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XENICAL is a brand name for Orlistat, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: XENICAL (orlistat), when used in conjunction with a mildly hypocaloric diet, is indicated for: • obesity management including weight loss and weight maintenance; • reducing the risk of weight regain in obese patients after prior weight loss. These indications for the use of XENICAL apply to obese patients with a BMI*…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • The patient should be on a nutritionally balanced, mildly hypocaloric diet that contains no more than 30% of calories from fat. The daily intake of fat, carbohydrate and protein should be distributed over three main meals.
• For patients with type 2 diabetes, the reduced calorie diet should be consistent with the dietary recommendations of the Canadian Diabetes Association Guidelines for the Nutritional Management of Diabetes Mellitus in the New Millennium.
3 Pharmacokinetics). • Since Xenical has been shown to reduce the absorption of some fat-soluble vitamins and beta- carotene, vitamin supplementation should be advised to ensure adequate nutrition. 4 Drug-Drug Interactions). 2 Recommended Dose and Dosage Adjustment The recommended dose of XENICAL (orlistat) is one 120 mg capsule three times daily with each main meal (during or up to 1 hour after the meal).
If a meal is occasionally missed or contains no fat, the dose of XENICAL may be omitted. Doses above 120 mg three times daily have not been shown to provide additional benefit. No dose adjustment is necessary for the geriatric patient.
Based on fecal fat measurements, the effect of XENICAL 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. 3 Pharmacokinetics, Special Populations and Conditions).
4 Administration XENICAL (orlistat) is administered orally with food (during a meal or up to 1 hour after the meal). 5 Missed Dose If a dose is missed, it can be taken as soon as the patient remembers, provided this is within one hour of the last meal.
Patients should not take a double dose (two doses at the same time) to make up for a forgotten dose. XENICAL cannot work properly if many doses are missed.
g. in a 2000 Calorie/day diet, a diet high in fat would contain > 30% calories from fat, which equates to > 67g fat). The daily intake of fat should be distributed over three main meals. If XENICAL is taken with any one meal very high in fat, the possibility of gastrointestinal effects may increase.
XENICAL only inhibits the absorption of dietary fat. Patients should be advised that if the resulting caloric reduction is compensated by an increase in calories from protein or carbohydrates, the expected weight loss will not occur.
Cases of rectal bleeding have been reported with XENICAL. Prescribers should investigate further in case of severe and/or persistent symptoms.
See also 7 WARNINGS AND PRECAUTIONS, Reproductive Health:
Female and Male Potential. Hepatic/Biliary/Pancreatic There have been rare post-marketing reports of severe liver injury with hepatocellular necrosis or acute hepatic failure in patients treated with XENICAL with some of these cases resulting in liver transplant or death.
Patients should be instructed to report any symptoms of hepatic dysfunction (anorexia, pruritus, jaundice, dark urine, light colored stools, or right upper quadrant pain) while taking XENICAL. When these symptoms occur, XENICAL should be discontinued immediately and liver function tests and ALT and AST levels obtained.
3 Pharmacokinetics, Special Populations and Conditions. Monitoring and Laboratory Tests Diabetic patients treated with orlistat should have tests for fasting glucose and HbA1c as required. 4 Drug-Drug Interactions).
Neurologic Anticonvulsants:
Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic drugs. 4 Drug-Drug Interactions).
4 Drug-Drug Interactions). 2 Recommended Dose and Dosage Adjustment The recommended dose of XENICAL (orlistat) is one 120 mg capsule three times daily with each main meal (during or up to 1 hour after the meal). If a meal is occasionally missed or contains no fat, the dose of XENICAL may be omitted.
Doses above 120 mg three times daily have not been shown to provide additional benefit. No dose adjustment is necessary for the geriatric patient. Based on fecal fat measurements, the effect of XENICAL 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. 3 Pharmacokinetics, Special Populations and Conditions). 4 Administration XENICAL (orlistat) is administered orally with food (during a meal or up to 1 hour after the meal).
5 Missed Dose If a dose is missed, it can be taken as soon as the patient remembers, provided this is within one hour of the last meal. Patients should not take a double dose (two doses at the same time) to make up for a forgotten dose.
XENICAL cannot work properly if many doses are missed. 5 OVERDOSAGE Single doses of 800 mg XENICAL (orlistat) and multiple doses of up to 400 mg tid for 15 days have been studied in normal weight and obese subjects without significant adverse findings.
In addition, doses of 240 mg tid have been administered to obese patients for 6 months without a significant increase in adverse findings.
Product Monograph Template Date:
September 2020 XENICAL, orlistat Page 6 of 48 Orlistat overdose cases received during post-marketing reported either no adverse events or adverse events that are similar to those reported with the recommended dose. Should a significant overdose of XENICAL occur, it is recommended that the patient be observed for 24 hours.
2 Breast-feeding); • who are hypersensitive to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Product Monograph Template Date:
September 2020 XENICAL, orlistat Page 5 of 48
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Renal Renal Calculi:
Some patients may develop increased levels of urinary oxalate following treatment with XENICAL. Cases of hyperoxaluria and oxalate nephropathy with renal failure have been reported in patients treated with XENICAL. Caution should be exercised when prescribing XENICAL to patients with Product Monograph Template Date: September 2020 XENICAL, orlistat Page 8 of 48 a history of hyperoxaluria or calcium oxalate nephrolithiasis.
3 Pharmacokinetics, Special Populations and Conditions. 3 Drug-Behavioural Interactions). 1 Pregnant Women XENICAL is contraindicated during pregnancy, because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm.
Teratogenicity studies were conducted in rats and rabbits at doses up to 800 mg/kg/day. Neither study showed embryotoxicity or teratogenicity. This dose is 22 and 43 times the daily human dose calculated, on a body surface area (mg/m2) basis, for rats and rabbits, respectively.
However, animal reproductive studies are not always predictive of human response. There are no adequate and well-controlled studies of orlistat in pregnant women. See 2 CONTRAINDICATIONS. 2 Breast-feeding XENICAL is contraindicated in nursing women.
It is not known if orlistat is secreted in human milk. See 2 CONTRAINDICATIONS. 3 Pediatrics Pediatrics (< 12 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric patients below the age of 12 years.
3 Pharmacokinetics, Special Populations and Conditions. 4 Geriatrics Geriatrics (> 65 years of age): Clinical studies of XENICAL did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients.
1 Adverse Reaction Overview Adverse reactions to XENICAL are largely gastrointestinal in nature and related to the pharmacologic effect of the drug on preventing the absorption of ingested fat. Commonly observed events are oily spotting, flatus with discharge, fecal urgency, fatty/oily stool, oily evacuation, increased defecation and fecal incontinence.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the Product Monograph Template Date:
September 2020 XENICAL, orlistat Page 9 of 48 clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Treatment of Obesity:
Commonly Observed (based on first year and second year data - 120 mg versus placebo): Gastrointestinal symptoms are the most commonly observed treatment-emergent adverse events associated with the use of XENICAL (orlistat) in double-blind, placebo-controlled clinical trials and are primarily a manifestation of the mechanism of action.
2 Increased Defecation […]
Based on human and animal studies, any systemic effects attributable to the lipase-inhibiting properties of orlistat should be rapidly reversible. For management of a suspected drug overdose, contact your regional poison control centre.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 - Dosage Forms, Strengths, Composition and Packaging Description Each XENICAL 120 mg capsule contains 120 mg orlistat. XENICAL 120 mg Capsules: turquoise cap and turquoise body with "XENICAL 120" printed in black ink.
XENICAL is supplied in blister packages in cartons of 84 capsules. 7 WARNINGS AND PRECAUTIONS General Patient Counselling Information: Patients should be advised to adhere to dietary guidelines. The patient should be on a nutritionally balanced, mildly hypocaloric diet that contains no more than 30% of calories from fat.
The daily intake of fat, carbohydrate and protein should be distributed over three main meals. See 4 DOSAGE AND ADMINISTRATION. g. patients with anorexia nervosa or bulimia). See 1 INDICATIONS for appropriate prescribing guidelines. 4 Drug-Drug Interactions).
4 Drug- Drug Interactions). g. 4 Drug-Drug Interactions). , gelatin, indigo carmine, microcrystalline cellulose, povidone K30, sodium lauryl sulphate, sodium starch glycolate, talc, titanium dioxide Product Monograph Template Date: September 2020 XENICAL, orlistat Page 7 of 48 Carcinogenesis and Mutagenesis For animal data, refer to 16 NON-CLINICAL TOXICOLOGY.
Endocrine and Metabolism Hypothyroidism and/or reduced control of hypothyroidism may occur. The mechanism may involve a decreased absorption of iodine salts and/or levothyroxine. 4 Drug-Drug Interactions). Gastrointestinal XENICAL should be used with caution in patients with pre-existing disease of the large bowel or rectum.
The possibility of experiencing gastrointestinal events (see