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USP DI Vol. II - ORLISTAT (Oral?Local)

ORLISTAT (Oral?Local)?


Some commonly used brand names are:

In the U.S.?

  • Xenical

? Not commercially available in Canada.


Category

  • Lipase inhibitor

Description

Orlistat (OR-li-stat) is used as an aid to help you lose weight. The medicineprevents the digestion of some of the fat you eat. Fats that are not digestedcannot be absorbed and therefore do not contribute calories. To give the greatestweight loss, orlistat must be used with a weight-reduction diet.

Orlistat is available only with your doctor's prescription, in the followingdosage form(s):

    Oral
  • Capsules (U.S.)


Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual or allergicreaction to orlistat. Also tell your health care professional if you are allergicto any other substances, such as foods, preservatives, or dyes.

Pregnancy?Orlistat has not been studied in pregnantwomen. However, orlistat may decrease the amount of certain vitamins thatyour body can absorb from the food you eat. Make sure you have discussed withyour doctor the use of this medication during pregnancy.

Breast-feeding?It is not known whether orlistat passes intobreast milk. Although most medicines pass into breast milk in small amounts,many of them may be used safely while breast-feeding. Mothers who are takingthis medicine and who wish to breast-feed should discuss this with their doctor.

Children? Studies on this medicine have been done only inadult patients, and there is no specific information comparing use of orlistatin children with use in other age groups.

Older adults?There is no specific information comparing useof orlistat in the elderly with use in younger adults. However, this medicineis not expected to cause different side effects or problems in older peoplethan it does in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingorlistat, it is especially important that your health care professional knowif you are taking the following:

  • Warfarin?Orlistat may decrease the absorption of vitamin Kand may change your bleeding time

Other medical problems?The presence of other medicalproblems may affect the use of orlistat. Make sure you tell your doctor ifyou have any other medical problems, especially:

  • Kidney stones or
  • Gallbladder problems?Orlistat may make the condition worse

Proper Use of This Medicine

Orlistatprevents the absorption of some of the fat you eat. Therefore, you shouldtake it during the meal or within 1 hour of eating. If you occasionally missa 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 bodycan absorb from food, you will need to take a multivitamin supplement oncea day. Take the vitamin supplement at least 2 hours before or after takingorlistat.

When using orlistat, your diet should contain no more than 30% of caloriesas 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.

Dosing?The dose of orlistat will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of orlistat. If your dose is different,do not change it unless your doctor tells you to do so.

  • For oral dosage form (capsules):
    • For treatment of obesity:
      • Adults?120 milligrams (mg) three times a day with meals containingfat.
      • Children?Use and dose must be determined by your doctor.

Missed dose? If you miss a dose of orlistat after a fat-containing meal,skip that dose. Wait until your next meal, and take the medicine on yourregular schedule. Do not double doses.

Storage?To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Keep the medicine from freezing. Do not refrigerate.
  • Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress atregular visits to make sure that this medicine is working properlyand to check for unwanted effects.

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


Side Effects of This Medicine

Along with its needed effects, a medicine may cause someunwanted effects. Although not all of these side effects may occur, if theydo occur they may need medical attention. Check with your doctor as soon aspossible if any of the following side effects occur:

    More common

      Bodyache; chills; cough; fever; headache; nasal congestion; runny nose; sneezing; sore throat

    Less common

      Tightness in chest; tooth or gum problems; troubled breathing; wheezing

    Rare

      Bloody or cloudy urine; change in hearing; contagious diarrhea; difficult or painful urination; earache; frequent urge to urinate; pain in ear

Other side effects may occur that usually do not need medical attention. Theseside effects may go away during treatment as your body adjusts to the medicine.However, check with your doctor if any of the following side effects continueor are bothersome:

More common

Gas with leaky bowel movements; inabilityto hold bowel movement; increases in bowel movements; oily bowel movements; oily spotting of underclothes

Less common

Anxiety; back pain; menstrual changes; rectal pain or discomfort

After you stop using this medicine, your body may needtime to adjust. Side effects caused by orlistat usually disappear within 2to 3 days after stopping it.

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.


Developed: 11/22/1999
Revised: 06/28/2002