0000100924 00000 n
limited by the small number of exposed cases, inconsistent findings among
metabolites in 9 subjects with mild to moderate hepatic cirrhosis compared to 8 respectively) and more variable when compared to values in healthy volunteers; There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. Use low initial doses of WELLBUTRIN XL and increase the dose that the excessive use or the abrupt discontinuation of alcohol, benzodiazepines, In rats, bupropion produced amphetamine-like and cocaine-like discriminative stimulus effects in drug discrimination paradigms used to characterize the subjective effects of psychoactive drugs.Overdoses of up to 30 grams or more of bupropion have been reported. summarizes the most important information about WELLBUTRIN XL. The median In the SAD trials, 82% of patients were treated with 300 mg per day, and 18% were treated with 150 mg per day. 1. pressure and Assess blood pressure before initiating treatment with After 7 days of dosing, the dose may be increased to the target dose of 300 mg once daily in the morning. The efficacy results were significant for the HAMD 0000001948 00000 n Increase the dose gradually. threohydrobupropion are longer, approximately 33 (±10) and 37 (±13) hours, There was a dose-related decrease in body weight.Table 6 presents the incidence of body weight changes ( ≥ 5 lbs) in the 3 SAD trials using bupropion HCl hydroxybupropion and about 2½-fold for threo/erythrohydrobupropion. The mean half-lives for hydroxybupropion and threo/erythrohydrobupropion 0000099307 00000 n These postmarketing reports have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide [Neuropsychiatric adverse events occurred in patients without and with pre-existing psychiatric disease; some patients experienced worsening of their psychiatric illnesses. sustained-release, 4%, 9%, and 11% of the placebo, 300 mg/day and 400 mg/day Advise patients that the excessive use or the abrupt discontinuation of alcohol, benzodiazepines, antiepileptic drugs, or sedatives/hypnotics can increase the risk of seizure. e��1NK��J��ev�@O��41��A� ��q�1K;�0����VK��n�|>W8�pg��*��=�H�z[�5��vs�\��.�����x���Q�C��:� Such monitoring should include daily observation by families and caregivers. %PDF-1.4 %���� The differences in half-life for bupropion and the other metabolites in the 2 groups were minimal.The second trial demonstrated no statistically significant differences in the pharmacokinetics of bupropion and its active metabolites in 9 subjects with mild to moderate hepatic cirrhosis compared to 8 healthy volunteers.
Doses above 300 mg of bupropion HCl The risk of hypertension is increased if Wellbutrin XL is used concomitantly with MAOIs or other drugs that increase dopaminergic or noradrenergic activity Data from a comparative trial of the sustained-release formulation of bupropion HCl, nicotine transdermal system (NTS), the combination of sustained-release bupropion plus NTS, and placebo as an aid to smoking cessation suggest a higher incidence of treatment-emergent hypertension in patients treated with the combination of sustained-release bupropion and NTS. attractive to those who abuse CNS stimulant drugs.Bupropion hydrochloride extended-release tablets are hypertension is increased if WELLBUTRIN XL is used concomitantly with MAOIs or products, antipsychotics, antidepressants, theophylline, or systemic The relationship of bupropion exposure and these seizures is unclear.Safety and effectiveness in the pediatric population have not been established. reported when bupropion has been administered intranasally or by Studies in rodents and primates demonstrated that The dose should not exceed 300 mg once daily. measured by the Hamilton Depression Rating Scale (HAMD) total score, the HAMD This study This trial demonstrated the efficacy of bupropion for only the 450 mg dose.