Label: METHYLPHENIDATE capsule, extended release

  • NDC Code(s): 0781-2383-01, 0781-2384-01, 0781-2385-01, 0781-2386-01
  • Packager: Sandoz Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CII
  • Marketing Status: New Drug Application Authorized Generic

Drug Label Information

Updated March 29, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES 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 capsules 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 capsules, 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 extended-release capsules, 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 treatment with methylphenidate hydrochloride extended-release capsules, 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), Drug Abuse and Dependence (9.2)].

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  • 1     INDICATIONS AND USAGE
    Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical ...
  • 2     DOSAGE AND ADMINISTRATION
    2.1     Pretreatment Screening - Prior to treating patients with methylphenidate hydrochloride extended-release capsules, assess: • for the presence of cardiac disease (i.e., perform a ...
  • 3     DOSAGE FORMS AND STRENGTHS
    • 10 mg extended-release capsules white/light brown, (imprinted "SDZ R10") • 20 mg extended-release capsules white, (imprinted "SDZ R20") • 30 mg extended-release capsules yellow, (imprinted "SDZ ...
  • 4     CONTRAINDICATIONS
    • Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release capsules. Hypersensitivity reactions, such as angioedema and anaphylactic reactions ...
  • 5     WARNINGS AND PRECAUTIONS
    5.1    Abuse, Misuse, and Addiction - Methylphenidate hydrochloride extended-release capsules have a high potential for abuse and misuse. The use of methylphenidate hydrochloride ...
  • 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 Extended-Release Capsules - Table 3 presents clinically important drug interactions with methylphenidate ...
  • 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 extended-release capsules are Schedule II controlled substance. 9.2     Abuse - Methylphenidate hydrochloride extended-release ...
  • 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 extended-release capsules are CNS stimulant. Methylphenidate hydrochloride extended-release capsules is an extended-release formulation of methylphenidate for oral ...
  • 12     CLINICAL PHARMACOLOGY
    12.1     Mechanism of Action - Methylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD is not known. 12.2     Pharmacodynamics - Methylphenidate is a racemic ...
  • 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
    14.1     Children and Adolescents - Methylphenidate hydrochloride extended-release capsules were evaluated in a randomized, double-blind, placebo-controlled, parallel group clinical study in ...
  • 16     HOW SUPPLIED/STORAGE AND HANDLING
    • 10 mg extended-release capsules (NDC 0781-2383-01) white/light brown, (imprinted “SDZ R10”) supplied in bottles of 100 - • 20 mg extended-release capsules (NDC 0781-2384-01) white, (imprinted ...
  • 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 (meth-ill-FEN-ih-date) Hydrochloride - Extended-Release Capsules for Oral Use, CII - What is the most important information I should know about ...
  • PRINCIPAL DISPLAY PANEL
    NDC 0781-2383-01       Rx only - Methylphenidate - HCl Extended- Release Capsules - 10 mg - Dispense with Medication Guide - attached or provided separately. 100 capsules - SANDOZ
  • PRINCIPAL DISPLAY PANEL
    NDC 0781-2384-01       Rx only - Methylphenidate - HCl Extended- Release Capsules - 20 mg - Dispense with Medication Guide - attached or provided separately. 100 capsules - SANDOZ
  • PRINCIPAL DISPLAY PANEL
    NDC 0781-2385-01 Rx only - Methylphenidate - HCl Extended-   Release Capsules       30 mg - Dispense with Medication Guide - attached or provided separately. 100 capsules - SANDOZ
  • PRINCIPAL DISPLAY PANEL
    NDC 0781-2386-01 Rx only - Methylphenidate - HCl Extended-   Release Capsules       40 mg - 100 capsules - Dispense with Medication Guide - attached or provided separately. SANDOZ
  • INGREDIENTS AND APPEARANCE
    Product Information