INDICATIONS AND USES
Orlistat is indicated for obesity management including weight loss and
weight maintenance when used in conjunction with a reduced-calorie diet.
Orlistat is also indicated for the reduction of the risk of weight regain after
prior weight loss. Orlistat120 mg 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) and Orlistat 60
mg is indicated for overweight & obese patients with an initial body mass
index (BMI) ≥25 kg/m2.
DOSAGE AND ADMINISTRATION
The recommended dose of Orlistat is one 60 mg or 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 Orlistat can be
omitted.
Because 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 vitamin to ensure adequate
nutrition. The vitamin supplement should be taken at least 2 hours before
or after the administration of Orlistat, such as at bedtime.
CONTRAINDICATIONS
Orlistat is contraindicated in: Pregnancy, Patients with chronic
malabsorption syndrome, Patients with cholestasis, Patients with known
hypersensitivity to Orlistat or to any component of this product.
ADVERSE EFFECTS
Commonly-observed adverse events associated with the use of Orlistat
include oily spotting, flatus with discharge, fecal urgency, fatty/oily stool,
oily evacuation, increased defecation, fecal incontinence.
WARNINGS AND PRECAUTIONS
Concomitant Drug and Vitamin Use: Orlistat and cyclosporine should not be
simultaneously coadministered. To reduce the chance of a drug-drug
interaction, cyclosporine should be taken at least 3 hours before or after
taking Orlistat in patients taking both drugs. In addition, in those patients
whose cyclosporine levels are being measured, more frequent monitoring
should be considered. Patients should be strongly encouraged to take a
multivitamin supplement that contains fat-soluble vitamins to ensure
adequate nutrition because Orlistat has been shown to reduce the
absorption of some fat-soluble vitamins and beta-carotene. In addition, the
levels of vitamin D and betacarotene may be low in obese patients
compared with non-obese subjects. The supplement should be taken once
DRUG INTERACTIONS
Cyclosporine: Data from a Orlistat and cyclosporine drug interaction study
indicate a reduction in cyclosporine plasma levels when Orlistat was
coadministered with cyclosporine. Orlistat and cyclosporine should not be
simultaneously coadministered. Cyclosporine should be administered 3
hours before or after the administration of Orlistat.
Fat-soluble Vitamin Supplements and Analogues: Data from a pharmacokinetic
interaction study showed that the absorption of beta-carotene supplement
is reduced when concomitantly administered with Orlistat. Orlistat
inhibited absorption of a vitamin E acetate supplement. The effects of
Orlistat on the absorption of supplemental vitamin D, vitamin A, and
nutritionally-derived vitamin K are not known at this time.
USE IN PREGNANCY AND LACTATION
Pregnancy Category X. Orlistat is contraindicated during pregnancy,
because weight loss offers no potential benefit to a pregnant woman and
may result in fetal harm.
It is not known whether Orlistat is present in human milk or not. Caution
should be exercised when Orlistat is administered to a nursing woman.
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