Adult Dosing

Management of obesity

• 120 mg PO tid with each meal containing fat (during or up to 1 hour after the meal)
• Alt (OTC): 60 mg PO tid with each meal containing fat (during or up to 1 hour after the meal)
• Max duration: 4 yrs

• Must have nutritionally balanced, reduced-calorie diet that contains about 30% of calories form fat. Omit the dose if a meal is missed or contains no fat
• It is advisable to take multivitamin containing fat-soluble vitamins to ensure adequate nutrition; these must be taken at least 2 hrs before or after taking orlistat, such as at bedtime
• Give levothyroxine and orlistat at least 4 hrs apart in patients receiving this combination therapy
• Continue with diet and exercise program after discontinuation of orlistat therapy; may start taking orlistat again when weight regain occurs

Pediatric Dosing

• Safety and effectiveness in pediatric patients <12 yrs of age have not been established for Xenical
• Safety and effectiveness in pediatric patients <18 yrs of age have not been established for OTC orlistat

Management of obesity

• 120 mg PO tid with each meal containing fat (during or up to 1 hour after the meal)
• Max duration: 4 yrs

• Must have nutritionally balanced, reduced-calorie diet that contains about 30% of calories form fat. Omit the dose if a meal is missed or contains no fat
• It is advisable to take multivitamin containing fat-soluble vitamins to ensure adequate nutrition; these must be taken at least 2 hrs before or after taking orlistat, such as at bedtime

[Outline]

• Adult Dosing
• Pediatric Dosing

• Management of obesity including weight loss and weight maintenance when used in conjunction with a reduced-calorie and low-fat diet in patients with an initial BMI 30 kg/m <SUP>2</SUP> or 27 kg/m <SUP>2</SUP> in the presence of additional risk factors such as diabetes, hypertension, dyslipidemia
• Indicated to reduce the risk for weight regain after prior weight loss

• Hypersensitivity to any of the ingredients of product
• Chronic malabsorption syndrome
• Cholestasis
• Organ transplant
• Co-administration with cyclosporine

• N/A

Renal Dose Adjustment

• Renal impairment: No dose adjustment

Hepatic Dose Adjustment

• Hepatic impairment: No dose adjustment

• Organic causes of obesity such as hypothyroidism should be excluded before initiating orlistat therapy
• Avoid co-administration of cyclosporine and orlistat as it may cause reduction in cyclosporine plasma levels; to reduce such incidence, cyclosporine must be taken at least 2 hrs before or after administration of orlistat. Also, consider frequent monitoring of cyclosporine levels in these patients
• Patients should be advised to adhere to dietary guidelines
• Increased incidence of GI events may occur on taking orlistat with a high-fat diet (>30% total daily calories from fat); the daily intake of fat must be distributed over three main meals
• Patients must have nutritionally balanced diet. It is advisable to take multivitamin containing fat-soluble vitamins to ensure adequate nutrition; these must be taken at least 2 hrs before or after taking orlistat, such as at bedtime
• Severe liver injury with hepatocellular necrosis or acute hepatic failure may occur during orlistat therapy, which sometimes resulting in liver transplant or death. If symptoms of hepatic dysfunction occur, discontinue therapy immediately and obtain LFT's and ALt and AST levels
• Weight-loss induction using orlistat may be accompanied by improvement of metabolic control in diabetics, which might require a reduction in dose of oral hypoglycemic medication or insulin; substantial weight loss may increase the risk of cholelithiasis
• Avoid use of orlistat in patients with anorexia nervosa or bulimia because there exists a potential for misuse in this population
• May produce increased levels of urinary oxalate in some patients following orlistat administration
• Discontinue therapy and consult a physician if severe or continuous abdominal pain occurs; this may be a sign of serious medical condition

Cautions: Use cautiously in

• History of hyperoxaluria or calcium oxalate nephrolithiasis

Pregnancy Category:B

Breastfeeding: Safety unknown. As per manufacturer's data, orlistat should not to be taken by nursing women.

• CNS: Headache, dizziness
• GI: Hepatotoxicity, fecal urgency, loose stools, fatty/oily stools, increased defecation, flatus with discharge, fecal incontinence, oily spotting, oily evacuation, abdominal pain, nausea, infectious diarrhea, rectal pain/discomfort, vomiting
• DERM: Rash
• GU: Menstrual irregularities, UTI
• IMMU: Anaphylaxis, hypersensitivity reaction
• RESP: URI
• MUSC: Back pain, arthritis, myalgia
• MISC: Fat-soluble vitamin deficiency, angioedema, influenza, fatigue, tooth disorder
• REPRODUCTIVE: Menstrual irregularity, vaginitis

• Lipase inhibitor; inhibits dietary fat absorption by reversibly inhibiting pancreatic lipase, an enzyme necessary for the breakdown and subsequent absorption of fat
• Minimal systemic absorption following oral administration
• Metabolized within GI wall to two metabolites namely M1 (4-member lactone ring hydrolyzed) and M3 (M1 with N-formyl leucine moiety cleaved)
• Excretion: Fecal excretion (major route), biliary excretion. Feces: 97% (83% unchanged), urine: <2%
• Half life:
• Orlistat : 1-2 hrs
• M1: 3 hrs
• M3: 13.5 hrs

US Trade Name(s)

• Alli
• Xenical

US Availability

Alli

• OTC CAPS: 60 mg

Xenical

• CAPS: 120 mg

Canadian Trade Name(s)

• Xenical

Canadian Availability

Xenical

• CAPS: 120 mg

UK Trade Name(s)

• Alli
• Xenical

UK Availability

Alli

• OTC CAPS: 60 mg

Xenical

• CAPS: 120 mg

Australian Trade Name(s)

• Xenical

Australian Availability

Xenical

• CAPS: 120 mg

[Outline]

Endocrine/Metabolic

Metabolic Agents

Enzyme Inhibitors

Pricing data from www.DrugStore.com in U.S.A.

• Xenical 120 MG CAPS [Bottle] (GENENTECH)
  10 mg = $53.99
  20 mg = $96.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Alli 60 MG Oral Capsule

Ingredient(s): Orlistat

Imprint: Orlistat;60

Color(s): Turquoise, Blue

Shape: Capsule

Size (mm): 15.00

Score: 1

Inactive Ingredient(s): fd&c blue no. 2 / gelatin / cellulose, microcrystalline / povidone / sodium lauryl sulfate / sodium starch glycolate type a potato / talc / titanium dioxide

Drug Label Author:
GlaxoSmithKline Consumer Healthcare LP

DEA Schedule:
Non-Scheduled

Drug Name: Xenical 120 MG Oral Capsule

Pill Image:

[
See full size image]

Ingredient(s): Orlistat

Imprint: Roche;XENICAL;120

Color(s): Blue

Shape: Capsule

Size (mm): 19.00

Score: 1

Inactive Ingredient(s): cellulose, microcrystalline / sodium starch glycolate type a potato / sodium lauryl sulfate / povidone / talc / gelatin / titanium dioxide / fd&c blue no. 1 / aluminum oxide

Drug Label Author:
Hoffmann-La Roche Inc

DEA Schedule:
Non-Scheduled