A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Xenical Indications, Dosage, Storage, Stability - Orlistat
Xenical Indications, Dosage, Storage, Stability - Orlistat
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 5 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 5. 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
|
| 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 |
DOSAGE AND ADMINISTRATION
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 beta-carotene, patients should be
counseled to take a multivitamin containing fat-soluble vitamins to ensure
adequate nutrition (see PRECAUTIONS : General ). The supplement should be
taken at least 2 hours before or after the administration of XENICAL, such
as at bedtime.
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.
The safety
and effectiveness of XENICAL beyond 2 years have not been determined at
this time.
HOW
SUPPLIED
XENICAL is a dark-blue, hard-gelatin capsule
containing pellets of powder.
XENICAL 120 mg Capsules: Dark-blue, two-piece, No.
1 opaque hard-gelatin capsule imprinted with Roche and XENICAL 120 in
light-blue ink — bottle of 90 (NDC 0004-0256-52).
Storage Conditions: Store at 25°C (77°F);
excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room
Temperature]. Keep bottle tightly closed.
XENICAL should not be used after the given
expiration date.
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