24 HR Aplenzin 174 MG Extended Release Tablet
1 INDICATIONS AND USAGE APLENZIN is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. ( 1 ) 1.1 Major Depressive Disorder APLENZIN® (bupropion hydrobromide extended-release tablets) is indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies (14.1) ]. 1.2 Seasonal Affective Disorder APLENZIN is indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). The efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see Clinical Studies (14.2) ].
sanofi-aventis U.S. LLC
ROUND WHITE BR 174
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16 HOW SUPPLIED/STORAGE AND HANDLING APLENZIN ® Extended-Release Tablets, 174 mg of bupropion hydrobromide, are white to off-white, round tablets printed with "BR" over "174" in bottles of 30 tablets (NDC 0024-5810-30). APLENZIN ® Extended-Release Tablets, 348 mg of bupropion hydrobromide, are white to off-white, round tablets printed with "BR" over "348" in bottles of 30 tablets (NDC 0024-5811-30). APLENZIN ® Extended-Release Tablets, 522 mg of bupropion hydrobromide, are white to off-white, round tablets printed with "BR" over "522" in bottles of 30 tablets (NDC 0024-5812-30). Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
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