XENICAL is an oral prescription weight loss medication used to help
obese people lose weight and keep this weight off. XENICAL works in your
intestines, where it blocks some of the fat you eat from being absorbed.
This undigested fat is then eliminated in your bowel movements. XENICAL
should be used together with a reduced-calorie diet that your doctor will
recommend.
Excess weight has been proven to contribute to an increased risk of
developing many medical problems, including high blood pressure, high
cholesterol, heart disease, and diabetes. The consumption of excess fatty
food and calories plays a significant role in the development of excess
weight. While fat is an important component of a balanced diet, the
consumption of excess fat contributes to excess body weight, since fat
provides twice the number of calories per gram of weight as carbohydrates
and protein. Reduction of dietary fat intake is one potential way of
losing weight.
If you eat an excess amount of fat or calories, the excess is
stored as fat by the body resulting in weight gain. When you eat fat, your
body breaks it down into its simplest components so that it can be
absorbed. Enzymes in your intestinal tract, called lipases, help digest
(or breakdown) fat. When you take XENICAL with meals, XENICAL attaches to
the lipases and blocks them from breaking down some of the fat you have
eaten. The undigested fat cannot be absorbed and is eliminated in your
bowel movements. By working this way, XENICAL helps block about 30% of the
fat eaten in food from being absorbed by your body.
Following one year of treatment, XENICAL in
combination with diet was shown to be more effective in reducing weight
than diet alone. In most cases, weight loss was gradual. Patients treated
with XENICAL and a reduced-calorie diet for one year lost an average of
13.4 pounds while those on a reduced-calorie diet alone lost 5.8
pounds.
A weight loss program that includes a
reduced-calorie diet and appropriate physical activity may be adequate in
some patients. You should discuss with your doctor or other health care
provider whether XENICAL should be added to such a program.
XENICAL may be right for you if you are
considerably overweight (at least 30% above ideal weight or a body mass
index of 30 or greater). XENICAL may also be right for you if you are
overweight (at least 20% above ideal weight or a body mass index of 27 or
greater) and also have other risk factors such as high blood pressure,
high cholesterol, heart disease, or diabetes.
Who
should not use XENICAL?
Those who:
- consistently have problems absorbing food
(chronic malabsorption); or
- have gallbladder problems; or
- are pregnant or are breastfeeding a child; or
- have ever had an allergic reaction to orlistat
or any of the inactive ingredients in XENICAL.
What
should I tell my doctor before taking XENICAL?
Before beginning treatment with XENICAL, make
sure your doctor knows if you are:
- allergic to any medicines, foods, or dyes;
- taking any other weight-loss medication;
- taking cyclosporine;
- taking any other medicines (including those not
prescribed by your doctor);
- taking any dietary supplements, including herbal
products;
- planning to become pregnant; or
- anorexic or bulimic.
This information will help you and your physician
decide if the expected advantages of XENICAL are greater than any possible
disadvantages.
How
should I take XENICAL?
The recommended dose is one 120 mg capsule by
mouth with liquid at each main meal that contains fat. You can take
XENICAL in conjunction with a mildly reduced-calorie diet up to 3 times a
day. Each time you take XENICAL, your meal should contain no more than
about 30% of calories from fat. Take XENICAL during meals or up to one
hour after a meal. If you occasionally miss a meal or have a meal without
fat, you can omit your dose of XENICAL. Doses greater than 120 mg three
times a day have not been shown to provide an additional weight loss
benefit.
You should use XENICAL together with a
nutritionally balanced, mildly reduced-calorie diet that contains no more
than about 30% of calories from fat. You should evenly divide your daily
intake of fat, carbohydrates, and protein over 3 main meals.
You should try to follow a healthy eating plan such
as the one developed by the American Heart Association. Following this
eating plan will help you lose weight while decreasing some of the
possible gastrointestinal effects you may experience while taking
XENICAL.
IF YOUR DAILY CALORIE
LEVEL IS: |
THE RECOMMENDED DAILY GRAMS OF FAT (in a 30% fat diet) ARE: |
1500 1600 1800 2000 |
50 53 60 67 |
Should I take a multivitamin with XENICAL?
XENICAL interferes with your body’s absorption
of some fat-soluble vitamins. Therefore, when you use XENICAL, you should
take a daily multivitamin supplement that contains vitamins D, E, K, and
beta-carotene. Take your multivitamin once a day at least 2 hours before
or after taking XENICAL, such as at bedtime.
Can I
take XENICAL while taking other medications?
Be sure to discuss with your doctor all
medications (including herbal products) you are currently taking,
including medicines you can get without a prescription (over-the-counter),
to determine if XENICAL can be taken in addition to these medications. If
you are taking cyclosporine, XENICAL and cyclosporine should be taken at
least 2 hours apart. If your cyclosporine levels are being measured, more
frequent monitoring may be necessary.
How
long should I use XENICAL?
The use of XENICAL for more than 2 years has
not been studied. You and your doctor should discuss how long you should
use XENICAL.
What
are the most common side effects of XENICAL?
Because XENICAL works by blocking the
absorption of dietary fat, it is likely that you will experience some
changes in bowel habits. These generally occur during the first weeks of
treatment; however, they may continue throughout your use of XENICAL.
These changes may include oily spotting, gas with discharge, urgent need
to go to the bathroom, oily or fatty stools, an oily discharge, increased
number of bowel movements, and inability to control bowel movements. Due
to the presence of undigested fat, the oil seen in a bowel movement may be
clear or have a coloration such as orange or brown.
These bowel changes are a natural effect of
blocking the fat from being absorbed and indicate that XENICAL is working.
They generally occur early in treatment, particularly after meals
containing higher amounts of fat than are recommended. These symptoms are
often temporary and may lessen or disappear as you continue treatment and
keep to your recommended diet of meals containing no more than about 30%
fat. However, these side effects may occur in some individuals over a
period of 6 months or longer.
If you are concerned about
these or any other side effects you experience while taking XENICAL, talk
to your doctor or pharmacist.
What lifestyle changes
should I consider when taking XENICAL?
You must use XENICAL with a
recommended mildly reduced-calorie diet. You should also
follow a program of regular physical activity, such as
walking. However, before
you undertake any activity or exercise program, be sure to speak with your
doctor or health care professional.
How can I reduce dietary
fat?
To help you get started on reducing the fat in
your diet to around 30%, read the labels on all the foods you buy. You
should avoid foods that contain more than 30% fat while you are taking
XENICAL.
- When eating meat, poultry or fish, limit your
portion to 2 or 3 ounces (roughly the size of a deck of cards). Choose
lean cuts of meat and remove the skin from poultry. Fill up your meal
plate by including more grains, fruits, and vegetables.
- Replace whole-milk products with nonfat or 1%
milk and nonfat, reduced-fat, or low-fat dairy items.
- Cook with less fat. Use vegetable oil spray when
cooking. Salad dressings, many baked items, and prepackaged, processed,
and fast foods are usually high in fat. Use the low- or non-fat versions
and/or cut back on serving sizes.
- When dining out, ask how foods are prepared and
request that they be prepared with little or no added fat.