Bupropion Hydrochloride 75 MG Oral Tablet
INDICATIONS AND USAGE Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder. A physician considering bupropion hydrochloride tablets for the management of a patient’s first episode of depression should be aware that the drug may cause generalized seizures in a dose-dependent manner with an approximate incidence of 0.4% (4/1,000). This incidence of seizures may exceed that of other marketed antidepressants by as much as 4-fold. This relative risk is only an approximate estimate because no direct comparative studies have been conducted (see WARNINGS ). The efficacy of bupropion hydrochloride tablets has been established in 3 placebo-controlled trials, including 2 of approximately 3 weeks’ duration in depressed inpatients and one of approximately 6 weeks’ duration in depressed outpatients. The depressive disorder of the patients studied corresponds most closely to the Major Depression category of the APA Diagnostic and Statistical Manual III. Major Depression implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts. Effectiveness of bupropion hydrochloride tablets in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use bupropion hydrochloride tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Aphena Pharma Solutions - Tennessee, Inc.
ROUND PURPLE GG 929
GG 929 ROUND PURPLE
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HOW SUPPLIED Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Bupropion hydrochloride tablets, USP are supplied as: 75 mg: Lavender, round, film-coated tablets, debossed GG 929 on one side and plain on the reverse side. NDC 0781-1053-31 in bottles of 30 tablets NDC 0781-1053-01 in bottles of 100 tablets NDC 0781-1053-10 in bottles of 1000 tablets 100 mg: Lavender, round, film-coated tablets, debossed GG 930 on one side and plain on the reverse side. NDC 0781-1064-31 in bottles of 30 tablets NDC 0781-1064-01 in bottles of 100 tablets NDC 0781-1064-10 in bottles of 1000 tablets Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP.
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