As the world's first approved weight loss prescription drug, Orestat was approved as a Class A over-the-counter drug in China in 2007. It is suitable for overweight or obese individuals with a BMI ≥ 24 and is particularly recommended as an adjunct to diet control and exercise.

1、 Drug name

1. Common name: Orlistat

2. Product Name: XENICAL ®

2、 Indications

1. Used for obesity management, including weight loss and weight maintenance, in conjunction with a low calorie diet.

2. It also applies to reducing the risk of weight rebound after pre weight loss.

3. It is applicable to patients with initial body mass index (BMI) ≥ 30kg/m ², or patients with BMI ≥ 27kg/m ² and other risk factors (such as hypertension, diabetes, dyslipidemia).

3、 Specifications and characteristics

1. Specification: Capsule, 120mg.

2. Appearance: This product is a pine green hard gelatin capsule with the black lettering "XENICAL120" printed on it. The content is medicated microspheres.

4、 Main components

1. Active ingredient: Orlistat.

5、 Usage and dosage

1. Recommended dose: The recommended dose is 120mg each time, three times a day. Take during each main meal containing fat, or within 1 hour after a meal.

2. Dietary coordination: Patients should follow a nutritionally balanced, low calorie diet, with about 30% of calories coming from fat. The daily intake of fat, carbohydrates, and protein should be divided into three main meals.

3. Omission treatment: If you occasionally miss a meal or a meal without fat, you can skip the current dose of orlistat.

4. Vitamin supplementation: As this product may affect the absorption of fat soluble vitamins, patients should take a daily multivitamin supplement containing vitamins A, D, E, K, and beta carotene. Supplements should be taken at least 2 hours before or after taking orlistat, such as before bedtime.

6、 Dose adjustment

Special combination therapy:

1. Cyclosporine: Cyclosporine should be taken at least 3 hours after taking Orlistat.

2. Levothyroxine: Levothyroxine should be taken at least 4 hours apart from orlistat.

3. Dose limit: Doses of 120mg or more three times a day have not been shown to provide additional benefits.

7、 Medication precautions

1. Timing of administration: Take with the main meal or within 1 hour after the meal. If the food does not contain fat, you can skip this dose.

2. High fat diet warning: If taken with high-fat meals containing more than 30% of daily total calories, the incidence of gastrointestinal adverse reactions will increase.

3. Discontinuation reaction: After discontinuation, the fat content in feces usually returns to pre-treatment levels within 48 to 72 hours.

8、 Medication for special populations

1. Pregnant women: Due to the potential risks of weight loss during pregnancy to the fetus, it is contraindicated for pregnant women.

2. Breastfeeding women: It is not yet clear whether this product is secreted by human milk, and breastfeeding women should use it with caution.

3. Children: The safety and effectiveness of children under 12 years old have not yet been determined. The safety and efficacy of adolescents aged 12 to 16 are similar to adults, but they must take multivitamin supplements.

4. Elderly patients: Clinical studies did not include a sufficient number of patients aged 65 and above to determine whether their reactions were different from those of younger patients.

9、 Adverse reactions

1. Common adverse reactions (incidence ≥ 5% and higher than placebo):

Mainly gastrointestinal reactions, including oily spots, exhaust with oil overflow, urgency, fat/oily stools, oily stools, increased frequency of bowel movements, and fecal incontinence. These reactions usually occur in the early stages of treatment and are related to a high-fat diet.

2. Serious adverse reactions (rare):

Liver injury: Rare reports of severe liver injury, such as hepatocyte necrosis and acute liver failure.

Kidney problems: Oxalate kidney stones and oxalate nephropathy with renal failure may occur.

Gallbladder disease: Significant weight loss may increase the risk of gallstones.

Pancreatitis: There have been reports of pancreatitis occurring after use.

Other: May cause rash, allergic reactions (such as itching, urticaria, angioedema, allergic reactions), etc.

10、 Contraindications

1. Pregnant women.

2. Patients with chronic malabsorption syndrome.

3. Patients with cholestasis.

4. Individuals who are allergic to Orlistat or any of its ingredients.

11、 Drug interactions

1. Cyclosporine: Co administration can reduce the plasma concentration of cyclosporine and should be taken at least 3 hours apart.

2. Levothyronine: Co administration may lead to hypothyroidism, and should be taken at least 4 hours apart and monitored for thyroid function.

3. Warfarin (anticoagulant): may affect the absorption of vitamin K, leading to changes in coagulation parameters (such as INR), and requires close monitoring.

4. Amiodarone: Combined use can reduce exposure to amiodarone and its metabolites.

5. Antiepileptic drugs: There have been reports of seizures when used in combination, and changes in seizure frequency or severity need to be monitored.

6. Antiretroviral drugs: There have been reports of virological control failure in HIV infected individuals, and frequent monitoring of HIV RNA levels is necessary.

7. Fat soluble vitamins: can reduce the absorption of supplements such as beta carotene and vitamin E acetate.

12、 Storage method

1. Temperature: Store at 25 ° C (77 ° F) environment; Allow fluctuations between 15 ° and 30 ° C (59 ° and 86 ° F).

2. Container: Keep the bottle tightly sealed.

3. Validity period: Cannot be used after expiration.

Orlistatinformation