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 INFORMATIONThese highlights do not include all the information needed to use FOCALIN safely and effectively. See full prescribing information for FOCALIN. FOCALIN® (dexmethylphenidate hydrochloride) tablets ...
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Table of ContentsTable of Contents
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BOXED WARNING
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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 USAGEFocalin is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].
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2 DOSAGE AND ADMINISTRATION2.1 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 ...
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3 DOSAGE FORMS AND STRENGTHSFocalin (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 ...
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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 ...
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5 WARNINGS AND PRECAUTIONS5.1 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 ...
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6 ADVERSE REACTIONSThe 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 ...
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7 DRUG INTERACTIONS7.1 Clinically Important Drug Interactions with Focalin - Table 2 presents clinically important drug interactions with Focalin. Table 2: Clinically Important Drug Interactions with ...
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8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including Focalin, during ...
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9 DRUG ABUSE AND DEPENDENCE9.1 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 ...
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10 OVERDOSAGEClinical Effects of Overdose - Overdose of CNS stimulants is characterized by the following sympathomimetic effects: • Cardiovascular effects including tachyarrhythmias, and hypertension or ...
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11 DESCRIPTIONFocalin contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin is available as 2.5 ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Dexmethylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD is not ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility - Carcinogenesis - Lifetime carcinogenicity studies have not been carried out with dexmethylphenidate. In a lifetime ...
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14 CLINICAL STUDIESThe 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 ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGFocalin (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 ...
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17 PATIENT COUNSELING INFORMATIONAdvise 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 ...
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MEDICATION GUIDEMEDICATION GUIDE - FOCALIN® (foh-kuh-lin) (dexmethylphenidate hydrochloride) tablets for oral use, CII - What is the most important information I should know about FOCALIN? FOCALIN ...
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PRINCIPAL DISPLAY PANELSandoz NDC 66758-250-01 - Focalin® dexmethylphenidate - hydrochloride - 2.5 mg - 100 Tablets - Rx only - Dispense with Medication Guide - attached or provided separately.
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PRINCIPAL DISPLAY PANELSandoz NDC 66758-251-01 - Focalin® dexmethylphenidate - hydrochloride - 5 mg - 100 Tablets - Rx only - Dispense with Medication Guide - attached or provided separately.
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PRINCIPAL DISPLAY PANELSandoz NDC 66758-252-01 - Focalin® dexmethylphenidate - hydrochloride - 10 mg - 100 Tablets - Rx only - Dispense with Medication Guide - attached or provided separately.
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INGREDIENTS AND APPEARANCEProduct Information