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Aplenzin(TM), the Only Single Tablet Once-Daily Treatment for Depression at All Doses, Now Available in the United States
Date:4/7/2009

Indication:

APLENZIN is indicated for the treatment of major depressive disorder in adults aged 18 years and older.

Important Safety Information:

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.

APLENZIN is contraindicated in patients who have a seizure disorder, patients being treated with Zyban(R) (bupropion HCl) Sustained-Release Tablets, WELLBUTRIN(R) (bupropion HCl), WELLBUTRIN SR(R) (bupropion HCl) Sustained-Release Tablets, or any other medications that contain bupropion, patients who have or had bulimia or anorexia nervosa, patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines), patients who have shown an allergic response to bupropion and patients taking MAO inhibitors. At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of APLENZIN.


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