DESCRIPTION

Bupropion HCl, an antidepressant of the aminoketone class and a non-nicotine aid to smoking cessation, 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 empirical formula is C13H18ClNO·HCl. Bupropion HCl 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.

Immediate Release Tablets: Wellbutrin is supplied for oral administration as 75 mg (yellow-gold) and 100 mg (red) film-coated tablets. Each tablet contains the labeled amount of bupropion HCl and the inactive ingredients: 75 mg tablet: D&C yellow no. 10 lake, FD&C yellow no. 6 lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide; 100 mg tablet: FD&C red no. 40 lake, FD&C yellow no. 6 lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.

Sustained Release Tablets: Wellbutrin SR: Wellbutrin SR tablets are supplied for oral administration as 100 mg (blue) and 150 mg (purple), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion HCl and the inactive ingredients: carnauba wax, cysteine hydrochloride, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polythylene glycol, and titanium dioxide and is printed with edible black ink. In addition, the 100 mg tablet contains FD&C blue no.1 lake and polysorbate 80, and the 150 mg tablet contains FD&C blue no. 2 lake, FD&C red no. 40 lake, and polysorbate 80. Zyban: Zyban (bupropion HCl for smoking cessation) is supplied for oral administration as 150-mg (purple), film-coated, sustained-release tablets. Each tablet contains the labeled amount of bupropion HCl and the inactive ingredients carnuba wax, cysteine HCl, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80 and titanium dioxide and is printed with edible black ink. In addition, the 150-mg tablet contains FD&C blue no. 2 lake and FD&C red no. 40 lake.

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