Bupropione

Bupropion hydrochloride SR

Usi approvati

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

Forme e dosaggi

• 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.

Come si assume

• 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.

Non deve essere usato in caso di

• 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.

Interazioni

• 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).

Avvertenze e precauzioni

• 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.

Effetti indesiderati comuni

• 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.

Gravidanza

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.

Meccanismo d'azione

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.

Titolare dell'autorizzazione:

Epic Pharma, LLC

Versione della scheda:

28 febbraio 2026

Le sezioni qui sopra sono citate dalla scheda in lingua inglese, perché è quel documento a portare l'approvazione. Dove un'autorità europea pubblica le stesse informazioni in italiano, il link è tra le fonti. Non traduciamo da soli i testi regolatori: un errore di traduzione in una controindicazione sarebbe più pericoloso di una riga in un'altra lingua.

Questa sezione riporta le informazioni sul prodotto approvate. Il testo è condensato dalla sintesi dell'autorità stessa e il documento completo è linkato tra le fonti.