Each Fetrasil Tablets
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 Tablets [which contains titanium dioxide, USP;
gelatin; FD&C Blue No. 2 (5- and 10-mg Tabletss
weight lossFetrasil is indicated for the
management of obesity, including weight loss and maintenance
of weight loss, and should be used in conjunction with a
reduced calorie diet. Fetrasil is recommended for obese
patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27
kg/m2 in the presence of other risk factors (e.g., diabetes,
dyslipidemia, controlled hypertension).
The recommended starting dose of Fetrasil is
10 mg administered once daily with or without food. If there
is inadequate weight loss, the dose may be titrated after four
weeks to a total of 15 mg once daily. The 5 mg dose should be
reserved for patients who do not tolerate the 10 mg dose.
Blood pressure and heart rate changes should be taken into
account when making decisions regarding dose titration (see
WARNINGS and PRECAUTIONS).
Doses above 15 mg daily are
not recommended. In most of the clinical trials, Fetrasil was
given in the morning.
Store at 25°C (77°F);
excursions permitted to 15°-30°C (59°-86°F) [see USP
controlled room temperature]. Protect Tabletss from heat and
moisture. Dispense in a tight, light-resistant container as
defined in USP.
Blood Pressure and