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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)
 Fetrasil 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
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.
In placebo-controlled obesity studies, sibutramine 5 to 20 mg once
daily was associated with mean increases in systolic and diastolic
blood pressure of approximately 1 to 3 mm Hg relative to placebo,
and with mean increases in pulse rate relative to placebo of
approximately 4 to 5 beats per minute. Larger increases were seen
in some patients, particularly when therapy with sibutramine was
initiated at the higher doses (see table below). In premarketing
placebo-controlled obesity studies, 0.4% of patients treated with
sibutramine were discontinued for hypertension (SBP ≥ 160 mm Hg or
DBP ≥ 95 mm Hg), compared with 0.4% in the placebo group, and 0.4%
of patients treated with sibutramine were discontinued for
tachycardia (pulse rate ≥ 100 bpm), compared with 0.1% in the
placebo group. Blood pressure and pulse should be measured prior
to starting therapy with Fetrasil and should be monitored at
regular intervals thereafter. For patients who experience a
sustained increase in blood pressure or pulse rate while receiving
Fetrasil, either dose reduction or discontinuation should be
considered. Fetrasil should be given with caution to those
patients with a history of hypertension (see DOSAGE AND
ADMINISTRATION), and should not be given to patients with
uncontrolled or poorly controlled hypertension.
PRECAUTIONS
Pulmonary Hypertension
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.
Seizures
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.
Bleeding
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.
Presentation
Fetrasil
Tablets
Blister of 10 Tablets
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Quality
