 mg: white to off-white powder filled in pink opaque cap and pink opaque body imprinted with 'RM46' on cap and '10 mg' on body in black ink, bottles of 100 CRC, NDC 57664-046-88
LISDEXAMFETAMINE DIMESYLATE capsules 20 mg: white to off-white powder filled in off white opaque cap and off white opaque imprinted with 'RM47' on cap and '20 mg' on body in black ink, bottles of 100 CRC, NDC 57664-047-88
LISDEXAMFETAMINE DIMESYLATE capsules 30 mg: white to off-white powder filled in orange opaque cap and white opaque body imprinted with 'RM48' on cap and '30 mg' on body in black ink, bottles of 100 CRC, NDC 57664-048-88
LISDEXAMFETAMINE DIMESYLATE capsules 40 mg: white to off-white powder filled dark green opaque cap and white opaque body imprinted with 'RM49' on cap and '40 mg' on body in black ink, bottles of 100 CRC, NDC 57664-049-88
LISDEXAMFETAMINE DIMESYLATE capsules 50 mg: white to off-white powder filled in blue opaque cap and white opaque body imprinted with 'RM50' on cap and '50 mg' on body in black ink, bottles of 100 CRC, NDC 57664-050-88
LISDEXAMFETAMINE DIMESYLATE capsules 60 mg: white to off-white powder filled in aqua blue opaque cap and aqua blue opaque body imprinted with 'RM51' on cap and '60 mg' on body in black ink, bottles of 100 CRC, NDC 57664-051-88
LISDEXAMFETAMINE DIMESYLATE capsules 70 mg: white to off-white powder filled in blue opaque cap and orange opaque body imprinted with 'RM52' on cap and '70 mg' on body in black ink, bottles of 100 CRC, NDC 57664-052-88 Information for
LISDEXAMFETAMINE DIMESYLATE Chewable Tablets:
LISDEXAMFETAMINE DIMESYLATE chewable tablets 10 mg: white to off-white round shaped tablet debossed with ‘10’ on one side and ‘S83’ on the other side, bottles of 100 CRC, NDC 57664-083-88
LISDEXAMFETAMINE DIMESYLATE chewable tablets 20 mg: white to off-white hexagonal shaped tablet debossed with ‘20’ on one side and ‘S84’ on the other side, bottles of 100 CRC, NDC 57664-084-88
LISDEXAMFETAMINE DIMESYLATE chewable tablets 30 mg: white to off-white arc triangular shaped tablet debossed with ‘30’ on one side and ‘S85’ on the other side, bottles of 100 CRC, NDC 57664-085-88
LISDEXAMFETAMINE DIMESYLATE chewable tablets 40 mg: white to off-white capsule shaped tablet debossed with ‘40’ on one side and ‘S86’ on the other side, bottles of 100 CRC, NDC 57664-086-88
LISDEXAMFETAMINE DIMESYLATE chewable tablets 50 mg: white to off-white arc square shaped tablet debossed with ‘50’ on one side and ‘S87’ on the other side, bottles of 100 CRC, NDC 57664-087-88
LISDEXAMFETAMINE DIMESYLATE chewable tablets 60 mg: white to off-white arc diamond shaped tablet debossed with ‘60’ on one side and ‘S88’ on the other side, bottles of 100 CRC, NDC 57664-088-88 16.2 Storage and Handling Dispense in a tight, light-resistant container as defined in the USP. Store at room temperature 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature] .
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