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)depression, associated with seasonal affective disorder; prophylaxis. 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)

Major depressive disorder (MDD)

• To minimize the risk of seizure, increase the dose gradually [see Warnings and Precautions]. Increases in dose should not exceed 100 mg per day in a 3‑day period. Bupropion Tablets should be swallowed whole and not crushed, divided, or chewed. Bupropion may be taken with or without food.

• The recommended starting dose is 200 mg per day, given as 100 mg twice daily. After 3 days of dosing, the dose may be increased to 300 mg per day, given as 100 mg 3 times daily, with at least 6 hours between successive doses. Dosing above 300 mg per day may be accomplished using the 75- or 100-mg tablets.

• A maximum of 450 mg per day, given in divided doses of not more than 150 mg each, may be considered for patients who show no clinical improvement after several weeks of treatment at 300 mg per day. Administer the 100‑mg tablet 4 times daily to not exceed the limit of 150 mg in a single dose.

• It is generally agreed that acute episodes of depression require several months or longer of antidepressant drug treatment beyond the response in the acute episode. It is unknown whether the dose of Bupropion needed for maintenance treatment is identical to the dose that provided an initial response. Periodically reassess the need for maintenance treatment and the appropriate dose for such treatment.

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

• Seizure disorder
• Bulimia or anorexia nervosa
• Patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs

• 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.

Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults

• Worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior.

• Pooled analyses of short‑term placebo‑controlled trials of antidepressant drugs (selective serotonin reuptake inhibitors [SSRIs] and others) show that these drugs *Increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with MDD and other psychiatric disorders. Short-term clinical trials did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults beyond age 24; there was a reduction with antidepressants compared with placebo in adults aged 65 and older.

• The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short‑term trials of 9 antidepressant drugs in over 4,400 subjects. The pooled analyses of placebo‑controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short‑term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 subjects. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger subjects for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1,000 subjects treated) are provided in Table 1

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Adverse Reactions

Clinical Trials Experience

Central Nervous System

Confusion (major depressive disorder, 8% ), dizziness (6% to 11%), headache (25% to 34% ), insomnia (11% to 20% )

Cardiovascular

Tachycardia (major depressive disorder, 11% )

Respiratory

Nasopharyngitis (seasonal affective disorder, 13% ), pharyngitis (major depressive disorder, 3% to 11% ), upper respiratory infection (seasonal affective disorder, 9% )

Gastrointestinal

Abdominal pain (2% to 9%), constipation (5% to 10%), nausea (13% to 18%), xerostomia (17% to 26%)

Endocrine metabolic

Weight gain (2% to 9% ), weight loss (major depressive disorder, 14% to 19% )

Psychiatric

Agitation (2% to 9%)

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

• 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 reported with overdoses of bupropion alone included hallucinations, loss of consciousness, sinus tachycardia, and ECG changes such as conduction disturbances (including QRS prolongation) or arrhythmias. Fever, muscle rigidity, rhabdomyolysis, hypotension, stupor, coma, and respiratory failure have been reported mainly when bupropion was part of multiple drug overdoses.

• Although most patients recovered without sequelae, deaths associated with overdoses of bupropion alone have been reported in patients ingesting large doses of the drug. Multiple uncontrolled seizures, bradycardia, cardiac failure, and cardiac arrest prior to death were reported in these patients.

• Overdosage Management

Consult a Certified Poison Control Center for up-to-date guidance and advice. Telephone numbers for certified poison control centers are listed in the Physician’s Desk Reference (PDR). Call 1-800-222-1222 or refer to www.poison.org.

There are no known antidotes for bupropion. In case of an overdose, provide supportive care, including close medical supervision and monitoring. Consider the possibility of multiple drug overdose. Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. Induction of emesis is not recommended.

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

For patient information, please click here.

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.