BUPROPION — 150 mg / 300 mg extended-release tablets
📦 Product Snapshot
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🧠 Overview
Bupropion is an aminoketone antidepressant that is chemically unrelated to other antidepressants (SSRIs, TCAs, MAOIs). It acts as a norepinephrine‑dopamine reuptake inhibitor (NDRI), weakly inhibiting the reuptake of these neurotransmitters while having no significant effect on serotonin. This unique dopaminergic activity distinguishes it from most other antidepressants and contributes to its activating profile and lack of sexual side effects.
Dual clinical utility: First approved for major depressive disorder (MDD) in 1985, bupropion is also indicated for prevention of seasonal affective disorder (SAD) and as a smoking cessation aid (Zyban®). For smoking cessation, bupropion reduces nicotine cravings and withdrawal symptoms by replacing the dopamine deficiency experienced during nicotine withdrawal and by noncompetitively blocking nicotinic acetylcholine receptors. Large trials (EAGLES, 8,134 patients) confirm quit rates nearly double placebo (19.9% vs 11.8%), with no increased neuropsychiatric risk even in patients with psychiatric histories.
Off‑label uses: Extensively used for antidepressant‑induced sexual dysfunction (due to its neutral sexual profile), ADHD (especially in adults), and in combination with naltrexone for obesity (FDA‑approved as Contrave®). The American Gastroenterological Association recommends naltrexone‑bupropion for weight management.
Critical safety context: Bupropion carries an FDA boxed warning for suicidal thoughts and behaviors in children, adolescents, and young adults. It also has a dose‑dependent seizure risk (0.4% at 300 mg, 0.9% at 450 mg) — the highest among common antidepressants — and is contraindicated in seizure disorders and eating disorders (bulimia/anorexia) due to increased seizure susceptibility.
🏷️ Strengths & Brand Examples
- Immediate‑release (IR): 75 mg, 100 mg (3× daily)
- Sustained‑release (SR): 100 mg, 150 mg, 200 mg (12‑hour, twice daily)
- Extended‑release (XL): 150 mg, 300 mg, 450 mg (24‑hour, once daily)
- Hydrobromide salts (Aplenzin®): 174 mg, 348 mg, 522 mg (once daily)
- Wellbutrin® SR / XL (originally GSK, now generic) — MDD, SAD
- Zyban® SR (GSK) — smoking cessation
- Aplenzin® (hydrobromide, 24‑hour) — MDD
- Forfivo® XL (450 mg, once daily) — MDD maintenance
- Bupron® SR 150 mg / XL 300 mg (Sun Pharma) — widely prescribed
- Buprogen® SR 150 mg (Cadila Pharmaceuticals)
- Wellbutrin® SR (GSK India — available in select markets)
- Zyban® SR (GSK India) — smoking cessation
- Generic versions from Granules India (USFDA approved 100/150/200 mg SR)
- Zydus Lifesciences — 150 mg, 300 mg XL (export to US)
⚠️ Safety, Side Effects & Monitoring
- Insomnia (dose‑dependent — avoid bedtime dosing)
- Dry mouth, nausea, constipation
- Headache, dizziness, tremor
- Agitation, anxiety (especially during initiation)
- Excessive sweating, tinnitus, blurred vision
- Anorexia / weight loss (opposite of many antidepressants)
- Rash, pruritus, palpitations
• Seizure risk (dose‑related): Incidence ~0.4% at 300 mg/day, increases to ~0.9% at 450 mg. Contraindicated in seizure disorders, bulimia, anorexia, and abrupt withdrawal from alcohol/benzodiazepines.
• Neuropsychiatric events (smoking cessation): Postmarketing reports of mood changes, psychosis, hallucinations, paranoia, aggression, hostility. Observe patients for such symptoms.
• Hypertension: Can increase blood pressure — monitor BP at baseline and periodically. Risk increased with nicotine patch combination.
• Activation of mania/hypomania: Screen for bipolar disorder before initiation.
• Angle‑closure glaucoma: Rare; advise patients to seek help if eye pain/vision changes occur.
• Allergic reactions: Angioedema, urticaria — discontinue immediately.
- Seizure disorder / history of seizures
- Current or prior diagnosis of bulimia or anorexia nervosa
- Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptics
- Concurrent MAOIs or within 14 days of MAOI discontinuation (risk hypertensive crisis)
- Known hypersensitivity to bupropion or any tablet excipients
CYP2B6 inhibitors (↑ bupropion, seizure risk): Ticlopidine, clopidogrel, fluvoxamine, ketoconazole — reduce dose or avoid
CYP2B6 inducers (↓ efficacy): Rifampin (↓ AUC by 87%), carbamazepine, phenobarbital, efavirenz — may need dose increase
MAOIs: Absolute contraindication — 14‑day washout required
Drugs that lower seizure threshold: Tramadol (4× seizure risk), fluoroquinolones, antipsychotics (clozapine), stimulants — avoid or extreme caution
CYP2D6 substrates: Bupropion inhibits CYP2D6, increasing levels of antidepressants (SSRIs, TCAs), antipsychotics (haloperidol, risperidone), beta‑blockers (metoprolol), Type 1C antiarrhythmics — consider dose reduction
Dopaminergic drugs (levodopa, amantadine): CNS toxicity possible
False‑positive amphetamine urine screens: Warn patients
- Hepatic impairment: Mild — consider dose reduction; moderate‑severe (Child‑Pugh 7–15) — max 75 mg/day IR or 150 mg every other day
- Renal impairment (eGFR 30–60): Max 150 mg once daily; metabolites accumulate — monitor
- Pregnancy: Category C — limited data; avoid unless benefit outweighs risk. Enroll in pregnancy registry if exposed (800-336-2176)
- Breastfeeding: Excreted in milk — caution, especially with newborns/preterm infants
- Geriatric (≥65): Increased sensitivity to CNS effects; start low, go slow
- Pediatric: Not approved for depression (boxed warning); off‑label for ADHD with monitoring
- CYP2B6 poor metabolizers (*6/*6, *18): 30% African descent, 15–20% Asian — higher parent drug, lower metabolite; consider lower starting dose