Label: DEXMETHYLPHENIDATE HYDROCHLORIDE capsule, extended release

  • NDC Code(s): 43602-327-05, 43602-327-30, 43602-328-05, 43602-328-30, view more
  • Packager: Ascent Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CII
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 10, 2021

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: ABUSE AND DEPENDENCE

    CNS stimulants, including dexmethylphenidate hydrochloride extended-release capsules, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2, 9.3)].

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  • 1 INDICATIONS AND USAGE
    Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Pretreatment Screening - Prior to treating pediatric patients and adults with central nervous system (CNS) stimulants, including dexmethylphenidate hydrochloride extended-release capsules ...
  • 3 DOSAGE FORMS AND STRENGTHS
    5 mg extended-release capsules – Hard gelatin capsule size “2” light brown cap and white opaque body, imprinted with “M5” on cap and “AC” on body in black ink filled with white to off white ...
  • 4 CONTRAINDICATIONS
    Hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride extended-release capsules. Hypersensitivity reactions such as angioedema and anaphylactic reactions ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Potential for Abuse and Dependence - CNS stimulants, including dexmethylphenidate hydrochloride extended-release capsules, other methylphenidate-containing products, and amphetamines, have a ...
  • 6 ADVERSE REACTIONS
    The following are discussed in more detail in other sections of the labeling: Abuse and Dependence [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2, 9.3) ...
  • 7 DRUG INTERACTIONS
    7.1 Clinically Important Drug Interactions With Dexmethylphenidate Hydrochloride Extended-Release Capsules - Table 5 presents clinically important drug interactions with dexmethylphenidate ...
  • 8. USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including dexmethylphenidate ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Dexmethylphenidate hydrochloride extended-release capsules contains dexmethylphenidate hydrochloride, a Schedule II controlled substance. 9.2 Abuse - CNS stimulants ...
  • 10 OVERDOSAGE
    Human Experience - Signs and symptoms of acute methylphenidate overdosage, resulting principally from overstimulation of the CNS and from excessive sympathomimetic effects, may include the ...
  • 11 DESCRIPTION
    Dexmethylphenidate hydrochloride extended-release capsules contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d­-threo enantiomer of racemic ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Dexmethylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD is not known. 12.2 Pharmacodynamics - Dexmethylphenidate is the more ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility - Carcinogenesis - Lifetime carcinogenicity studies have not been carried out with dexmethylphenidate. In a lifetime carcinogenicity ...
  • 14 CLINICAL STUDIES
    14.1 Pediatric Patients - A randomized, double-blind, placebo-controlled, parallel-group study (Study 1) was conducted in 103 pediatric patients (ages 6 to 12, n = 86; ages 13 to 17, n = 17) who ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Dexmethylphenidate hydrochloride extended-release capsules are available containing 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg or 40 mg of dexmethylphenidate hydrochloride. 5 mg ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise patients to read the FDA-approved patient labeling (Medication Guide). Controlled Substance Status/High Potential for Abuse and Dependence - Advise patients that dexmethylphenidate ...
  • MEDICATION GUIDE
    MEDICATION GUIDE - Dexmethylphenidate Hydrochloride - (dex meth″ il fen′ i date hye″ droe klor′ ide) Extended-Release Capsules CII - What is the most important information I should ...
  • PRINCIPAL DISPLAY PANEL
    5 mg ...
  • INGREDIENTS AND APPEARANCE
    Product Information