DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Wellbutrin XL (Bupropion Hydrochloride) - Summary

 
 



WARNING

Suicidality and Antidepressant Drugs

Use in Treating Psychiatric Disorders: 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 in Treating Psychiatric Disorders, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

Use in Smoking Cessation Treatment: WELLBUTRIN®*, WELLBUTRIN SR and WELLBUTRIN XL are not approved for smoking cessation treatment, but bupropion under the name ZYBAN®* is approved for this use. Serious neuropsychiatric events, including but not limited to depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking bupropion for smoking cessation. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking bupropion who continued to smoke.

All patients treated with Bupropion for smoking cessation treatment should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide have been reported in some patients attempting to quit smoking while taking ZYBAN in the post-marketing experience. When symptoms were reported, most were during treatment with ZYBAN, but some were following discontinuation of treatment with ZYBAN. These events have occurred in patients with and without pre-existing psychiatric disease; some have experienced worsening of their psychiatric illnesses.

Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies of ZYBAN.

Advise patients and caregivers that the patient using bupropion for smoking cessation should stop taking bupropion and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in thinking or behavior that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many post-marketing cases, resolution of symptoms after discontinuation of ZYBAN was reported, although in some cases the symptoms persisted; therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

The risks of using bupropion for smoking cessation should be weighed against the benefits of its use. ZYBAN has been demonstrated to increase the likelihood of abstinence from smoking for as long as six months compared to treatment with placebo. The health benefits of quitting smoking are immediate and substantial. (See WARNINGS: Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment and PRECAUTIONS: Information for Patients.)

 

WELLBUTRIN XL SUMMARY

WARNING

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.

Major Depressive Disorder: 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 TRIALS).

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 TRIALS). 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.

Seasonal Affective Disorder: WELLBUTRIN XL is indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder.

The efficacy of WELLBUTRIN XL for the prevention of seasonal major depressive episodes was established in 3 controlled trials of adult outpatients with a history of major depressive disorder with an autumn-winter seasonal pattern as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria (see CLINICAL TRIALS).

Seasonal affective disorder is characterized by recurrent major depressive episodes, most commonly occurring during the autumn and/or winter months. Episodes may last up to 6 months in duration, typically beginning in the autumn and remitting in the springtime. Although patients with seasonal affective disorder may have depressive episodes during other times of the year, the diagnosis of seasonal affective disorder requires that the number of seasonal episodes substantially outnumber the number of non-seasonal episodes during the individual's lifetime.


See all Wellbutrin XL indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Wellbutrin XL (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

more studies >>

Clinical Trials Related to Wellbutrin XL (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.

Does Sleep Quality Change After Switch From Wellbutrin SR to Wellbutrin XL in Patients With Major Depressive Disorder? [Active, not recruiting]
Wellbutrin (bupropion) is an effective antidepressant (Thase, M 2005). It exists in instant release (IR), sustained release (SR) and extended release (XL) forms. The IR formulation was never approved for use in Canada. The XL formulation allows for once daily dosing. Wellbutrin is both a norepinephrine and dopamine reuptake inhibitor, and as such increases the synaptic concentration of both neurotransmitters. This adds to its positive effects on cognition, apathy, tiredness and executive functioning. The increased activation may be also responsible for some of its side effects such as initial insomnia and reduced sleep efficiency, especially when taken at night.

The Effects of Wellbutrin (Bupropion) on Residual and Cognitive Symptoms in SSRI-treated Depression [Completed]
Many people with depression are treated with a serotonin-specific reuptake inhibitor anti-depressant (SSRI) and feel 'better'. Although many people feel 'better', they do not feel completely 'well'. Often, individuals continue to complain of cognitive problems such as lack of attention, diminished motivation, and impaired problem-solving. This study looks at whether residual and cognitive symptoms of depression in individuals are affected by the addition of Wellbutrin (bupropion).

Female Orgasmic Disorder (FOD) and Wellbutrin XL [Completed]
A recently completed multi-site double-blind placebo-controlled study found that bupropion (Wellbutrin XL) increased female orgasmic function in a group of pre-menopausal women with a diagnosis of hypoactive sexual desire disorder. The purpose of this study is to ascertain whether bupropion will improve orgasmic function in pre-menopausal women with a primary complaint of idiopathic orgasmic disorder who do not have hypoactive sexual desire disorder. This will be a multicenter, placebo-controlled, double blind study of women with a diagnosis of female orgasm disorder. During a baseline visit, psychiatric, medical, alcohol and drug, and sexual histories will be obtained. Patients who continue to meet screening inclusion/exclusion criteria at their baseline visit will be randomly assigned to either placebo or bupropion XL for 8 weeks. A flexible dosing paradigm will be used. Sexual desire and activity will be assessed by patient diaries, investigator interview of sexual functioning every two weeks, and by standardized questionnaire every four weeks. The primary endpoint will be the increase in orgasm completion as measured by the Changes in Sexual Functioning Questionnaire-F (CSFQ-F). Secondary endpoints will be changes in sexual arousal, sexual desire, and sexual pleasure as assessed by the CSFQ-F.

Wellbutrin XL for Dysthymic Disorder [Completed]
This is a ten-week, double-blind study of Wellbutrin XL in outpatients with dysthymic disorder, a form of low-grade chronic depression. We hypothesize that patients taking Wellbutrin XL will show greater improvement in depression symptoms and psychosocial functioning than patients taking placebo.

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: 2015-08-10

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015