bupropion hydrochloride tablet extended release
1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (XL) are 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) ].
accord healthcare inc.
ROUND WHITE GS1
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16 HOW SUPPLIED/STORAGE AND HANDLING
BUPROPION HYDROCHLORIDE extended-release tablets, USP (XL) are supplied as: NDC Strength Quantity Description 16729-443-10 150 mg bottle of 30 tablets with a child-resistant closure creamy-white to pale yellow, round tablets printed with “GS1” on one side and plain on the other side 16729-443-15 150 mg bottle of 90 tablets with a child-resistant closure creamy-white to pale yellow, round tablets printed with “GS1” on one side and plain on the other side 16729-443-16 150 mg bottle of 500 tablets creamy-white to pale yellow, round tablets printed with “GS1” on one side and plain on the other side 16729-444-10 300 mg bottle of 30 tablets with a child-resistant closure creamy-white to pale yellow, round tablets printed with “GS2” on one side and plain on the other side 16729-444-15 300 mg bottle of 90 tablets with a child-resistant closure creamy-white to pale yellow, round tablets printed with “GS2” on one side and plain on the other side 16729-444-16 300 mg bottle of 500 tablets creamy-white to pale yellow, round tablets printed with “GS2” on one side and plain on the other side Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Protect from light. Do not remove the canisters until all tablets are consumed. Canister pouch with 17 canisters is included with 500’s count pack. Canisters should be dispensed with the tablets as per the instructions on the canister pouch. Reclose the pouch after dispensing canisters. Include one canister per each 30 or fewer tablets dispensed.
BUPROPION HYDROCHLORIDE extended-release tablets, USP (XL) may have an odor.
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