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Pharmacology Page 7
Symptoms And Treatment Of Overdose: Symptoms and Treatment: Human Overdose Experience: Three overdoses with bupropion occurred during clinical trials. One patient ingested 3 000 mg of bupropion and vomited quickly after
the overdose; the patient experienced lightheadedness. A second patient ingested a "handful" of bupropion and experienced confusion, lethargy, nausea, jitteriness and seizure. A third patient ingested 3 600 mg of bupropion tablets and
a bottle of wine; the patient experienced nausea, visual hallucinations and "grogginess". None of the patients experienced further sequelae.
The information included in the remainder of this section is based on the clinical 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 bupropion immediate release 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 bupropion alone
included hallucinations, loss of consciousness and sinus tachycardia. Fever, muscle rigidity, rhabdomyolysis, hypotension, stupor, coma and respiratory failure have been reported when bupropion was part of multiple drug overdoses.
Although most patients recovered without sequelae, deaths associated with overdoses of bupropion alone have been reported rarely in patients ingesting massive doses of bupropion immediate release tablets. Multiple uncontrolled seizures, bradycardia,
cardiac failure, and cardiac arrest prior to death were reported in these patients.
Management of Overdose: Following suspected overdose, hospitalization is advised. If the patient is conscious, vomiting should be induced by syrup of ipecac. Activated charcoal also may be administered every 6 hours during the first 12 hours after
ingestion. Baseline laboratory values should be obtained. ECG and EEG monitoring also are recommended for the next 48 hours. Adequate fluid intake should be provided.
If the patient is stuporous, comatose, or convulsing, airway intubation is recommended prior to undertaking gastric lavage. Although there is little clinical experience with lavage following an overdose of bupropion immediate release and none
with bupropion sustained release, it is likely to be of benefit within the first 12 hours after ingestion since absorption of the drug may not yet be complete.
While diuresis, dialysis, or hemoperfusion are sometimes used to treat overdosage, there is no experience with their use in the management of overdoses of bupropion sustained release. Because diffusion of bupropion and its metabolites from tissue
to plasma may be slow, dialysis may be of minimal benefit.
Based on studies in animals, it is recommended that seizures be treated with an i.v. benzodiazepine preparation and other supportive measures, as appropriate.
Further information about the treatment of overdoses may be available from a poison control center.
Pregnancy , Labor and Delivery: There are no adequate and well-controlled studies of bupropion in pregnant women.
Bupropion should thus not be used during pregnancy unless the potential benefit is judged to outweigh the potential risk. To monitor fetal outcomes of pregnant women exposed to bupropion, Glaxo Wellcome Inc. maintains a Bupropion Pregnancy Registry.
Health care providers are encouraged to register patients by calling (800) 722-9292, ext. 39441.
Lactation: Like many other drugs, bupropion and its metabolites are secreted in human milk. Because of the potential
for serious adverse reactions in nursing infants from bupropion, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. |
