Bupropion

Bupropion hydrochloride SR

Zugelassene Anwendungsgebiete

• Bupropion Hydrochloride Extended-Release Tablets (SR) are an aminoketone agent indicated as an aid to smoking cessation treatment.

Darreichungsformen und Stärken

• 150 mg - purple, film coated, round, biconvex tablets, debossed with "YH" and "111" on one side and plain on the other side.
• Tablets: 150 mg.

Einnahme

• Starting dose: 150 mg per day for first 3 days.
• General: Increase dose gradually to reduce seizure risk.
• Begin dosing one week before quit day.
• After 3 days, increase the dose to 300 mg per day, given as 150 mg twice daily at an interval of at least 8 hours.
• May be used with a nicotine transdermal system.
• Moderate to severe hepatic impairment: 150 mg every other day.

Darf nicht angewendet werden bei

• Bupropion Hydrochloride Extended-Release Tablets (SR) are contraindicated in patients with a seizure disorder.
• The use of MAOIs (intended to treat psychiatric disorders) concomitantly with Bupropion Hydrochloride Extended-Release Tablets (SR) or within 14 days of discontinuing treatment with Bupropion Hydrochloride Extended-Release Tablets (SR) is contraindicated.

Wechselwirkungen

• 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.
• 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).
• Digoxin: May decrease plasma digoxin levels. Monitor digoxin levels.
• Drugs that lower seizure threshold: Dose bupropion hydrochloride extended-release tablets (SR) with caution.
• Dopaminergic drugs (levodopa and amantadine): Central nervous system (CNS) toxicity can occur when used concomitantly with bupropion hydrochloride extended-release tablets (SR).
• MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly with bupropion hydrochloride extended-release tablets (SR).

Warnhinweise und Vorsichtsmaßnahmen

• Neuropsychiatric adverse events: 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.
• Seizure risk: The risk is dose-related. Can minimize risk by gradually increasing the dose and limiting daily dose to 300 mg. Discontinue if seizure occurs.
• Hypertension: Bupropion hydrochloride extended-release tablets (SR) can increase blood pressure. Monitor blood pressure before initiating treatment and periodically during treatment, especially if used with nicotine replacement.
• Activation of mania/hypomania: Screen patients for bipolar disorder and monitor for these symptoms.
• Psychosis and other neuropsychiatric reactions. Instruct patients to contact a healthcare professional if reactions occur.
• Angle-closure glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants.

Häufige Nebenwirkungen

• Most common adverse reactions (incidence ≥5% and ≥1% more than placebo rate) are insomnia, rhinitis, dry mouth, dizziness, nervous disturbance, anxiety, nausea, constipation, and arthralgia.
• most common adverse events in subjects treated with bupropion hydrochloride extended-release tablets (SR) were broadly similar to those observed in premarketing studies.

Schwangerschaft

Pregnancy Category C. Risk Summary Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester indicate no increased risk of congenital malformations overall. All pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss.

Wirkmechanismus

The exact mechanism by which bupropion hydrochloride extended-release tablets (SR) enhances the ability of patients to abstain from smoking 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.

Zulassungsinhaber:

Epic Pharma, LLC

Stand der Fachinformation:

28. Februar 2026

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