24 HR Bupropion Hydrochloride 300 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (XL) is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. ( 1 ) 1.1 Major Depressive Disorder 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 (14.1) ]. 1.2 Seasonal Affective Disorder Bupropion hydrochloride extended-release tablets (XL) are 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) ].
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ROUND WHITE 300 XL
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16 HOW SUPPLIED/STORAGE AND HANDLING Bupropion Hydrochloride Extended-release Tablets, USP (XL) are available containing 150 mg or 300 mg of bupropion hydrochloride, USP. The 300 mg tablets are supplied as white, round, film-coated, unscored tablets with “300 XL” imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 68788-7509-03: bottles of 30 tablets NDC 68788-7509-06: bottles of 60 tablets NDC 68788-7509-09: bottles of 90 tablets NDC 68788-7509-01: bottles of 100 tablets NDC 68788-7509-08: bottles of 120 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Bupropion hydrochloride extended-release tablets (XL) may have an odor.
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