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

 

WELLBUTRIN SUMMARY

WELLBUTRIN®
(bupropion hydrochloride)
Tablets

WELLBUTRIN (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 is indicated for the treatment of depression. A physician considering WELLBUTRIN for the management of a patient's first episode of depression should be aware that the drug may cause generalized seizures in a dose-dependent manner with an approximate incidence of 0.4% (4/1,000). This incidence of seizures may exceed that of other marketed antidepressants by as much as 4-fold. This relative risk is only an approximate estimate because no direct comparative studies have been conducted (see WARNINGS).

The efficacy of WELLBUTRIN has been established in 3 placebo-controlled trials, including 2 of approximately 3 weeks' duration in depressed inpatients and one of approximately 6 weeks' duration in depressed outpatients. The depressive disorder of the patients studied corresponds most closely to the Major Depression category of the APA Diagnostic and Statistical Manual III.

Major Depression implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.

Effectiveness of WELLBUTRIN in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use WELLBUTRIN for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.


See all Wellbutrin indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Wellbutrin (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 (Bupropion)

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.

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

more studies >>

Clinical Trials Related to Wellbutrin (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 (Bupropion) Side Effects

Drug Ineffective (103)Depression (45)Suicidal Ideation (32)Weight Increased (27)Anxiety (27)Nausea (25)Convulsion (25)Feeling Abnormal (25)Pain (23)Insomnia (23)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 42 ratings/reviews, Wellbutrin has an overall score of 7.19. The effectiveness score is 7.43 and the side effect score is 7.48. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Wellbutrin review by 27 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Depression
Dosage & duration:   300mg / day taken 2x daily for the period of I have been on it for 6 years now
Other conditions:   Inreased sweating at night, mild dehydration, trouble sleeping at times
Other drugs taken:   Celexia
  
Reported Results
Benefits:   I began taking the drug to control my Bulimia, which was the main symptom of my depression. It also helped me stop smoking.
Side effects:   Very few. I noticed right away that I had trouble sleeping from my high dosage. My ddoctor then prescribed 40mg / day of Celexia to counteract the restlessness.
Comments:   After about 1 month of taking the drug, the bingeing and purging decreased greatly. (from maybe 4 or 5 times /day to about once a month, if that. After 6 years of being on the medication, my Bulimia is under control and depression seems situational.

 

Wellbutrin review by 40 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Bipolar Disorder II
Dosage & duration:   100 mg taken 2x daily for the period of 6 Years
Other conditions:   None
Other drugs taken:   Topomax
  
Reported Results
Benefits:   I had a nervous breakdown suddenly and unexpectedly. After 1 week in the psych ward, I was prescribed 2 medications that I soon realized didn't help. Over the course of 1 year, I tried many different combinations of anti-depresants which didn't work. Not until I tried both wellbutrin and topomax together did I start recovering from my breakdown. About 1 1/2 years ago I discontinued the Topomax and I've only used the Wellbutrin since it helps me maintain my health.
Side effects:   I didn't experience any side effects.
Comments:   See above as that thoroughly explains everything.

 

Wellbutrin review by 37 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   Anxety / Depression
Dosage & duration:   150mg taken daily / 150mg in morning for the period of 1 month
Other conditions:   sexual dysfunction
Other drugs taken:   birth control, Hydrochlorothiadzide
  
Reported Results
Benefits:   I only started this medication to still treat my Anxiety and mild depression, but eliminate the desire not to want sex.
Side effects:   Irritable, sleeplessness, rages of angry, fatigue, high blood pressure
Comments:   My OBGYN switched me from Prozac to Wellbutrin in efforts to help with the sexual side affects. Well, it did absolulte nothing to help in that area and instead made me more depressed, irritable, had severe rages, crying all the time, no desire to get out of bed, hot flashes and my blood pressure spiked tremendously. I went back to my PCP and I'm back to Zoloft which I had taken in the past and although I'm still having w/d's from the Wellbutrin, I'm felling 80% better in it's only been 3 days. I tossed all the remaining pills out. This drug clearly didn't work for my body. What a horrible experience to go through. I will in the future only get these types of meds from my PCP and not my OBGYN.

See all Wellbutrin reviews / ratings >>

Page last updated: 2014-09-11

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