Label: METHYLPHENIDATE HYDROCHLORIDE tablet, extended release

  • NDC Code(s): 57664-710-83, 57664-710-88
  • Packager: Sun Pharmaceutical Industries, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CII
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 15, 2024

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

    WARNING: ABUSE, MISUSE, AND ADDICTION

    Methylphenidate hydrochloride extended-release tablets have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride extended-release tablets, can result in overdose and death[seeOverdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

    Before prescribing methylphenidate hydrochloride extended-release tablets, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout methylphenidate hydrochloride extended-release tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction[seeWarnings and Precautions (5.1)andDrug Abuse and Dependence (9.2)].

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  • 1 INDICATIONS AND USAGE
    Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Pretreatment Screening - Prior to treating patients with methylphenidate hydrochloride extended-release tablets, assess: for the presence of cardiac disease (i.e., perform a careful ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Methylphenidate hydrochloride extended-release tablets, USP 72 mg are round, biconvex, light blue to blue colored, film-coated tablets, imprinted with “72”, with the presence of an orifice.
  • 4 CONTRAINDICATIONS
    4.1 Hypersensitivity to Methylphenidate - Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been observed in patients treated with methylphenidate hydrochloride ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Abuse, Misuse, and Addiction - Methylphenidate hydrochloride extended-release tablets have a high potential for abuse and misuse. The use of methylphenidate hydrochloride extended-release ...
  • 6 ADVERSE REACTIONS
    The following are discussed in more detail in other sections of the labeling: Abuse, Misuse, and Addiction - [see - Boxed Warning,Warnings and Precautions (5.1)] Hypersensitivity to ...
  • 7 DRUG INTERACTIONS
    7.1 MAO Inhibitors - Methylphenidate hydrochloride extended-release tablets should not be used in patients being treated (currently or within the preceding 2 weeks) with MAO inhibitors - [see ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Category C - Methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day, which is approximately 100 times and 40 times ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Methylphenidate hydrochloride extended-release tablets contain methylphenidate, a Schedule II controlled substance. 9.2 Abuse - Methylphenidate hydrochloride ...
  • 10 OVERDOSAGE
    10.1 Clinical Effects of Overdose - Overdose of CNS stimulants is characterized by the following sympathomimetic effects: Cardiovascular effects including tachyarrhythmias, and hypertension or ...
  • 11 DESCRIPTION
    Methylphenidate hydrochloride extended-release tablets, USP are a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets are available in one tablet ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Methylphenidate HCl is a central nervous system (CNS) stimulant. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility - Carcinogenesis - In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in ...
  • 14 CLINICAL STUDIES
    Methylphenidate hydrochloride extended-release tablets were demonstrated to be effective in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in 4 randomized, double-blind ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Methylphenidate hydrochloride extended-release tablets, USP are available in the 72 mg strength, as round, biconvex, light blue to blue colored, film-coated tablets, imprinted with “72”, with the ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Abuse, Misuse, and Addiction - Educate patients and their families about the risks of abuse, misuse, and addiction ...
  • Medication Guide
    MEDICATION GUIDE - Methylphenidate Hydrochloride Extended-Release Tablets, USP, for oral use, CII - (meth" ǝl-fen 'i-dāt) What is the most important information I should know about ...
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
    mpd-er-72mg
  • INGREDIENTS AND APPEARANCE
    Product Information