"Oct. 5, 2012 -- The FDA has withdrawn its approval of Teva Pharmaceutical's Budeprion XL 300-mg tablets, a generic version of GSK's Wellbutrin XL extended-relief antidepressant.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"...
- Patient Information:
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 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. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients.
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 BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) , 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).
BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) is contraindicated in patients with a seizure disorder.
BUDEPRION XL™ is contraindicated in patients treated with ZYBAN® or bupropion hydrochloride sustained-release tablets, WELLBUTRIN® or bupropion hydrochloride immediate-release formulation, WELLBUTRIN SR® or bupropion hydrochloride sustained-release formulation, or any other medications that contain bupropion because the incidence of seizure is dose dependent.
BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) 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.
BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) is contraindicated in patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines).
The concurrent administration of BUDEPRION XL™ (bupropion hydrochloride extended-release 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 BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) .
BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) is contraindicated in patients who have shown an allergic response to bupropion or the other ingredients that make up BUDEPRION XL™ (bupropion hydrochloride extended-release tablets) .
Last reviewed on RxList: 8/8/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Budeprion XL Information
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