Label: BUPROPION HYDROCHLORIDE tablet, film coated, extended release

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

Drug Label Information

Updated April 29, 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 over age 24; there was a reduction in risk 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. Bupropion hydrochloride extended-release tablets (XL) is not approved for use in pediatric patients [see Warnings and Precautions (5.1)].

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  • 1 INDICATIONS AND USAGE
    Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 General Instructions for Use - One tablet (450 mg) of bupropion hydrochloride extended-release tablets (XL) should be taken once daily without regard to meals. Bupropion hydrochloride ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Bupropion hydrochloride extended-release tablets (XL), 450 mg of bupropion hydrochloride, USP, are white to off-white, oblong-shaped tablets with “BUP450” printed on one side.
  • 4 CONTRAINDICATIONS
    • Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with a seizure disorder [see Warnings and Precautions (5.3)]. • Bupropion hydrochloride extended-release ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults - Patients with MDD, both adult and pediatric, may experience worsening of their depression and/or the emergence of ...
  • 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 exists ...
  • 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 antidepressants during pregnancy. Healthcare providers ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Bupropion is not a controlled substance. 9.2 Abuse - Humans - Controlled clinical studies of bupropion hydrochloride (immediate-release formulation) conducted 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 (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or ...
  • 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
    The efficacy of bupropion in the treatment of MDD was established with the immediate-release formulation of bupropion hydrochloride in two 4-week, placebo-controlled trials in adult inpatients ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Bupropion hydrochloride extended-release tablets (XL), 450 mg of bupropion hydrochloride, USP, are white to off-white, oblong-shaped tablets printed with the “BUP450” on one side supplied in ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise 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 ...
  • SPL UNCLASSIFIED SECTION
    Brands listed are trademarks of their respective owners. Manufactured by: Pillar5 Pharma Inc. Arnprior, Ontario - K7S 0C9 Canada - Distributed by: Alvogen, Inc. Morristown, NJ 07960 USA - Product of ...
  • MEDICATION GUIDE
    Bupropion Hydrochloride Extended-Release Tablets (XL) (bue proe' pee on hye" droe klor' ide) IMPORTANT: Be sure to read the three sections of this Medication Guide. The first section is ...
  • PRINCIPAL DISPLAY PANEL
    NDC 47781-637-30 - Once Daily - buPROPion Hydrochloride - Extended-release Tablets (XL) 450 mg - Pharmacist: Dispense the accompanying Medication Guide to each patient - WARNING: Do not use with ...
  • INGREDIENTS AND APPEARANCE
    Product Information