WELLBUTRIN SR bupropion hydrochloride 150 mg Tablet, Film Coated, 60-count
Other active recalls for Bupropion Hydrochloride (different manufacturers) — 3 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Aminoketone class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Bupropion is an antidepressant primarily used to treat major depressive disorder — that's clinical depression. Depending on which formulation you're prescribed, it may also be used...
- Most people don't notice a full effect immediately — antidepressant treatment for depression typically requires several months or longer. Your dose may also be increased gradually...
- Will bupropion make me feel better right away?
- The most common ones are dry mouth, nausea, trouble sleeping, dizziness, headache, and feeling anxious or agitated — especially early on. Many of these improve as your body adjusts...
Patient education
Supplement & herbal interactions
Bupropion may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII R12CBM0EIZ
A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
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UNII ZT934N0X4W
A naturally occurring amino acid salt used as a reducing agent and antioxidant in medications. It helps prevent ingredient breakdown and may improve product stability during storage.
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UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
10 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $7.514 | $450.81 / 60 tablets |
| Medicaid paysCMS SDUD · 12 mo | $6.97 | $418.12 / 60 tablets |
| Medicare drug plans payPart D · Q2 2026 | $7.73 | $463.60 / 60 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Bupropion hydrochloride 150 mg 68001-0613-03 | BluePoint | 500 tablets | $0.079 | AB3 | Availability likely | save 99% |
| Bupropion Hydrochloride SR 150 mg 00591-3541-05 | Actavis | 500 tablets | $0.082 | AB1 | Availability likely | save 99% |
| bupropion hydrochloride SR 150 mg 00904-7465-61 | Major | 1 tablet | $0.082 | AB1 | Availability likely | save 99% |
| Bupropion hydrochloride 150 mg 31722-0067-01 | Camber | 100 tablets | $0.082 | AB1 | Availability likely | save 99% |
| Bupropion Hydrochloride 150 mg 42806-0415-01 | Epic | 100 tablets | $0.082 | AB1 | Availability likely | save 99% |
| Bupropion Hydrochloride SR 150 mg 42806-0425-01 | Epic | 100 tablets | $0.082 | AB1 | Availability likely | save 99% |
| Bupropion Hydrochloride SR 150 mg 43598-0752-01 | Dr. | 100 tablets | $0.082 | AB1 | Availability likely | save 99% |
| Bupropion Hydrochloride SR 150 mg 50228-0175-01 | ScieGen | 100 tablets | $0.082 | AB1 | Availability likely | save 99% |
| Bupropion Hydrochloride 150 mg 59651-0847-01 | Aurobindo | 100 tablets | $0.082 | AB1 | Availability likely | save 99% |
| BuPROPion Hydrochloride 150 mg 68084-0708-25 | American | 1 tablet | $0.082 | AB1 | Availability likely | save 99% |
| Bupropion Hydrochloride SR 150 mg 70436-0059-01 | Slate | 100 tablets | $0.084 | AB1 | FDA listed | save 99% |
| Wellbutrin Sr 150 mgthis 00173-0135-55 | GlaxoSmithKline | 60 tablets | $7.514 | AB1 | Availability likely | — |
| Bupropion hydrochloride 150 mg 00615-8602-39 | NCS | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride Sr 150 mg 43063-0744-30 | PD-Rx | 30 tablets | — | — | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 43063-0913-30 | PD-Rx | 30 tablets | — | AB1 | FDA listed | — |
| bupropion hydrochloride SR 150 mg 43547-0289-06 | Solco | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 43598-0537-01 | Dr. | 100 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 47335-0737-08 | Sun | 100 tablets | — | — | FDA listed | — |
| Bupropion Hydrochloride 150 mg 50090-6353-00 | A-S | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 50090-6871-00 | A-S | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 50090-6872-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 50090-7422-00 | A-S | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 50090-7423-00 | A-S | 90 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 51655-0115-25 | Northwind | 60 tablets | — | AB1 | FDA listed | — |
| bupropion 150 mg 51655-0357-26 | Northwind | 90 tablets | — | AB1 | FDA listed | — |
| bupropion hydrochloride SR 150 mg 55154-0183-00 | Cardinal | 1 tablet | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 63187-0052-30 | Proficient | 30 tablets | — | — | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 63187-0726-30 | Proficient | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 63629-8473-01 | Bryant | 500 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 68071-2890-03 | NuCare | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 68788-7807-01 | Preferred | 100 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 68788-8769-01 | Preferred | 100 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride (Sr) 150 mg 69097-0878-02 | Cipla | 30 tablets | — | — | FDA listed | — |
| Bupropion Hydrochloride 150 mg 70010-0126-03 | Granules | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 70518-4056-01 | REMEDYREPACK | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 70518-4081-01 | REMEDYREPACK | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 71205-0550-30 | Proficient | 30 tablets | — | AB1 | FDA listed | — |
| bupropion 150 mg 71205-0565-30 | Proficient | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 71335-0135-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 71335-1702-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 71335-1837-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 71335-2457-01 | Bryant | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 71610-0576-30 | Aphena | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 71610-0990-30 | Aphena | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 72162-1529-05 | Bryant | 500 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride Sr 150 mg 72189-0349-30 | DirectRx | 30 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 77771-0175-05 | Radha | 500 tablets | — | AB1 | FDA listed | — |
| Bupropion Hydrochloride SR 150 mg 82868-0019-60 | Northwind | 60 tablets | — | AB1 | FDA listed | — |
| Bupropion hydrochloride 150 mg 70518-4448-00 | REMEDYREPACK | 30 tablets | — | AB3 | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00173-0135-55 You're viewing this | 60 TABLET, FILM COATED in 1 BOTTLE (0173-0135-55) | 1996-11-15 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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 )] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. • Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants. ( 5.1 ) • Monitor for worsening and emergence of suicidal thoughts and behaviors.
( 5.1 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE WELLBUTRIN SR (bupropion hydrochloride) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies ( 14 )] . The efficacy of WELLBUTRIN SR in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo‑controlled trial [see Clinical Studies ( 14 )] .
WELLBUTRIN SR is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Starting dose: 150 mg/day. ( 2.1 ) • General: Increase dose gradually to reduce seizure risk. ( 2.1 , 5.3 ) • After 3 days, may increase the dose to 300 mg/day, given as 150 mg twice daily at an interval of at least 8 hours.
( 2.1 ) • Usual target dose: 300 mg/day as 150 mg twice daily. ( 2.1 ) • Maximum dose: 400 mg/day, given as 200 mg twice daily, for patients not responding to 300 mg/day. ( 2.1 ) • Periodically reassess the dose and need for maintenance treatment.
( 2.1 ) • Moderate to severe hepatic impairment: 100 mg daily or 150 mg every other day. ( 2.2 , 8.7 ) • Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing. ( 2.2 , 8.7 ) • Renal impairment: Consider reducing the dose and/or frequency.
( 2.3 , 8.6 )
2.1General Instructions for Use To minimize the risk of seizure, increase the dose gradually [see Warnings and Precautions ( 5.3 )] . WELLBUTRIN SR tablets should be swallowed whole and not crushed, divided, or chewed. WELLBUTRIN SR may be taken with or without food.
The usual adult target dose for WELLBUTRIN SR is 300 mg/day, given as 150 mg twice daily. Initiate dosing with 150 mg/day given as a single daily dose in the morning. After 3 days of dosing, the dose may be increased to the 300-mg/day target dose, given as 150 mg twice daily.
There should be an interval of at least 8 hours between successive doses. A maximum of 400 mg/day, given as 200 mg twice daily, may be considered for patients in whom no clinical improvement is noted after several weeks of treatment at 300 mg/day. To avoid high peak concentrations of bupropion and/or its metabolites, do not exceed 200 mg in any 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 WELLBUTRIN SR 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.
2.2Dose Adjustment in Patients with Hepatic Impairment In patients with moderate to severe hepatic impairment (Child-Pugh score: 7 to 15), the maximum dose of WELLBUTRIN SR is 100 mg/day or 150 mg every other day. In patients with mild hepatic impairment (Child-Pugh score: 5 to 6), consider reducing the dose and/or frequency of dosing [see Use in Specific Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )].
2.3Dose Adjustment in Patients with Renal Impairment Consider reducing the dose and/or frequency of WELLBUTRIN SR in patients with renal impairment (Glomerular Filtration Rate [GFR] less than 90 mL/min) [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] .
2.4Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Antidepressant At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with WELLBUTRIN SR. Conversely, at least 14 days should be allowed after stopping WELLBUTRIN SR before starting an MAOI antidepressant [see Contraindications ( 4 ), Drug Interactions ( 7.6 )] .
2.5Use of WELLBUTRIN SR with Reversible MAOIs Such as Linezolid or Methylene Blue Do not start WELLBUTRIN SR in a patient who is being treated with a reversible MAOI such as linezolid or intravenous methylene blue. Drug interactions can increase the risk of hypertensive reactions. In a patient who requires more urgent treatment of a psychiatric condition, non-pharmacological interventions, including hospitalization, should be considered [see Contraindications ( 4 ), Drug Interactions ( 7.6 )] .
In some cases, a patient already receiving therapy with WELLBUTRIN SR may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene b…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS • 100 mg – blue, round, biconvex, film‑coated, sustained-release tablets printed with “WELLBUTRIN SR 100”. • 150 mg – purple, round, biconvex, film‑coated, sustained-release tablets printed with “WELLBUTRIN SR 150”. • 200 mg – light pink, round, biconvex, film-coated, sustained-release tablets printed with “WELLBUTRIN SR 200”. Tablets: 100 mg, 150 mg, 200 mg. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS • WELLBUTRIN SR is contraindicated in patients with a seizure disorder. • WELLBUTRIN SR is contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with the immediate‑release formulation of bupropion [see Warnings and Precautions ( 5.3 )]. • WELLBUTRIN SR is contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions ( 5.3 ), Drug Interactions ( 7.3 )] . • The use of MAOIs (intended to treat psychiatric disorders) concomitantly with WELLBUTRIN SR or within 14 days of discontinuing treatment with WELLBUTRIN SR is contraindicated.
There is an increased risk of hypertensive reactions when WELLBUTRIN SR is used concomitantly with MAOIs. The use of WELLBUTRIN SR within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting WELLBUTRIN SR in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated [see Dosage and Administration ( 2.4 , 2.5 ), Warnings and Precautions ( 5.4 ), Drug Interactions ( 7.6 )] . • WELLBUTRIN SR is contraindicated in patients with known hypersensitivity to bupropion or other ingredients of WELLBUTRIN SR.
Anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported [see Warnings and Precautions ( 5.8 )]. • Seizure disorder. ( 4 , 5.3 ) • Current or prior diagnosis of bulimia or anorexia nervosa. ( 4 , 5.3 ) • Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptic drugs.
( 4 , 5.3 ) • Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with WELLBUTRIN SR or within 14 days of stopping treatment with WELLBUTRIN SR. Do not use WELLBUTRIN SR within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start WELLBUTRIN SR in a patient who is being treated with linezolid or intravenous methylene blue.
( 4 , 7.6 ) • Known hypersensitivity to bupropion or other ingredients of WELLBUTRIN SR. ( 4 , 5.8 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Neuropsychiatric adverse events during smoking cessation: Postmarketing reports of serious or clinically significant neuropsychiatric adverse events have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients attempting to quit smoking with bupropion for the occurrence of such symptoms and instruct them to discontinue bupropion and contact a healthcare provider if they experience such adverse events.
( 5.2 ) • Seizure risk: The risk is dose-related. Can minimize risk by gradually increasing the dose and limiting daily dose to 400 mg. Discontinue if seizure occurs.
( 4 , 5.3 , 7.3 ) • Hypertension: WELLBUTRIN SR can increase blood pressure. Monitor blood pressure before initiating treatment and periodically during treatment. ( 5.4 ) • Activation of mania/hypomania: Screen patients for bipolar disorder and monitor for these symptoms.
( 5.5 ) • Psychosis and other neuropsychiatric reactions: Instruct patients to contact a healthcare professional if such reactions occur. ( 5.6 ) • Angle-closure glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.7 )
5.1Suicidal 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 suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.
There has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. 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 . Table 1. Risk Differences in the Number of Suicidality Cases by Age Group in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Subjects Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1,000 Subjects Treated Increases Compared with Placebo <…
🤒 Adverse Reactions ▾
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 Warning, Warnings and Precautions ( 5.1 )] • Neuropsychiatric symptoms and suicide risk in smoking cessation treatment [see Warnings and Precautions ( 5.2 )] • Seizure [see Warnings and Precautions ( 5.3 )] • Hypertension [see Warnings and Precautions ( 5.4 )] • Activation of mania or hypomania [see Warnings and Precautions ( 5.5 )] • Psychosis and other neuropsychiatric reactions [see Warnings and Precautions ( 5.6 )] • Angle-closure glaucoma [see Warnings and Precautions ( 5.7 )] • Hypersensitivity reactions [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (incidence ≥5% and ≥2% more than placebo rate) are: headache, dry mouth, nausea, insomnia, dizziness, pharyngitis, constipation, agitation, anxiety, abdominal pain, tinnitus, tremor, palpitation, myalgia, sweating, rash, and anorexia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions Leading to Discontinuation of Treatment In placebo‑controlled clinical trials, 4%, 9%, and 11% of the placebo, 300‑mg/day, and 400‑mg/day groups, respectively, discontinued treatment due to adverse reactions.
The specific adverse reactions leading to discontinuation in at least 1% of the 300‑mg/day or 400‑mg/day groups and at a rate at least twice the placebo rate are listed in Table 2 . Table 2. Treatment Discontinuations Due to Adverse Reactions in Placebo-Controlled Trials Adverse Reaction Placebo (n = 385) WELLBUTRIN SR 300 mg/day (n = 376) WELLBUTRIN SR 400 mg/day (n = 114) Rash 0.0% 2.4% 0.9% Nausea 0.3% 0.8% 1.8% Agitation 0.3% 0.3% 1.8% Migraine 0.3% 0.0% 1.8% Commonly Observed Adverse Reactions Adverse reactions from Table 3 occurring in at least 5% of subjects treated with WELLBUTRIN SR and at a rate at least twice the placebo rate are listed below for the 300- and 400‑mg/day dose groups.
WELLBUTRIN SR 300 mg/day: Anorexia, dry mouth, rash, sweating, tinnitus, and tremor. WELLBUTRIN SR 400 mg/day: Abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency. Adverse reactions reported in placebo-controlled trials are presented in Table 3.
Reported adverse reactions were classified using a COSTART‑based Dictionary. Table 3. Adverse Reactions Reported by at Least 1% of Subjects and at a Greater Frequency than Placebo in Controlled Clinical Trials a Incidence based on the number of female subjects. — Hyphen denotes adverse events occurring in greater than 0 but less than 0.5% of subjects.
Body System/ Adverse Reaction WELLBUTRIN SR 300 mg/day (n = 376) WELLBUTRIN SR 400 mg/day (n = 114) Placebo (n = 385) Body (general) Headache 26% 25% 23% Infection 8% 9% 6% Abdominal pain 3% 9% 2% Asthenia 2% 4% 2% Chest pain 3% 4% 1% Pain 2% 3% 2% Fever 1% 2% — Cardiovascular Palpitation 2% 6% 2% Flushing 1% 4% — Migraine 1% 4% 1% Hot flashes 1% 3% 1% Digestive Dry mouth 17% 24% 7% Nausea 13% 18% 8% Constipation 10% 5% 7% Diarrhea 5% 7% 6% Anorexia 5% 3% 2% Vomiting 4% 2% 2% Dysphagia 0% 2% 0% Musculoskeletal Myalgia 2% 6% 3% Arthralgia 1% 4% 1% Arthritis 0% 2% 0% Twitch 1% 2% — Nervous system Insomnia 11% 16% 6% Dizziness 7% 11% 5% Agitation 3% 9% 2% Anxiety 5% 6% 3% Tremor 6% 3% 1% Nervousness 5% 3% 3% Somnolence 2% 3% 2% Irritability 3% 2% 2% Memory decreased — 3% 1% Paresthesia 1% 2% 1% Central nervous system stimulation 2% 1% 1% Respiratory Pharyngitis 3% 11% 2% Sinusitis 3% 1% 2% Increas…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • CYP2B6 inducers: Dose increase may be necessary if coadministered with CYP2B6 inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, and phenytoin) based on clinical response, but should not exceed the maximum recommended dose. ( 7.1 ) • Drugs metabolized by CYP2D6: Bupropion inhibits CYP2D6 and can increase concentrations of: antidepressants (e.g., venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline), antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone, flecainide).
Consider dose reduction when using with bupropion. ( 7.2 ) • Digoxin: May decrease plasma digoxin levels. Monitor digoxin levels.
( 7.2 ) • Drugs that lower seizure threshold: Dose WELLBUTRIN SR with caution. ( 5.3 , 7.3 ) • Dopaminergic drugs (levodopa and amantadine): CNS toxicity can occur when used concomitantly with WELLBUTRIN SR. ( 7.4 ) • MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly with WELLBUTRIN SR.
( 7.6 ) • Drug-laboratory test interactions: WELLBUTRIN SR can cause false-positive urine test results for amphetamines. ( 7.7 )
7.1Potential for Other Drugs to Affect WELLBUTRIN SR Bupropion is primarily metabolized to hydroxybupropion by CYP2B6. Therefore, the potential exists for drug interactions between WELLBUTRIN SR and drugs that are inhibitors or inducers of CYP2B6. Inhibitors of CYP2B6 Ticlopidine and Clopidogrel: Concomitant treatment with these drugs can increase bupropion exposure but decrease hydroxybupropion exposure.
Based on clinical response, dosage adjustment of WELLBUTRIN SR may be necessary when coadministered with CYP2B6 inhibitors (e.g., ticlopidine or clopidogrel) [see Clinical Pharmacology ( 12.3 )] . Inducers of CYP2B6 Ritonavir, Lopinavir, and Efavirenz : Concomitant treatment with these drugs can decrease bupropion and hydroxybupropion exposure. Dosage increase of WELLBUTRIN SR may be necessary when coadministered with ritonavir, lopinavir, or efavirenz [see Clinical Pharmacology ( 12.3 )] but should not exceed the maximum recommended dose.
Carbamazepine, Phenobarbital, Phenytoin: While not systematically studied, these drugs may induce the metabolism of bupropion and may decrease bupropion exposure [see Clinical Pharmacology ( 12.3 )] . If bupropion is used concomitantly with a CYP inducer, it may be necessary to increase the dose of bupropion, but the maximum recommended dose should not be exceeded.
7.2Potential for WELLBUTRIN SR to Affect Other Drugs Drugs Metabolized by CYP2D6 Bupropion and its metabolites (erythrohydrobupropion, threohydrobupropion, hydroxybupropion) are CYP2D6 inhibitors. Therefore, coadministration of WELLBUTRIN SR with drugs that are metabolized by CYP2D6 can increase the exposures of drugs that are substrates of CYP2D6. Such drugs include certain antidepressants (e.g., venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, and sertraline), antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone and flecainide).
When used concomitantly with WELLBUTRIN SR, it may be necessary to decrease the dose of these CYP2D6 substrates, particularly for drugs with a narrow therapeutic index. Drugs that require metabolic activation by CYP2D6 to be effective (e.g., tamoxifen) theoretically could have reduced efficacy when administered concomitantly with inhibitors of CYP2D6 such as bupropion. Patients treated concomitantly with WELLBUTRIN SR and such drugs may require increased doses of the drug [ see Clinical Pharmacology ( 12.3 )] .
Digoxin Coadministration of WELLBUTRIN SR with digoxin may decrease plasma digoxin levels. Monitor plasma digoxin levels in patients treated concomitantly with WELLBUTRIN SR and digoxin [see Clinical Pharmacology ( 12.3 )] .
7.3 Drugs that Lower Seizure Threshold Use extreme c…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Pregnancy Exposure Registry There is an independent pregnancy exposure registry that monitors pregnancy outcomes in women exposed to any antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/. Risk Summary Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester have not identified an increased risk of congenital malformations overall (see Data) .
There are risks to the mother associated with untreated depression in pregnancy (see Clinical Considerations). When bupropion was administered to pregnant rats during organogenesis, there was no evidence of fetal malformations at doses up to approximately 11 times the maximum recommended human dose (MRHD) of 400 mg/day. When given to pregnant rabbits during organogenesis, non-dose–related increases in incidence of fetal malformations, and skeletal variations were observed at doses approximately equal to the MRHD and greater.
Decreased fetal weights were seen at doses twice the MRHD and greater (see Animal Data) . The estimated background risk for major birth defects and miscarriage is unknown for the indicated population. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants during pregnancy at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants.
Consider the risks to the mother of untreated depression and potential effects on the fetus when discontinuing or changing treatment with antidepressant medications during pregnancy and postpartum. Data Human Data: Data from the international bupropion Pregnancy Registry (675 first trimester exposures) and a retrospective cohort study using the United Healthcare database (1,213 first trimester exposures) did not show an increased risk for malformations overall. The Registry was not designed or powered to evaluate specific defects but suggested a possible increase in cardiac malformations.
No increased risk for cardiovascular malformations overall has been observed after bupropion exposure during the first trimester. The prospectively observed rate of cardiovascular malformations in pregnancies with exposure to bupropion in the first trimester from the international Pregnancy Registry was 1.3% (9 cardiovascular malformations/675 first trimester maternal bupropion exposures), which is similar to the background rate of cardiovascular malformations (approximately 1%). Data from the United Healthcare database, which had a limited number of exposed cases with cardiovascular malformations, and a case-control study (6,853 infants with cardiovascular malformations and 5,763 with non-cardiovascular malformations) of self-reported bupropion use from the National Birth Defects Prevention Study (NBDPS) did not show an increased risk for cardiovascular malformations overall after bupropion exposure during the first trimester.
Study findings on bupropion exposure during the first trimester and risk for left ventricular outflow tract obstruction (LVOTO) are inconsistent and do not allow conclusions regarding a possible association. The United Healthcare database lacked sufficient power to evaluate this association; the NBDPS found increased risk for LVOTO (n = 10; adjusted OR = 2.6; 95% CI: 1…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is an independent pregnancy exposure registry that monitors pregnancy outcomes in women exposed to any antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/. Risk Summary Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester have not identified an increased risk of congenital malformations overall (see Data) .
There are risks to the mother associated with untreated depression in pregnancy (see Clinical Considerations). When bupropion was administered to pregnant rats during organogenesis, there was no evidence of fetal malformations at doses up to approximately 11 times the maximum recommended human dose (MRHD) of 400 mg/day. When given to pregnant rabbits during organogenesis, non-dose–related increases in incidence of fetal malformations, and skeletal variations were observed at doses approximately equal to the MRHD and greater.
Decreased fetal weights were seen at doses twice the MRHD and greater (see Animal Data) . The estimated background risk for major birth defects and miscarriage is unknown for the indicated population. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants during pregnancy at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants.
Consider the risks to the mother of untreated depression and potential effects on the fetus when discontinuing or changing treatment with antidepressant medications during pregnancy and postpartum. Data Human Data: Data from the international bupropion Pregnancy Registry (675 first trimester exposures) and a retrospective cohort study using the United Healthcare database (1,213 first trimester exposures) did not show an increased risk for malformations overall. The Registry was not designed or powered to evaluate specific defects but suggested a possible increase in cardiac malformations.
No increased risk for cardiovascular malformations overall has been observed after bupropion exposure during the first trimester. The prospectively observed rate of cardiovascular malformations in pregnancies with exposure to bupropion in the first trimester from the international Pregnancy Registry was 1.3% (9 cardiovascular malformations/675 first trimester maternal bupropion exposures), which is similar to the background rate of cardiovascular malformations (approximately 1%). Data from the United Healthcare database, which had a limited number of exposed cases with cardiovascular malformations, and a case-control study (6,853 infants with cardiovascular malformations and 5,763 with non-cardiovascular malformations) of self-reported bupropion use from the National Birth Defects Prevention Study (NBDPS) did not show an increased risk for cardiovascular malformations overall after bupropion exposure during the first trimester.
Study findings on bupropion exposure during the first trimester and risk for left ventricular outflow tract obstruction (LVOTO) are inconsistent and do not allow conclusions regarding a possible association. The United Healthcare database lacked sufficient power to evaluate this association; the NBDPS found increased risk for LVOTO (n = 10; adjusted OR = 2.6; 95% CI: 1.2, 5.7), and the Slone Epidem…
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in the pediatric population have not been established [see Boxed Warning, Warnings and Precautions ( 5.1 )] .
🧓 Geriatric Use ▾
8.5Geriatric Use Of the approximately 6,000 subjects who participated in clinical trials with bupropion sustained-release tablets (depression and smoking cessation trials), 275 were aged ≥65 years and 47 were aged ≥75 years. In addition, several hundred subjects aged ≥65 years participated in clinical trials using the immediate-release formulation of bupropion (depression trials). No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
Reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Bupropion is extensively metabolized in the liver to active metabolites, which are further metabolized and excreted by the kidneys. The risk of adverse reactions may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, it may be necessary to consider this factor in dose selection; it may be useful to monitor renal function [see Dosage and Administration ( 2.3 ), Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )].
🆘 Overdosage ▾
10 OVERDOSAGE
10.1Human 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, mental status changes, sinus tachycardia, ECG changes such as conduction disturbances (including QRS prolongation) or arrhythmias, clonus, myoclonus, and hyperreflexia.
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.
10.2Overdosage Management Consult a Certified Poison Control Center for up-to-date guidance and advice. 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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 relatively weak inhibitor of the neuronal reuptake of norepinephrine and dopamine and does not inhibit the reuptake of serotonin. Bupropion does not inhibit monoamine oxidase.
12.3Pharmacokinetics Bupropion is a racemic mixture. The pharmacological activity and pharmacokinetics of the individual enantiomers have not been studied. The mean elimination half‑life (±SD) of bupropion after chronic dosing is 21 (±9) hours, and steady-state plasma concentrations of bupropion are reached within 8 days.
Absorption The absolute bioavailability of WELLBUTRIN SR in humans has not been determined because an intravenous formulation for human use is not available. However, it appears likely that only a small proportion of any orally administered dose reaches the systemic circulation intact. In rat and dog studies, the bioavailability of bupropion ranged from 5% to 20%.
In humans, following oral administration of WELLBUTRIN SR, peak plasma concentration (C max ) of bupropion is usually achieved within 3 hours. In a trial comparing chronic dosing with WELLBUTRIN SR 150 mg twice daily to bupropion immediate‑release formulation 100 mg 3 times daily, the steady state C max for bupropion after WELLBUTRIN SR administration was approximately 85% of those achieved after bupropion immediate-release formulation administration. Exposure (AUC) to bupropion was equivalent for both formulations.
Bioequivalence was also demonstrated for all three major active metabolites (i.e., hydroxybupropion, threohydrobupropion and erythrohydrobupropion) for both C max and AUC. Thus, at steady state, WELLBUTRIN SR given twice daily, and the immediate‑release formulation of bupropion given 3 times daily, are essentially bioequivalent for both bupropion and the 3 quantitatively important metabolites. WELLBUTRIN SR can be taken with or without food.
Bupropion C max and AUC were increased by 11% to 35% and 16% to 19%, respectively, when WELLBUTRIN SR was administered with food to healthy volunteers in three trials. The food effect is not considered clinically significant. Distribution In vitro tests show that bupropion is 84% bound to human plasma proteins at concentrations up to 200 mcg/mL.
The extent of protein binding of the hydroxybupropion metabolite is similar to that for bupropion; whereas, the extent of protein binding of the threohydrobupropion metabolite is about half that seen with bupropion. Metabolism Bupropion is extensively metabolized in humans. Three metabolites are active: hydroxybupropion, which is formed via hydroxylation of the tert ‑butyl group of bupropion, and the amino‑alcohol isomers, threohydrobupropion and erythrohydrobupropion, which are formed via reduction of the carbonyl group.
In vitro findings suggest that CYP2B6 is the principal isoenzyme involved in the formation of hydroxybupropion, while cytochrome P450 enzymes are not involved in the formation of threohydrobupropion. Oxidation of the bupropion side chain results in the formation of a glycine conjugate of meta‑chlorobenzoic acid, which is then excreted as the major urinary metabolite. The potency and toxicity of the metabolites relative to bupropion have not been fully characterized.
However, it has been demonstrated in an antidepressant screening test in mice that hydroxybupropion is one-half as potent as bupropion, while threohydrobupropion and erythrohydrobupropion are 5-fold less potent than bupropion. This may be of clinical importance because the plasma concentrations of the metabolites are as high as or higher than those of bupropion. Following a single-dose administration of WELLBUTRIN SR in humans, C max of hydroxybupropion occurs approximately 6 hours post‑dose and is approximately 10 times the peak level of the parent drug at steady state.
The elimination half…
🧬 Mechanism of Action ▾
12.1Mechanism 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 relatively weak inhibitor of the neuronal reuptake of norepinephrine and dopamine and does not inhibit the reuptake of serotonin. Bupropion does not inhibit monoamine oxidase.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING WELLBUTRIN SR sustained‑release tablets, 100 mg of bupropion hydrochloride, are blue, round, biconvex, film‑coated tablets printed with “WELLBUTRIN SR 100” in bottles of 60 (NDC 0173-0947-55) tablets. WELLBUTRIN SR sustained‑release tablets, 150 mg of bupropion hydrochloride, are purple, round, biconvex, film‑coated tablets printed with “WELLBUTRIN SR 150” in bottles of 60 (NDC 0173-0135-55) tablets. WELLBUTRIN SR sustained‑release tablets, 200 mg of bupropion hydrochloride, are light pink, round, biconvex, film‑coated tablets printed with “WELLBUTRIN SR 200” in bottles of 60 (NDC 0173-0722-00) tablets.
Store at room temperature, 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture.
📋 Description ▾
11 DESCRIPTION WELLBUTRIN SR (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re‑uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride.
The molecular weight is 276.2. The molecular formula is C 13 H 18 ClNO•HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water.
It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: WELLBUTRIN SR is supplied for oral administration as 100‑mg (blue), 150‑mg (purple), and 200‑mg (light pink), film‑coated, sustained‑release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: carnauba wax, cysteine hydrochloride, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide and is printed with edible black ink.
In addition, the 100‑mg tablet contains FD&C Blue No. 1 Lake, the 150‑mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No.
40 Lake, and the 200‑mg tablet contains FD&C Red No. 40 Lake. buproprion hydrochloride chemical structure
💬 Information for Patients ▾
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 emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down.
Advise families and caregivers of patients to observe for the emergence of such symptoms on a day‑to‑day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or healthcare professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.
Neuropsychiatric Adverse Events and Suicide Risk in Smoking Cessation Treatment Although WELLBUTRIN SR is not indicated for smoking cessation treatment, it contains the same active ingredient as ZYBAN which is approved for this use. Inform patients that some patients have experienced changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation and suicide when attempting to quit smoking while taking bupropion.
Instruct patients to discontinue bupropion and contact a healthcare professional if they experience such symptoms [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6.2 )] . Severe Allergic Reactions Educate patients on the symptoms of hypersensitivity and to discontinue WELLBUTRIN SR if they have a severe allergic reaction. Seizure Instruct patients to discontinue and not restart WELLBUTRIN SR if they experience a seizure while on treatment.
Advise patients that the excessive use or abrupt discontinuation of alcohol, benzodiazepines, antiepileptic drugs, or sedatives/hypnotics can increase the risk of seizure. Advise patients to minimize or avoid use of alcohol. As the dose is increased during initial titration to doses above 150 mg/day, instruct patients to take WELLBUTRIN SR in 2 divided doses, preferably with at least 8 hours between successive doses, to minimize the risk of seizures.
Angle-Closure Glaucoma Patients should be advised that taking WELLBUTRIN SR can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma.
Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions ( 5.7 )]. Bupropion-Containing Products Educate patients that WELLBUTRIN SR contains the same active ingredient (bupropion hydrochloride) found in ZYBAN, which is used as an aid to smoking cessation treatment, and that WELLBUTRIN SR should not be used in combination with ZYBAN or any other medications that contain bupropion (such as WELLBUTRIN, the immediate-release formulation and WELLBUTRIN XL or FORFIVO XL, the extended-release formulations, and APLENZIN, the extended-release formulation of bupropion hydrobromide).
In addition, there are a number of generic bupropion HCl products for the immediate-, sustained-, and extended-release formulations. Potential for Cognitive and Motor Impairment Advise patients that any CNS‑active drug like WELLBUTRIN SR may impair their ability to perform tasks requiring judgment or motor a…
💬 Medication Guide ▾
MEDICATION GUIDE WELLBUTRIN SR (WELL byu-trin) (bupropion hydrochloride) Sustained ‑ Release Tablets IMPORTANT: Be sure to read the three sections of this Medication Guide. The first section is about the risk of suicidal thoughts and actions with antidepressant medicines; the second section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; and the third section is entitled “What Other Important Information Should I Know About WELLBUTRIN SR?” Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions This section of the Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines.
What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? 1. Antidepressant medicines may increase the risk of suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment.
2. Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions.
These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? o Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
This is very important when an antidepressant medicine is started or when the dose is changed. o Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. o Keep all follow-up visits with your healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling very agitated or restless • panic attacks • trouble sleeping (insomnia) • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood What else do I need to know about antidepressant medicines? • Never stop an antidepressant medicine without first talking to a healthcare provider.
Stopping an antidepressant medicine suddenly can cause other symptoms. • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. • Antidepressant medicines have other side effects.
Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider.
Do not start new medicines without first checking with your healthcare provider. It is not known if WELLBUTRIN SR is safe and effective in children under the age of 18. Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions This section of the Medication Guide is only about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with drugs used to quit smoking.
Although WELLBUTRIN SR is not a treatme…