ORLISTATO (XENICAL) INDICATIONS
Orlistato 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. Orlistato 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.
ORLISTATO (XENICAL) INSTRUCTIONS
Use Orlistato as directed by your doctor.
- Take Orlistato 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 Orlistato.
- You can take Orlistato in conjunction with a mildly reduced-calorie diet up to 3 times a day. Each time you take Orlistato, 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 Orlistato, such as at bedtime.
- If you also take a thyroid hormone (eg, levothyroxine), do not take it within 4 hours before or after Orlistato. Check with your doctor if you have questions.
- If you also take cyclosporine, do not take it within 2 hours before or after Orlistato. Check with your doctor if you have questions.
- If you miss a dose of Orlistato, 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.
ORLISTATO (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 Orlistato.
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 Orlistato.
Warnings/Precautions
Do not use Orlistato if:
- ·you are allergic to any ingredient in Orlistato;
- ·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.
- ·Orlistato 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 Orlistato before you receive any medical or dental care, emergency care, or surgery.
- ·Diabetes patients - Orlistato may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- ·Orlistato 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 Orlistato if you are pregnant. If you become pregnant, contact your doctor. It is not known if Orlistato is found in breast milk. Do not breast-feed while taking Orlistato.
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
Orlistato is to be used only by the patient for whom it is prescribed. Do not share it with other people.
ORLISTATO (XENICAL) STORAGE
Store Orlistato 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 Orlistato out of the reach of children.
ORLISTATO (XENICAL) MORE INFO:
Active Ingredient:Orlistat.
Other Ingredients:Microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, povidone, and talc.
Do NOT use Orlistato if:
- you are allergic to any ingredient in Orlistato
- 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 Orlistato. 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 Orlistato. 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 Orlistato
- Amiodarone, cyclosporine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Orlistato.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Orlistato 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 Orlistato 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 Orlistato increases the risk of side effects involving the stomach and intestines.
- Diabetes patients - Orlistato 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 Orlistato have developed severe liver problems. It is not known if liver problems may be caused by Orlistato. 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.
- Orlistato 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 Orlistato while you are pregnant. It is not known if Orlistato is found in breast milk. Do not breastfeed while taking Orlistato.
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.