methylphenidate hydrochloride
Drug Details
- Generic Name
- methylphenidate hydrochloride
- Brand Names
- RELEXXII, METADATE CD, methylphenidate hydrochloride, QuilliChew ER, APTENSIO XR, Methylphenidate Hydrochloride Extended-Release, Ritalin LA, Quillivant XR, Ritalin, methylphenidate hydrochloride CD
- Application Number
- NDA216117
- Sponsor
- Societal CDMO Gainesville, LLC
- NDC Codes
- 50
- Dosage Forms
- CAPSULE, EXTENDED RELEASE, TABLET, EXTENDED RELEASE, TABLET, CHEWABLE, EXTENDED RELEASE, SUSPENSION, EXTENDED RELEASE, TABLET
- Routes
- ORAL
- Active Ingredients
- METHYLPHENIDATE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14 )]. Limitations of Use The use of dexmethylphenidate hydrochloride extended-release 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 (5.7) , Use in Specific Populations (8.4) ] . Dexmethylphenidate hydrochloride extended-release capsules are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1 ). Limitations of Use The use of dexmethylphenidate hydrochloride extended-release 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 ( 5.7 , 8.4 ).