bupropion hydrochloride XL 150 MG 24 HR Extended Release Tablet
1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (XL) are 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) ] .
Mylan Institutional Inc.
ROUND WHITE M B8
M B8 ROUND WHITE
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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 150 mg tablets are supplied as off-white to pale yellow, film-coated, round, unscored tablets with M over B8 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-047-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 300 mg tablets are supplied as off-white to pale yellow, film-coated, oval, unscored tablets with M B9 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 51079-109-03 – Unit dose blister packages of 30 (3 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Bupropion hydrochloride extended-release tablets (XL) may have an odor. PHARMACIST: Dispense a Medication Guide with each prescription.
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