Label: FOCALIN- dexmethylphenidate hydrochloride tablet

  • NDC Code(s): 66758-250-01, 66758-251-01, 66758-252-01
  • Packager: Sandoz Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CII
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 15, 2023

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

    WARNING: ABUSE, MISUSE, AND ADDICTION

    Focalin has 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 Focalin, 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 Focalin, 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 Focalin 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
    Focalin is 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 patients with Focalin, assess: • for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ...
  • 3     DOSAGE FORMS AND STRENGTHS
    Focalin (dexmethylphenidate hydrochloride) tablets are D-shaped, embossed “D” on upper convex face and dosage strength on lower convex face in the following colors: • 2.5 mg tablets – blue - • 5 mg ...
  • 4     CONTRAINDICATIONS
    • Hypersensitivity to methylphenidate or other components of Focalin. Hypersensitivity reactions, such as angioedema and anaphylactic reactions have been reported in patients treated with ...
  • 5     WARNINGS AND PRECAUTIONS
    5.1     Abuse, Misuse, and Addiction - Focalin has a high potential for abuse and misuse. The use of Focalin exposes individuals to the risks of abuse and misuse, which can lead 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 Focalin - Table 2 presents clinically important drug interactions with Focalin. Table 2: Clinically Important Drug Interactions with ...
  • 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 Focalin, during ...
  • 9     DRUG ABUSE AND DEPENDENCE
    9.1     Controlled Substance - Focalin contains dexmethylphenidate hydrochloride, a Schedule II controlled substance. 9.2     Abuse - Focalin has a high potential for abuse and misuse which can ...
  • 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
    Focalin contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin is available as 2.5 ...
  • 12     CLINICAL PHARMACOLOGY
    12.1     Mechanism of Action - Dexmethylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD is not ...
  • 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 ...
  • 14     CLINICAL STUDIES
    The efficacy of Focalin for the treatment of ADHD was established in two double-blind, parallel-group, placebo-controlled trials in untreated or previously treated patients (ages 6 to 17 years ...
  • 16     HOW SUPPLIED/STORAGE AND HANDLING
    Focalin (dexmethylphenidate hydrochloride) tablets (D-shaped, embossed “D” on upper convex face and dosage strength on lower convex face) are available as follows: • 2.5 mg tablets (NDC ...
  • 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 - FOCALIN® (foh-kuh-lin) (dexmethylphenidate hydrochloride) tablets for oral use, CII - What is the most important information I should know about FOCALIN? FOCALIN ...
  • PRINCIPAL DISPLAY PANEL
    Sandoz             NDC 66758-250-01 - Focalin® dexmethylphenidate - hydrochloride - 2.5 mg - 100 Tablets - Rx only - Dispense with Medication Guide - attached or provided separately.
  • PRINCIPAL DISPLAY PANEL
    Sandoz             NDC 66758-251-01 - Focalin® dexmethylphenidate - hydrochloride - 5 mg - 100 Tablets - Rx only - Dispense with Medication Guide - attached or provided separately.
  • PRINCIPAL DISPLAY PANEL
    Sandoz             NDC 66758-252-01 - Focalin® dexmethylphenidate - hydrochloride - 10 mg - 100 Tablets - Rx only - Dispense with Medication Guide - attached or provided separately.
  • INGREDIENTS AND APPEARANCE
    Product Information