Orlistat 60 mg (Alli)
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Orlistat 60 mg (Alli)

Alli™
(orlistat 60 mg) Capsules

DRUG DESCRIPTION

The active ingredient in alli (orlistat 60 mg) (orlistat) has been used in the United States as a prescription-only medication at double the dose found in alli (orlistat 60 mg) . Xenical® (orlistat 120 mg/TID) was introduced in the United States in 1999 following rigorous clinical studies and FDA approval. Orlistat has an extensive clinical history. It has had 25 million patient treatments and has been studied in more than 100 controlled clinical trials.

Behavior Support programs are part of the foundation for successful weight loss. Xenical® provided a separate support program for patients known as Xenicare, which, at the time, was considered a comprehensive plan. But a lot has changed since the introduction of Xenical®, including consumer expectations, healthcare professional involvement within the weight loss category and consumer, information utilization, namely, the sophistication of the Internet user. Applying learnings from Xenicare, our insights from consumers & healthcare professionals, and our understanding of current Internet usage, we have developed the alli (orlistat 60 mg) support program, called myalli (orlistat 60 mg) plan. The myalli (orlistat 60 mg) plan is an individually tailored support plan based on sound clinical practices and designed by nutrition and weight loss experts. It is free with the purchase of alli (orlistat 60 mg) . The myalli (orlistat 60 mg) plan.com is an extremely comprehensive online support program, including personalized online pages to view goals, check-ins with individualized feedback and advice, continuous follow-up and weekly monitoring, personalized emails on eating right/meal planning, guidance on treatment effects, online journal, menus and shopping lists, direct advice from clinical experts and a connection to a community of other alli (orlistat 60 mg) users. Research indicates that those who receive one-on-one counseling or online support may have a long-term advantage in successfully losing weight.

alli (orlistat 60 mg) is different than Xenical® because it offers informational materials with the actual product. The alli (orlistat 60 mg) starter pack includes over 200 pages of free in-pack materials to help guide individuals through the alli (orlistat 60 mg) program and set expectations for gradual weight loss, help them make healthy eating choices, monitor daily diets, and manage treatment effects. Eighty percent of patients found these materials to be very helpful. Overall, the alli (orlistat 60 mg) program offers unprecedented support and resources designed to help modify behavior by creating self-assessment and self-management skills. Assuming personal responsibility is integral to achieving sustainable weight loss.

Another difference when comparing alli (orlistat 60 mg) to Xenical® is the manageability and tolerability of GI events. In clinical studies, the 60-mg capsule of alli (orlistat 60 mg) demonstrated comparable efficacy and safety profiles to the 120-mg prescription capsule, but had a lower incidence of treatment effects, compared with the 120-mg dosage. Only a small percentage of trial subjects withdrew due to GI-AEs (5.4% on 120mg compared to only 3.2% on 60-mg), further reinforcing the tolerability of the 60mg dose. After 90 days of using alli (orlistat 60 mg) , 81% of study participants reported being satisfied or very satisfied with orlistat, and 91% reported losing weight. In addition, alli (orlistat 60 mg) will tell consumers and HCPs alike that the likelihood of treatment effects is greater if individuals aren't committed to following a reduced-calorie, low-fat diet (no more than 15 grams of fat per meal) and eating smaller portions.

alli (orlistat 60 mg) is available for oral administration in dark-blue, hard-gelatin capsules. Each capsule contains 60 mg of the active ingredient, orlistat. The capsules also contain the inactive ingredients FD&C Blue No. 2, edible ink, gelatin, iron dioxide, microcrystalli (orlistat 60 mg) ne cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, titanium dioxide.

What are the possible side effects of orlistat (alli, Xenical)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking orlistat and call your doctor at once if you have severe pain in your upper stomach spreading to your back, nausea and vomiting, and a fast heart rate. These could be signs of pancreatitis.

The following side effects occur commonly with the use of orlistat. They are the natural effects of orlistat's fat-blocking action and are actually signs that the medication is working properly. These side effects...

Read All Potential Side Effects and See Pictures of Alli »

What are the precautions when taking orlistat 60 mg (Alli)?

Before taking orlistat, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain digestive problem (chronic malabsorption syndrome), a certain gall bladder problem (cholestasis), underactive thyroid (hypothyroidism), kidney stones/problems (such as calcium oxalate kidney stones, hyperoxaluria), certain eating disorders (anorexia nervosa/bulimia).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal...

Read All Potential Precautions of Alli »

Last reviewed on RxList: 6/20/2007
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

alli™ (orlistat 60 mg) is indicated for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet.

Diet and exercise are the starting points for any weight loss program. Try these first before adding alli (orlistat 60 mg) . Check with your doctor before starting any exercise program.

To determine if alli (orlistat 60 mg) capsules are right for you, find your height on the chart below. You may consider starting with alli (orlistat 60 mg) if your weight is the same or more than the weight shown for your height.

alli (orlistat 60 mg)  weight, height chart

DOSAGE AND ADMINISTRATION

The recommended dose of alli (orlistat 60 mg) for overweight adults 18 years and older is 1 60-mg capsule with each meal containing fat.

  • do not exceed 3 capsules daily
  • use with a reduced-calorie, low-fat diet until you reach your weight loss goal.

Most weight loss occurs within the first 6 months. If you stop using alli (orlistat 60 mg) , continue with a diet and exercise program. If you start to regain weight after you stop taking alli (orlistat 60 mg) , you may need to start taking alli (orlistat 60 mg) again along with your diet and exercise program.

Take a multivitamin once a day, at bedtime, when using alli (orlistat 60 mg) capsules.

HOW SUPPLIED

Storage Conditions: Store at 20 - 25°C (68 - 77°F); protect drug from excessive light, humidity, and temperature over 30°C (86°F)

Alli (orlistat 60 mg) , MyAlli (orlistat 60 mg) .com, MyAlli (orlistat 60 mg) Plan.com, Alli (orlistat 60 mg) Shuttle and various design elements are trademarks of GlaxoSmithKline.

Distributed by:
GlaxoSmithKline
Consumer Healthcare, L.P.
Moon Township, PA 15108
Made in the U.S.A.

US Patent Nos. 4,598,089
6,004,996
Shuttle Patent Pending

© 2007 GlaxoSmithKline

Last reviewed on RxList: 6/20/2007
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Some people on alli™ (orlistat 60 mg) will experience GI side effects, which is expected since alli (orlistat 60 mg) works by inhibiting about 25% of dietary fat. alli (orlistat 60 mg) is half the strength of prescription Xenical® (orlistat 120 mg), and, as a result, has fewer GI events overall than Xenical®. In clinical trials, subjects on 120 mg withdrew due to GI adverse events at a rate of 5.4%-and at 60 mg it was only 3.2%.

The main treatment effect occurs when an individual eats a meal with too much fat while taking alli (orlistat 60 mg) . Treatment effects may include:

  • Loose or more frequent stools that may be hard to control
  • An urgent need to go to the bathroom
  • Gas with oily spotting
  • While excess fat that is excreted is not harmful, patients could be distressed by the experience. Treatment effects can be lessened if an individual sticks with reduced-calorie, low-fat meals that average 15 grams of fat per meal (or 30% fat or less). Diets may vary from 1,200 calories to 1,800 calories per day, so 15 grams is an average. Individuals need to be aware of hidden fat in food, so that they can lower the chance of having treatment effects.

Not all individuals will experience treatment effects, but those that do can reduce the likelihood of these effects by taking alli (orlistat 60 mg) as directed and sticking with a reduced-calorie, low-fat diet. The alli (orlistat 60 mg) starter pack includes portable reference guides and online support at myalli (orlistat 60 mg) .com to help patients follow the program accurately. Some patients may experience treatment effects as they begin therapy until they learn to adjust their diet.

Read the Alli (orlistat 60 mg) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Patients should not use alli (orlistat 60 mg) if they have had an organ transplant or if they are taking medicine to reduce organ rejection.

alli™ (orlistat 60 mg) has low potential for misuse and drug interactions because of the mechanism of action and minimal systemic absorption. The only known drug interactions can occur with cyclosporine and warfarin (blood-thinning medicine).

Patients should not use alli (orlistat 60 mg) if taking cyclosporine; alli (orlistat 60 mg) can reduce levels of cyclosporine in the blood.

Patients on warfarin should talk with their doctor before taking alli (orlistat 60 mg) ; they will need to be monitored closely for changes in coagulation parameters and have their blood tested regularly, which is standard for any individual taking warfarin who is considering starting a new concomitant drug.

Patients taking medicine for thyroid disease should talk to their doctor before taking alli (orlistat 60 mg) .

alli (orlistat 60 mg) does not negatively interfere with diabetes medication; In fact, a clinical trial has demonstrated that patients taking orlistat have been able to reduce or discontinue their diabetes medicine.1

No clinically relevant drug interactions were seen when alli (orlistat 60 mg) was taken in combination with weight loss drugs, such as phentermine or sibutramine.2

References
1 Miles J, Leiter L, Hollander P, et al. Effect of orlistat in overweight and obese patients with type 2 diabetes treated with metformin. Diabetes Care. 2002;25:1123-1128.
2 Zhi J, Moore R, Kanitra L, Mulligan TE. Pharmacokinetic evaluation of the possible interaction between selected concomitant medications and orlistat at steady state in healthy subjects. Amer Coll Clin Pharmacol. 2002;42:1011-1019.

Last reviewed on RxList: 6/20/2007
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Organ transplant alert:

Do not use if you have had an organ transplant. alli (orlistat 60 mg) interferes with the medicines used to prevent transplant rejection.

Allergy alert:

Do not use if you are allergic to any of the ingredients in alli (orlistat 60 mg) capsules.

Do not use;

  • if you are taking cyclosporine
  • if you have been diagnosed with problems absorbing food
  • if you are not overweight

Ask a doctor before use if you have ever had:

PRECAUTIONS

Ask a doctor or pharmacist before use if you are

  • taking warfarin (blood thinning medicine), or taking medicine for diabetes or thyroid disease. Your medication dose may need to be adjusted.
  • taking other weight loss products.

When using this product

  • take a multivitamin containing vitamins A, D, E, K, and beta-carotene once daily at bedtime is recommended. Orlistat inhibits 25% of dietary fat, and may reduce the absorption of some fat-soluble vitamins. alli (orlistat 60 mg) and a multivitamin should not be taken at the same time to gain the most benefit of a multivitamin. However, if they are taken at the same time, at least 70% of the fat-soluble vitamins would be absorbed.
  • follow a well-balanced, reduced-calorie, low-fat diet. Try starting this diet before taking alli (orlistat 60 mg) capsules.
  • alli (orlistat 60 mg) capsules work by preventing the absorption of some of the fat you eat. The fat passes out of your body so you may have bowel changes. You may get:
    • gas with oily spotting
    • loose stools
    • more frequent stools that may be hard to control

Eating a low-fat diet lowers the chance of having these bowel changes.

For every 5 pounds you lose from diet alone, alli (orlistat 60 mg) can help you lose 2-3 pounds more. In studies, most people lost 5-10 pounds over 6 months.

Stop use and ask a doctor if severe or continuous abdominal pain occurs. This may be a sign of a serious medical condition.

If pregnant or breast-feeding, do not use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if an individual has been diagnosed with problems absorbing food or is allergic to any of the ingredients in an alli (orlistat 60 mg) capsule.

Do not use if not overweight.

Last reviewed on RxList: 6/20/2007
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

alli (orlistat 60 mg) is contraindicated in patients who have had an organ transplant or are taking medicine to reduce organ rejection, patients who are taking cyclosporine, and in patients with known problems absorbing food or are allergic to any of the ingredients in an alli (orlistat 60 mg) capsule.

Last reviewed on RxList: 6/20/2007
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

No information provided

Last reviewed on RxList: 6/20/2007
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

The alli (orlistat 60 mg) program

The alli (orlistat 60 mg) program is a comprehensive approach to weight loss. Combining the only FDA approved, over-the-counter weight loss product, alli (orlistat 60 mg) , combined with an online action plan, the alli (orlistat 60 mg) program brings together effective medical therapy and strong behavioral support. The alli (orlistat 60 mg) program is designed to bridge the gap between weight loss medications and the patients' role in their own healthcare and weight loss objectives.

Patients and other healthcare professionals engage in honest discussions and share resources that enable both parties to better understand the complexities involved in weight reduction.

The alli starter pack

Inside the alli™ (orlistat 60 mg) starter pack you'll find:

  • alli (orlistat 60 mg) weight loss capsules

    The capsules are easy to swallow and are taken with each meal containing fat (up to 3 per day). They work in your digestive system to prevent about a quarter of the fat you eat from being absorbed.


  • alli (orlistat 60 mg) Shuttle™

    The Shuttle™ makes it easy to carry the alli (orlistat 60 mg) capsules so you can have them with you at every meal, wherever you go. It's also a great visual reminder to use the alli (orlistat 60 mg) capsules - and it keeps them from getting lost in your purse, gym bag, or briefcase. There's room in the Shuttle for your daily multivitamin, too.


  • Handy reference booklets

    The booklets to help you follow the alli (orlistat 60 mg) program. Check out the alli (orlistat 60 mg) "Read Me First Guide" with the keys to successful weight loss, the Welcome Guide, Companion Guide, Healthy Eating Guide, Calorie & Fat Counter, Daily Journal, and Quick Facts cards for the support you need to succeed with alli (orlistat 60 mg) .


  • myalli (orlistat 60 mg) plan online guidance

    Losing weight takes effort and commitment. That's why the alli (orlistat 60 mg) program includes an individually tailored online action plan. And it's free with your purchase of alli (orlistat 60 mg) . Following a reduced-calorie, low-fat diet is a great way to start with weight loss, but participating in the action plan can give you the added direction and practical advice you need to support your goal. And that support is available 24 hours a day.

FAQs

Q. How does alli (orlistat 60 mg) work?
A. As part of an overall weight loss program, alli (orlistat 60 mg) works in conjunction with behavior modification to achieve a calorie balance that is both nutritionally sound and conducive to weight reduction.

alli (orlistat 60 mg) is the only OTC drug for weight loss that is FDA approved. It has a non-systemic mechanism of action. The unique molecular structure of alli (orlistat 60 mg) enables it to bind to and inactivate some GI lipases, which aid in the digestion of dietary fats (triglycerides). alli (orlistat 60 mg) binds to gastric and pancreatic lipases, blocking absorption of about 25% of consumed fat. Undigested fat is excreted from the body instead of turning into stored fat. The absorption of carbohydrates and proteins is not affected. alli (orlistat 60 mg) is not an appetite suppressant nor does it impact the heart or nervous system. It is minimally absorbed, and there is no residual effect once the drug is stopped.

Q. Who is the ideal candidate for alli (orlistat 60 mg) ?
A. Ideal candidates are individuals who are overweight and are motivated and ready to make lifestyle changes. They have realistic expectations for gradual, modest weight loss. These individuals are committed to a reduced-calorie, low-fat diet (no more than 15 grams of fat per meal) and eating smaller portions. An ideal candidate for alli (orlistat 60 mg) will read and follow the label directions. They understand that treatment effects (loose or more frequent stools that may be hard to control, an urgent need to go to the bathroom, gas with oily spotting) can occur if they eat too much fat in a meal while taking alli (orlistat 60 mg) . Lastly, these individuals will make the time to be more physically active.

Q. How is alli (orlistat 60 mg) different from other weight loss products available?
A. alli (orlistat 60 mg) is the only FDA approved, over-the-counter weight loss product. It combines a pill (alli (orlistat 60 mg) 60 mg orlistat) with an individually tailored, online action plan based on sound clinical practices and designed by nutritional and weight loss experts. alli (orlistat 60 mg) can help an individual achieve gradual and healthy weight loss and lose 50% more weight than dieting alone. It works in the digestive system, not the central nervous system, so it does not affect the heart or brain. Orlistat has an extensive clinical history and has been studied in more than 100 controlled clinical trials. Additionally, orlistat has been used in more than 25 million patient treatments in 145 countries worldwide.

Q. I remember the difficulties with prescription Xenical®; how will the experience with over-the-counter alli (orlistat 60 mg) be different?
Behavior Support programs are part of the foundation for successful weight loss. Xenical® provided a separate support program for patients known as Xenicare, which, at the time, was considered a comprehensive plan. But a lot has changed since the introduction of Xenical®, including consumer expectations, healthcare professional involvement within the weight loss category and consumer information utilization, namely, the sophistication of the Internet user. Applying learnings from Xenicare, our insights from consumers & healthcare professionals, and our understanding of current Internet usage, we have developed the alli (orlistat 60 mg) support program, called myalli (orlistat 60 mg) plan. The myalli (orlistat 60 mg) plan is an individually tailored support plan based on sound clinical practices and designed by nutrition and weight loss experts. It is free with the purchase of alli (orlistat 60 mg) . The myalli (orlistat 60 mg) plan.com is an extremely comprehensive online support program, including personalized online pages to view goals, check-ins with individualized feedback and advice, continuous follow-up and weekly monitoring, personalized emails on eating right/meal planning, guidance on treatment effects, online journal, menus and shopping lists, direct advice from clinical experts and a connection to a community of other alli (orlistat 60 mg) users. Research indicates that those who receive one-on-one counseling or online support may have a long-term advantage in successfully losing weight.

alli (orlistat 60 mg) is different than Xenical® because it offers informational materials with the actual product. The alli (orlistat 60 mg) starter pack includes over 200 pages of free in-pack materials to help guide individuals through the alli (orlistat 60 mg) program and set expectations for gradual weight loss, help them make healthy eating choices, monitor daily diets, and manage treatment effects. Eighty percent of patients found these materials to be very helpful. Overall, the alli (orlistat 60 mg) program offers unprecedented support and resources designed to help modify behavior by creating self-assessment and self-management skills. Assuming personal responsibility is integral to achieving sustainable weight loss.

Another difference when comparing alli (orlistat 60 mg) to Xenical® is the manageability and tolerability of GI events. In clinical studies, the 60-mg capsule of alli (orlistat 60 mg) demonstrated comparable efficacy and safety profiles to the 120-mg prescription capsule, but had a lower incidence of treatment effects, compared with the 120-mg dosage. Only a small percentage of trial subjects withdrew due to GI-AEs (5.4% on 120mg compared to only 3.2% on 60mg), further reinforcing the tolerability of the 60-mg dose. After 90 days of using alli (orlistat 60 mg) , 81% of study participants reported being satisfied or very satisfied with orlistat and 91% reported losing weight. In addition, alli (orlistat 60 mg) will tell consumers and HCPs alike that the likelihood of treatment effects is greater if individuals aren't committed to following a reduced-calorie, low-fat diet (no more than 15 grams of fat per meal) and eating smaller portions.

Learning from experience and developing self-assessment and self-improvement skills are the cornerstones of the alli (orlistat 60 mg) program. alli (orlistat 60 mg) is not a program for everyone; without a commitment to adopting healthy habits, patients will not achieve their weight loss goals.

Last reviewed on RxList: 6/20/2007
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

The alli (orlistat 60 mg) program

The alli (orlistat 60 mg) program is a comprehensive approach to weight loss. Combining the only FDA approved, over-the-counter weight loss product, alli (orlistat 60 mg) , combined with an online action plan, the alli (orlistat 60 mg) program brings together effective medical therapy and strong behavioral support. The alli (orlistat 60 mg) program is designed to bridge the gap between weight loss medications and the patients' role in their own healthcare and weight loss objectives.

Patients and other healthcare professionals engage in honest discussions and share resources that enable both parties to better understand the complexities involved in weight reduction.

The alli starter pack

Inside the alli™ (orlistat 60 mg) starter pack you'll find:

  • alli (orlistat 60 mg) weight loss capsules

    The capsules are easy to swallow and are taken with each meal containing fat (up to 3 per day). They work in your digestive system to prevent about a quarter of the fat you eat from being absorbed.


  • alli (orlistat 60 mg) Shuttle™

    The Shuttle™ makes it easy to carry the alli (orlistat 60 mg) capsules so you can have them with you at every meal, wherever you go. It's also a great visual reminder to use the alli (orlistat 60 mg) capsules - and it keeps them from getting lost in your purse, gym bag, or briefcase. There's room in the Shuttle for your daily multivitamin, too.


  • Handy reference booklets

    The booklets to help you follow the alli (orlistat 60 mg) program. Check out the alli (orlistat 60 mg) "Read Me First Guide" with the keys to successful weight loss, the Welcome Guide, Companion Guide, Healthy Eating Guide, Calorie & Fat Counter, Daily Journal, and Quick Facts cards for the support you need to succeed with alli (orlistat 60 mg) .


  • myalli (orlistat 60 mg) plan online guidance

    Losing weight takes effort and commitment. That's why the alli (orlistat 60 mg) program includes an individually tailored online action plan. And it's free with your purchase of alli (orlistat 60 mg) . Following a reduced-calorie, low-fat diet is a great way to start with weight loss, but participating in the action plan can give you the added direction and practical advice you need to support your goal. And that support is available 24 hours a day.

FAQs

Q. How does alli (orlistat 60 mg) work?
A. As part of an overall weight loss program, alli (orlistat 60 mg) works in conjunction with behavior modification to achieve a calorie balance that is both nutritionally sound and conducive to weight reduction.

alli (orlistat 60 mg) is the only OTC drug for weight loss that is FDA approved. It has a non-systemic mechanism of action. The unique molecular structure of alli (orlistat 60 mg) enables it to bind to and inactivate some GI lipases, which aid in the digestion of dietary fats (triglycerides). alli (orlistat 60 mg) binds to gastric and pancreatic lipases, blocking absorption of about 25% of consumed fat. Undigested fat is excreted from the body instead of turning into stored fat. The absorption of carbohydrates and proteins is not affected. alli (orlistat 60 mg) is not an appetite suppressant nor does it impact the heart or nervous system. It is minimally absorbed, and there is no residual effect once the drug is stopped.

Q. Who is the ideal candidate for alli (orlistat 60 mg) ?
A. Ideal candidates are individuals who are overweight and are motivated and ready to make lifestyle changes. They have realistic expectations for gradual, modest weight loss. These individuals are committed to a reduced-calorie, low-fat diet (no more than 15 grams of fat per meal) and eating smaller portions. An ideal candidate for alli (orlistat 60 mg) will read and follow the label directions. They understand that treatment effects (loose or more frequent stools that may be hard to control, an urgent need to go to the bathroom, gas with oily spotting) can occur if they eat too much fat in a meal while taking alli (orlistat 60 mg) . Lastly, these individuals will make the time to be more physically active.

Q. How is alli (orlistat 60 mg) different from other weight loss products available?
A. alli (orlistat 60 mg) is the only FDA approved, over-the-counter weight loss product. It combines a pill (alli (orlistat 60 mg) 60 mg orlistat) with an individually tailored, online action plan based on sound clinical practices and designed by nutritional and weight loss experts. alli (orlistat 60 mg) can help an individual achieve gradual and healthy weight loss and lose 50% more weight than dieting alone. It works in the digestive system, not the central nervous system, so it does not affect the heart or brain. Orlistat has an extensive clinical history and has been studied in more than 100 controlled clinical trials. Additionally, orlistat has been used in more than 25 million patient treatments in 145 countries worldwide.

Q. I remember the difficulties with prescription Xenical®; how will the experience with over-the-counter alli (orlistat 60 mg) be different?
Behavior Support programs are part of the foundation for successful weight loss. Xenical® provided a separate support program for patients known as Xenicare, which, at the time, was considered a comprehensive plan. But a lot has changed since the introduction of Xenical®, including consumer expectations, healthcare professional involvement within the weight loss category and consumer information utilization, namely, the sophistication of the Internet user. Applying learnings from Xenicare, our insights from consumers & healthcare professionals, and our understanding of current Internet usage, we have developed the alli (orlistat 60 mg) support program, called myalli (orlistat 60 mg) plan. The myalli (orlistat 60 mg) plan is an individually tailored support plan based on sound clinical practices and designed by nutrition and weight loss experts. It is free with the purchase of alli (orlistat 60 mg) . The myalli (orlistat 60 mg) plan.com is an extremely comprehensive online support program, including personalized online pages to view goals, check-ins with individualized feedback and advice, continuous follow-up and weekly monitoring, personalized emails on eating right/meal planning, guidance on treatment effects, online journal, menus and shopping lists, direct advice from clinical experts and a connection to a community of other alli (orlistat 60 mg) users. Research indicates that those who receive one-on-one counseling or online support may have a long-term advantage in successfully losing weight.

alli (orlistat 60 mg) is different than Xenical® because it offers informational materials with the actual product. The alli (orlistat 60 mg) starter pack includes over 200 pages of free in-pack materials to help guide individuals through the alli (orlistat 60 mg) program and set expectations for gradual weight loss, help them make healthy eating choices, monitor daily diets, and manage treatment effects. Eighty percent of patients found these materials to be very helpful. Overall, the alli (orlistat 60 mg) program offers unprecedented support and resources designed to help modify behavior by creating self-assessment and self-management skills. Assuming personal responsibility is integral to achieving sustainable weight loss.

Another difference when comparing alli (orlistat 60 mg) to Xenical® is the manageability and tolerability of GI events. In clinical studies, the 60-mg capsule of alli (orlistat 60 mg) demonstrated comparable efficacy and safety profiles to the 120-mg prescription capsule, but had a lower incidence of treatment effects, compared with the 120-mg dosage. Only a small percentage of trial subjects withdrew due to GI-AEs (5.4% on 120mg compared to only 3.2% on 60mg), further reinforcing the tolerability of the 60-mg dose. After 90 days of using alli (orlistat 60 mg) , 81% of study participants reported being satisfied or very satisfied with orlistat and 91% reported losing weight. In addition, alli (orlistat 60 mg) will tell consumers and HCPs alike that the likelihood of treatment effects is greater if individuals aren't committed to following a reduced-calorie, low-fat diet (no more than 15 grams of fat per meal) and eating smaller portions.

Learning from experience and developing self-assessment and self-improvement skills are the cornerstones of the alli (orlistat 60 mg) program. alli (orlistat 60 mg) is not a program for everyone; without a commitment to adopting healthy habits, patients will not achieve their weight loss goals.

Last reviewed on RxList: 6/20/2007
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Alli Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ORLISTAT - ORAL

(OR-li-stat)

COMMON BRAND NAME(S): Alli, Xenical

USES: This medication is used along with a doctor-approved reduced-calorie diet, exercise, and behavior modification program to help significantly overweight (obese) persons lose weight. Taking orlistat can also help prevent you from regaining the weight you have lost. Losing weight and keeping it off can reduce the many health risks that obesity causes, including heart disease, diabetes, high blood pressure, some forms of cancer, certain breathing problems, and a shorter life span.

Dietary fats need to be broken down into smaller pieces before the body can absorb them. Orlistat works by blocking the enzyme that breaks down fats in your diet. This undigested fat then passes out of your body in your bowel movement. Orlistat does not block the absorption of calories from sugar and other non-fat foods, so you still need to restrict your total intake of calories.

HOW TO USE: If you are taking the over-the-counter product to self-treat, read all directions on the product package before taking this medication.

If your doctor has prescribed this medication, read the Patient Information Leaflet if available from your pharmacist before you start taking orlistat and each time you get a refill. Take this medication as directed by your doctor, by mouth with liquid sometime during each meal that contains fat or within 1 hour after the meal, usually 3 times daily. If you miss a meal or your meal contains no fat, skip that dose of the medication. To decrease the chance of unpleasant side effects, it is very important that no more than 30% of the calories in your diet come from fat. Your daily intake of fat, protein, and carbohydrates should be evenly spread over 3 main meals.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Because this drug can interfere with the absorption of certain vitamins (fat-soluble vitamins including A, D, E, K), a daily multivitamin supplement containing these nutrients is recommended. Take the multivitamin at least 2 hours before or 2 hours after taking orlistat (such as at bedtime).

If you take cyclosporine, take it at least 3 hours before or after orlistat to make sure the full dose of cyclosporine is absorbed into your bloodstream. If you take levothyroxine, take it at least 4 hours before or after orlistat.

You should see some weight loss within 2 weeks after you start orlistat. Tell your doctor if your condition does not improve or if it worsens.

Disclaimer

Alli Consumer (continued)

SIDE EFFECTS: Changes in your bowel function often occur because of the unabsorbed fat. Fatty/oily stool, oily spotting, intestinal gas with discharge, a feeling of needing to have a bowel movement right away, increased number of bowel movements, or poor bowel control may occur. These side effects may get worse if you eat more fat than you should. If these effects persist or worsen, notify your doctor promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Stop taking this medication and tell your doctor immediately if any of these rare but serious side effects occur: symptoms of liver disease (such as persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin), symptoms of kidney stones (such as back pain, pain when urinating, pink/bloody urine).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Alli (orlistat 60 mg) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking orlistat, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain digestive problem (chronic malabsorption syndrome), a certain gall bladder problem (cholestasis), underactive thyroid (hypothyroidism), kidney stones/problems (such as calcium oxalate kidney stones, hyperoxaluria), certain eating disorders (anorexia nervosa/bulimia).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If you are diabetic, weight loss may improve your blood sugar control. Be sure to check your blood sugar regularly and tell your doctor the results. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication must not be used during pregnancy. Weight loss offers no potential benefit to a pregnant woman and may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Alli Consumer (continued)

DRUG INTERACTIONS: See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: "blood thinners" (such as warfarin).

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: If this medication has been prescribed for you, do not share this medication with others.

For best results, this medication should be used along with a doctor-approved exercise program and diet plan. Consult your doctor or dietician for help designing an appropriate exercise and food plan for you.

MISSED DOSE: If you miss a dose, take it as soon as you remember unless it has been more than 1-2 hours since your meal. In that case, skip the missed dose since most of the fat from your meal will already have been absorbed and the medication will not work. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details.

Information last revised March 2012. Copyright(c) 2012 First Databank, Inc.

Alli Patient Information Including Side Effects

Brand Names: alli, Xenical

Generic Name: orlistat (Pronunciation: OR li stat)

What is orlistat (Alli)?

Orlistat blocks some of the fat that you eat, keeping it from being absorbed by your body.

Orlistat is used together with a reduced-calorie diet and weight maintenance to treat obesity in people with certain risk factors (such as diabetes, high blood pressure, and high cholesterol or triglycerides).

Orlistat may also be used for other purposes not listed in this medication guide.

It is dangerous to purchase orlistat on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of "Alli" purchased on the Internet have been found to contain sibutramine (Meridia), a prescription weight loss medication that can have dangerous side effects in certain people. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.

What are the possible side effects of orlistat (Alli)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking orlistat and call your doctor at once if you have severe pain in your upper stomach spreading to your back, nausea and vomiting, and a fast heart rate. These could be signs of pancreatitis.

The following side effects occur commonly with the use of orlistat. They are the natural effects of orlistat's fat-blocking action and are actually signs that the medication is working properly. These side effects are usually temporary and may lessen as you continue treatment with orlistat:

  • oily spotting in your undergarments;
  • oily or fatty stools;
  • orange or brown colored oil in your stool;
  • gas with discharge, an oily discharge;
  • loose stools, or an urgent need to go to the bathroom, inability to control bowel movements;
  • an increased number of bowel movements;
  • stomach pain, nausea, vomiting, diarrhea, rectal pain; or
  • weakness, dark urine, clay-colored stools, itching, loss of appetite, or jaundice (yellowing of the skin or eyes).

Other side effects that may occur while taking orlistat include:

  • problems with your teeth or gums;
  • cold symptoms such as stuffy nose, sneezing, cough;
  • fever, chills, sore throat, flu symptoms;
  • headache, back pain; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Alli (orlistat 60 mg) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about orlistat (Alli)?

Do not take this medication if you are allergic to orlistat, or if you have gallbladder problems, or chronic malabsorption syndrome (an inability to absorb food and nutrients properly).

Before taking orlistat, tell your doctor if you have an underactive thyroid, a history of gallstones or pancreatitis, type 1 or type 2 diabetes, an eating disorder, liver disease, or if you take other weight-loss medications (prescription or over-the-counter).

Do not give over-the-counter orlistat (Alli) to a child younger than 18 years old. Prescription orlistat (Xenical) should not be used by anyone age 12 to 18 without the advice of a doctor.

Orlistat should be used only by the person it was prescribed or recommended for. Never share orlistat with another person, especially someone who has a history of eating disorder. Keep the medication in a place where others cannot get to it.

Orlistat is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your daily intake of fat, protein, and carbohydrates should be evenly divided over all of your daily meals. Follow your diet, medication, and exercise routines very closely.

Avoid a diet that is high in fat. High-fat meals taken in combination with orlistat can increase your risk of unpleasant side effects on your stomach or intestines.

Side Effects Centers

Alli Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking orlistat (Alli)?

Do not take orlistat if you are allergic to it, or if you have:

  • chronic malabsorption syndrome (an inability to absorb food and nutrients properly); or
  • gallbladder problems.

If you have any of these other conditions, you may need an orlistat dose adjustment or special tests:

  • an underactive thyroid;
  • a history of gallstones;
  • a history of pancreatitis;
  • liver disease;
  • type 1 or type 2 diabetes;
  • an eating disorder (anorexia or bulimia); or
  • if you take any other weight-loss medications (prescription or over-the-counter).

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Taking orlistat can make it harder for your body to absorb certain vitamins. These vitamins are important if you are nursing a baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give over-the-counter orlistat (Alli) to a child younger than 18 years old. Prescription orlistat (Xenical) should not be used by anyone age 12 to 18 without the advice of a doctor.

Orlistat should be used only by the person it was prescribed or recommended for and should never be shared with another person, especially someone who has a history of eating disorder. Keep the medication in a secure place where others cannot get to it.

How should I take orlistat (Alli)?

Take exactly as directed on the label, or as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Orlistat is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your daily intake of fat, protein, and carbohydrates should be evenly divided over all of your daily meals. Follow your diet, medication, and exercise routines very closely.

Take orlistat during or within 1 hour after a meal that contains some fat (no more than 30% of the calories for that meal). Orlistat is usually taken 3 times daily.

If you skip a meal or you eat a meal that does not contain any fat, skip your orlistat dose for that meal.

The fat content of your daily diet should not be greater than 30% of your total daily caloric intake. For example, if you eat 1200 calories per day, no more than 360 of those calories should be in the form of fat.

Read the label of all food items you consume, paying special attention to the number of servings per container. Your doctor, nutrition counselor, or dietitian can help you develop a healthy eating plan.

Your doctor may recommend you take vitamin and mineral supplements while you are taking orlistat. This medication can make it harder for your body to absorb fat-soluble vitamins, such as vitamins A, D, E, and K. Follow your doctor's instructions about the type of multi-vitamin or mineral supplement to use.

Take the supplement at least 2 hours before or after you take orlistat.

Store orlistat at room temperature away from moisture and heat. Keep the bottle tightly closed.

Keep track of the amount of medicine used from each new bottle. Orlistat is a drug that may be misused as a weight-loss aid, and you should be aware if anyone is using your medicine improperly or without a prescription.

Side Effects Centers

Alli Patient Information including If I Miss a Dose

What happens if I miss a dose (Alli)?

Take the missed dose as soon as you remember, but no more than 1 hour after eating a meal. If it has been more than an hour since your last meal, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

If you miss a meal, or if you have a meal without fat, you can skip your dose of orlistat for that meal also.

What happens if I overdose (Alli)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking orlistat (Alli)?

Avoid a diet that is high in fat. High-fat meals taken in combination with orlistat can increase your risk of unpleasant side effects on your stomach or intestines.

What other drugs will affect orlistat (Alli)?

Tell your doctor about all other medications you use, especially:

  • insulin or diabetes medications you take by mouth;
  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • digoxin (digitalis, Lanoxin, Lanoxicaps);
  • levothyroxine (Synthroid, Levoxyl, Levothroid); or
  • a blood thinner such as warfarin (Coumadin).

This list is not complete and other drugs may interact with orlistat. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about orlistat.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 8.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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