XENICAL® 120mg Blister of 84 Caps - Xediton Pharmaceuticals
XENICAL® 120mg Blister of 84 Caps
INDICATIONS: XENICAL® is indicated for obesity management, weight maintenance and reducing the risk of weight regain in obese patients after prior weight loss
DIRECTIONS: One capsule 3x/day with each main meal containing fat
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* ≥ 30 kg/m2 or a BMI ≥ 27 kg/m2 in the presence of other risk factors (e.g., hypertension, type 2 diabetes, dyslipidemia, excess visceral fat).
XENICAL® (orlistat) is contraindicated in patients with chronic malabsorption syndrome, cholestasis and in patients with known hypersensitivity to XENICAL® or to any component of this product
Patient Counselling Information: Patients should be advised to adhere to dietary guidelines.
No serious adverse reactions or safety hazards related to the use of XENICAL® (orlistat) have been reported to date during large, long-term clinical trials (up to 4 years).
As with any weight-loss agent, the potential exists for misuse of XENICAL® in inappropriate patient populations (e.g. patients with anorexia nervosa or bulimia). See the INDICATIONS AND CLINICAL USE section for appropriate prescribing guidelines.
When using XENICAL® in combination with insulin or oral hypoglycemic agents in the treatment of type 2 diabetes, the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to the patient, family members, caregiver or
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. (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.)
Please refer to the product monograph for a complete list of adverse reactions
Obesity is a condition characterized by abnormal or excessive fat accumulation. Obesity isn’t just a cosmetic concern. It is a medical problem that increases your risk of other diseases and health problems, such as heart disease, diabetes, high blood pressure and certain cancers.
The good news is that even modest weight loss can improve or prevent the health problems associated with obesity. Dietary changes increased physical activity and behavior changes can help you lose weight. Prescription medications and weight-loss procedures are additional options for treating obesity
Click here to download Prescribing Information
Orlistat belongs to a class of medications known as anti-obesity agents, specifically gastrointestinal lipase inhibitors. When combined with a mildly reduced-calorie diet that contains no more than 30% of calories from fat, orlistat is used to help obese people lose weight and maintain weight loss.
Lipase is an enzyme that is needed to break down dietary fats into fatty acids, which is the form of fat that gets absorbed. Orlistat blocks the action of lipase and therefore prevents dietary fat from being absorbed. At the recommended dose, orlistat inhibits dietary fat absorption by approximately 30%.
This medication should only be used by people who have a body mass index (BMI) of 30 kg/m² or higher, or by people with a BMI of 27 kg/m² or higher with other health risk factors such as high blood pressure, type 2 diabetes, high cholesterol, or large waist measurement. BMI is not a direct measure of fat and these guidelines do not apply to athletes and pregnant women.
Orlistat can also be used in combination with diabetes medications to improve blood glucose control in overweight or obese people with type 2 diabetes whose blood glucose levels are inadequately controlled with diet, exercise, and diabetes medications (e.g., glyburide, insulin, metformin).
XENICAL® is supplied in blister packages in cartons of 84 capsules
The recommended adult dose is 120 mg three times daily with each main meal (breakfast, lunch, and dinner) or up to 1 hour after the meal. If you occasionally miss a meal or the meal does not contain fat, do not take the dose of orlistat. Swallow the capsule whole with some water.
Orlistat should be taken with a mildly reduced-calorie diet that contains no more than 30% of calories from fat, as recommended by your doctor, dietitian, or other health care professional.
are allergic to orlistat or any ingredients of the medication
have cholestasis (a condition where bile excretion in the liver is stopped)
have chronic malabsorption syndrome (a condition where you do not absorb nutrients from food properly)
The most common possible side effects from XENICAL® are directly related to the way XENICAL® works. By blocking the absorption of some dietary fat, it is likely that you will experience some change in bowel habits. These effects are generally mild and transient (occur for a short period of time). They can increase if you eat high fat foods. In clinical studies, only 3% of people experienced one of these effects more than twice:
Due to the presence of undigested fat, the oil in your bowel movement may be clear, orange or brown in colour. These bowel changes are a natural effect of blocking the fat from being absorbed and indicate that XENICAL® is working.
Kidney problems, including kidney failure, have been reported with the use of XENICAL®. Your doctor may do certain tests to check your kidney function while you are taking XENICAL®
If you are concerned about these or any other unexpected effects while on XENICAL®, talk with your doctor or pharmacist.
This is not a complete list of side effects. For any unexpected effects while taking XENICAL®, contact your doctor or pharmacist.
Drugs that may interact with XENICAL® include cyclosporine, amiodarone, and levothyroxine.
If you experience severe diarrhea, birth control pills might not work as well and you might need to use an additional birth control method
What happens if I forget to take XENICAL®?
Provided you remember within one hour of your last meal, take your XENICAL® capsule and then go back to taking it as you would normally. If it is more than one hour after your last main meal, skip the dose you missed and take your next dose when you are meant to.
If you are not sure whether to skip the dose, talk to your pharmacist or doctor.
If you have missed several doses just go back to taking XENICAL® as you would normally.
The amount of weight you lose depends on how well you stick to a reduced-calorie diet with no more than 30% of calories from fat and an appropriate physical activity level, as well as on your compliance with the prescribed medication regimen.
How soon after starting XENICAL® should I expect to notice weight loss?
Typically, people begin losing weight within 2 weeks of starting XENICAL®, and may continue to lose weight for 6 to 12 months, at which point weight loss usually begins to level off – even if you’re still taking XENICAL®. This doesn’t mean that XENICAL® is not working. People who continue to take XENICAL® are better able to maintain their weight loss
How should XENICAL® be stored?
Store XENICAL® in its original labeled container at room temperature (between 15-25°C). Keep the blister package in the XENICAL® outer carton, in order to protect it from light and moisture