bupropion hydrochloride xl bupropion hydrochloride tablet extended release
1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (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 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) ].
sandoz inc.
ROUND WHITE ST150
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16 HOW SUPPLIED/STORAGE AND HANDLING Bupropion hydrochloride extended-release tablets, USP (XL) are spplied as: NDC Strength Quantity Description 0781-5528-31 150 mg bottle of 30 tablets white to off-white, round, film coated tablets printed with "ST 150" on one side 0781-5528-10 150 mg bottle of 1,000 tablets white to off-white, round, film coated tablets printed with "ST 150" on one side 0781-5529-31 300 mg bottle of 30 tablets white to off-white, round, film coated tablets printed with "ST 300" on one side 0781-5529-10 300 mg bottle of 1,000 tablets white to off-white, round, film coated tablets printed with "ST 300" on one side Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Bupropion hydrochloride extended-release tablets (XL) may have an odor.
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