Label: BUPROPION HYDROCHLORIDE (XL)- bupropion hydrochloride tablet, extended release

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 13, 2024

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

    WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

    SUICIDALITY AND ANTIDEPRESSANT DRUGS

    Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects aged 65 and older [see Warnings and Precautions (5.1)].

    In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1)].

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  • 1 INDICATIONS AND USAGE
    1.1 Major Depressive Disorder (MDD) Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and ...
  • SPL UNCLASSIFIED SECTION
  • 2 DOSAGE AND ADMINISTRATION
    2.1 General Instructions for Use - To minimize the risk of seizure, increase the dose gradually [see Warnings and Precautions (5.3)]. Bupropion hydrochloride extended-release tablets (XL) should ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Bupropion hydrochloride extended-release tablets USP (XL), 150 mg of bupropion hydrochloride, are round, white film coated tablet printed with "T101" on one side and plain on the other ...
  • 4 CONTRAINDICATIONS
    Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with seizure disorder. Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults - Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are discussed in greater detail in other sections of the labeling: • Suicidal thoughts and behaviors in children, adolescents, and young adults [see Warnings and ...
  • 7 DRUG INTERACTIONS
    7.1 Potential for Other Drugs to Affect Bupropion Hydrochloride Extended-Release Tablets (XL)   Bupropion is primarily metabolized to hydroxybupropion by CYP2B6. Therefore, the potential ...
  • USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Bupropion is not a controlled substance. 9.2 Abuse - Humans - Controlled clinical studies of bupropion HCl immediate-release conducted in normal volunteers, in ...
  • 10 OVERDOSAGE
    10.1 Human Overdose Experience - Overdoses of up to 30 grams or more of bupropion have been reported. Seizure was reported in approximately one third of all cases. Other serious reactions ...
  • 11 DESCRIPTION
    Bupropion hydrochloride extended-release tablets USP (XL), an antidepressant of the aminoketone class, are chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The mechanism of action of bupropion is unknown, as is the case with other antidepressants. However, it is presumed that this action is mediated by noradrenergic and/or ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Lifetime carcinogenicity studies were performed in rats and mice at doses up to 300 and 150 mg/kg/day bupropion hydrochloride ...
  • 14 CLINICAL STUDIES
    14.1 Major Depressive Disorder - The efficacy of bupropion in the treatment of major depressive disorder was established with the immediate-release formulation of bupropion hydrochloride in two ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Product: 50090-7110 - NDC: 50090-7110-0 90 TABLET, EXTENDED RELEASE in a BOTTLE - NDC: 50090-7110-1 30 TABLET, EXTENDED RELEASE in a BOTTLE - NDC: 50090-7110-2 60 TABLET, EXTENDED ...
  • 17 PATIENT COUNSELING INFORMATION
    2Advise the patient to read the FDA-approved patient labeling (Medication Guide). Inform patients, their families, and their caregivers about the benefits and risks associated with treatment with ...
  • MEDICATION GUIDE
    MEDICATION GUIDE -                                        buPROPion (bue-PROE-pee-on) Hydrochloride Extended-Release Tablets USP ...
  • bupropion hydrochloride
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  • INGREDIENTS AND APPEARANCE
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