
The Science in Weight Loss.......
XENICAL 120mg 30s
(orlistat) Capsules
DESCRIPTION
XENICAL (orlistat) is a gastrointestinal lipase inhibitor for obesity management that acts by inhibiting the absorption of dietary fats.
XENICAL is a medicine used with a low calorie diet to increase weight loss in people with obesity. XENICAL may help obese people lose weight and keep the weight off.
INDICATIONS
XENICAL is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. XENICAL is also indicated to reduce the risk for weight regain after prior weight loss. XENICAL is indicated for obese patients with an initial body mass index (BMI) ≥ 30 kg/m² or ≥ 27 kg/m² in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia).
Table 1 illustrates body mass index (BMI) according to a variety of weights and heights. The BMI is calculated by dividing weight in kilograms by height in meters squared. For example, a person who weighs 180 lbs and is 5-5” would have a BMI of 30.
Table 1 Body Mass Index (BMI), kg/m²*
| WEIGHT (lb) | ||||||||||||||||||||||
| 120 | 130 | 140 | 150 | 160 | 170 | 180 | 190 | 200 | 210 | 220 | 230 | 240 | 250 | 260 | 270 | 280 | 290 | 300 | 310 | 320 | ||
| Height (ft/in) | 4'10” | 25 | 27 | 29 | 31 | 34 | 36 | 38 | 40 | 42 | 44 | 46 | 48 | 50 | 52 | 54 | 57 | 59 | 61 | 63 | 65 | 67 |
| 4'11” | 24 | 26 | 28 | 30 | 32 | 34 | 36 | 38 | 40 | 43 | 45 | 47 | 49 | 51 | 53 | 55 | 57 | 59 | 61 | 63 | 65 | |
| 5'0” | 23 | 25 | 27 | 29 | 31 | 33 | 35 | 37 | 39 | 41 | 43 | 45 | 47 | 49 | 51 | 53 | 55 | 57 | 59 | 61 | 63 | |
| 5'1” | 23 | 25 | 27 | 28 | 30 | 32 | 34 | 36 | 38 | 40 | 42 | 44 | 45 | 47 | 49 | 51 | 53 | 55 | 57 | 59 | 61 | |
| 5'2” | 22 | 24 | 26 | 27 | 29 | 31 | 33 | 35 | 37 | 38 | 40 | 42 | 44 | 46 | 48 | 49 | 51 | 53 | 55 | 57 | 59 | |
| 5'3” | 21 | 23 | 25 | 27 | 28 | 30 | 32 | 34 | 36 | 37 | 39 | 41 | 43 | 44 | 46 | 48 | 50 | 51 | 53 | 55 | 57 | |
| 5'4” | 21 | 22 | 24 | 26 | 28 | 29 | 31 | 33 | 34 | 36 | 38 | 40 | 41 | 43 | 45 | 46 | 48 | 50 | 52 | 53 | 55 | |
| 5'5” | 20 | 22 | 23 | 25 | 27 | 28 | 30 | 32 | 33 | 35 | 37 | 38 | 40 | 42 | 43 | 45 | 47 | 48 | 50 | 52 | 53 | |
| 5'6” | 19 | 21 | 23 | 24 | 26 | 27 | 29 | 31 | 32 | 34 | 36 | 37 | 39 | 40 | 42 | 44 | 45 | 47 | 49 | 50 | 52 | |
| 5'7” | 19 | 20 | 22 | 24 | 25 | 27 | 28 | 30 | 31 | 33 | 35 | 36 | 38 | 39 | 41 | 42 | 44 | 46 | 47 | 49 | 50 | |
| 5'8” | 18 | 20 | 21 | 23 | 24 | 26 | 27 | 29 | 30 | 32 | 34 | 35 | 37 | 38 | 40 | 41 | 43 | 44 | 46 | 47 | 49 | |
| 5'9” | 18 | 19 | 21 | 22 | 24 | 25 | 27 | 28 | 30 | 31 | 33 | 34 | 36 | 37 | 38 | 40 | 41 | 43 | 44 | 46 | 47 | |
| 5'10” | 17 | 19 | 20 | 22 | 23 | 24 | 26 | 27 | 29 | 30 | 32 | 33 | 35 | 36 | 37 | 39 | 40 | 42 | 43 | 45 | 46 | |
| 5'11” | 17 | 18 | 20 | 21 | 22 | 24 | 25 | 27 | 28 | 29 | 31 | 32 | 34 | 35 | 36 | 38 | 39 | 41 | 42 | 43 | 45 | |
| 6'0” | 16 | 18 | 19 | 20 | 22 | 23 | 24 | 26 | 27 | 29 | 30 | 31 | 33 | 34 | 35 | 37 | 38 | 39 | 41 | 42 | 43 | |
| 6'1” | 16 | 17 | 19 | 20 | 21 | 22 | 24 | 25 | 26 | 28 | 29 | 30 | 32 | 33 | 34 | 36 | 37 | 38 | 40 | 41 | 42 | |
| 6'2” | 15 | 17 | 18 | 19 | 21 | 22 | 23 | 24 | 26 | 27 | 28 | 30 | 31 | 32 | 33 | 35 | 36 | 37 | 39 | 40 | 41 | |
| *Conversion Factors: Weight in lbs · 2.2 = weight in kilograms (kg) Height in inches — 0.0254 = height in meters (m) 1 foot = 12 inches |
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DOSAGE AND ADMINISTRATION
Recommended Dosing
The recommended dose of XENICAL is one 120-mg capsule three times a day with each main meal containing fat (during or up to 1 hour after the meal).
The patient should be on a nutritionally balanced, reduced-calorie diet that contains approximately 30% of calories from fat. The daily intake of fat, carbohydrate, and protein should be distributed over three main meals. If a meal is occasionally missed or contains no fat, the dose of XENICAL can be omitted.
Because XENICAL has been shown to reduce the absorption of some fat-soluble vitamins and betacarotene, patients should be counseled to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition [see WARNINGS AND PRECAUTIONS]. The vitamin supplement should be taken at least 2 hours before or after the administration of XENICAL, such as at bedtime.
For patients receiving both XENICAL and cyclosporine therapy, administer cyclosporine 3 hours after XENICAL.
For patients receiving both XENICAL and levothyroxine therapy, administer levothyroxine and XENICAL at least 4 hours apart. Patients treated concomitantly with XENICAL and levothyroxine should be monitored for changes in thyroid function.
Doses above 120 mg three times a day have not been shown to provide additional benefit.
Based on fecal fat measurements, the effect of XENICAL is seen as soon as 24 to 48 hours after dosing. Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48 to 72 hours.
HOW SUPPLIED
Dosage Forms And Strengths
XENICAL 120 mg turquoise capsules imprinted with ROCHE and XENICAL 120 in black ink.
XENICAL is a turquoise, hard-gelatin capsule containing pellets of powder.
For Consumers
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 using orlistat and call your doctor at once if you have a serious side effect such as: