Sarafem (Fluoxetine Hydrochloride) - Description

DESCRIPTION

SARAFEM^® (fluoxetine hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) for oral administration; fluoxetine was initially developed and marketed as an antidepressant (Prozac^®, fluoxetine capsules, USP). It is designated (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p -tolyl)oxy]propylamine hydrochloride and has the empirical formula of C₁₇H₁₈F₃NO•HCl. Its molecular weight is 345.79. The structural formula is:

Fluoxetine hydrochloride is a white to off–white crystalline solid with a solubility of 14 mg/mL in water.

Each Pulvule^® contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol) or 20 mg (64.7 μmol) of fluoxetine. The Pulvules also contain dimethicone, FD&C Blue No. 1, FD&C Red No. 3, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate, starch, and titanium dioxide.