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

 

WELLBUTRIN XL SUMMARY

WELLBUTRIN XL®
(bupropion hydrochloride extended-release tablets)

WELLBUTRIN XL (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 XL is indicated for the treatment of major depressive disorder.

The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of 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 5 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 bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial with the sustained-release formulation of bupropion (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use WELLBUTRIN XL for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.


See all Wellbutrin XL indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Wellbutrin XL (Bupropion)

EU Finally Gives Green Light to New Obesity Drug
Source: Medscape Diabetes & Endocrinology Headlines [2014.12.19]
After many years with no new obesity drugs in their armamentarium, European physicians may soon have access to bupropion/naltrexone as an option to help aid weight loss.
International Approvals

more news >>

Published Studies Related to Wellbutrin XL (Bupropion)

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

Sustained-release bupropion for smoking cessation in a Chinese sample: a double-blind, placebo-controlled, randomized trial. [2013]
population... CONCLUSION: Bup-SR is efficacious for smoking cessation in healthy Chinese

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

more studies >>

Clinical Trials Related to Wellbutrin XL (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.

The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior [Recruiting]
The purpose of this study is to examine how smoking cessation medications (varenicline, bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in non-treatment seeking daily smokers.

more trials >>

Reports of Suspected Wellbutrin XL (Bupropion) Side Effects

Convulsion (21)Drug Ineffective (19)Depression (19)Product Quality Issue (14)Anxiety (13)Tremor (11)Agitation (10)Product Substitution Issue (10)Dizziness (10)Confusional State (9)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 35 ratings/reviews, Wellbutrin XL has an overall score of 7.97. The effectiveness score is 7.94 and the side effect score is 7.83. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Wellbutrin XL review by 49 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   anti-depressant
Dosage & duration:   350 (dosage frequency: once a day) for the period of 2 years
Other conditions:   n/a
Other drugs taken:   none
  
Reported Results
Benefits:   The biggest benefit was when I quit smoking, because I had been taking it for a while...it proved to assist with the cravings...it's probably why I was able to quit in the first place.
Side effects:   Made me kind of grumpy and a little weight gain.
Comments:   Started taking anti-depressant when my Mother passed away. Started a low-dose and increased over a period of 3 months. I believe Wellbuterin was very beneficial and did not have major side effects. I stopped taking them 2 months ago and haven't had any withdrawal symptoms.

 

Wellbutrin XL review by 56 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   depression
Dosage & duration:   150mg taken every am for the period of on going
Other conditions:   thyroid, high cholesterol
Other drugs taken:   Synthroid 25mg Simvastaton 20mg
  
Reported Results
Benefits:   Yes, I had taken Prozac for fourteen to fifteen years for the treatment of depession and experienced a loss of sexual desire. I tried the Wellbutrin XL in the hopes that it would not produce this side effect starting about 18 months ago. The Wellbutrin XL does not have this side effect in my experience.
Side effects:   I have not noticed side effects. I was hoping that a good side effect would be that it would help me quit smoking. It hasn't.
Comments:   I don't have any details. Have thought about asking my doctor to up the dosage when I was having a bout of feeling "down" but it passed and I didn't.

 

Wellbutrin XL review by 53 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   lose weight
Dosage & duration:   300mg taken 1x day for the period of 2 weeks
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   Positive- increased libido
Side effects:   Negative- 1)significant increase in breast pain on one side, leading to bloody discharge after only 2 weeks of taking drug 2)'coursing' feeling through veins on same side as breast pain 3)humongous hard pimple formed near nose.
Comments:   Discontinued treatment due to side effects. I would consider taking again if the negative side effects were noted in literature as temporary and insignificant over the long term

See all Wellbutrin XL reviews / ratings >>

Page last updated: 2014-12-19

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