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Wellbutrin SR (Bupropion Hydrochloride) - Summary

 

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Suicidality and Antidepressant Drugs

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 WELLBUTRIN SR 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. WELLBUTRIN SR is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

 

WELLBUTRIN SR SUMMARY

WELLBUTRIN SR®
(bupropion hydrochloride)
Sustained-Release Tablets

WELLBUTRIN SR (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride.

WELLBUTRIN SR is indicated for the treatment of depression.

The efficacy of bupropion in the treatment of depression was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL PHARMACOLOGY).

A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least five of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

The efficacy of WELLBUTRIN SR in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use WELLBUTRIN SR for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

WELLBUTRIN SR NEWS HIGHLIGHTS

Media Articles Related to Wellbutrin SR (Bupropion)

Nicotine Patch May Be More Helpful Than Bupropion for Adolescent Smoking Cessation
Source: Medscape Primary Care Headlines [2004.08.19]

Actavis Receives Approval Of Generic Wellbutrin XL(R) 300mg In The United States
Source: Depression News From Medical News Today [2008.08.19]

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Published Studies Related to Wellbutrin SR (Bupropion)

Randomized, placebo-controlled trial of bupropion for the treatment of methamphetamine dependence. [2008.08.01]

Eight-week, placebo-controlled, double-blind comparison of the antidepressant efficacy and tolerability of bupropion XR and venlafaxine XR. [2008.07.17]

A placebo-controlled trial of bupropion combined with nicotine patch for smoking cessation in schizophrenia. [2008.06.01]

A randomized, double-blind, placebo-controlled study of the effect of sustained-release bupropion on blood pressure in individuals with mild untreated hypertension. [2008.06]

Toward Personalized Therapy for Smoking Cessation: A Randomized Placebo-controlled Trial of Bupropion. [2008.04.02]

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Clinical Trials Related to Wellbutrin SR (Bupropion)

Wellbutrin XL, Major Depressive Disorder and Breast Cancer [Completed]

The Effects of Acute Administration of Bupropion on Neural Substrates Underlying Hedonic Capacity [Completed]

Randomized Trial of Ultrashort Psychotherapy vs Sustained-Release Bupropion for Smoking Cessation [Completed]

Chantix & Bupropion for Smoking Cessation [Active, not recruiting]

Wellbutrin XL for Dysthymic Disorder [Completed]

more>>

Page last updated: 2008-08-19

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