Bupropion

Bupropion
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

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Black Box Warning

Suicidal thoughts and behaviours; and neuropsychiatry reactions See full prescribing information for complete Boxed Warning. *Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. Monitor for worsening and emergence of suicidal thoughts and behaviors. Serious neuropsychiatric events have been reported in patients taking bupropion for smoking cessation.

Overview

Bupropion is a Tetracyclics and Unicyclics that is FDA approved for the {{{indicationType}}} of major depressive disorder (MDD). There is a Black Box Warning for this drug as shown here. Common adverse reactions include suicidal thoughts and behaviors in adolescents and young adults, neuropsychiatric symptoms and suicide risk in smoking cessation treatment, seizure, hypertension, activation of mania or hypomania, psychosis and other neuropsychiatric reactions, hypersensitivity reactions.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition 1

• Dosing Information

(Dosage)

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition 1

• Developed by: (Organization)

• Class of Recommendation: (Class) (Link)

• Strength of Evidence: (Category A/B/C) (Link)

• Dosing Information/Recommendation

• (Dosage)

Non–Guideline-Supported Use

Condition 1

• Dosing Information

• There is limited information about Off-Label Non–Guideline-Supported Use of Bupropion in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1

• Dosing Information

(Dosage)

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition 1

• Developed by: (Organization)

• Class of Recommendation: (Class) (Link)

• Strength of Evidence: (Category A/B/C) (Link)

• Dosing Information/Recommendation

• (Dosage)

Non–Guideline-Supported Use

Condition 1

• Dosing Information

• There is limited information about Off-Label Non–Guideline-Supported Use of Bupropion in pediatric patients.

Contraindications

• Condition 1
• Condition 2
• Condition 3
• Condition 4
• Condition 5

Warnings

Suicidal thoughts and behaviours; and neuropsychiatry reactions See full prescribing information for complete Boxed Warning. *Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. Monitor for worsening and emergence of suicidal thoughts and behaviors. Serious neuropsychiatric events have been reported in patients taking bupropion for smoking cessation.

Conidition 1

(Description)

Adverse Reactions

Clinical Trials Experience

Central Nervous System

(list/description of adverse reactions)

Cardiovascular

(list/description of adverse reactions)

Respiratory

(list/description of adverse reactions)

Gastrointestinal

(list/description of adverse reactions)

Hypersensitive Reactions

(list/description of adverse reactions)

Miscellaneous

(list/description of adverse reactions)

Postmarketing Experience

Central Nervous System

(list/description of adverse reactions)

Cardiovascular

(list/description of adverse reactions)

Respiratory

(list/description of adverse reactions)

Gastrointestinal

(list/description of adverse reactions)

Hypersensitive Reactions

(list/description of adverse reactions)

Miscellaneous

(list/description of adverse reactions)

Drug Interactions

• (Drug 1)

• (Description)

• (Drug 2)

• (Description)

• (Drug 3)

• (Description)

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Bupropion in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Bupropion in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Bupropion during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Bupropion in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Bupropion in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Bupropion in geriatric settings.

Gender

There is no FDA guidance on the use of Bupropion with respect to specific gender populations.

Race

There is no FDA guidance on the use of Bupropion with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Bupropion in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Bupropion in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Bupropion in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Bupropion in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Bupropion Administration in the drug label.

Monitoring

There is limited information regarding Bupropion Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Bupropion and IV administrations.

Overdosage

There is limited information regarding Bupropion overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Bupropion Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Bupropion Mechanism of Action in the drug label.

Structure

There is limited information regarding Bupropion Structure in the drug label.

Pharmacodynamics

There is limited information regarding Bupropion Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Bupropion Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Bupropion Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Bupropion Clinical Studies in the drug label.

How Supplied

There is limited information regarding Bupropion How Supplied in the drug label.

Storage

There is limited information regarding Bupropion Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Bupropion Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Bupropion interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Bupropion Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Bupropion Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.