DESCRIPTION

Sertraline HCl is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It is chemically unrelated to other SSRIs, tricyclic, tetracyclic, or other available antidepressant agents. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-nanphthalenamine hydrochloride. The empirical formula is C₁₇H₁₇NCl₂·HCl.

Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol.

Zoloft is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg and the following inactive ingredients: dibasic calcium phosphate dihydrate, Dy & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD&C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide.

Zoloft oral concentrate is available in a multidose 60 ml bottle. Each ml of solution contains sertraline HCl equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytolunene (BHT). The oral concentrate must be diluted prior to administration (see DOSAGE AND ADMINISTRATION).