2006-09-25T15:35:00.000-07:00

Sibutramine HCL is an orally administered agent for the treatment of obesity. Chemically, the active ingredient is a racemic mixture of the (+) and (-) enantiomers of cyclobutanemethanamine, 1-(4-chlorophenyl)-N,N-dimethyl-a -(2-methylpropyl)-, hydrochloride, monohydrate, and has an empirical formula of C17H29Cl2NO. Its molecular weight is 334.33.

Each Sibutramine HCL capsule contains 5 mg, 10 mg, and 15 mg of sibutramine hydrochloride monohydrate. It also contains as inactive ingredients: lactose monohydrate, NF; microcrystalline cellulose, NF; colloidal silicon dioxide, NF; and magnesium stearate, NF in a hard-gelatin capsule [which contains titanium dioxide, USP; gelatin; FD&C Blue No. 2 (5- and 10-mg capsules only); D&C Yellow No. 10 (5- and 15-mg capsules only), and other inactive ingredients].

Sibutramine HCL is used in the management of obesity by increasing the amount of neurotransmitters serotonin and norepinephrine. Sibutramine inhibits the re-uptake of these neurotransmitters by the nerve cells and alters the balance of neurotransmitters within the nerve cells. Unlike other diet drugs (fenfluramine, dexfenfluramine) which increase release of these neurotransmitters from the cells, the action of Sibutramine is similar to anti-depressants (fluoxetine) which inhibit reuptake of serotonin.

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