XENICAL- orlistat capsule

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

orlistat (UNII: 95M8R751W8) (orlistat - UNII:95M8R751W8)

Dostupné z:

Genentech, Inc.

INN (Medzinárodný Name):

orlistat

Zloženie:

orlistat 120 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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. XENICAL is contraindicated in: - Pregnancy [see Use in Specific Populations (8.1)] - Patients with chronic malabsorption syndrome - Patients with cholestasis - Patients with known hypersensitivity to XENICAL or to any component of this product Pregnancy Category X XENICAL is contraindicated during pregnancy, because weight loss offers no potential be

Prehľad produktov:

XENICAL is a turquoise, hard-gelatin capsule containing pellets of powder. XENICAL 120 mg Capsules: Turquoise, two-piece, No. 1 opaque hard-gelatin capsule imprinted with ROCHE and XENICAL 120 in black ink — bottle of 90 (NDC 0004-0257-52). Storage and Handling 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.

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

XENICAL- ORLISTAT CAPSULE
GENENTECH, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
XENICAL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR XENICAL
XENICAL (ORLISTAT) CAPSULES FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Warnings and Precautions (5.1)
08/2016
INDICATIONS AND USAGE
XENICAL is a reversible inhibitor of gastrointestinal lipases
indicated for obesity management including weight loss and
weight maintenance when used in conjunction with a reduced-calorie
diet. (1)
XENICAL is also indicated to reduce the risk for weight regain after
prior weight loss. (1)
DOSAGE AND ADMINISTRATION
One 120-mg capsule three times a day with each main meal containing
fat (during or up to 1 hour after the meal). (2)
Advise patients to take a nutritionally balanced, reduced-calorie diet
that contains approximately 30% of calories from
fat. (2)
Distribute the daily intake of fat, carbohydrate, and protein over
three main meals. (2)
Advise patients to take a multivitamin containing fat-soluble vitamins
to ensure adequate nutrition. (2)
Take the vitamin supplement at least 2 hours before or after the
administration of XENICAL, such as at bedtime. (2)
For patients receiving both XENICAL and cyclosporine therapy,
administer cyclosporine 3 hours after XENICAL. (2)
For patients receiving both XENICAL and levothyroxine therapy,
administer levothyroxine and XENICAL at least 4
hours apart. (2)
DOSAGE FORMS AND STRENGTHS
XENICAL 120 mg Capsules. (3)
CONTRAINDICATIONS
Pregnancy (4, 8.1)
Chronic malabsorption syndrome (4)
Cholestasis (4)
Known hypersensitivity to XENICAL or to any component of this product
(4)
WARNINGS AND PRECAUTIONS
XENICAL has drug interactions and can decrease vitamin absorption.
(5.1,7)
Take a multivitamin supplement that contains fat-soluble vitamins to
ensure adequate nutrition. (5.1)
Rare cases of severe liver injury with hepatocellular necrosis or
acute hepatic failure have been reported. (5.2)
Patients may dev