Orlistat Capsules (Orlistat)

Adult dose

The recommended dose of this drug is 120 mg of orlistat orally 3 times daily, taken with a fat-containing meal or within 1 hour after a meal. Patients should continue a nutritionally balanced, mildly low-calorie diet in which approximately 30 % of calories are derived from fat. Daily intake of fat, carbohydrates, and protein should be distributed evenly among the three meals. This drug may be omitted if a meal is skipped or if the meal contains no fat. Because absorption of some fat-soluble vitamins and beta-carotene may be reduced by this drug, patients are advised to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrient intake. The vitamin supplement should be taken at least 2 hours before this drug or at least 2 hours after it, such as at bedtime. Taking more than 120 mg of this drug 3 times daily does not increase its effectiveness. Based on measurements of fecal fat, the effect of this drug appears approximately 24 ∼ 48 hours after taking it. After treatment is discontinued, fecal fat content generally returns to pretreatment levels within 48 ∼ 72 hours. The efficacy and safety of this drug have not been evaluated for periods exceeding 4 years. ○Studies have not been conducted in patients with hepatic and/or renal impairment, children under 12 years of age, or elderly patients.

This medicine should not be used in patients with chronic malabsorption syndrome or those with biliary obstruction. Patients who have had allergic reactions to this drug or its components, pregnant or potentially pregnant women, and breastfeeding mothers should not be administered this drug. There have been reported cases of liver damage, so patients with liver dysfunction should use this drug with caution and consult a doctor immediately if symptoms of liver dysfunction occur. Caution is also necessary for patients with hyperoxaluria or calcium oxalate kidney stones. Gastrointestinal symptoms may frequently appear when taking this drug, which are normal responses related to the drug's action. These symptoms are typically mild and transient, and they tend to appear within 3 months after starting treatment, improving in most cases within 4 weeks. However, in some patients, symptoms may persist for more than 6 months. Taking this drug with a high-fat meal may increase gastrointestinal adverse reactions, so it is important to distribute fat intake evenly across three meals per day. Additionally, this drug may reduce the absorption of fat-soluble vitamins and beta-carotene, thus taking vitamin supplements to maintain nutritional status is recommended. Vitamin supplements should be taken at least 2 hours before or after taking this drug. If liver dysfunction occurs, symptoms such as loss of appetite, itching, jaundice, dark urine, pale stools, and pain in the right upper abdomen may be present, and if these symptoms occur, medical staff should be notified immediately. This drug can affect blood sugar control in diabetic patients, which may necessitate dosage adjustments of hypoglycemic agents or insulin. Caution is advised as excessive weight loss may increase the risk of gallstones. When taken with oral anticoagulants, the coagulation status should be closely monitored, and there may be interactions with this drug and certain others (e.g., cyclosporine, anticonvulsants), so it is essential to consult medical personnel about other medications being taken. This drug is not recommended for use during pregnancy, and breastfeeding women should not take it. It is also not recommended for children under 12 years of age. No specific severe adverse reactions have been reported in cases of overdose; however, monitoring for 24 hours is needed in instances of overdose. When storing, keep out of reach of children, protecting from light and moisture, and store in the original package.

• Fatty stools
• abdominal bloating and gas
• increased frequency of stools
• fatty stools
• fecal incontinence
• increased bowel movements
• fecal incontinence
• abdominal pain/discomfort
• nausea
• infectious diarrhea

This medicine is sensitive to air, light, and moisture, so it should be stored in a special container. Additionally, it is important to keep it in a cool place below 25 degrees Celsius to maintain its effectiveness.

Appearance

A hard capsule with greenish-blue color, containing white or off-white powder or granules.

Package unit

90 capsules/PTP [90 capsules (10 capsules/PTPX9)], 300 capsules/bottle [300 capsules/bottle]