"Oct. 5, 2012 -- The FDA has withdrawn its approval of Teva Pharmaceutical's Budeprion XL 300-mg tablets, a generic version of GSK's Wellbutrin XL extended-relief antidepressant.
The FDA action comes five years after patients complaine"...
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Details with Side Effects
Human Overdose Experience
Overdoses of up to 30 g or more of bupropion have been reported. Seizure was reported in approximately one third of all cases. Other serious reactions reported with overdoses of bupropion alone included hallucinations, loss of consciousness, sinus tachycardia, and ECG changes such as conduction disturbances (including QRS prolongation) or arrhythmias. Fever, muscle rigidity, rhabdomyolysis, hypotension, stupor, coma, and respiratory failure have been reported mainly when bupropion was part of multiple drug overdoses.
Although most patients recovered without sequelae, deaths associated with overdoses of bupropion alone have been reported in patients ingesting large doses of the drug. Multiple uncontrolled seizures, bradycardia, cardiac failure, and cardiac arrest prior to death were reported in these patients.
Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. EEG monitoring is also recommended for the first 48 hours post-ingestion. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended.
Activated charcoal should be administered. There is no experience with the use of forced diuresis, dialysis, hemoperfusion, or exchange transfusion in the management of bupropion overdoses. No specific antidotes for bupropion are known.
Due to the dose-related risk of seizures with WELLBUTRIN XL (bupropion hydrochloride extended-release) , hospitalization following suspected overdose should be considered. Based on studies in animals, it is recommended that seizures be treated with intravenous benzodiazepine administration and other supportive measures, as appropriate.
In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose. Telephone numbers for certified poison control centers are listed in the Physicians' Desk Reference (PDR).
WELLBUTRIN XL (bupropion hydrochloride extended-release) is contraindicated in patients with a seizure disorder. WELLBUTRIN XL is contraindicated in patients treated with ZYBAN®(bupropion hydrochloride) Sustained-Release Tablets; WELLBUTRIN®(bupropion hydrochloride), the immediate-release formulation; WELLBUTRIN SR, (bupropion hydrochloride), the sustained-release formulation; or any other medications that contain bupropion because the incidence of seizure is dose dependent.
WELLBUTRIN XL (bupropion hydrochloride extended-release) 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 XL (bupropion hydrochloride extended-release) is contraindicated in patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines).
The concurrent administration of WELLBUTRIN XL (bupropion hydrochloride extended-release) 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 XL (bupropion hydrochloride extended-release) .
WELLBUTRIN XL (bupropion hydrochloride extended-release) is contraindicated in patients who have shown an allergic response to bupropion or the other ingredients that make up WELLBUTRIN XL (bupropion hydrochloride extended-release) .
Last reviewed on RxList: 1/24/2011
This monograph has been modified to include the generic and brand name in many instances.
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