Label: METHYLPHENIDATE HYDROCHLORIDE tablet
- NDC Code(s): 72162-2428-1
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 75834-324
- 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 INFORMATIONThese highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE ...
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Table of ContentsTable of Contents
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BOXED WARNING
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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.
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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)]. -
1 INDICATIONS AND USAGEMethylphenidate hydrochloride tablets are indicated for the treatment of: • Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults - • Narcolepsy
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2 DOSAGE AND ADMINISTRATION2.1 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 ...
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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 ...
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4 CONTRAINDICATIONS• Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride tablets. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in ...
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5 WARNINGS AND PRECAUTIONS5.1 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 ...
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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 Methylphenidate Hydrochloride Tablets - Table 1 presents clinically important drug interactions with methylphenidate hydrochloride ...
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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 methylphenidate ...
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9 DRUG ABUSE AND DEPENDENCE9.1 Controlled Substance - Methylphenidate hydrochloride tablets contain methylphenidate hydrochloride, a Schedule II controlled substance. 9.2 Abuse - Methylphenidate hydrochloride tablets ...
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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 DESCRIPTIONMethylphenidate 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 ...
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12 CLINICAL PHARMACOLOGY12.1 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 ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility - Carcinogenesis - In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGTablets 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 ...
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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 ...
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MEDICATION GUIDEMEDICATION GUIDE - Methylphenidate Hydrochloride Tablets, USP CII - (meth" il fen' iI date hye" droe klor' ide) What is the most important information I should know ...
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PRINCIPAL DISPLAY PANELMethylphenidate HCl 5 mg Tab #100
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INGREDIENTS AND APPEARANCEProduct Information