bupropion hydrochloride 150 mg

1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets, USP (XL) are 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, USP (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, USP (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)].

sun pharmaceutical industries, inc.

FDA Reported Adverse Reactions
[1] drug ineffective    [2] fatigue    [3] pain    [4] off label use    [5] rash    [6] nausea    [7] dyspnoea    [8] arthralgia    [9] headache    [10] diarrhoea