An antidepressant - It is used to treat depression
FDA Alerts
Suicidality
Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Bupropion is not approved for use in pediatric patients. (See Pediatric Use under Cautions.)
In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.
Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.
Appropriately monitor and closely observe all patients who are started on bupropion therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Worsening of Depression and Suicidality Risk under Cautions.)
May be useful (alone or in combination with other antidepressants) in patients with refractory depression.
Seasonal Affective Disorder
Prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD; also referred to as winter depression).
Smoking Cessation
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Treatment of patients with bipolar depression† (bipolar disorder, depressive episode).
American Psychiatric Association (APA) considers bupropion one of several second-line agents for use when first-line agents are ineffective or not tolerated.
Attention Deficit Hyperactivity Disorder (ADHD)
Used in a limited number of children and adults in the management of ADHD†.
Panic Disorder
Ineffective in the treatment of panic disorder and concomitant phobic disorder†, but may improve symptoms of panic and depression in patients with major depression who have superimposed panic symptoms.
Bulimia Nervosa
Not recommended by APA for bulimia nervosa† because associated with seizures in purging bulimic patients.
Dosage and Administration
General
Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments. (See Worsening of Depression and Suicidality Risk under Cautions.)
Major Depressive Disorder
Increase dosages gradually to minimize the risk of seizures and other adverse effects; do not exceed recommended maximum individual doses or daily dosages. (See Prescribing Limits and see Seizures under Warnings.)
Maximum antidepressant effects of therapy may not be evident until ≥4 weeks of treatment.
Sustained therapy may be required; monitor periodically for need for continued therapy.
Administration
Oral Administration
Conventional Tablets
Initially, administer orally twice daily in the morning and evening, then increase to 3 times daily, preferably with 6 or more hours separating doses (e.g., in the morning, at midday, and in the evening).
Dosages ≥300 mg should be administered as divided doses that do not exceed 150 mg per dose. If components of a larger dosage includes 4 whole tablets of 100 mg each, administer the divided doses 4 times daily separated by 4 or more hours so that no individual dose exceeds 150 mg.
Avoid bedtime administration of evening dose to decrease incidence of insomnia.
Extended-release Tablets
Extended-release, film-coated tablets (e.g., Wellbutrin® SR): Initially, administer orally once daily in the morning, then increase to twice daily, in the morning and evening. Dosages >150 mg should be administered as divided doses twice daily, preferably with 8 or more hours separating the doses.
Extended-release, film-coated tablets (e.g., Zyban®): Administer orally once daily for the first 3 days, then usually increase to twice daily administration with 8 or more hours separating the doses.
Extended-release tablets (Wellbutrin® XL): Administer orally once daily in the morning, with an interval of 24 hours separating the doses.
Do not chew, divide, or crush the extended-release tablets (e.g., Zyban®, Wellbutrin® SR, Wellbutrin® XL); tablets should be swallowed whole.
The shell of the extended-release tablet (Wellbutrin® XL) does not dissolve and may be passed in the stool.
Children weighing ≥20 kg: Initially, 1 mg/kg daily in 2–3 divided doses. After 3 days, titrate up to 3 mg/kg daily in 2–3 divided doses by day 7, then up to 6 mg/kg daily in 2–3 divided doses or 300 mg (whichever is smaller) by third week of therapy.†
Alternatively, may give initial dose of 37.5 or 50 mg twice daily with titration over 2 weeks up to a maximum of 250 mg daily (300–400 mg daily in adolescents).†
Pediatric dosage for ADHD generally has ranged from 50–100 mg 3 times daily for conventional tablets or 100–150 mg twice daily for extended-release tablets.†
Adults
Major Depression
Therapy with Conventional Tablets
Oral
Initially, 100 mg twice daily. Alternatively, dosage may be initiated at 75 mg 3 times daily.
If clinical improvement not apparent after >3 days, may increase to 100 mg 3 times daily.
Dosages >300 mg should not be considered until completion of several weeks of therapy; if no improvement is apparent, then the dosage may be increased to 150 mg 3 times daily. Dosage should not be increased by more than 100 mg every 3 days.
If no improvement after appropriate trial at 450 mg daily, the drug should be discontinued.
Therapy with Extended-release Tablets
Oral
Extended-release, film-coated tablets (e.g., Wellbutrin® SR): Initially, 150 mg once daily in the morning. If tolerated, may increase to 150 mg twice daily as early as fourth day of therapy. Dosages >300 mg daily should not be considered until completion of several weeks of therapy; then, if no apparent improvement, may increase dosage to 200 mg twice daily.
Extended-release tablets (Wellbutrin® XL): Initially, 150 mg once daily. If tolerated, may increase to 300 mg once daily as early as fourth day of therapy. Dosages >300 mg should not be considered until completion of several weeks of therapy; then, if no apparent improvement, may increase dosage to 450 mg once daily.
When switching from conventional or extended-release, film-coated tablets (e.g., Wellbutrin® SR) to extended-release tablets (Wellbutrin® XL), administer same total daily dose when possible.
Seasonal Affective Disorder
Therapy with Extended-release Tablets
Oral
Extended-release tablets (Wellbutrin® XL): Initiate therapy in autumn prior to onset of depressive symptoms; continue treatment through the winter and taper and discontinue in early spring. Individualize timing of initiation and duration of therapy based on patient’s historical pattern of seasonal depressive episodes.
Initially, 150 mg once daily in the morning. If tolerated, may increase dosage after 1 week to 300 mg once daily. If this dosage is not tolerated, reduce dosage to 150 mg once daily.
Usual target dosage: 300 mg once daily in the morning.
For patients receiving 300 mg once daily during the autumn-winter period, taper dosage to 150 mg once daily for 2 weeks prior to discontinuance.
Smoking Cessation
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Therapy with Extended-release, Film-coated Tablets
Oral
Initially, 150 mg daily for the first 3 days of therapy. Initiate 1–2 weeks prior to discontinuance of cigarette smoking.
Maintenance, 150 mg twice daily. Continue therapy for 7–12 weeks; evaluate need for prolonged therapy after that period based on individual patient assessment.
Cessation of smoking is unlikely in patients who do not show substantial progress toward abstinence after 7 weeks of therapy, so such therapy should be discontinued at that time in these patients.
Combination Therapy with Extended-release Tablets and Transdermal Nicotine Patches
Oral
Initially, 150 mg daily, and after 3 days increase to 150 mg twice daily while still smoking.
After about 1 week of therapy, when the patient is scheduled to stop smoking, initiate transdermal nicotine therapy at a dosage of 21 mg/24 hours.
Taper transdermal nicotine to 14, then to 7 mg/24 hours during the eighth and ninth weeks of therapy, respectively.
Depression Associated With Bipolar Disorder
Oral
Dosages generally range from 75–400 mg in conjunction with a mood-stabilizing agent (e.g., carbamazepine, lithium, valproate).†
ADHD
Therapy with Conventional Tablets
Oral
Initially, 150 mg daily. May be titrated up to 450 mg daily.†
Prescribing Limits
Adults
Major Depression
Oral
Conventional tablets: Maximum 450 mg daily (not >150 mg per dose).
Extended-release, film-coated tablets (e.g., Wellbutrin® SR): Maximum 400 mg daily (not >200 mg per dose).
Extended-release tablets (Wellbutrin® XL): Maximum 450 mg daily.
Seasonal Affective Disorder
Oral
Extended-release tablets (e.g., Wellbutrin® XL): Dosages >300 mg daily have not been studied.
Smoking cessation in patients with severe hepatic cirrhosis: Maximum 150 mg every other day as extended-release, film-coated tablets (e.g., Zyban®).
Major depression, seasonal affective disorder, or smoking cessation in patients with mild to moderate hepatic impairment (e.g., mild to moderate hepatic cirrhosis): Reduce dosage and/or frequency of administration as required. (See Hepatic Impairment under Cautions.)
Renal Impairment
Active metabolites may accumulate; reduce dosage and/or frequency of administration as required. (See Renal Impairment under Cautions.)
Smoking cessation in patients undergoing hemodialysis: Some clinicians recommend a dosage of 150 mg every 3 days as extended-release, film-coated tablets (e.g., Zyban®).
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