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WELLBUTRIN XL is not for everyone. There is a risk of seizure with WELLBUTRIN XL which increases with higher doses. Taking more than 450 mg/day increases the chance of serious side effects. Don’t use it if you’ve had a seizure or eating disorder, or if you abruptly stop using alcohol or sedatives. Don’t take with MAOIs, or medicines that contain bupropion. When used with a nicotine patch or alone, there is a risk of increased blood pressure, sometimes severe. To reduce risk of serious side effects, tell your doctor if you have liver or kidney problems. Other side effects may include weight loss, dry mouth, nausea, difficulty sleeping, dizziness, sore throat, constipation, or flatulence.

WELLBUTRIN XL is approved only for adults 18 years and over. In some children, teens, and young adults, antidepressants increase suicidal thoughts or actions. Whether or not you are taking antidepressants, you or your family should call the doctor right away if you have worsening depression, thoughts of suicide, or sudden or severe changes in mood or behavior, especially at the beginning of treatment or after a change in dose (see Medication Guide: Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions).

Medication Guide for WELLBUTRIN XL
Medication Guide for WELLBUTRIN XL® (bupropion HCl extended-release tablets) is provided in Adobe’s Portable Document Format (PDF). To view this document you will need Adobe Acrobat Reader; if you do not have it, follow the link to download a copy.
Complete Prescribing  wellbutrin without prescription, Information for WELLBUTRIN XL® (bupropion HCl extended-release tablets).
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Wellbutrin without prescription
Wellbutrin (INN, previously known as amfebutamone;[1] Wellbutrin, Zyban) is an atypical antidepressant that acts as a norepinephrine and dopamine reuptake inhibitor, and nicotinic antagonist.[2][3] wellbutrin belongs to the chemical class of aminoketones and is similar in structure to the stimulant cathinone, to the anorectic diethylpropion, and to phenethylamines in general.

Initially researched and marketed as an <strong>wellbutrin</strong> antidepressant, wellbutrin was subsequently found to be effective as a smoking cessation aid. In 2007 it was the fourth-most prescribed antidepressant in the United States retail market, with 20.184 million retail prescriptions.[4]

wellbutrin lowers seizure threshold and its potential to cause seizures was widely publicized. However, at the recommended dose the risk of seizures is comparable to that observed for other antidepressants. wellbutrin is an effective antidepressant on its own but it is particularly popular as an add-on medication in the cases of incomplete response to the first-line SSRI antidepressant. In contrast to many psychiatric drugs, including nearly all antidepressants, wellbutrin does not cause weight gain nor sexual dysfunction.
Depression

Placebo-controlled <strong>wellbutrin</strong> double-blind clinical studies have confirmed the efficacy of bupropion for clinical depression.[9] Comparative clinical studies demonstrated the equivalency of wellbutrin and sertraline (Zoloft), fluoxetine (Prozac), paroxetine (Paxil)[10] and escitalopram (Lexapro)[11] as antidepressants. A significantly higher remission rate with wellbutrin treatment than for venlafaxine (Effexor) was observed in a recent study.[12] Unlike all other antidepressants, except mirtazapine (Remeron), maprotiline (Ludiomil) and tianeptine (Stablon), wellbutrin does not cause sexual dysfunction and the occurrence of sexual side effects is not different from placebo.[13][14] wellbutrin treatment is not associated with weight gain; on the contrary, at the end of every study comparing wellbutrin with placebo or other antidepressants the wellbutrin group had a lower average weight.[15] wellbutrin is more effective than SSRIs at improving symptoms of hypersomnia and fatigue in depressed pwellbutrinatients.[16] In a comparative meta-analysis, there appeared to be a modest advantage for the SSRIs compared to bupropion in the treatment of depression with high anxiety, while these medications were equivalent for the depression with moderate or low anxiety.[17]

According to several surveys, the augmentation of a prescribed SSRI with wellbutrin is the preferred strategy among clinicians when the patient does not respond to the SSRI.[18] For example, the combination of wellbutrin and citalopram (Celexa) was observed to be more effective than switching to another antidepressant. The addition of wellbutrin to an SSRI (primarily fluoxetine or sertraline) resulted in a significant improvement in 70–80% of patients who had an incomplete response to the first-line antidepressant.[19][20] wellbutrin improved ratings of “energy”, which had decreased under the influence of the SSRI; also noted were improvements of mood and motivation, and some improvement of cognitive and sexual functions. Sleep quality and anxiety ratings in most cases were unchanged.[20] In the STAR*D study, the patients who did not respond to citalopram (Celexa) were randomly assigned to augmentation by wellbutrin or buspirone (Buspar). Approximately 30% of subjects in both groups achieved a remission. Howwellbutrinwellbutrinwellbutrinwellbutrinever, bupropion augmentation gave better results based on the patients’ self-ratings and was much better tolerated. The authors observed that “these findings reveal a consistently more favorable outcome with sustained-release bupropion than with buspirone augmentation of citalopram.”[21] The same study indicated a possibility of higher remission rate when the non-responders to citalopram received bupropion augmentation rather than were switched to bupropion (30% vs. 20%).[22]

[edit] Smoking cessation  wellbutrin

wellbutrin reduces the severity of nicotine cravings and withdrawal symptoms. After a seven-week treatment, 27% of subjects who received wellbutrin reported that an urge to smoke was a problem, versus 56% of those who received placebo. In the same study, 21% of the wellbutrin group reported mood swings, versus 32% of the placebo group.[23] The wellbutrin treatment course lasts for seven to twelve weeks, with the patient halting the use of tobacco about ten days into the course. The efficacy of wellbutrin is similar to that of nicotine replacement therapy. wellbutrin approximately doubles the chance of quitting smoking successfully after three months. One year after the treatment, the odds of sustaining smoking cessation are still 1.5 times higher in the wellbutrin group than in the placebo group.[24] The combination of wellbutrin and nicotine appears not to further increase the cessation rate. In a direct comparison, varenicline (Chantix) showed superior efficacy: after one year, the rate of continuous abstiwellbutrinwellbutrinwellbutrinnence was 10% for placebo, 15% for bupropion, and 23% for varenicline.[25] Bupropion slows the weight gain that often occurs in the first weeks after quitting smoking (after seven weeks, the placebo group had an average 2.7 kg increase in weight, versus 1.5 kg for the bupropion group). With time, however, this effect becomes negligible (after 26 weeks, both groups recorded an average 4.8 kg weight gain).[23]

[edit] Sexual dysfunction  <strong>wellbutrin</strong>

wellbutrin according to a survey, wellbutrin is the drug of choice among psychiatrists for the treatment of SSRI-induced sexual dysfunction, although it is not an FDA-approved indication. Thirty-six percent of responding psychiatrists preferred switching patients with SSRI-induced sexual dysfunction to wellbutrin; however, 43 percent favored the augmentation of the current medication with wellbutrin.[26] There are studies demonstrating the efficacy of both approaches; improvement of the desire and orgasm components of sexual function were the most often noted. For the augmentation approach, the addition of at least 200 mg/day of wellbutrin to the SSRI regimen may be necessary to achieve an improvement since the addition of 150 mg/day of wellbutrin did not produce a statistically significant difference from placebo.[27][28][29][30][31][32]

Several studies have indicated that wellbutrin also relieves sexual dysfunction in people who do not have depression. In a mixed-gender double-blind study, 63% of subjects on a 12-week course of wellbutrin rated their condition as improved or much improved, versus 3% of subjects on placebo.[33] Two studies, one of which was placebo-controlled, demonstrated the efficacy of wellbutrin for women with hypoactive sexual desire,[34][35] resulting in significant improvement of arousal, orgasm and overall satisfaction. wellbutrin also showed promise as a treatment for sexual dysfunction caused by chemotherapy for breast cancer[36] and for orgasmic dysfunction.[37] As with the treatment of SSRI-induced sexual disorder, a higher dose of wellbutrin (300 mg) may be necessary: a randomized study employing a lower dose (150 mg) failed to find a significant difference between wellbutrin, sexual therapy or combined treatment.[38] wellbutrin does not affect any measures of sexual functioning in healthy men.[39]

[edit] Obesity

A recent meta-analysis of anti-obesity medications pooled the results of three double-blind, placebo-controlled trials of wellbutrin. It confirmed the efficacy of wellbutrin given at 400 mg per day for treating obesity. Over a period of 6 to 12 months, weight loss in the wellbutrin group (4.4 kg) was significantly greater than in the placebo group (1.7 kg). The same review found the differences in weight loss between wellbutrin and other established weight-loss medications, such as sibutramine, orlistat and diethylpropion, to be statistically insignificant.[40]
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[edit] Attention-deficit hyperactivity disorder

Although attention-deficit hyperactivity disorder (ADHD) is not an approved indication, wellbutrin was found to be effective for adult ADHD.[41] There have been many positive case studies and other uncontrolled clinical studies of wellbutrin for ADHD in minors.[42] However, in the largest to date double-blind study, which was conducted by GlaxoSmithKline, the results were inconclusive. Aggression and hyperactivity as rated by the children’s teachers were significantly improved in comparison to placebo; in contrast, parents and clinicians could not distinguish between the effects of wellbutrin and placebo.[42] The 2007 guideline on the ADHD treatment from American Academy of Child and Adolescent Psychiatry notes that the evidence for wellbutrin is “far weaker” than for the FDA-approved treatments. Its effect may also be “considerably less than of the approved agents… Thus it may be prudent for the clinician to recommend a trial of behavior therapy at this point, before moving to these second-line agents.”[4wellbutrin3] Similarly, the 2006 guideline from the Texas Department of State Health Services recommends considering bupropion or a tricyclic antidepressant as a fourth-line treatment after trying two different stimulants and atomoxetine (Strattera).[44][45]

A study of prophylactic wellbutrin for the prevention of smoking among teenagers with ADHD yielded unexpected results. The teenagers taking wellbutrin were two times more likely (close to statistical significance) to begin smoking than the teenagers in the placebo group. At the same time, the sub-group of patients taking stimulants in addition to wellbutrin or placebo had a five times lower risk of smoking initiation.[46]

[edit] Other uses

wellbutrin has been approved by the FDA[47] for the prevention of seasonal affective disorder.[48] There is considerable disagreement regarding whether it is useful to add an antidepressant, including wellbutrin, to a mood stabilizer in patients with bipolar depression.[49][50][51]

No properly controlled double-blind studies of wellbutrin for Parkinson’s disease have been conducted. A small 1984 study funded by wellbutrin’s manufacturer found that addition of wellbutrin to carbidopa or levodopa improved Parkinson’s symptoms in ten out of twenty patients; however, the side effects, particularly nausea and vomiting, were frequent.[52] The American Psychiatric Association notes that, “there is no evidence favoring any particular antidepressant medication from the standpoint of therapeutic efficacy in patients with Parkinson’s disease complicated by major depressive disorder.”[53]. According to several case studies and a pilot study, wellbutrin may also be useful for autoinflammatory conditions such as Crohn disease and psoriasis.

[edit] Contraindications

GlaxoSmithKline advises that wellbutrin should not be prescribed to individuals with epilepsy or other conditions that lower the seizure threshold, such as alcohol or benzodiazepine discontinuation, anorexia nervosa, bulimia, or active brain tumors. It should be avoided in individuals who are also taking MAO inhibitors (MAOIs). When switching from MAOIs to wellbutrin, it is important to include a washout period of about two weeks between the medications.[54] The prescribing information approved by the FDA recommends that caution should be exercised when treating patients with liver damage, severe kidney disease, and severe hypertension, as well as in pediatric patients, adolescents and young adults due to the increased risk of suicidal ideation.[54]

According wellbutrin to a retrospective case series published in 1993, wellbutrin treatment may exacerbate tics in children with co-occurring ADHD and Tourette syndrome.[55] No further research of this side effect has been conducted.

[edit] Risk of suicide wellbutrin

The FDA requires all antidepressants, including wellbutrin, to carry a black box warning stating that antidepressants may increase the risk of suicide in persons younger than 25. This warning is based on a statistical analysis conducted by the FDA which found a 2-fold increase of the suicidal ideation and behavior in children and adolescents, and 1.5-fold increase of suicidality in the 18–24 age group.[56]

Suicidal ideation and behavior in clinical trials are rare. For the above analysis, the FDA combined the results of 295 trials of 11 antidepressants for psychiatric indications in order to obtain statistically significant results. Considered separately, wellbutrin and nine other antidepressants were not statistically different from placebo. Only fluoxetine caused a significant decrease in suicidal ideation.[56]

Suicidal behavior is even less likely when wellbutrin is prescribed for smoking cessation. According to a Cochrane Database review, there have been four suicides per one million prescriptions and one case of suicidal ideation per ten thousand prescriptions of wellbutrin for smoking cessation in the UK. The review concludes, “Although some suicides and deaths while taking wellbutrin have been reported, thus far there is insufficient evidence to suggest they were caused by wellbutrin.”[57]

[edit] Adverse effects
Brand-name Wellbutrin

The common adverse effects associated with 12-hour sustained-release wellbutrin (with the greatest difference from placebo) are dry mouth, nausea, insomnia, tremor, excessive sweating and tinnitus. Those that most often resulted in interruption of the treatment in the same trial were rash (2.4%) and nausea (0.8%). The development of mild to moderate skin rashes is associated with sensitivity to dye components within the pill coating. This can often be alleviated simply by prescribing a differently colored pill.[54]
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Seizure is the most controversial side effect of wellbutrin, and was responsible for its initial withdrawal from the market. The risk of seizure is highly dose-dependent: 0.1% at 100–300 mg of wellbutrin, 0.4% at 300–450 mg, and 2% at 600 mg. For comparison, the incidence of the first unprovoked seizure in the general population is 0.07–0.09%. The risk of seizure for other antidepressants is as follows: 0.1–0.6% for imipramine, depending on dosage; 0–0.06% for amitriptyline, depending on dosage; 0.5% for clomipramine; 0.4% for maprotiline; and 0.2% for fluoxetine and fluvoxamine.[58] Experiments on mice indicate that increased susceptibility to seizure is a general side effect of chronically using antidepressants that inhibit norepinephrine transporter, such as imipramine, desipramine and reboxetine.[59] Clinical depression itself was reported to increase the occurrence of seizures two-to-sevenfold compared with the general population; in this light, the above statistics could indicate that low to moderate dwellbutrinoses of antidepressants, including bupropion, may actually have an anti-convulsive action.[60]

There is evidence of several neuropsychiatric symptoms associated with wellbutrin in patients with depression, including delusions, hallucinations, psychosis, concentration disturbance, paranoia, and confusion. In some cases, these symptoms are reduced or eliminated by decreasing the dose or ceasing treatment. The prescribing information notes that “it is generally believed (though not established in controlled trials)” that, should an episode of depression actually be the first presentation of bipolar disorder, treating it with antidepressants, including wellbutrin, may precipitate a manic episode.[54] More recent data indicate that the addition of newer antidepressants, including wellbutrin, to a mood stabilizer does not cause the switch to mania more often than the addition of placebo.[50] Moreover, when added to a mood stabilizer, wellbutrin and sertraline had a twice lower switch risk than venlafaxine.[61]

The wellbutrin prescribing information wellbutrin notes that hypertension, sometimes severe, was observed in some patients, both with and without pre-existing hypertension. The frequency of this adverse effect was under 1% and not significantly higher than that found with placebo.[54] In a group of cardiac patients with depression, high doses of wellbutrin (400–500 mg/day) caused a rise in supine blood pressure but had no effect on pulse rate.[62] No statistically significant changes in blood pressure or heart rate occurred in patients with or without heart conditions at a lower dose of 300 mg/day.[63] In a study of wellbutrin for ADHD, a rise of systolic blood pressure by 6 mm Hg and of heart rate by 7 beats per minute (both statistically significant) were observed.[64] A study of smokers hospitalized for heart disease found a 1.5-fold increase (close to being statistically significant) in subsequent cardiovascular events in the wellbutrin group, compared with the placebo group, but found no difference in bwellbutrinlood pressure.[65] Although the cardiovascular side effects of bupropion appear to be mild, it cannot be recommended for patients with heart disease, since the safety comparison with SSRIs (such as sertraline and fluoxetine, which may have a preventative effect after a myocardial infarction[66]) is not in its favor.

In the UK, more than 7,600 reports of suspected adverse <strong>wellbutrin</strong> reactions were collected in the first two years after wellbutrin’s approval by the MHRA as part of the Yellow Card Scheme, which monitored side effects. Approximately 540,000 people were treated with wellbutrin for smoking cessation during that period. The MHRA received 60 reports of “suspected [emphasis MHRA's] adverse reactions to Zyban which had a fatal outcome”. The agency concluded that “in the majority of cases the individual’s underlying condition may provide an alternative explanation.”[67] This is consistent with a large, 9,300-patient safety study that showed that the mortality of smokers taking wellbutrin is not higher than the natural mortality of smokers of the same age.[68]

According to several wellbutrin case reports, stopping wellbutrin abruptly may result in discontinuation syndrome expressed as dystonia, irritability, anxiety, mania, headache, aches and pains.[69][70][71][72]

Other isolated adverse affects have been reported. Three cases of liver toxicity have been described in the literature,[73] a very low incidence given the widespread use of the drug. A single case of clitoral priapism (clitorism) has been reported in the literature.[74]

[edit] Overdose

Overdose of wellbutrin results in significant clinical effects in over one-third of cases.[75] The most common symptoms include sinus tachycardia, hypertension, drowsiness, lethargy, agitation, nausea and vomiting, and in particular delirium and seizures.[75][76][77] Less commonly additional symptoms include auditory and visual hallucinations,[78] coma,[77] and ECG changes such as conduction disturbance or arrhythmia.[79][80][81]

In the majority of childhood wellbutrin exploratory ingestions involving one or two tablets, children will remain asymptomatic.[82][83] In teenagers and adults seizures are more commonly observed with the seizure rate increasing tenfold with doses of 600 mg daily.[84] One overdose study suggested a dose-dependent relationship with seizures; patients ingesting more than 4.5 g were likely to have a seizure and nearly all patients ingesting more than 9 g had a seizure.[75]
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There is no specific antidote for wellbutrin; treatment is supportive, and focuses on maintaining airway patency and controlling seizures with high dose intravenous benzodiazepines or barbiturates if seizures are refractory to benzodiazepines.[76] Gastric decontamination may be of little benefit given the risk of seizures and aspiration[76] but activated charcoal is recommended.[75] Additionally, whole bowel irrigation should be undertaken in those ingesting sustained release formulations.[76] Toxic effects may be delayed in onset, with seizures developing as late as 32 hours.[76] Subsequently patients should undergo electroencephalographic monitoring for 48 hours.[54]

wellbutrin overdose rarely results in death, although cases have been reported.[79][85][86] Fatalities are typically associated with large overdosage and related to metabolic acidosis and hypoxia as complications of status epilepticus with associated cardiorespiratory arrest.[87] There is one published case report of successful treatment of refractory cardiac arrest in overdose of wellbutrin and lamotrigine using lipid rescue.[88]
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