Label: BUPROPION HYDROCHLORIDE SR- bupropion hydrochloride tablet, film coated, extended release

  • NDC Code(s): 43598-751-01, 43598-751-05, 43598-751-60, 43598-752-01, view more
  • Packager: Dr. Reddy’s Laboratories Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 7, 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 (SR) 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 [see Warnings and Precautions ( 5.1)] .

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  • 1 INDICATIONS AND USAGE
    Bupropion hydrochloride extended-release tablets (SR) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 General Instructions for Use - To minimize the risk of seizure, increase the dose gradually - [see Warnings and Precautions ...
  • 3 DOSAGE FORMS AND STRENGTHS
    100 mg – blue, round, biconvex, film coated tablets, debossed with ‘SG, 174’ on one side and plain on other side. 150 mg – purple, round, biconvex, film coated tablets, debossed with ‘SG, 175’ on ...
  • 4 CONTRAINDICATIONS
    Bupropion hydrochloride extended-release tablets (SR) are contraindicated in patients with a seizure disorder. Bupropion hydrochloride extended-release tablets (SR) are contraindicated in ...
  • 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 ...
  • 7 DRUG INTERACTIONS
    7.1 Potential for Other Drugs to Affect Bupropion Hydrochloride Extended-Release Tablets (SR) 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 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 drug ...
  • 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 (SR), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor ...
  • 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 ...
  • 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 the immediate-release formulation of bupropion in the treatment of major depressive disorder was established in two 4-week, placebo-controlled trials in adult inpatients with MDD ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg of bupropion hydrochloride, are blue, blackberry flavored, round, biconvex, film coated tablets, debossed with ‘SG, 174’ on one ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling ( Medication Guide) . Suicidal Thoughts and Behaviors - Instruct patients, their families ...
  • MEDICATION GUIDE
    MEDICATION GUIDE - Bupropion Hydrochloride Extended-Release Tablets, USP (SR) (bue proe' pee on hye'' droe klor' ide) IMPORTANT: Be sure to read the three sections of this Medication Guide ...
  • Package/Label Display Panel
    NDC 43598-751-60 - Twice-A-Day (After Initial Titration) buPROPion HCl - Extended-Release - Tablets, USP (SR) 100 mg - PHARMACIST: Dispense the accompanying - Medication Guide to each ...
  • INGREDIENTS AND APPEARANCE
    Product Information