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 only)
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).
DOSAGE AND ADMINISTRATION
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 Pulse