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Aplenzin (Bupropion Hydrobromide) - Summary




Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of APLENZIN or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber [see Warnings and Precautions ].


Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation [see Warnings and Precautions ]. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking bupropion who continued to smoke. Although APLENZIN is not approved for smoking cessation, observe all patients for neuropsychiatric reactions. Instruct the patient to contact a healthcare provider if such reactions occur [see Warnings and Precautions ].



Aplenzin (bupropion hydrobromide), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents.

Aplenzin™ (bupropion hydrobromide extended-release tablets) is indicated for the treatment of major depressive disorder.
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Published Studies Related to Aplenzin (Bupropion)

Interactions between bupropion and 3,4-methylenedioxymethamphetamine in healthy subjects. [2015]
3,4-Methylenedioxymethamphetamine (MDMA; "ecstasy") is a popular recreational drug. The aim of the present study was to explore the role of dopamine in the psychotropic effects of MDMA using bupropion to inhibit the dopamine and norepinephrine transporters through which MDMA releases dopamine and norepinephrine by investigating.

Bupropion in adults with Attention-Deficit/Hyperactivity Disorder: a randomized, double-blind study. [2014]
Attention-Deficit/Hyperactivity Disorder is one of the most common mental disorders in childhood, and it continues to adulthood without proper treatment. Stimulants have been used in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) for many years, and the efficacy of methylphenidate in the treatment of adults with ADHD has been proven to be acceptable according to meta-analysis studies.

SSRI versus bupropion effects on symptom clusters in suicidal depression: post hoc analysis of a randomized clinical trial. [2013]
CONCLUSIONS: The results require replication but suggest a pathway by which

Bupropion for smoking cessation in patients hospitalized with acute myocardial infarction: a randomized, placebo-controlled trial. [2013]
patients with acute myocardial infarction (AMI)... CONCLUSIONS: Two-thirds of patients return to smoking by 12 months after AMI.

The DRD4 exon III VNTR, bupropion, and associations with prospective abstinence. [2013]
cognitive-behavioral mood management therapy... CONCLUSIONS: VNTR by treatment interaction differences between these and previous

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Clinical Trials Related to Aplenzin (Bupropion)

Bupropion Depression [Recruiting]
Determine bioequivalence between branded and generic bupropion extended release (XL) products (and between generic products) at steady state in patients with major depressive disorder.

Drug Interaction Study of Multiple Doses of Isavuconazole and a Single Dose of Bupropion [Completed]

Bupropion for Smoking Cessation During Pregnancy [Recruiting]
This is a prospective, double-blind placebo-controlled randomized controlled trial of the preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for smoking cessation during pregnancy.

Phase I Study to Evaluate the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients [Recruiting]
This is a multi center, open-label study to evaluate the drug-drug interaction of LDE225 on the PK of bupropion and warfarin patients with advanced solid tumors. Subjects will receive 800mg daily of LDE225 and two separate doses of either bupropion or warfarin.

Influence of Bupropion on the Effects of MDMA [Completed]
The purpose of this study is to determinate the effect of a pre-treatment with bupropion, a dopamine and norepinephrine transporter inhibitor, on the pharmacodynamics and pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy"). The study will provide further understanding of the dopaminergic regulation of mood.

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Page last updated: 2015-08-10

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