ORLISTATUM (XENICAL) INDICATIONS
Orlistatum is used for managing obesity in adults and adolescents 12 years old and older. It is also used to reduce the risk of weight regain after previous weight loss. Orlistatum is a gastrointestinal lipase inhibitor. It works by inhibiting the digestion of fats from the diet and should be used with a reduced-calorie diet.
ORLISTATUM (XENICAL) INSTRUCTIONS
Use Orlistatum as directed by your doctor.
- Take Orlistatum by mouth with or up to 1 hour after each main meal that contains fat (up to 3 per day).
- If a meal is missed or contains no fat, do not take a dose of Orlistatum.
- You can take Orlistatum in conjunction with a mildly reduced-calorie diet up to 3 times a day. Each time you take Orlistatum, your meal should contain no more than about 30% of calories from fat.
- You should take a multivitamin supplement containing vitamins A, D, E, and K to ensure good nutrition. The supplement should be taken at least 2 hours before or after you take Orlistatum, such as at bedtime.
- If you also take a thyroid hormone (eg, levothyroxine), do not take it within 4 hours before or after Orlistatum. Check with your doctor if you have questions.
- If you also take cyclosporine, do not take it within 2 hours before or after Orlistatum. Check with your doctor if you have questions.
- If you miss a dose of Orlistatum, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
ORLISTATUM (XENICAL) STORAGE
The recommended dose is one 120 mg capsule by mouth with liquid at each main meal that contains fat. Doses greater than 120 mg three times a day have not been shown to provide an additional weight loss benefit.
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 Orlistatum.
If your daily calorie level is: | The recommended daily grams of fat (in a 30% fat diet) are: |
1500 | 50 |
1600 | 53 |
1800 | 60 |
2000 | 67 |
Ask your health care provider any questions you may have about how to use Orlistatum.
Warnings/Precautions
Do not use Orlistatum if:
- ·you are allergic to any ingredient in Orlistatum;
- ·you are not overweight;
- ·you have problems absorbing food or bile flow problems (e.g., cholestasis);
- ·you have received an organ transplant;
- ·you take cyclosporine.
Contact your doctor or health care provider right away if any of these apply to you.
- ·Do not take more than the recommended dose without checking with your doctor. Taking more than the recommended dose may not help you lose more weight. It may increase your risk of side effects.
- ·Proper diet and exercise are important in order to lose weight and keep it off. Follow the diet and exercise program given to you by your health care provider.
- ·Orlistatum may cause changes in your bowel or stool (e.g., gas with oily spotting, loose stools, more frequent stools). Eating a low-fat diet may help lessen these side effects.
- ·Tell your doctor or dentist that you take Orlistatum before you receive any medical or dental care, emergency care, or surgery.
- ·Diabetes patients - Orlistatum may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- ·Orlistatum should not be used in children younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- ·Pregnancy and breast-feeding: Do not take Orlistatum if you are pregnant. If you become pregnant, contact your doctor. It is not known if Orlistatum is found in breast milk. Do not breast-feed while taking Orlistatum.
Possible Side Effects
Check with your doctor if any of these most common side effects persist or become bothersome:
- ·diarrhea; gas with discharge; frequent or loose stools; oily spotting; trouble controlling bowel movements.
Seek medical attention right away if any of these severe side effects occur:
- ·severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe or persistent stomach pain.
More Information
Orlistatum is to be used only by the patient for whom it is prescribed. Do not share it with other people.
ORLISTATUM (XENICAL) STORAGE
Store Orlistatum at room temperature beetwen 68 and 77 degrees F (20-25 degrees C) in a tight, light-resistant container, away from heat, moisture and light. Keep Orlistatum out of the reach of children.
ORLISTATUM (XENICAL) MORE INFO:
Active Ingredient:Orlistat.
Other Ingredients:Microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, povidone, and talc.
Do NOT use Orlistatum if:
- you are allergic to any ingredient in Orlistatum
- you constantly have problems absorbing food (chronic malabsorption)
- you have gallbladder problems
- you have cholestasis (a problem of bile flow from the liver to the intestines).
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Orlistatum. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have an underactive thyroid.
Some medicines may interact with Orlistatum. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Anticoagulants (eg, warfarin) because side effects, including risk of bleeding, may be increased by Orlistatum
- Amiodarone, cyclosporine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Orlistatum.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Orlistatum may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Important safety information:
- Do NOT take more than the recommended dose without checking with your doctor. Exceeding the recommended dose will not make you lose more weight and may increase side effects.
- Tell your doctor or dentist that you take Orlistatum before you receive any medical or dental care, emergency care, or surgery.
- Follow the diet program given to you by your health care provider. Your daily intake of fat should be divided evenly over 3 meals.
- Eating a meal high in fat while taking Orlistatum increases the risk of side effects involving the stomach and intestines.
- Diabetes patients - Orlistatum may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Some patients taking Orlistatum have developed severe liver problems. It is not known if liver problems may be caused by Orlistatum. Contact your doctor right away if you experience yellowing of the skin or eyes, dark urine, pale stools, unusual weakness, or severe or persistent nausea.
- Orlistatum should not be used in children younger than 12 years old; safety and effectiveness in these children have not been confirmed.
- Pregnancy and breast-feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Orlistatum while you are pregnant. It is not known if Orlistatum is found in breast milk. Do not breastfeed while taking Orlistatum.
All medicines may cause side effects, but many people have no, or minor, side effects.
Check with your doctor if any of these most common side effects persist or become bothersome:
Diarrhea; frequent or loose stools; gas with discharge; oily spotting; trouble controlling bowel movements.
Seek medical attention right away if any of these severe side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); bloody urine; new or unusual back pain; severe or persistent stomach pain (with or without nausea and vomiting); symptoms of liver damage (eg, yellowing of the eyes or skin, dark urine, pale stools, loss of appetite, severe or persistent nausea).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.