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Orlistat (Oral route)

Pronunciation:

OR-li-stat

Brand Names:

  • Alli
  • Xenical

Dosage Forms:

  • Capsule

Classifications:

Therapeutic—

Dietary Fat Absorption Inhibitor

Pharmacologic—

Lipase Inhibitor

Uses of This Medicine:

Orlistat is used together with a reduced-calorie diet to help you lose weight and to help keep the lost weight from returning. It is also used in overweight people who may also have diabetes, high blood pressure, high cholesterol, or heart disease.

Orlistat works by keeping your intestines from absorbing some of the fats from the food that you eat. The undigested fat goes out of your body in your bowel movements.

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of orlistat in teenagers. Safety and efficacy have not been established in children younger than 12 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of orlistat in the elderly.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersXStudies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abacavir
  • Acenocoumarol
  • Apixaban
  • Ardeparin
  • Argatroban
  • Atazanavir
  • Bivalirudin
  • Carbamazepine
  • Certoparin
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Cobicistat
  • Cyclosporine
  • Dabigatran Etexilate
  • Dalteparin
  • Danaparoid
  • Darunavir
  • Desirudin
  • Diazepam
  • Didanosine
  • Edoxaban
  • Efavirenz
  • Elvitegravir
  • Emtricitabine
  • Enoxaparin
  • Eslicarbazepine Acetate
  • Ethosuximide
  • Ethotoin
  • Etravirine
  • Ezogabine
  • Felbamate
  • Fondaparinux
  • Fosamprenavir
  • Fosphenytoin
  • Gabapentin
  • Gabapentin Enacarbil
  • Heparin
  • Indinavir
  • Lacosamide
  • Lamivudine
  • Lamotrigine
  • Lepirudin
  • Levetiracetam
  • Lopinavir
  • Lorazepam
  • Methsuximide
  • Midazolam
  • Nadroparin
  • Nelfinavir
  • Nevirapine
  • Oxcarbazepine
  • Parnaparin
  • Perampanel
  • Phenindione
  • Phenobarbital
  • Phenprocoumon
  • Phenytoin
  • Piracetam
  • Pregabalin
  • Primidone
  • Protein C
  • Raltegravir
  • Reviparin
  • Rilpivirine
  • Ritonavir
  • Rivaroxaban
  • Rufinamide
  • Saquinavir
  • Stavudine
  • Stiripentol
  • Telaprevir
  • Tenofovir
  • Tiagabine
  • Tinzaparin
  • Tipranavir
  • Topiramate
  • Valproic Acid
  • Vigabatrin
  • Warfarin
  • Zidovudine
  • Zonisamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Linoleic Acid

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diabetes or
  • Underactive thyroid—Use with caution. May increase risk for more serious side effects.
  • Eating disorders (e.g., anorexia nervosa or bulimia) or
  • Hyperoxaluria (high oxalic acid in the urine), history of or
  • Kidney failure or
  • Kidney stones or
  • Liver disease—Use with caution. May make these conditions worse.
  • Gallbladder problems or
  • Malabsorption syndrome (problems with absorbing or digesting food)—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Talk to your doctor if you have any questions.

Orlistat prevents the absorption of some of the fat you eat. You should take it with liquids during the meal or up to 1 hour after eating. If you occasionally miss a meal or eat a meal that contains no fat, you should skip the dose of orlistat.

Because orlistat may decrease the amount of some vitamins that your body absorbs from food, you will need to take a multivitamin supplement once a day. Take the vitamin supplement at least 2 hours before or after taking orlistat. You may also take your multivitamin supplement at bedtime.

When using orlistat, your diet should contain no more than 30% of calories as fat. More fat in your diet will increase the side effects of this medicine. Your diet should be nutritionally balanced, and your daily intake of fat, carbohydrates, and protein should be distributed over three main meals.

Carefully follow your doctor's instructions for a reduced-calorie diet plan and regular exercise. Talk with your doctor before starting any exercise program.

If you are using cyclosporine (Gengraf®, Neoral®, Sandimmune®) and levothyroxine (Levothroid®, Synthroid®), do not take them at the same time that you take this medicine. It is best to take cyclosporine at least 3 hours before or 3 hours after taking orlistat. Levothyroxine must be used at least 4 hours before or 4 hours after you take orlistat.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For treatment of obesity:
      • Adults and teenagers—120 milligrams (mg) three times a day with meals containing fat.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits, to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

For patients with diabetes: Weight loss may result in an improvement in your condition, and your doctor may need to change your dose of oral diabetes medicine or insulin.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Stop using this medicine and check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual itching; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase your risk of having kidney stones. Check with your doctor right away if you or your child have blood in the urine, nausea and vomiting, pain in the groin or genitals, or sharp back pain just below the ribs.

Weight loss with this medicine may increase your risk of having gallstones. Check with your doctor right away if you or your child have severe stomach pain with nausea and vomiting.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Bladder pain
body aches
chills
cough
diarrhea
difficulty with breathing
ear congestion
fever
general feeling of discomfort or illness
headache
loss of appetite
loss of voice
lower back or side pain
muscle aches and pains
nasal congestion
nausea
runny nose
shivering
sneezing
sore throat
sweating
trouble sleeping
unusual tiredness or weakness
vomiting
Less common
Tightness in the chest
tooth or gum problems
troubled breathing
wheezing
Rare
Bloody or cloudy urine
change in hearing
contagious diarrhea
dark urine
difficult or painful urination
earache
fast heartbeat
frequent urge to urinate
general tiredness and weakness
hives
hoarseness
irritation
itching
joint pain, stiffness, or swelling
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
light-colored stools
noisy breathing
pain in the ears
rash
redness of the skin
shortness of breath
skin blisters
swelling of the eyelids, face, lips, hands, or feet
troubled swallowing
upper right abdominal or stomach pain
yellow eyes and skin
Incidence not known
Anxiety
bloating
blurred vision
cold sweats
coma
confusion
constipation
cool, pale skin
depression
dizziness
dry skin and hair
feeling cold
hair loss
hoarseness or husky voice
increased hunger
indigestion
loss of appetite
muscle cramps and stiffness
nervousness
nightmares
pains in the stomach, side, or abdomen, possibly radiating to the back
seizures
weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Abdominal or stomach pain or discomfort
back pain
difficulty with moving
gas with leaky bowel movements
inability to hold bowel movement
increases in bowel movements
loss of bowel control
oily bowel movements
oily spotting of underclothes
Less common
Itching of the vagina or genital area
menstrual changes
pain during sexual intercourse
rectal pain or discomfort
thick, white vaginal discharge with no odor or with a mild odor

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 9/4/2017
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