Wellbutrin SR

[Bupropion HCL]

Warnings & Precautions
WARNINGS

Patients should be made aware that WELLBUTRIN SR contains the same active ingredient found in ZYBAN, used as an aid to smoking cessation treatment, and that WELLBUTRIN SR should not be used in combination with ZYBAN, or any other medications that contain bupropion. Seizures: Bupropion is associated with a dose-related risk of seizures. The risk of seizures is also related to patient factors, clinical situations, and concomitant medications, which must be considered in selection of patients for therapy with WELLBUTRIN SR.

WELLBUTRIN SR should be discontinued and not restarted in patients who experience a seizure while on treatment.

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WELLBUTRIN SR ® (bupropion hydrochloride) Sustained-Release Tablets

Dose

At doses of WELLBUTRIN SR up to a dose of 300 mg/ day, the incidence of seizure is approximately 0.1% (1/ 1,000) and increases to approximately 0.4% (4/ 1,000) at the maximum recommended dose of 400 mg/ day. Data for the immediate-release formulation of bupropion revealed a seizure incidence of approximately 0.4% (i. e., 13 of 3,200 patients followed prospectively) in patients treated at doses in a range of 300 to 450 mg/ day. The 450-mg/ day upper limit of this dose range is close to the currently recommended maximum dose of 400 mg/ day for WELLBUTRIN SR Tablets. This seizure incidence (0.4%) may exceed that of other marketed antidepressants and WELLBUTRIN SR Tablets up to 300 mg/ day by as much as 4-fold. This relative risk is only an approximate estimate because no direct comparative studies have been conducted.

Additional data accumulated for the immediate-release formulation of bupropion suggested that the estimated seizure incidence increases almost tenfold between 450 and 600 mg/ day, which is twice the usual adult dose and one and one-half the maximum recommended daily dose (400 mg) of WELLBUTRIN SR Tablets. This disproportionate increase in seizure incidence with dose incrementation calls for caution in dosing. Data for WELLBUTRIN SR Tablets revealed a seizure incidence of approximately 0.1% (i. e., 3 of 3,100 patients followed prospectively) in patients treated at doses in a range of 100 to 300 mg/ day.

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