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Wellbutrin SR

[Bupropion HCL]

It is not possible to know if the lower seizure incidence observed in this study involving the sustained-release formulation of bupropion resulted from the different formulation or the lower dose used. However, as noted above, the immediate-release and sustained-release formulations are bioequivalent with regard to both rate and extent of absorption during steady state (the most pertinent condition to estimating seizure incidence), since most observed seizures occur under steady-state conditions.

Patient factors

Predisposing factors that may increase the risk of seizure with bupropion use include history of head trauma or prior seizure, central nervous system (CNS) tumor, the presence of severe hepatic cirrhosis, a

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nd concomitant medications that lower seizure threshold.

Clinical situations

Circumstances associated with an increased seizure risk include, among others, excessive use of alcohol or sedatives (including benzodiazepines); addiction to opiates, cocaine, or stimulants; use of over-the-counter stimulants and anorectics; and diabetes treated with oral hypoglycemics or insulin.

Concomitant medications

Many medications (e. g., antipsychotics, antidepressants, theophylline, systemic steroids) are known to lower seizure threshold.

Recommendations for Reducing the Risk of Seizure

Retrospective analysis of clinical experience gained during the development of bupropion suggests that the risk of seizure may be minimized if the total daily dose of WELLBUTRIN SR Tablets does not exceed 400 mg, the daily dose is administered twice daily, and the rate of incrementation of dose is gradual.

No single dose should exceed 200 mg to avoid high peak concentrations of bupropion and/ or its metabolites.

WELLBUTRIN SR ® (bupropion hydrochloride) Sustained-Release Tablets

WELLBUTRIN SR should be administered with extreme caution to patients with a history of seizure, cranial trauma, or other predisposition( s) toward seizure, or patients treated with other agents (e. g., antipsychotics, other antidepressants, theophylline, systemic steroids, etc.) that lower seizure threshold.

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