IMPORTANT SAFETY INFORMATION
SUICIDALITY AND ANTIDEPRESSANT DRUGS:
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of APLENZIN or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. APLENZIN is not approved for use in pediatric patients.

NEUROPSYCHIATRIC REACTIONS IN PATIENTS TAKING BUPROPION FOR SMOKING CESSATION:
Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking bupropion who continued to smoke. Although APLENZIN is not approved for smoking cessation, observe all patients for neuropsychiatric reactions. Instruct the patient to contact a healthcare provider if such reactions occur [see Warnings and Precautions in Full Prescribing Information].

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Why Aplenzin?
The active ingredient in Aplenzin is bupropion, which has been prescribed by doctors to treat depression for over 25 years. Aplenzin is made with a different type of salt than other bupropion treatments. So what does that mean to you?
Aplenzin has no generic substitute.
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Aplenzin is one pill a day, even at the highest strength.
The chance of having seizures increases with higher doses of Aplenzin.


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Talk to your doctor to see if Aplenzin is right for you.

INDICATION

APLENZIN (bupropion hydrobromide) is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and seasonal affective disorder (SAD).

IMPORTANT SAFETY INFORMATION

SUICIDALITY AND ANTIDEPRESSANT DRUGS:

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of APLENZIN or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. APLENZIN is not approved for use in pediatric patients.

NEUROPSYCHIATRIC REACTIONS IN PATIENTS TAKING BUPROPION FOR SMOKING CESSATION:
Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking bupropion who continued to smoke. Although APLENZIN is not approved for smoking cessation, observe all patients for neuropsychiatric reactions. Instruct the patient to contact a healthcare provider if such reactions occur [see Warnings and Precautions in Full Prescribing Information].

 

APLENZIN is not for everyone. There is a chance of having a seizure (convulsion, fit) with APLENZIN, especially in people with certain medical problems or who take certain medicines. The risk of having seizures increases with higher doses of APLENZIN. Tell your doctor about all of your medical conditions, especially if you have liver or kidney problems, and all the medicines you take. Do not take any other medicines while you are using APLENZIN unless your doctor has said it is okay to take them. If you have a seizure while taking APLENZIN stop taking the tablets and call your doctor right away. Do not take APLENZIN again if you have a seizure.

Do not take with monoamine oxidase inhibitors (MAOIs), or medicines that contain bupropion like ZYBAN* or WELLBUTRIN*. Some people get high blood pressure that can be severe while taking APLENZIN. The risk for high blood pressure may be increased if you also use nicotine replacement therapy (such as a nicotine patch) to help you stop smoking.

Who should NOT take APLENZIN?

Do not take APLENZIN if you:

  • Have or had a seizure disorder or epilepsy
  • Are taking ZYBAN (used to help people stop smoking) or any other medicines that contain bupropion hydrochloride, such as WELLBUTRIN Tablets, WELLBUTRIN SR Sustained-Release Tablets, or WELLBUTRIN XL Extended-Release Tablets.
  • Drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy) or benzodiazepines and you stop using them all of a sudden
  • Have taken within the last 14 days medicine for depression called a monoamine oxidase inhibitor (MAOI), such as NARDIL* (phenelzine sulfate), PARNATE* (tranylcypromine sulfate), or MARPLAN* (isocarboxazid)
  • Have or had an eating disorder such as anorexia nervosa or bulimia
  • Are allergic to the active ingredient in APLENZIN, bupropion, or to any of the inactive ingredients

Possible side effects of APLENZIN

The most common side effects of APLENZIN include dry mouth, nausea, trouble sleeping, dizziness, sore throat, stomach pain, agitation, anxiety, shakiness, fast heartbeat, sweating, ringing in the ears, muscle pain, anorexia, urinating more often than normal for you, and rash. Some people may also experience visual problems (eye pain, changes in vision, swelling or redness around the eye) or manic episodes (excitement, euphoria, and over activity). These are not all of the possible side effects of APLENZIN. Tell your healthcare provider right away about any side effects that bother you.

Click here for full Prescribing Information, including Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact Valeant Customer Service at
1-800-556-1937.

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