methylphenidate extended-release
methylphenidate extended-release is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including Methylphenidate Extended-Release. Available dosage form: tablet, orally disintegrating.
Drug Details
- Generic Name
- methylphenidate extended-release
- Brand Names
- Methylphenidate Extended-Release
- Application Number
- NDA205489
- Sponsor
- Neos Therapeutics, LP
- NDC Codes
- 3
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING
- Routes
- ORAL
- Active Ingredients
- METHYLPHENIDATE
Indications and Usage
1 INDICATIONS AND USAGE Methylphenidate extended-release orally disintegrating tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age [see Clinical Studies (14) ] . Limitations of Use The use of methylphenidate extended-release orally disintegrating tablets 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) ]. Methylphenidate extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. ( 1 ) Limitations of Use The use of methylphenidate extended-release orally disintegrating tablets 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. ( 5.7 , 8.4 )