IMPORTANT SAFETY INFORMATION
APLENZIN® (bupropion hydrobromide 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.
- APLENZIN is contraindicated in patients with seizure disorder.
- APLENZIN 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 APLENZIN.
- APLENZIN 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 APLENZIN or within 14 days of discontinuing treatment with APLENZIN is contraindicated. There is an increased risk of hypertensive reactions when APLENZIN is used concomitantly with MAOIs. The use of APLENZIN within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting APLENZIN in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated.
- APLENZIN is contraindicated in patients with known hypersensitivity to bupropion or other ingredients of APLENZIN. Anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported.
- APLENZIN is not approved for smoking cessation treatment, however, bupropion HCl sustained-release is approved for this use. Postmarketing reports of serious or clinically significant neuropsychiatric adverse events 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 APLENZIN for the occurrence of such symptoms and instruct them to discontinue APLENZIN and contact a healthcare provider if they experience such adverse events.
- APLENZIN can cause seizures. The risk of seizures is dose-related. The dose should not exceed 522 mg once daily. Increase the dose gradually. Discontinue APLENZIN and do not restart treatment if the patient experiences a seizure.
- Treatment with APLENZIN can result in elevated blood pressure and hypertension. Assess blood pressure before initiating treatment with APLENZIN, and monitor periodically during treatment.
- Antidepressant treatment can precipitate a manic, mixed, or hypomanic manic episode. Prior to initiating APLENZIN, 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). APLENZIN 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 APLENZIN if these reactions occur.
- The pupillary dilation that occurs following use of many antidepressant drugs including APLENZIN 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.
- APLENZIN 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 174 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 APLENZIN and counsel them in its appropriate use.
To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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References: 1. Coleman CC, King BR, Bolden-Watson C, et al. A placebo-controlled comparison of the effects on sexual functioning of bupropion sustained release and fluoxetine. Clin Ther. 2001;23:1040–1058. 2. Clayton AH, Croft HA, Horrigan JP, et al. Bupropion extended release compared with escitalopram: effects on sexual functioning and antidepressant efficacy in 2 randomized, double-blind, placebo-controlled studies. J Clin Psychiatry. 2006;67:736–746. 3. Coleman CC, Cunningham LA, Foster VJ, et al. Sexual dysfunction associated with the treatment of depression: a placebo-controlled comparison of bupropion sustained release and sertraline treatment. Ann Clin Psychiatry. 1999;11(4):205–215. 4. Croft H, Settle E Jr., Houser T, et al. A placebo-controlled comparison of the antidepressant efficacy and effects on sexual functioning of sustained-release bupropion and sertraline. Clin Ther. 1999;21:643-658. 5. Gelenberg AJ, Freeman MP, Markowitz JC, et al. Practice guideline for the treatment of patients with major depressive disorder (revision). American Psychiatric Association. Am J Psychiatry. 2000;157(4 Suppl):1–45. 6. APLENZIN (bupropion hydrobromide extended-release) Prescribing Information. 2014. Valeant Pharmaceuticals, Inc. 7. US Patents 7649019 B2 and 8349900 B2. 8. Gregorian RS, Golden KA, Bahce A, Goodman C, Kwong WJ, Kahn ZM. Antidepressant-induced sexual dysfunction. Ann Pharmacother. 2002;36:1577–1589. 9. Montejo AL, Llorca G, Izquierdo JA, Rico-Villademoros F. Incidence of sexual dysfunction associated with antidepressant agents: a prospective multicenter study of 1022 outpatients. J Clin Psychiatry. 2001;62[suppl 3]:10–21.