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Wellbutrin
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 6 weeks.
| Approved Uses |
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Indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). WELLBUTRIN is not approved for smoking cessation treatment. Effectiveness of WELLBUTRIN in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials. 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. The recommended starting dose is 200 mg/day, given as 100 mg twice daily. After 3 days of dosing, the dose may be increased to 300 mg/day, given as 100 mg 3 times daily, with at least 6 hours between successive doses. A maximum of 450 mg/day, given in divided doses of not more than 150 mg each, may be considered for patients who show no clinical improvement 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 is 75 mg per day. In patients with mild hepatic impairment (Child-Pugh score: 5 to 6), consider reducing the dose and/or frequency of dosing. Serious neuropsychiatric symptoms have been reported in patients taking bupropion for smoking cessation. These have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. WELLBUTRIN can cause seizure. The risk of seizure is dose-related. The dose should not exceed 450 mg per day To minimize the risk of seizure, increase the dose gradually. Increases in dose should not exceed 100 mg per day in a 3-day period. A maximum of 450 mg per day, given in divided doses of not more than 150 mg each, may be considered for patients who show no clinical improvement after several weeks of treatment at 300 mg per day. The following conditions can 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. Consider reducing the dose and/or frequency of WELLBUTRIN in patients with renal impairment (Glomerular Filtration Rate less than 90 mL per min). Treatment with WELLBUTRIN can result in elevated blood pressure and hypertension. Assess blood pressure before initiating treatment with WELLBUTRIN, and monitor periodically during treatment. 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. The pupillary dilation that occurs following use of many antidepressant drugs including WELLBUTRIN may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. The consumption of alcohol during treatment with WELLBUTRIN should be minimized or avoided. WELLBUTRIN is contraindicated in patients with:
Concomitant treatment with Ticlopidine and Clopidogrel (Inhibitors of CYP2B6) can increase bupropion exposure but decrease hydroxybupropion exposure. Concomitant treatment with Ritonavir, Lopinavir, and Efavirenz (Inducers of CYP2B6) can decrease bupropion and hydroxybupropion exposure. Co-administration of WELLBUTRIN 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). While not systematically studied, Carbamazepine, Phenobarbital, Phenytoin 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. 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. Co-administration of WELLBUTRIN with digoxin may decrease plasma digoxin levels. 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 450 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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