Label: BUPROPION HYDROCHLORIDE tablet, film coated

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

Drug Label Information

Updated June 11, 2024

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use - BUPROPIONHYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for - BUPROPIONHYDROCHLORIDE TABLETS ...
  • 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[see Warnings and Precautions ( 5.1)].

    Close
  • 1 INDICATIONS AND USAGE
    Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion ...
  • 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)] . Increases in dose should not exceed 100 mg/day ...
  • 3 DOSAGE FORMS AND STRENGTHS
    75 mg – orange, round, unscored, film coated tablets, imprinted "APO" on one side and "BU" over "75" on the other side.
  • 4 CONTRAINDICATIONS
    Bupropion hydrochloride tablets are contraindicated in patients with a seizure disorder. Bupropion hydrochloride tablets are contraindicated in patients with a current or prior diagnosis of ...
  • 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 adolescents and young adults - [see Boxed ...
  • 7 DRUG INTERACTIONS
    7.1 Potential for Other Drugs to Affect Bupropion Hydrochloride Tablets - Bupropion is primarily metabolized to hydroxybupropion by CYP2B6. Therefore, the potential exists for drug interactions ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Exposure Registry - There is an independent pregnancy exposure registry that monitors pregnancy outcomes in women exposed to any antidepressants during pregnancy ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Bupropion is not a controlled substance. 9.2 Abuse - Humans - Controlled clinical trials conducted in normal volunteers, in subjects with a history of multiple ...
  • 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, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The exact mechanism of the antidepressant action of bupropion is not known but is presumed to be related to noradrenergic and/or dopaminergic mechanisms. Bupropion is a ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Lifetime carcinogenicity studies were performed in rats and mice at bupropion doses up to 300 and 150 mg/kg/day, respectively. These ...
  • 14 CLINICAL STUDIES
    The efficacy of bupropion hydrochloride tablets in the treatment of major depressive disorder was established in two 4-week, placebo-controlled trials in adult inpatients with MDD (Trials 1 and 2 ...
  • HOW SUPPLIED
    Bupropion hydrochloride tablets, USP 75 mg are available for oral administration as orange, round, unscored, film coated tablets, imprinted "APO" on one side and "BU" over "75" on the other side ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors - Instruct patients, their families, and/or their caregivers to be alert to the ...
  • MEDICATION GUIDE
    Bupropion Hydrochloride(bue proe' pee on hye'' droe klor' ide) Tablets. Medication Guide available at - https://www.apotex.com/products/us/mg.asp - IMPORTANT: Be sure to read the three ...
  • PRINCIPAL DISPLAY PANEL
    DRUG: Bupropion Hydrochloride - GENERIC: Bupropion Hydrochloride - DOSAGE: TABLET, FILM COATED - ADMINSTRATION: ORAL - NDC: 70518-1566-0 - COLOR: orange - SHAPE: ROUND - SCORE: No score - SIZE: 8 mm - IMPRINT ...
  • INGREDIENTS AND APPEARANCE
    Product Information