methylphenidate hydrochloride extended release
Drug Details
- Generic Name
- methylphenidate hydrochloride extended release
- Brand Names
- METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE
- Application Number
- ANDA207488
- Sponsor
- KVK-Tech, Inc.
- NDC Codes
- 2
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- METHYLPHENIDATE HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of: • Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults • Narcolepsy Limitations of Use: The use of Methylphenidate hydrochloride 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)]. Methylphenidate hydrochloride extended-release tablet is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy (1). Limitations of Use: The use of Methylphenidate hydrochloride 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 and 8.4).