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)
Fetrasil is indicated for the management of obesityFetrasil 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,
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
Fetrasil SUBSTANTIALLY INCREASES BLOOD
PRESSURE AND/OR PULSE RATE IN SOME PATIENTS. REGULAR MONITORING OF
BLOOD PRESSURE AND PULSE RATE IS REQUIRED WHEN PRESCRIBING Fetrasil.
Certain centrally-acting weight loss agents that cause release of
serotonin from nerve terminals have been associated with pulmonary
hypertension (PPH), a rare but lethal disease. In premarketing
clinical studies, no cases of PPH have been reported with
sibutramine Tabletss. Because of the low incidence of this disease
in the underlying population, however, it is not known whether or
not Fetrasil may cause this disease.
During premarketing testing, seizures were reported in < 0.1% of
sibutramine treated patients. Fetrasil should be used cautiously in
patients with a history of seizures. It should be discontinued in
any patient who develops seizures.
There have been reports of bleeding in patients taking sibutramine.
While a causal relationship is unclear, caution is advised in
patients predisposed to bleeding events and those taking concomitant
medications known to affect hemostasis or platelet function.
Loravan Tablets Blister of 10 Tablets
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