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Wellbutrin SR (Bupropion Hydrochloride) - Summary

 
 



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.


See all Wellbutrin SR indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Wellbutrin SR (Bupropion)

FDA Approves Bupropion/Naltrexone (Contrave) for Obesity
Source: Medscape Diabetes & Endocrinology Headlines [2014.09.10]
After a rocky start, the FDA has finally approved the obesity medication, but with a boxed warning about the risk for suicidal thoughts and serious neuropsychiatric events.
FDA Approvals

Third Obesity Drug Wins FDA Okay
Source: MedPage Today Cardiovascular [2014.09.11]
(MedPage Today) -- Following an earlier snub, the FDA finally approved the weight-loss drug Contrave, a combination of bupropion and naltrexone, the agency announced.

more news >>

Published Studies Related to Wellbutrin SR (Bupropion)

Bupropion sustained release added to group support for smoking cessation in schizophrenia: a new randomized trial and a meta-analysis. [2012]
CONCLUSIONS: New clinical trial data and a meta-analysis strongly support the

The DRD4 Exon III VNTR, Bupropion, and Associations With Prospective Abstinence. [2012]
cognitive-behavioral mood management therapy... CONCLUSIONS: VNTR by treatment interaction

A retrospective analysis of two randomized trials of bupropion for methamphetamine dependence: suggested guidelines for treatment discontinuation/augmentation. [2012]
BACKGROUND: Two clinical trials have shown efficacy for bupropion in treating methamphetamine (MA) dependence among those with moderate baseline MA use. However, treatment response is highly variable and it is unclear what duration of treatment is necessary to determine if maintaining the treatment course is indicated or if discontinuation or augmentation is appropriate.

Smoking cessation pharmacogenetics: analysis of varenicline and bupropion in placebo-controlled clinical trials. [2012]
Despite effective therapies for smoking cessation, most smokers find quitting difficult and most successful quitters relapse. Considerable evidence supports a genetic risk for nicotine dependence; however, less is known about the pharmacogenetics of smoking cessation... Different loci are associated with varenicline vs bupropion response, suggesting that additional research may identify clinically useful markers to guide treatment decisions.

Effects of varenicline and bupropion on cognitive processes among nicotine-deprived smokers. [2012]
Nicotine deprivation is associated with craving, negative affect, and difficulty concentrating, which may contribute to subsequent relapse... Identifying these mechanisms may help in the development of new pharmacological treatments.

more studies >>

Clinical Trials Related to Wellbutrin SR (Bupropion)

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

- To evaluate the efficacy of bupropion extended release (Wellbutrin XL™) in the treatment

of Major Depressive Disorder in women with breast cancer.

- To evaluate the tolerability of bupropion extended-release (Wellbutrin XL™) in these

patients

The Effects of Acute Administration of Bupropion on Neural Substrates Underlying Hedonic Capacity [Completed]
The purpose of the study is to evaluate the effects of a single-dose of Wellbutrin XL (bupropion hydrochloride) on reward processing.

Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions [Recruiting]
The objective of this study is to evaluate the comparative bioavailability between bupropion hydrochloride 300 mg extended release tablets (Teva Pharmaceuticals USA) and Wellbutrin XL® 300 mg extended release tablets (Biovail Pharmaceuticals, Inc.) at steady-state in patients under fasting conditions.

Zyban as an Effective Smoking Cessation Aid for Patients Following an Acute Coronary Syndrome: The ZESCA Trial [Recruiting]
Patients who continue to smoke after a heart attack have a 35% increased risk of a recurrent event or death compared with those who quit. Many patients attempt to stop smoking after a heart attack, but relapse rates approach 66%. A variety of smoking cessation aids have been shown to be effective for the general population. However, bupropion is the only non-nicotine replacement therapy shown to improve abstinence rates in healthy young smokers. Furthermore, nicotine replacement therapies (NRTs) are contraindicated in the immediate period following a heart attack because of the undesirable effects of nicotine. Although bupropion has been successfully used to reduce smoking rates in healthy young populations, its efficacy and safety in the setting of patients recovering from an ACS is unknown. These patients, if they continue to smoke, are at exceptionally high risk for recurrent cardiac events. If bupropion is effective in this population, it will have a major impact on secondary prevention of recurrent clinical events in patients who suffer a heart attack.

Phase I Study to Evaluate the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients [Not yet recruiting]
This is a multi center, open-label study to study the drug-drug interaction of LDE225 on the PK of warfarin and bupropion in patients with advanced solid tumors. Subjects will receive 800mg daily of LDE225 and two separate doses of either bupropion or warfarin.

more trials >>

Reports of Suspected Wellbutrin SR (Bupropion) Side Effects

Drug Ineffective (15)Nausea (14)Diarrhoea (11)Headache (9)Fatigue (9)Dizziness (9)Product Quality Issue (9)Decreased Appetite (8)Anxiety (8)Constipation (7)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 11 ratings/reviews, Wellbutrin SR has an overall score of 8.27. The effectiveness score is 8.36 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Wellbutrin SR review by 45 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   depression
Dosage & duration:   200 mg taken 1x am for the period of 24 months
Other conditions:   N/A
Other drugs taken:   trazadone
  
Reported Results
Benefits:   I began to notice the positive benefits within a few weeks. My mood brightened, I stopped feeling grief and self-loathing, began to remember what I liked to do. I also had increased ability to concentrate, increased energy, increased sex drive. I was no longer depressed. I stopped taking the medication after a couple of years, and the symptoms of depression did not return.
Side effects:   I actually felt pretty upset during the first couple of weeks - shaky, a little manic and sensitive. That did go away, though. I also had occasional insomnia throughout.
Comments:   I met with my physician four weeks after I began taking the medication, then 3 months later, then every six months. I did not attend talk therapy or receive any other treatment.

 

Wellbutrin SR review by 55 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   depression
Dosage & duration:   1 per day 150 mg SR taken daily for the period of 7yrs
Other conditions:   acid reflux
Other drugs taken:   Prilosec; Effexor
  
Reported Results
Benefits:   It helped with depression and suicidal thoughts. I was able to sleep better and deal with anxiety and stress better.
Side effects:   dry mouth was the worst side effect but since I should drink more water anyway it was a mixed blessing.
Comments:   Effexor and Wellbutrin kept my depression under control - I took more during the winter months and less the rest of the year.

 

Wellbutrin SR review by 41 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   depression
Dosage & duration:   150 mg x2 daily taken morning and bight for the period of 3 months
Other conditions:   menopausal
Other drugs taken:   premarin
  
Reported Results
Benefits:   i dont think i felt anything positive, no mood change, just the same really although i am smoking a lot less, it does a good job of taking away cravings for nicotine
Side effects:   anxiety, anxiety, anxiety
Comments:   to take 2 daily, the results are meant to be felt about 1 month after starting treatment

See all Wellbutrin SR reviews / ratings >>

Page last updated: 2014-09-11

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