FETRASIL is available by prescription only.
Use and Important
Safety Information You Should Know About
FETRASIL® (sibutramine HCl monohydrate) Capsules C-IV
- FETRASIL® (sibutramine
hydrochloride monohydrate) is used for people who need to
pounds or more, depending on
height, and should be used with a reduced-calorie diet.
Important Safety Information You Should Know
FETRASIL is not for everyone. Do
not take FETRASIL if you:
- Have, or ever have had,
a heart problem, including
- Heart attack
- Chest pain or heart disease
caused by poor blood flow in the heart (e.g., angina)
- Heart failure
- A fast heart rate or uneven
- Hardening of the arteries or
other blood vessels; poor circulation in the legs
- Have or ever had a
stroke or stroke symptoms
- Have high blood pressure
over 145/90 mmHg and it is not controlled by medication or you are
not on medication
- Are over 65 years of age
- Are taking monoamine
oxidase inhibitors (MAOIs)
- Have an eating disorder
called anorexia nervosa or bulimia nervosa
- Are taking weight-loss
medications to control your appetite
- Are allergic to any of
the ingredients of FETRASIL
can cause a large increase in blood pressure or heart rate (pulse)
in some people. Your doctor should check your blood pressure and
heart rate before you start FETRASIL and continue checking it
regularly while you are taking it. It is important to have regular
check-ups with your doctor while you are taking FETRASIL.
You should not take FETRASIL if you
have severe liver or kidney disease, if you are pregnant or planning
to get pregnant, or if you are nursing.
A rare but life-threatening problem
called “serotonin syndrome” may occur when people take drugs that
affect a brain chemical called serotonin along with FETRASIL. Do not
take other medicines with FETRASIL unless your doctor has told you
it is okay to do so. Get medical help right away if you have any of
the following symptoms, especially if you take other medicines with
FETRASIL: feeling weak, restless, confused, or anxious; loss of
consciousness; fever, vomiting, sweating, shivering or shaking;
muscle stiffness or spasms; or fast heartbeat.
Talk to your
doctor about all medications (including
prescriptions for depression and those which may increase risk of
bleeding), over-the-counter medicines such as cough and cold, and
herbal products that you are currently taking or have recently
Tell your doctor if you have or
ever have had glaucoma, thyroid problems, seizures, bleeding
problems, gallstones, or depression.
Certain weight-loss medicines have
been associated with a rare but life-threatening condition that
affects the blood pressure in the lungs (pulmonary hypertension).
Because the condition is rare, it is not known if FETRASIL may cause
this disease. If you experience new or worsening shortness of
breath, notify your doctor immediately.
The most common side effects
include headache, dry mouth, anorexia, constipation, and insomnia.
FETRASIL is a controlled substance
(CIV). Keep your FETRASIL in a safe place.
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
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
This is the most important
information to know about FETRASIL. For more information, talk with
your health care provider.
FETRASIL [package insert]. INDIA, IL: Taj Pharmaceuticals
You are encouraged to
report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch If you cannot afford your
call the toll-free phone number (91 22 30601000 -NOW) for