24 HR Bupropion Hydrochloride 450 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (XL) are 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 )] . The physician who elects to use bupropion hydrochloride extended-release tablets (XL) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient. Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant indicated for the treatment of major depressive disorder (MDD) ( 1 ). The efficacy was established in two 4-week trials, one 6-week trial with bupropion immediate-release formulation, and one maintenance trial with bupropion sustained-release formulation, all in adults ( 14 ). Periodically re-evaluate long-term usefulness for the individual patient ( 1 ).
alvogen inc.
OVAL WHITE BUP450
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16 HOW SUPPLIED/STORAGE AND HANDLING
BUPROPION HYDROCHLORIDE extended-release tablets (XL), 450 mg of
BUPROPION HYDROCHLORIDE, USP, are white to off-white, oblong-shaped tablets printed with the “BUP450” on one side supplied in bottles of 30 tablets (NDC 47781-637-30). Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].
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