Experience Matters

WELLBUTRIN XL® is a once-daily, extended-release formulation of bupropion HCl backed by:

More than

15

years of clinical experience in MDD1,2

More than

10

years of clinical experience in SAD1,3

Share the proven efficacy of WELLBUTRIN XL with appropriate patients by demanding the brand when writing scripts for bupropion HCl extended-release.

Wellbutrin prescription

Efficacy Experience With WELLBUTRIN XL in Clinical Trials

MDD, major depressive disorder; SAD, seasonal affective disorder.

IMPORTANT SAFETY INFORMATION (cont)
  • WELLBUTRIN XL is contraindicated in patients with seizure disorder.
  • WELLBUTRIN XL is contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with WELLBUTRIN XL.
  • WELLBUTRIN XL is contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs.
  • The use of MAOIs (intended to treat psychiatric disorders) concomitantly with WELLBUTRIN XL or within 14 days of discontinuing treatment with WELLBUTRIN XL is contraindicated. There is an increased risk of hypertensive reactions when WELLBUTRIN XL is used concomitantly with MAOIs. The use of WELLBUTRIN XL within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting WELLBUTRIN XL in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated.
References:
  1. WELLBUTRIN XL (bupropion hydrochloride extended-release) Prescribing Information. 2017. Bausch Health Companies Inc.
  2. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21515ltr.pdf. Accessed June 21, 2019.
  3. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021515s010,021515s018LTR.pdf. Accessed June 21, 2019.
  4. Zung WWK, Brodie HKH, Fabre L, et al. Comparative efficacy and safety of bupropion and placebo in the treatment of depression. Psychopharmacology. 1983;79(4):343-347.
  5. Lineberry CG, Johnston JA, Raymond RN, et al. A fixed-dose (300 mg) efficacy study of bupropion and placebo in depressed outpatients. J Clin Psychiatry. 1990;51(5):194-199.
  6. Modell JG, Rosenthal NE, Harriett AE, et al. Seasonal affective disorder and its prevention by anticipatory treatment with bupropion XL. Biol Psychiatry. 2005;58(8):658-667.
INDICATION

WELLBUTRIN XL® (bupropion hydrochloride extended-release tablets) is indicated for the treatment of major depressive disorder (MDD), and for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient.

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

SUICIDALITY AND ANTIDEPRESSANT DRUGS:

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressants use in subjects aged 65 and older.

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.

  • WELLBUTRIN XL is contraindicated in patients with seizure disorder.
  • WELLBUTRIN XL is contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with WELLBUTRIN XL.
  • WELLBUTRIN XL is contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs.
  • The use of MAOIs (intended to treat psychiatric disorders) concomitantly with WELLBUTRIN XL or within 14 days of discontinuing treatment with WELLBUTRIN XL is contraindicated. There is an increased risk of hypertensive reactions when WELLBUTRIN XL is used concomitantly with MAOIs. The use of WELLBUTRIN XL within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting WELLBUTRIN XL in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated.
  • WELLBUTRIN XL is contraindicated in patients with known hypersensitivity to bupropion or other ingredients of WELLBUTRIN XL. Anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported.
  • Neuropsychiatric Adverse Events During Smoking Cessation: WELLBUTRIN XL is not approved for smoking cessation treatment, however, bupropion HCl sustained-release is approved for this use. 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. Observe patients attempting to quit smoking with WELLBUTRIN XL for the occurrence of such symptoms and instruct them to discontinue WELLBUTRIN XL and contact a healthcare provider if they experience such adverse events.
  • WELLBUTRIN XL can cause seizures. The risk of seizures is dose-related. The dose should not exceed 300 mg once daily. Increase the dose gradually. Discontinue WELLBUTRIN XL and do not restart treatment if the patient experiences a seizure.
  • Treatment with WELLBUTRIN XL can result in elevated blood pressure and hypertension. Assess blood pressure before initiating treatment with WELLBUTRIN XL, and monitor periodically during treatment.
  • Antidepressant treatment can precipitate a manic, mixed, or hypomanic manic episode. Prior to initiating WELLBUTRIN XL, 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 XL is not approved for the treatment of bipolar depression.
  • Depressed patients treated with bupropion have had a variety of neuropsychiatric signs and symptoms, including delusions, hallucinations, psychosis, concentration disturbance, paranoia, and confusion. Some of these patients had a diagnosis of bipolar disorder. In some cases, these symptoms abated upon dose reduction and/or withdrawal of treatment. Discontinue WELLBUTRIN XL if these reactions occur.
  • The pupillary dilation that occurs following use of many antidepressant drugs including WELLBUTRIN XL may trigger an angle closure attack (Angle-Closure Glaucoma) in a patient with anatomically narrow angles who does not have a patent iridectomy.
  • The most common adverse reactions that occurred in at least 5% of patients treated with bupropion HCl sustained-release (300 mg and 400 mg per day) and at a rate at least twice the placebo rate were: dry mouth, nausea, insomnia, dizziness, pharyngitis, abdominal pain, agitation, anxiety, tremor, palpitation, sweating, tinnitus, myalgia, anorexia, urinary frequency, and rash.
  • An increased dose of bupropion may be necessary if coadministered with CYP2B6 inducers based on clinical exposure, but should not exceed the maximum recommended dose. Bupropion inhibits CYP2D6 and can increase concentrations of: antidepressants, antipsychotics, beta-blockers, and Type 1C antiarrhythmics. Consider dose reduction when using with bupropion. Dose bupropion with caution when used with drugs that lower seizure threshold. CNS toxicity can occur when bupropion is used concomitantly with dopaminergic drugs.
  • WELLBUTRIN XL can cause false-positive urine test results for amphetamines.
  • Pregnancy Category C: Use only if benefit outweighs potential risk to the fetus.
  • In patients with moderate to severe hepatic impairment (Child-Pugh score: 7 to 15), the maximum dose is 150 mg every other day. In patients with mild hepatic impairment (Child-Pugh score: 5 to 6) or renal impairment (glomerular filtration rate <90 mL/min), consider reducing the dose and/or frequency of dosing.
  • Advise patients to read the FDA-approved patient labeling (Medication Guide). Inform patients, their families, and their caregivers about the benefits and risks associated with treatment with WELLBUTRIN XL and counsel them in its appropriate use.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health Companies Inc. at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Click here for full Prescribing Information including Boxed Warning regarding suicidal thoughts and behaviors.