Xenical 120 mg/1
orlistat · CAPSULE · H2-Pharma LLC
Xenical (orlistat) is a prescription capsule that works by blocking the absorption of dietary fat in your digestive system and is used to help with weight loss when combined with a reduced-calorie diet. It is taken by mouth as a 120 mg capsule.
Key Facts
- Brand Name
- Xenical
- Generic Name
- orlistat
- NDC Code (Product)
61269-460- Manufacturer
- H2-Pharma LLC
- Strength
- 120 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- NDA020766
- Drug Class
- Intestinal Lipase Inhibitor [EPC]
- Marketing Start
- 12/17/2010
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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/m 2 or ≥27 kg/m 2 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/m 2 Conversion Factors: Weight in lbs ÷ 2.2 = weight in kilograms (kg) Height in inches × 0.0254 = height in meters (m) 1 foot = 12 inches 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 ) Table 1
Dosage & Administration
2 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 ) 2.1 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 dis…
Contraindications
4 CONTRAINDICATIONS 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 ( 4 , 8.1 ) Chronic malabsorption syndrome ( 4 ) Cholestasis ( 4 ) Known hypersensitivity to XENICAL or to any component of this product ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Cyclosporine: Reduction in cyclosporine plasma levels was observed when XENICAL was coadministered with cyclosporine. ( 7.1 ) Fat-soluble Vitamin Supplements and Analogues: All patients should take a daily multivitamin that contains vitamins A, D, E, K, and beta-carotene. ( 7.2 ) Levothyroxine: Patients treated concomitantly with XENICAL and levothyroxine should be monitored for changes in thyroid function. ( 7.3 ) Warfarin: Patients on chronic stable doses of warfarin who are prescribed XENICAL should be monitored closely for changes in coagulation parameters. ( 7.4 ) Amiodarone: A reduction in exposure to amiodarone was observed when XENICAL was co-administered. ( 7.5 ) Antiepileptic Drugs: Convulsions have been reported in patients taking XENICAL with antiepileptic drugs. Patients should be monitored for possible changes in frequency or severity of convulsions. ( 7.6 ) Antiretroviral Drugs: Loss of virological control has been reported in HIV-infected patients. Patients should be monitored frequently for changes in HIV RNA levels. ( 7.7 ) 7.1 Cyclosporine Data from a XENICAL and cyclosporine drug interaction study indicate a reduction in cyclosporine plasma l…
Adverse Reactions
6 ADVERSE REACTIONS Most common treatment emergent adverse reactions (≥5% and at least twice that of placebo) include oily spotting, flatus with discharge, fecal urgency, fatty/oily stool, oily evacuation, increased defecation and fecal incontinence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact the Safety Call Center at 1-888-236-5445 or FDA at 1‑800‑FDA‑1088 (1-800-332-1088) or www.fda.gov/medwatch. 6.1 Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in patients. Commonly Observed (based on first year and second year data) Gastrointestinal (GI) symptoms were the most commonly observed treatment-emergent adverse events associated with the use of XENICAL in the seven double-blind, placebo-controlled clinical trials and are primarily a manifestation of the mechanism of action. (Commonly observed is defined as an incidence of ≥5% and an incidence in the XENICAL 120 mg group that is at least twice that of placebo.) Table 2 Commonly Observed Adverse Events Adver…
Frequently Asked Questions
What is Xenical used for?
Xenical (orlistat) is a prescription capsule that works by blocking the absorption of dietary fat in your digestive system and is used to help with weight loss when combined with a reduced-calorie diet. It is taken by mouth as a 120 mg capsule.
Is Xenical a controlled substance?
Xenical is not classified as a controlled substance by the DEA.
What is the generic name for Xenical?
The generic name for Xenical is orlistat. There are 3 other brand versions of orlistat.
What is the NDC code for Xenical 120 mg/1?
The NDC (National Drug Code) for Xenical 120 mg/1 is 61269-460, listed by H2-Pharma LLC.