Bupropion: Indications…Dosage
- attention-deficit hyperactivity disorder (ADHD)
- depression
- diabetic neuropathy
- neuropathic pain
- nicotine withdrawal
- postherpetic neuralgia
For the treatment of major depression:
NOTE: Generally, acute episodes of depression require several months of sustained pharmacologic therapy. Whether the dose needed to induce remission is identical to that needed for maintenance is unknown. Reassess the patient periodically to determine the individual need for continued treatment and dosage.
Oral dosage (regular-release tablets - e.g., Wellbutrin®):
Adults: Initially, 100 mg PO twice daily; titrate after no less than 3 days to 100 mg PO three times per day if needed; no single dose should exceed 150 mg. The onset of antidepressant effects takes 1-3 weeks, maximal effect may not be noted for 4 weeks. Use the lowest dosage that maintains remission.
Elderly: See adult dosage; may require a reduced initial dose.
Adolescents and children>= 6 years: Not FDA-approved. Suggested dosage ranges from 1.4-6 mg/kg/day PO, titrated upward slowly and administered in divided doses. In trials, the average effective dose is roughly 3 mg/kg/day PO; the maximum dosage is generally 250-300 mg/day PO. Safety data are not extensive; most patients studied have been diagnosed with ADHD.[2503]
Oral dosage (sustained-release tablets - Wellbutrin® SR):
Adults: Initially, 150 mg PO once daily in the morning; titrate after no less than 4 days to 150 mg PO twice daily if needed. After several weeks, titrate to 200 mg PO twice daily if needed; administer doses at least 8 hours apart. The onset of antidepressant effects takes 1-3 weeks, maximal effect may not be noted for 4 weeks. Use the lowest dose that maintains remission.
Elderly: See adult dosage; may require a reduced initial dose.
Adolescents and children: Safe and effective use has not been established.
Oral dosage (extended-release tablets - Wellbutrin® XL):
Adults: Initially, 150 mg PO once daily in the morning; after no less than 4 days titrate to a usual target dose of 300 mg PO once daily based upon patient response and tolerance. Maximum dosage 450 mg/day PO; no single dose should exceed 450 mg/day. According to the manufacturer, the incidence of seizures in patients taking a Wellbutrin® XL single dose of 450 mg is 0.4%.
Elderly: See adult dosage; may require a reduced initial dose.
Adolescents and children: Safe and effective use has not been established.
For use as an adjunct in the management of smoking cessation (including smokeless tobacco cessation) in patients with nicotine withdrawal:
for aide with tobacco cessation using bupropion as the sole pharmacologic agent:
Oral dosage (sustained-release tablets - Zyban ®):
Adults: Initially, 150 mg PO once daily for the first 3 days, then 150 mg PO twice daily for the remainder of the treatment period; doses should be at least 8 hours apart. Do not exceed 300 mg/day PO. Initiate bupropion therapy 1-2 weeks before the patient’s target smoking ‘quit day’. The goal is complete abstinence. Bupropion should be continued for 7-12 weeks. Nicotine abstinence rates in clinical trials after 6 weeks of therapy were 44.2% for bupropion 300 mg/day versus 19% with placebo. At one year, the abstinence rate was superior to placebo for those patients receiving bupropion at 300 mg/day or 150 mg/day, but not for the 100 mg/day dosage.[1485]
Elderly: See adult dosage; may require a reduced initial dose.
Adolescents and children: Not recommended for smoking cessation.
for aide with smoking cessation using bupropion in combination with a nicotine transdermal system (NTS):
NOTE: Prior to use of combination therapy, review the complete prescribing information for both bupropion and the NTS (see Nicotine monograph). Monitor for treatment-induced hypertension.
Oral dosage (sustained-release tablets - Zyban ®):
Adults: 150 mg PO once daily for the first 3 days, then 150 mg PO twice daily for the remainder of the treatment period; doses should be at least 8 hours apart. Do not exceed 300 mg/day PO. Initiate bupropion 1-2 weeks before the target ‘quit day’. The NTS should be initiated on the target ‘quit date’. Continue bupropion for 7-12 weeks. Most NTS can be continued for 8-20 weeks. The goal is complete abstinence. One clinical trial indicates that the combination of bupropion with NTS results in abstinence rates of 51% at week 10 following a 4-week quit program, however, one year after the target quit-date, the bupropion and NTS combination is not significantly better at maintaining abstinence than the use of bupropion alone.[2508]
Elderly: See adult dosage; may require a reduced initial dose.
Adolescents and children: Not recommended for smoking cessation.
For use as an alternative to stimulants for the adjunctive treatment of attention-deficit hyperactivity disorder (ADHD):
Oral dosage (regular-release tablets - e.g., Wellbutrin®):
Adults: Initially, 100 mg PO twice daily; may titrate after at least 3 days to 100 mg PO three times per day; no single dose should exceed 150 mg. The lowest dosage that maintains remission is recommended. Insomnia may be minimized by avoiding bedtime doses.
Adolescents and children>= 6 years: Not FDA-approved. Suggested dosages range from 1.4-6 mg/kg/day PO, titrated upward slowly and administered in divided doses. In trials, the average effective dose is roughly 3 mg/kg/day PO; the maximum dosage is generally 250-300 mg/day PO. Bupropion appears to work as effectively as psychostimulants in these small trials; however safety data are not extensive.[2509-2510]
Children< 6 years: Not recommended.
For the symptomatic treatment of neuropathic pain due to various causes, including pain associated with peripheral diabetic neuropathy or postherpetic neuralgia:
Oral dosage (sustained-release tablets - e.g., Wellbutrin® SR):
Adults: In one trial, 150-300 mg/day PO was reported effective; 73% of patients receiving bupropion reported improvement in pain versus 10% with placebo. Patients began to experience pain relief at week 2 of treatment.[3397]
Maximum Dosage Limits:
Adults: Regular-release tablets 450 mg/day PO, no single dose should exceed 150 mg. Wellbutrin® SR, 400 mg/day PO; no single dose should exceed 200 mg. Zyban ® 300 mg/day PO for smoking cessation; no single dose should exceed 150 mg. For Wellbutrin® XL 450 mg/day PO; no single dose should exceed 450 mg.
Elderly: Regular-release tablets 450 mg/day PO, no single dose should exceed 150 mg. Wellbutrin® SR, 400 mg/day PO; no single dose should exceed 200 mg. Zyban ® 300 mg/day PO for smoking cessation; no single dose should exceed 150 mg. For Wellbutrin® XL 450 mg/day PO; no single dose should exceed 450 mg.
Adolescents: Limited data; 250-300 mg/day PO for regular-release tablets has been suggested; not FDA-approved.
Children>= 6 years: Limited data; 250-300 mg/day PO for regular-release tablets has been suggested; not FDA-approved.
Children<= 5 years: Safe and effective use has not been established.
Patients with hepatic impairment:
In patients with severe hepatic cirrhosis, initiate therapy at a lower dosage and do not exceed 75 mg/day PO for immediate-release Wellbutrin® and should not exceed 100 mg/day or 150 mg every other day for Wellbutrin® SR or Zyban ®. Consider reduced dosage or dosage frequency in patients with mild-to-moderate hepatic impairment; however, no guidelines are available.
Patients with renal impairment:
Dosage should be modified depending on clinical response and degree of renal impairment, but no quantitative recommendations are available. Consider reduced dosage or dosage frequency.
[ Last revised: 9/23/2004 11:48:00 AM ]
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References
1485. Hurt RD, Sachs DPL, Glover ED et al. A comparison of sustained-release bupropion and placebo for smoking cessation. N Engl J Med 1997;337:1195-202.
2503. McConville BJ, Chaney RO, Browne KL, et al. Newer antidepressants-beyond selective serotonin reuptake inhibitor antidepressants. Ped Clin North Am 1998;45:1157-71.
2508. Jorenby DE, Leischow SJ, Nides MA, et al. A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation. N Engl J Med 1999;340:685-91.
2509. Conners CK, Casat CD, Gualtieri CT, et al. Bupropion versus methylphenidate for the treatment of attention-deficit hyperactivity disorder. J Am Acad Child Adolesc Psychiatry 1995;34:649-57.
2510. Barrickman LL, Perry PJ, Allen AJ, et al. Bupropion hydrochloride in attention deficit disorder with hyperactivity. J Am Acad Child Adolesc Psychiatry 1996;35:1314-21.
3397. Semenchuk MR, Sherman S, Davis B. Double-blind, randomized trial of bupropion SR for the treatment of neuropathic pain. Neurology 2001;57:1583-8.
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