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Xenical (Orlistat)
Roche, Switzerland
1 x 21 caps » 120 mg/cap
General information:
Manufacturer: Roche
Substance: Orlistat
Pack: 21 caps (120 mg/cap)
Orlistat is a white to off-white crystalline powder.
Orlistat is practically insoluble in water, freely soluble in chloroform, and very soluble in methanol and ethanol.
Orlistat has no pKa within the physiological pH range.
Xenical (
Orlistat)
is
available for oral administration in dark-blue, hard-gelatin capsules,
with light-blue imprinting. Each capsule contains 120 mg of the active
ingredient, orlistat. The capsules also contain the inactive
ingredients microcrystalline cellulose, sodium starch glycolate, sodium
lauryl sulfate, povidone, and talc.
Xenical is a prescription medication that can help considerably
overweight people lose weight and keep it off. We know that managing
your weight can be frustrating, and sometimes you need a little extra
support. Support you can't find in a pill alone. To succeed you may
have to change the way you feel about food and about your body.
Xenical (
Orlistat)
is a drug that promotes loss of weight by preventing the digestion and
absorption of fat in food. In the intestine, an enzyme called lipase
(produced primarily by the pancreas) breaks apart fat in food so that
it can be absorbed into the body.
Xenical (
Orlistat)
blocks the action of lipase and thereby prevents the breakup and absorption of fat.
Xenical (
Orlistat)
blocks absorption of about 25% of the fat in a meal. The unabsorbed fat is excreted in the stool.
Xenical (
Orlistat)
is indicated for obesity management including weight loss and weight
maintenance when used in conjunction with a reduced-calorie diet.
Xenical (
Orlistat)
is also indicated to reduce the risk for weight regain after prior weight loss.
Xenical (
Orlistat)
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 (eg,
hypertension, diabetes, dyslipidemia).
USAGE:
The recommended dose of
Xenical (
Orlistat)
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 (
Orlistat)
can be omitted.
Because
Xenical (
Orlistat)
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 (
Orlistat)
,
such as at bedtime.For patients receiving both orlistat and
levothyroxine therapy, administer levothyroxine and orlistat at least 4
hours apart.
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 (
Orlistat)
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.
SIDE EFFECTS:
The most common side effects of
Xenical (
Orlistat)
are oily spotting on underwear, flatulence, urgent bowel movements,
fatty or oily stools, increased number of bowel movements, abdominal
pain or discomfort, and inability to control stool (incontinence).
Between 1 in 250 and 1 in 70 patients experienced one or more of these
symptoms in the first year. Generally, the side effects occurred within
three months of starting therapy. In about 50% of patients, the side
effects resolved within one to four weeks, but the effects in some
patients lasted six months or longer. To reduce the occurrence of these
side effects, meals should
contain no more than 30% fat because it is the unabsorbed fat that
causes most of the symptoms. alli causes fewer side effects because it
contains half the dose of prescription-strength
Xenical (
Orlistat).
Patients receiving orlistat with a history of oxalate kidney stones may
develop increased levels of oxalate in their urine, which may increase
the risk of kidney stones.