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 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.

Storage
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.

WARNINGS
Blood Pressure and Pulse