TM Owner Cheplapharm (EU); H2-Pharma (US)
Xenical 120mg Capsule
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Indications & Clinical Uses
- Xenical 120 mg (orlistat) capsules contain a gastrointestinal lipase inhibitor that reduces the fat absorbed from food.
- In the US, Xenical is approved with a reduced-calorie diet for obesity management in people with a body mass index (BMI) of 30 kg/m² or more, or 27 kg/m² or more with risk factors such as high blood pressure, diabetes or high cholesterol, and it is approved for adolescents aged 12 to 16.
- In the EU it is for obese patients (BMI 30 or more) or overweight patients (BMI above 28) with risk factors, alongside a mildly reduced-calorie diet.
- The dose is one 120 mg capsule three times a day with each main meal that contains fat.
- Xenical 120 mg is the prescription strength; do not swap it for other orlistat products without advice.
- The US label holder is H2-Pharma; in the EU it is Cheplapharm.
Side Effects
- In the first year of the US trials the most frequent reactions, compared with placebo, were oily spotting (26.6% vs 1.3%), abdominal pain or discomfort (25.5%), flatus with discharge (23.9%), urgent need to open the bowels (22.1%) and fatty or oily stool (20.0%).
- EU labelling lists headache, abdominal pain, oily spotting, fatty stools and flatulence as very common, and rectal pain, soft stools and faecal incontinence as common.
- These effects are linked to fat in the diet and usually lessen with a lower-fat meal.
- Xenical has no boxed warning.
- Rare serious effects include severe liver injury, kidney damage from oxalate deposits, gallstones and seizures in people on antiepileptic drugs.
- Stop and seek help for yellow skin or eyes, dark urine, severe upper abdominal pain or a seizure.
Precautions & Warnings
- Xenical is contraindicated in chronic malabsorption syndrome, cholestasis, and hypersensitivity to orlistat; the US label also contraindicates pregnancy, and the EU label contraindicates breastfeeding and does not recommend use in pregnancy.
- Warnings include rare severe liver injury, oxalate nephrolithiasis or nephropathy with a risk of kidney failure, cholelithiasis with substantial weight loss, and reduced absorption of fat-soluble vitamins, so a multivitamin containing vitamins A, D, E and K is advised.
- Hypothyroidism has been reported, so thyroid function should be monitored, and seizures have been reported with antiepileptic drugs.
- Take the capsule with a main meal, or up to one hour after, that contains fat; skip the dose if a meal is missed or contains no fat.
- Follow a balanced reduced-calorie diet with fat spread across meals.
Avoid Interactions
- Tell your healthcare provider about every medicine, herbal product and supplement you use.
- Xenical mainly reduces absorption of other substances.
- Reduce efficacy: fat-soluble vitamins A, D, E and K and beta-carotene (take a multivitamin at least 2 hours apart, such as at bedtime); cyclosporine (blood levels fall, so separate doses by 3 hours and check levels; the EU label does not recommend the combination); levothyroxine (separate by 4 hours and monitor thyroid function); amiodarone (exposure reduced by 23% to 27%); and antiepileptic drugs and antiretrovirals (monitor for loss of control).
- Warfarin and other anticoagulants: monitor clotting parameters.
- Increase gut side effects: high-fat meals.
- Avoid taking Xenical without a meal.
References
Frequently Asked Questions
Xenical (orlistat) 120 mg is a prescription capsule for obesity management alongside a reduced-calorie diet, in adults with a BMI of 30 or more, or 27 or more with risk factors, and in adolescents aged 12 to 16 in the US.
Take one Xenical (orlistat) 120 mg capsule three times daily with each main meal that contains fat (or up to one hour afterwards). Skip the capsule if you miss a meal or it has no fat. Follow a reduced-calorie diet with fat spread evenly across meals.
Xenical (orlistat) mainly causes bowel effects: oily spotting, gas with discharge, urgent bowel movements, fatty or oily stools and abdominal pain. Rare serious effects are liver injury, kidney damage and gallstones. Seek help for yellow skin, dark urine, severe upper stomach pain or a seizure.
Avoid taking Xenical (orlistat) within 3 hours of cyclosporine or 4 hours of levothyroxine. Warfarin, antiepileptics, amiodarone and antiretrovirals need monitoring. High-fat meals worsen bowel effects. Do not use it in pregnancy, chronic malabsorption or cholestasis, and do not breastfeed in the EU.
Yes. Xenical (orlistat) reduces absorption of fat-soluble vitamins A, D, E and K, so take a daily multivitamin containing them. Take it at least 2 hours before or after your Xenical dose, such as at bedtime, and tell your provider if you are on other medicines.
No. The US Xenical (orlistat) label lists pregnancy as a contraindication, and the EU label does not recommend it in pregnancy and contraindicates breastfeeding. Tell your healthcare provider if you become pregnant while taking it, and ask about other ways to manage your weight during pregnancy.
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