Bupropion Hydrochloride

What it is and how it works

Mechanism of Action The mechanism of action of bupropion is unknown, as is the case with other antidepressants. However, it is presumed that this action is mediated by noradrenergic and/or dopaminergic mechanisms. Bupropion is a relatively weak inhibitor of the neuronal uptake of norepinephrine and dopamine and does not inhibit monoamine oxidase or the reuptake of serotonin.

Indications

Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: • treatment of major depressive disorder (MDD) • prevention of seasonal affective disorder (SAD) Major Depressive Disorder (MDD) Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [ see Clinical Studies ] .

Dosage and administration (summary)

General Increase dose gradually to reduce seizure risk. ( 2.1 , 5.3 ) Periodically reassess the dose and need for maintenance treatment. Major Depressive Disorder Starting dose: 150 mg once daily. Usual target dose: 300 mg once daily. After 4 days, may increase the dose to 300 mg once daily. Seasonal Affective Disorder Initiate treatment in the autumn prior to onset of seasonal depressive symptoms. Starting dose: 150 mg once daily. Usual target dose: 300 mg once daily. After one week, may increase the dose to 300 mg once daily. Continue treatment through the winter season. Hepatic Impairment Moderate to severe hepatic impairment: 150 mg every other day.

Contraindications

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with seizure disorder. Bupropion hydrochloride extended-release tablets (XL) are 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 bupropion hydrochloride extended-release tablets (XL) .

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.

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to 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…

Storage and supply

Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg of bupropion hydrochloride, are white to pale yellow, round biconvex tablet with imprinting “YH 101” in NDC: 70518-4014-00 NDC: 70518-4014-01 PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOTTLE PLASTIC Store at 20° to 25°C (68° to 77°F).

Source: Bupropion Hydrochloride (Bupropion Hydrochloride Xl) — US FDA prescribing information, 2026-06-12, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.