Wellbutrin SR - Overdosage & Contraindications

CONTRAINDICATIONS

WELLBUTRIN SR is contraindicated in patients with a seizure disorder.

WELLBUTRIN SR is contraindicated in patients treated with ZYBAN ® (bupropion hydrochloride) Sustained-Release Tablets, or any other medications that contain bupropion because the incidence of seizure is dose dependent. WELLBUTRIN SR is contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa because of a higher incidence of seizures noted in patients treated for bulimia with the immediate-release formulation of bupropion.

WELLBUTRIN SR is contraindicated in patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines).

The concurrent administration of WELLBUTRIN SR Tablets and a monoamine oxidase (MAO) inhibitor is contraindicated.

At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of treatment with WELLBUTRIN SR Tablets. WELLBUTRIN SR is contraindicated in patients who have shown an allergic response to bupropion or the other ingredients that make up WELLBUTRIN SR Tablets.

OVERDOSAGE

Human Overdose Experience

There has been very limited experience with overdosage of WELLBUTRIN SR Tablets; 3 cases were reported during clinical trials. One patient ingested 3,000 mg of WELLBUTRIN SR Tablets and vomited quickly after the overdose; the patient experienced blurred vision and lightheadedness. A second patient ingested a "handful" of WELLBUTRIN SR Tablets and experienced confusion, lethargy, nausea, jitteriness, and seizure. A third patient ingested 3,600 mg of WELLBUTRIN SR Tablets and a bottle of wine; the patient experienced nausea, visual hallucinations, and "grogginess." None of the patients experienced further sequelae. There has been extensive experience with overdosage of the immediate-release formulation of bupropion.

Thirteen overdoses occurred during clinical trials. Twelve patients ingested 850 to 4,200 mg and recovered without significant sequelae. Another patient who ingested 9,000 mg of the immediate-release formulation of bupropion and 300 mg of tranylcypromine experienced a grand mal seizure and recovered without further sequelae. Since introduction, overdoses of up to 17,500 mg of the immediate-release formulation of bupropion have been reported. Seizure was reported in approximately one third of all cases. Other serious reactions reported with overdoses of the immediate-release formulation of bupropion alone included hallucinations, loss of consciousness, and sinus tachycardia. Fever, muscle rigidity, rhabdomyolysis, hypotension, stupor, coma, and respiratory failure have been reported when the immediate-release formulation of bupropion was part of multiple drug overdoses.