Xenical prescribing information |
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Full prescription information or package insert for Xenical
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Xenical Description
Why is this drug prescribed?
Xenical blocks absorption of dietary fat into the bloodstream, thereby reducing the number of calories you get from a meal. At the usual dosage level, it cuts fat absorption by almost one-third. Combined with a low-calorie diet, it is used to promote weight loss and discourage the return of unwanted pounds.
The drug is prescribed for the frankly obese and for merely overweight people who have other health problems such as high blood pressure, diabetes, or high cholesterol levels. Your weight status is determined by your body mass index (BMI), a comparison of height to weight.
Most important fact about this drug:
Along with dietary fat, Xenical decreases the absorption of some fat-soluble vitamins and beta-carotene. To compensate, you should take a multivitamin containing vitamins A, E, D, and K once a day, at least 2 hours before or 2 hours after taking Xenical (xenecal).
How should you take this medication?
Take a capsule of Xenical during, or up to 1 hour after, each main meal. You should follow a nutritionally balanced, low-calorie diet that provides no more than 30 percent of its calories from fat. If you miss a meal, or the meal contains no fat, you can skip the accompanying dose of Xenical.
• If you miss a dose...
Resume taking Xenical at the next meal. Don't try to make up the loss with a double dose. The extra drug won't help.
• Storage instructions...
Store at room temperature, in a tightly sealed container.
What side effects may occur?
Side effects of Xenical are more common during the first year of treatment. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Xenical.
• More common side effects may include:
Abdominal discomfort or pain, anxiety, arthritis, back pain, diarrhea, dizziness, earache, fatigue, fatty or oily stools, fecal urgency or incontinence, flu, gas with fecal discharge, gum problems, headache, increased defecation, menstrual problems, muscle pain, nausea, oily discharge, rectal discomfort or pain, respiratory tract infections, skin rash, sleep problems, tooth problems, urinary tract infections, vaginal inflammation, vomiting
• Less common side effects may include:
Dry skin, ear/nose/throat problems, joint disorders
Side effects that usually occur after the first year of treatment with Xenical include: depression, leg pain, swollen feet, and tendonitis.
Why should this drug not be prescribed?
Do not take Xenical if you suffer from "chronic malabsorption syndrome"--a condition that prevents nutrients from passing from your stomach into your bloodstream--or from cholestasis, a blockage in the supply of bile needed for digestion. You'll also need to avoid Xenical if it gives you an allergic reaction.
Special warnings about this medication:
Weight loss begins within 2 weeks and continues for 6 to 12 months. The effect of using Xenical for more than 2 years is still unknown.
Side effects such as diarrhea and abdominal pain may be worse if you continue eating a high fat diet or even take a high-fat meal. Limit your fat intake.
Your doctor will test your thyroid function before starting you on Xenical to make sure that your weight problem is not due to an underactive thyroid gland (hypothyroidism). Xenical is not an appropriate remedy for this problem.
Xenical increases the likelihood of kidney stones. Use it with caution if you have a history of this problem.
If you have diabetes, weight-loss is likely to reduce your blood sugar levels. If you're taking an oral diabetes medication or insulin, your dose may have to be reduced.
Note that the safety and efficacy of this drug in children have not been established.
Possible food and drug interactions when taking this medication:
If Xenical is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Xenical with the following:
Cyclosporine (Neoral and Sandimmune)
Warfarin (Coumadin)
Special information if you are pregnant or breastfeeding:
The effects of Xenical during pregnancy have not been adequately studied and the drug is not recommended for pregnant women. If you are pregnant or plan to become pregnant, inform your doctor immediately.
It is not known whether Xenical appears in breast milk. Do not take it while breastfeeding.
Recommended dosage
ADULTS:
The recommended dose is one 120-milligram capsule 3 times daily with each main meal containing fat.
Overdosage:
The results of a massive overdose of Xenical are unknown, although the drug seems relatively harmless. However, any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention.
Xenical notes:
Xenical (xenecal) generic name orlistat blocks absorption of dietary fat into the bloodstream, thereby reducing the number of calories getting from meal. Combined with a low-calorie diet, it is used to treat obesity in people.
Xenical side effects includes orange or brown colored oil in your stool, gas with discharge, inability to control bowel movements, stomach pain, nausea, vomiting, diarrhea, rectal pain, fever, chills, sore throat, flu symptoms, skin rash or itching, problems with teeth or gums.
Drugs like cyclosporine, digoxin, levothyroxine or insulin taken along, may effect the orlistat performance. The prospective xendos study was primarily designed to determine the long-term (four years) diabetes-preventing and weight-reducing effects of orlistat in combination with lifestyle changes in obese patients.
Orlistat includes diet and exercise as a complete treatment. Avoid diet that is high in fats.
Sibutramine hydrochloride monohydrate is a prescription drug that can be prescribed to help people lose weight. It can also be used to help people who have already lost weight to keep the weight off.
Xenikal is a weight-control medication for the long-term treatment of significant obesity.
The orlistat 60mg capsules are approved as the over the counter treatment (OTC) for overweight adults. Xenical inhibits the functioning of enzyme lipase secreted by pancreas so that the fat in food leaves body with digestion which reduces large amount of calories and burns the stored body fat.
Weight loss news:
Fatty women need to change food attitude – A study
A recent study of middle-aged women has revealed that impulsive eaters and those too busy to focus on food are the most likely to show signs of obesity. The study published in Health Education & Behavior journal distributed 200 women into five groups based on their attitudes about food. The average age of women in the participation was 46 who were well-educated and 86 percent of the total participation were white.
The researchers then compared the groups of women by measurements such as percentage of body fat, waist size and body mass index (BMI). The women who concerned about nutrition and focused on food for their families scored the lowest in the weight categories while the impulsive eaters scored highest in weight categories. Women with the busy cooking avoiders attitude shows the result that was in between the other two groups.
According to Degeneffe who is a research fellow at the University of Minnesota's Food Industry Center said that women in the middle group tend to lead busy lifestyles and are often preoccupied with other activities and responsibilities and usually takes food on a back seat. Cynthia Sass, a registered dietitian and author in New York City was found saying that women who have a big responsibility to take care of their families take less care of themselves in context of food. She had urged such women to take proper food as it helps them to feel rewarded and cope with their lives.
Weight loss proves helpful in heart function – A study
According to study at Washington University School of Medicine obese people who loses their weight considerably by eating less and by doing frequent exercise shows improvement in cardiovascular health. The improvements seen in the participants of the study includes decrease in thickness of heart muscle, improved pumping and relaxation functions of the heart and decreased thickness of the carotid artery walls which are the primary reasons for heart failure.
The study includes 60 obese participants ranged in age from 22 to 64 and had BMIs (body mass indexes) of between 30 and 44. During study the participants were instructed to take low calorie diet and to do regular physical exercise for about three to four hours a week. All participants on an average lost their weight in six months, after that most participants slowly regained some of their lost weight and at the end of two years they averaged about nine pounds below their initial weight. Inspite of regaining weight the participants continue retaining the heart and blood vessel benefits.
None of the patients enrolled in the study had clinically evident signs of heart failure, shortness of breath, coughing or fluid buildup and none were taking cholesterol-lowering medications. Generally obesity leads to abnormal thickening of heart muscle as the heart works harder to pump blood throughout the body, but this study has prove that by losing weight obese people can make their heart function in proper and healthy manner. The result of this study is significant because of its duration of two years which helped the investigators to document what happens as weight is regained and its impact on heart functionality.
Obesity news:
Obesity can be healthy too-say researchers.
Researchers from Oxford centre for diabetes, endocrinology, and metabolism(OCDEM) have found that glueofemoral (buttocks and thighs) obesity is an indicator of good health. Initially study had shown that waist hip ratio is better measurement than BMI for relating mortality risk by obesity in elderly. It has been known that fat distribution is important for health.
Population studies showed that an increased gluteofemoral fat mass is helpful as it is independently associated with protective lipid and glucose profile with decrease in cardiovascular and metabolic risk. In vitro and In vivo studies show distinct properties of gluteofemoral fat with lipolysis and fatty acid uptake. The body uses fat tissues to store fatty acids which can be released when energy is needed. The abdominal fat is more active in storing and releasing fatty acids as compared to thighs which store fat for long term. Thus abdominal fat leads to more fatty acids floating around the body which gets deposited in other organs like liver and muscle resulting in insulin resistance and heart disease. On the other hand, thigh traps the fatty acids for long term, preventing abdominal organ deposition with no harm. Further, gluteofemoral fat is associated with increase in beneficial leptin and adiponectin levels with decrease in inflammatory cytokines.
At the age of forty, men have more fat around the waist as compared to women who have more fat on their thighs and hips explaining why men are at higher risk of diabetes and heart disease. However, after menopause women also experiences change in the body shape with more male like fat distribution resulting in same risk of heart disease and diabetes as men.
2008;31(1):53-65.
Filippatos TD, Derdemezis CS, Gazi IF, Nakou ES, Mikhailidis DP, Elisaf MS.
Department of Internal Medicine, Medical School, University of Ioannina, Ioannina, Greece.
Orlistat-associated adverse effects and drug interactions: a critical review.
2008 Nov;4(4):340-56.
Eleftheriadou I, Grigoropoulou P, Katsilambros N, Tentolouris N.
1st Department of Propaedeutic Medicine, Athens University Medical School, Athens, Greece.
The effects of medications used for the management of diabetes and obesity on postprandial lipid metabolism.
2008 Jul;120(2):18-33.
Citrome L, Vreeland B.
New York University School of Medicine, Department of Psychiatry, and the Nathan S. Kline Institute for Psychiatric Research, Orangeburg, NY 10962, USA. citrome@nki.rfmh.org
Schizophrenia, obesity, and antipsychotic medications: what can we do?
2008 Oct;93(10):3995-8. Epub 2008 Jul 22.
Ellrichmann M, Kapelle M, Ritter PR, Holst JJ, Herzig KH, Schmidt WE, Schmitz F, Meier JJ.
Department of Medicine I, St. Josef-Hospital, Ruhr-University Bochum, Gudrunstrasse 56, 44791 Bochum, Germany. mark.ellrichmann@rub.de
Orlistat inhibition of intestinal lipase acutely increases appetite and attenuates postprandial glucagon-like peptide-1-(7-36)-amide-1, cholecystokinin, and peptide YY concentrations.
2007;3(6):817-21.
Drew BS, Dixon AF, Dixon JB.
Centre for Obesity Research and Education, Monash University, Melbourne, Victoria, Australia.
Obesity management: update on orlistat.
2007 Oct;10(10A):1200-5.
Rubio MA, Gargallo M, Isabel Millán A, Moreno B.
Department of Endocrinology and Nutrition, Hospital Clínico San Carlos, c/ Martín Lagos s/n, 28040 Madrid, Spain. mrubio.hcsc@salud.madrid.org
Drugs in the treatment of obesity: sibutramine, orlistat and rimonabant.
2007 Oct;31(10):1567-70. Epub 2007 Apr 10.
Padwal R, Kezouh A, Levine M, Etminan M.
Division of General Internal Medicine, Walter C. Mackenzie Health Sciences Center, University of Alberta Hospital, 8440-112th Street, Edmonton, Alberta, Canada. rpadwal@ualberta.ca
Long-term persistence with orlistat and sibutramine in a population-based cohort.
2007 Mar;10(2):156-64.
Armand M.
INSERM, U476 'Nutrition Humaine et Lipides', INRA, UMR1260, Université Méditerranée Aix-Marseille 2, Faculté de Médecine, IPHM-IFR 125, Marseille, France. martine.armand@medecine.univ-mrs.fr
Lipases and lipolysis in the human digestive tract: where do we stand?
2007 Oct 19;61:612-26.
Zieba R.
Zak³ad Farmakodynamiki, Uniwersytet Medyczny w £odzi, £ódŸ. remusz@wp.pl
[Obesity: a review of currently used antiobesity drugs and new compounds in clinical development] [Article in Polish]
Cancer Res. 2004 Mar 15;64(6):2070-5.
Kridel SJ, Axelrod F, Rozenkrantz N, Smith JW.
Cancer Research Center, The Burnham Institute, 10901 North Torrey Pines Road, La Jolla, CA 92037, USA.
Orlistat is a novel inhibitor of fatty acid synthase with antitumor activity.
Metabolism. 2004 Apr;53(4):430-4.
Valsamakis G, McTernan PG, Chetty R, Al Daghri N, Field A, Hanif W, Barnett AH, Kumar S.
Department of Diabetes and Endocrinology, Birmingham Heartlands Hospital, Birmingham, UK.
Modest weight loss and reduction in waist circumference after medical treatment are associated with favorable changes in serum adipocytokines.
Int J Obes Relat Metab Disord. 2005 Mar 01.
Ruof J, Golay A, Berne C, Collin C, Lentz J, Maetzel A.
[1] 1Health Services Research Unit, Division of Rheumatology, Center of Internal Medicine, Hannover Medical School, Hannover, Germany [2] 2Global Health Economics Department, Roche Pharmaceuticals, Basel, Switzerland.
Orlistat in responding obese type 2 diabetic patients: meta-analysis findings and cost-effectiveness as rationales for reimbursement in Sweden and Switzerland.
BMC Fam Pract. 2005 Jan 29;6(1):5.
Feigenbaum A, Pasternak S, Zusk E, Sarid M, Vinker S.
Department of Family Medicine, Sackler School of Medicine, Tel Aviv University; Tel Aviv, Israel.
Influence of intense multidisciplinary follow-up and orlistat on weight reduction in a primary care setting.
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