The risk of adverse reactions may be greater in patients with impaired renal function. Bupropion Hydrochloride Extended-release (SR) tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM).The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD This trial demonstrated the effectiveness of the immediate-release formulation of bupropion, but only at the 450-mg-per-day dose. The efficacy results were significant for the HDRS total score and the CGI-S score, but not for HDRS item 1. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. Discontinue Bupropion Hydrochloride Extended-release (SR) tablets and do not restart treatment if the patient experiences a seizure.The risk of seizures is also related to patient factors, clinical situations, and concomitant medications that lower the seizure threshold. Adverse Reactions Reported by at Least 1% of Subjects and at a Greater Frequency than Placebo in Controlled Clinical TrialsOther Adverse Reactions Observed During the Clinical Development of Bupropion:Table 4. Consider reducing the dose and/or frequency of Bupropion Hydrochloride Extended-release (SR) tablets in patients with renal impairment (Glomerular Filtration Rate less than 90 mL per min) Telephone numbers for certified poison control centers are listed in the Physicians' Desk Reference (PDR). Patients receiving continued treatment with Bupropion Hydrochloride Extended-release (SR) tablets experienced significantly lower relapse rates over the subsequent 44 weeks compared with those receiving placebo.Bupropion Hydrochloride Extended-release Tablets USP (SR), 100 mg of bupropion hydrochloride, are blue, round, biconvex, film-coated tablets debossed with “S” on one side and “522” on the other.Bupropion Hydrochloride Extended-release Tablets USP (SR), 150 mg of bupropion hydrochloride, are purple, round, biconvex, film-coated tablets debossed with “S” on one side and “525” on the other.Bupropion Hydrochloride Extended-release Tablets USP (SR), 200 mg of bupropion hydrochloride, are pink, round, biconvex, film-coated tablets debossed with “S” on one side and “527” on the other.Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Ensure an adequate airway, oxygenation, and ventilation. Advise families and caregivers of the need for close observation and communication with the prescriber [see In patients with moderate to severe hepatic impairment (Child-Pugh score: 7 to 15), the maximum dose is Consider reducing the dose and/or frequency of bupropion hydrochloride extended-release tablets (XL) in patients with renal impairment (Glomerular Filtration Rate < 90 mL/min) [see At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with bupropion hydrochloride extended-release tablets (XL). Adverse reactions have included restlessness, agitation, tremor, ataxia, gait disturbance, vertigo, and dizziness. Therapy with Bupropion Hydrochloride Extended-release (SR) tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue.The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg per kg with Bupropion Hydrochloride Extended-release (SR) tablets is unclear. 0000014748 00000 n
It is unknown whether the dose of Bupropion Hydrochloride Extended-release (SR) tablets needed for maintenance treatment is identical to the dose that provided an initial response. 0000001990 00000 n
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Some people get high blood pressure, that can be severe, while taking Bupropion Hydrochloride Extended-release (SR) tablets.Severe allergic reactions. 0000007802 00000 n
Fever, muscle rigidity, rhabdomyolysis, hypotension, stupor, coma, and respiratory failure have been reported mainly when bupropion was part of multiple drug overdoses.Although most patients recovered without sequelae, deaths associated with overdoses of bupropion alone have been reported in patients ingesting large doses of the drug.