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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. 

Proven Effectiveness in Treating Depression
Provided Efficacy Similar to SSRIs in Major Depressive Disorder
  • In 5 head-to-head studies, with more than 1,900 cumulative patients, bupropion was found to be similarly effective as the SSRIs Lexapro, Zoloft, and Prozac *1-5
      - Based on HAM-D-17 total score analysis at treatment week 8 - Studies evaluated the mean change in HAM-D scores and were conducted using bupropion HCl sustained-release tablets.
American Psychiatric Association practice guidelines state that effectiveness of antidepressants is generally comparable, so choosing an antidepressant is typically based on other factors, including anticipated side effects. 6

Common Side Effects
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.
Please see below for additional Important Safety Information.
A Common Problem With Depression Treatment

Risk of Sexual Side Effects With Some Antidepressants

Antidepressant use is associated with a number of possible side effects, including sexual side effects (such as loss of sex drive, inability to become aroused or difficulty achieving sexual satisfaction), which can affect both men and women.

  • Sexual side effects may start early—problems may appear within a week of starting treatment4
  • In one study of 344 patients, 58% of the patients taking the most commonly prescribed antidepressants were having sexual side effects when asked by their doctor, but only 14% had voluntarily mentioned them to their doctor. 7* There's no need to be shy—the American Psychiatric Association encourages doctors to discuss sexual side effects with patients to help determine a cause and a solution to the problem 6
*Only the following SSRIs were included in this study: fluoxetine, fluvoxamine, paroxetine, sertraline. Sexual dysfunction includes loss of sex drive, inability to become aroused, and problems achieving sexual satisfaction.
Low Risk of Orgasm Dysfunction
In studies of 8 week duration, men and women taking WELLBUTRIN SR to treat depression reported:
  • Significantly lower rate of orgasm dysfunction vs. escitalopram†4
    • - Study 1: Randomized, double-blind, placebo-controlled; ITT : n=397; P < 0.001
    • Study 2: Randomized, double-blind, placebo-controlled; ITT : n=388; P = 0.014
  • Lower incidence of orgasm dysfunction than fluoxetinetreated subjects †1,5
    • - Study 1: Multicenter, randomized, double-blind, double-dummy, parallel-group; n=456; P < 0.001
    • Study 2: Multicenter, double-blind, placebo-controlled; ITT : n=297; P < 0.001
  • Significantly lower rate of orgasm dysfunction vs. sertraline †3
    • Study 1: Randomized, double-blind, placebo-controlled; n=348; P <0.001

Studies were conducted with bupropion HCl sustained-release tablets. WELLBUTRIN XL has been shown to be bioequivalent to bupropion HCl sustained-release tablets.

ITT=Intention To Treat

Incidence of Body Weight Changes in Clinical Trials
Low risk of weight gain8
MDD Trials
Weight Change Bupropion HCl Sustained-Release 300 mg/day (n=339) Bupropion HCl Sustained-Release 400 mg/day (n=112) Placebo (n=347)
Gained > 5 lbs 3% 2% 4%
Lost > 5 lbs 14% 19% 6%
WELLBUTRIN XL is not indicated for weight loss
SAD Trials
Weight Change Bupropion HCl Extended- Release 150-300 mg/day (n=537) Placebo
(n=511)
Gained > 5 lbs 11% 21%
Lost > 5 lbs 23% 11%
WELLBUTRIN XL is not indicated for weight loss

Commonly Observed Adverse Reactions in Controlled Clinical Trials of Sustained-Release Bupropion Hydrochloride ll

300 mg/day of bupropion HCl sustained-release:
anorexia, dry mouth, rash, sweating, tinnitus, and tremor.

400 mg/day of bupropion HCl sustained-release:
abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequecy.

llAdverse 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 are listed.

SmartCoat Technology
Patented SmartCoat extended-release delivery system provides a slow, steady release of the drug in the body over a 24-hour period. 8,9
  • Moisture-barrier Coating
  • Bupropion Core
  • Porous inner coating controls bupropion release

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; AND NEUROPSYCHIATRIC REACTIONS

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, bupropinon 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 Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or www.fda.gov/medwatch.

Click here for full Prescribing Information including Boxed Warning regarding suicidal thoughts and behaviors. Please see full Prescribing Information including Boxed Warning regarding suicidal thoughts and behaviors [location].


© 2018 Valeant Pharmaceuticals North America LLC

WXL.0055.USA.18

  •  INDICATION
    • 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
    • IMPORTANT SAFETY INFORMATION

      WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC REACTIONS

      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, bupropinon 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 Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or www.fda.gov/medwatch.

      Click here for full Prescribing Information including Boxed Warning regarding suicidal thoughts and behaviors. Please see full Prescribing Information including Boxed Warning regarding suicidal thoughts and behaviors [location].


      © 2018 Valeant Pharmaceuticals North America LLC

      WXL.0055.USA.18