bupropion 300 mg

1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablet, (XL) is an aminoketone antidepressant, indicated for treatment of major depressive disorder (MDD) ( 1.1 ) prevention of seasonal affective disorder (SAD) ( 1.2 ) 1.1 Major Depressive Disorder (MDD) 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 (SAD) 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, (XL) 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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FDA Reported Adverse Reactions
[1] fatigue    [2] drug ineffective    [3] off label use    [4] nausea    [5] pain    [6] toxicity to various agents    [7] headache    [8] dyspnoea    [9] diarrhoea    [10] arthralgia