Bupropion Hydrochloride Sr

Bupropion Hydrochloride Sr

Bupropion Hydrochloride Sr Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Bupropion hydrochloride extended-release tablets, USP (SR) 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 [see Clinical Studies (14)].

The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].

History

There is currently no drug history available for this drug.

Other Information

Bupropion hydrochloride extended-release tablets, USP (SR) ,an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1‑ dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13 H18 ClNO•HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:

Chemical Structure

Bupropion hydrochloride extended-release tablets, USP (SR) are supplied for oral administration as 100 mg, 150 mg, and 200 mg white to off-white, film-coated, extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the following inactive ingredients: hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, magnesium stearate, and diluted hydrochloric acid. The film coating contains lactose monohydrate, hydroxypropyl cellulose, titanium dioxide, and polyethylene glycol

Bupropion Hydrochloride Sr Manufacturers


  • Golden State Medical Supply, Inc.
    Bupropion Hydrochloride Sr (Bupropion Hydrochloride) Tablet, Film Coated, Extended Release [Golden State Medical Supply, Inc.]
  • Physicians Total Care, Inc.
    Bupropion Hydrochloride Sr (Bupropion Hydrochloride) Tablet, Extended Release [Physicians Total Care, Inc.]
  • Aidarex Pharmaceuticals Llc
    Bupropion Hydrochloride Sr (Sr) (Bupropion Hydrochloride) Tablet, Film Coated, Extended Release [Aidarex Pharmaceuticals Llc]
  • Proficient Rx Lp
    Bupropion Hydrochloride Sr (Bupropion Hydrochloride) Tablet, Film Coated, Extended Release [Proficient Rx Lp]

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