dexmethylphenidate hydrochloride
Drug Details
- Generic Name
- dexmethylphenidate hydrochloride
- Brand Names
- Dexmethylphenidate Hydrochloride Extended-Release, DEXMETHYLPHENIDATE HYDROCHLORIDE, Focalin, Dexmethylphenidate Hydrochloride, Focalin XR
- Application Number
- ANDA210279
- Sponsor
- Lannett Company, Inc.
- NDC Codes
- 50
- Dosage Forms
- CAPSULE, EXTENDED RELEASE, TABLET, POWDER
- Routes
- ORAL
- Active Ingredients
- DEXMETHYLPHENIDATE 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 ).