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Wellbutrin SR
Generic Name: Bupropion Hydrochloride
Drug Category: Aminoketone Antidepressant
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 1 year.
| Approved Uses |
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Indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. To minimize the risk of seizure, increase the dose gradually. The usual adult target dose for WELLBUTRIN SR is 300 mg/day, given as 150 mg twice daily. A maximum of 400 mg/day, given as 200 mg twice daily, may be considered for patients in whom no clinical improvement is noted after several weeks of treatment at 300 mg/day. In patients with moderate to severe hepatic impairment (Child-Pugh score: 7 to 15), the maximum dose of WELLBUTRIN SR is 100 mg/day or 150 mg every other day. In patients with mild hepatic impairment (Child-Pugh score: 5 to 6), consider reducing the dose and/or frequency of dosing. Consider reducing the dose and/or frequency of WELLBUTRIN SR in patients with renal impairment (Glomerular Filtration Rate less than 90 mL/min). In postmarketing experience, there have been rare reports of adverse neuropsychiatric events or reduced alcohol tolerance in patients who were drinking alcohol during treatment with WELLBUTRIN SR. The consumption of alcohol during treatment with WELLBUTRIN SR should be minimized or avoided. WELLBUTRIN SR is contraindicated:
Use of MAOIs (intended to treat psychiatric disorders) concomitantly with WELLBUTRIN SR or within 14 days of discontinuing treatment with WELLBUTRIN SR is contraindicated. There is an increased risk of hypertensive reactions when WELLBUTRIN SR is used concomitantly with MAOIs. The use of WELLBUTRIN SR within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting WELLBUTRIN SR in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated. WELLBUTRIN SR is not approved for smoking cessation treatment; however, it contains the same active ingredient as the smoking cessation medication ZYBAN. Serious neuropsychiatric adverse events have been reported in patients taking bupropion for smoking cessation. These postmarketing reports have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Some patients who stopped smoking may have been experiencing symptoms of nicotine withdrawal, including depressed mood. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these adverse events occurred in patients taking bupropion who continued to smoke. Neuropsychiatric adverse events occurred in patients without and with pre-existing psychiatric disease; some patients experienced worsening of their psychiatric illnesses. WELLBUTRIN SR can cause seizures. The risk of seizures is also related to patient factors, clinical situations, and concomitant medications that lower the seizure threshold. The following conditions can also increase the risk of seizure: severe head injury; arteriovenous malformation; CNS tumor or CNS infection; severe stroke; concomitant use of other medications that lower the seizure threshold (e.g., other bupropion products, antipsychotics, tricyclic antidepressants, theophylline, and systemic corticosteroids); metabolic disorders (e.g., hypoglycemia, hyponatremia, severe hepatic impairment, and hypoxia); use of illicit drugs (e.g., cocaine); or abuse or misuse of prescription drugs such as CNS stimulants. Additional predisposing conditions include diabetes mellitus treated with oral hypoglycemic drugs or insulin; use of anorectic drugs; and excessive use of alcohol, benzodiazepines, sedative/hypnotics, or opiates. Antidepressant treatment can precipitate a manic, mixed, or hypomanic manic episode. The risk appears to be increased in patients with bipolar disorder or who have risk factors for bipolar disorder. Prior to initiating WELLBUTRIN SR, screen patients for a history of bipolar disorder and the presence of risk factors for bipolar disorder (e.g., family history of bipolar disorder, suicide, or depression). WELLBUTRIN SR is not approved for use in treating bipolar depression. Treatment with WELLBUTRIN SR can result in elevated blood pressure and hypertension. Assess blood pressure before initiating treatment with WELLBUTRIN SR and monitor periodically during treatment. The risk of hypertension is increased if WELLBUTRIN SR is used concomitantly with MAOIs or other drugs that increase dopaminergic or noradrenergic activity. The pupillary dilation that occurs following use of many antidepressant drugs including WELLBUTRIN SR may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Anaphylactoid/anaphylactic reactions have occurred during clinical trials with bupropion. Reactions have been characterized by pruritus, urticaria, angioedema, and dyspnea requiring medical treatment. In addition, there have been rare, spontaneous postmarketing reports of erythema multiforme, Stevens Johnson syndrome, and anaphylactic shock associated with bupropion. Bupropion is primarily metabolized to hydroxybupropion by CYP2B6. Therefore, the potential exists for drug interactions between WELLBUTRIN SR and drugs that are inhibitors or inducers of CYP2B6. Ticlopidine and Clopidogrel: Concomitant treatment with these drugs can increase bupropion exposure but decrease hydroxybupropion exposure. Based on clinical response, dosage adjustment of WELLBUTRIN SR may be necessary when coadministered with CYP2B6 inhibitors (e.g., ticlopidine or clopidogrel). Ritonavir, Lopinavir, and Efavirenz: Concomitant treatment with these drugs can decrease bupropion and hydroxybupropion exposure. Dosage increase of WELLBUTRIN SR may be necessary when co- administered with ritonavir, lopinavir, or efavirenz but should not exceed the maximum recommended dose. Carbamazepine, Phenobarbital, Phenytoin: While not systematically studied, these drugs may induce the metabolism of bupropion and may decrease bupropion exposure. If bupropion is used concomitantly with a CYP inducer, it may be necessary to increase the dose of bupropion, but the maximum recommended dose should not be exceeded. Bupropion and its metabolites (erythrohydrobupropion, threohydrobupropion, hydroxybupropion) are CYP2D6 inhibitors. Therefore, coadministration of WELLBUTRIN SR with drugs that are metabolized by CYP2D6 can increase the exposures of drugs that are substrates of CYP2D6. Such drugs include certain antidepressants (e.g., venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, and sertraline), antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone and flecainide). When used concomitantly with WELLBUTRIN SR, it may be necessary to decrease the dose of these CYP2D6 substrates, particularly for drugs with a narrow therapeutic index. Drugs that require metabolic activation by CYP2D6 to be effective (e.g., tamoxifen) theoretically could have reduced efficacy when administered concomitantly with inhibitors of CYP2D6 such as bupropion. Patients treated concomitantly with WELLBUTRIN SR and such drugs may require increased doses of the drug. Co-administration of WELLBUTRIN SR with digoxin may decrease plasma digoxin levels. Monitor plasma digoxin levels in patients treated concomitantly with WELLBUTRIN SR and digoxin. Use extreme caution when co-administering WELLBUTRIN SR with other drugs that lower seizure threshold (e.g., other bupropion products, antipsychotics, antidepressants, theophylline, or systemic corticosteroids). Use low initial doses and increase the dose gradually. Bupropion, levodopa, and amantadine have dopamine agonist effects. CNS toxicity has been reported when bupropion was co-administered with levodopa or amantadine. False-positive urine immunoassay screening tests for amphetamines have been reported in patients taking bupropion. This is due to lack of specificity of some screening tests. False-positive test results may result even following discontinuation of bupropion therapy. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish bupropion from amphetamines. Study findings on bupropion exposure during the first trimester and risk for ventricular septal defect (VSD) are inconsistent and do not allow conclusions regarding a possible association. Animal studies: fetal malformations and skeletal variations. Bupropion and its metabolites are present in human milk. |
| Off-label Uses |
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• Use in patients under the age of 18. GoToSource • Dosage greater than 400 mg per day in patients without hepatic or renal impairment. GoToSource • Smoking cessation, bipolar disorder, attention-deficit/hyperactivity disorder and weight loss. GoToSource • Antidepressant-induced sexual dysfunction, social phobia, post-traumatic stress disorder, neuropathic pain, cocaine addiction and eating disorders. GoToSource • Fatigue in patients with multiple sclerosis. GoToSource • Restless legs syndrome. GoToSource • Seasonal affective disorder. GoToSource |
| Adverse Events |
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Seizures. GoToSource Suicidal ideation and behavior. GoToSource Birth defects. GoToSource Sexual dysfunction. GoToSource Liver injury. GoToSource Constipation. GoToSource Pruritus (severe itching), urticaria (hives) serum-sickness like reaction (inflammatory reaction) and stevens-johnson syndrome with acute psoriatic exacerbation (severe skin reaction). GoToSource Erythema multiforme (skin disorder). GoToSource Psychosis. GoToSource Angioedema (swelling in deep layers of skin) and anaphylactoid reactions (severe allergic reaction). GoToSource Mania and hypomania. GoToSource Hypertension (high blood pressure). GoToSource Angle-closure glaucoma. GoToSource Dry mouth, agitation and abuse. GoToSource |
| Litigation |
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Lawsuits filed for suicides and birth defects. |
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