Label: METHYLPHENIDATE HYDROCHLORIDE tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CII
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 18, 2024

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

    WARNING: ABUSE, MISUSE, AND ADDICTION


    Methylphenidate hydrochloride 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 tablets, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

    Before prescribing methylphenidate hydrochloride 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 tablets treatment, reassess each patient's risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1) and Drug Abuse and Dependence (9.2)].

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  • 1 INDICATIONS AND USAGE
    Methylphenidate hydrochloride tablets are indicated for the treatment of: • Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults - • Narcolepsy
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Pretreatment Screening - Prior to treating patients with methylphenidate hydrochloride tablets, assess: • for the presence of cardiac disease (i.e., perform a careful history, family history ...
  • 3 DOSAGE FORMS AND STRENGTHS
    • Tablets 5 mg- yellow, round, uncoated tablets debossed with a logo and identification number "NP018" on one side and "5" on the other side. • Tablets 10 mg- white, round, uncoated, partially ...
  • 4 CONTRAINDICATIONS
    • Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride tablets. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Abuse, Misuse, and Addiction - Methylphenidate hydrochloride tablets have a high potential for abuse and misuse. The use of methylphenidate hydrochloride tablets exposes individuals to the ...
  • 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), Drug Abuse and Dependence (9.2 ...
  • 7 DRUG INTERACTIONS
    7.1 Clinically Important Drug Interactions with Methylphenidate Hydrochloride Tablets - Table 1 presents clinically important drug interactions with methylphenidate hydrochloride ...
  • 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 methylphenidate ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Methylphenidate hydrochloride tablets contain methylphenidate hydrochloride, a Schedule II controlled substance. 9.2 Abuse - Methylphenidate hydrochloride tablets ...
  • 10 OVERDOSAGE
    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 tablets contain methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strengths for oral administration ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Methylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD and narcolepsy is not known. 12.2 Pharmacodynamics - Methylphenidate is a ...
  • 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 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Tablets 5 mg- yellow, round, uncoated tablets debossed with a logo and identification number "NP018" on one side and "5" on the other side. NDC: 72162-2428-1: 100 Tablets in a BOTTLE - Store at 20°C ...
  • 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 ...
  • MEDICATION GUIDE
    MEDICATION GUIDE - Methylphenidate Hydrochloride Tablets, USP CII - (meth" il fen' iI date hye" droe klor' ide)  What is the most important information I should know ...
  • PRINCIPAL DISPLAY PANEL
    Methylphenidate HCl 5 mg Tab #100
  • INGREDIENTS AND APPEARANCE
    Product Information