Orlistat Capsule 60 mg (Orlistat)

Adult dose

○ Adults 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 hypocaloric diet in which fat accounts for approximately 30 % of calories. Daily intake of fat, carbohydrates, and protein should be distributed evenly across the three meals. This drug may be omitted if a meal is missed or contains no fat. As 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 nutritional 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 per dose 3 times daily does not increase the efficacy of this drug. Measurements of fecal fat indicate that the effect of this drug becomes apparent 24 ∼ 48 hours after administration. 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 or in elderly patients.

Child dose

Studies have not been conducted in children under 12 years of age.

This medication should not be used by patients with chronic malabsorption syndrome or those with biliary obstruction. Additionally, patients with a known allergy to this medication or its components, pregnant women or women who may become pregnant, and nursing mothers should not take this medication. Rare instances of liver damage have been reported; patients should notify a physician immediately if there are any abnormalities in liver function and undergo liver function tests. Patients with hyperoxaluria or calcium oxalate kidney stones should also use caution. Various gastrointestinal symptoms may occur with the use of this drug, including oily stools, abdominal bloating, flatulence, and constipation, all of which are common and typically arise within 3 months of starting treatment and are mostly temporary. However, in some patients, these symptoms may persist for more than 6 months. Some patients may discontinue the medication due to gastrointestinal adverse reactions; therefore, patients should consult a physician if symptoms are severe. Taking this medication with a high-fat meal may exacerbate gastrointestinal adverse reactions; therefore, it is recommended to distribute the daily fat intake evenly across three meals. This medication may also interfere with the absorption of fat-soluble vitamins and beta-carotene, making it advisable for patients to take a multivitamin that includes vitamins A, D, E, K, and beta-carotene. Vitamin supplements should be taken at least 2 hours before or 2 hours after taking this medication to avoid interference with absorption. The use of this medication is not recommended during pregnancy, and nursing mothers should avoid taking it as well. For children under 12 years of age, the safety and efficacy of this medication have not been adequately studied, and its use is advised against. If symptoms of liver dysfunction (such as decreased appetite, itching, jaundice, dark urine, pale stools, and right upper quadrant pain) occur during the use of this medication, the patient should notify a physician immediately. Diabetic patients should closely monitor blood glucose levels, as this medication may alter blood sugar control and may require adjustment of diabetes medication doses. Additionally, certain medications (e.g., cyclosporine, anticoagulants, antiepileptics, etc.) may interact with this medication, necessitating consultation with a physician or pharmacist for dose adjustments or monitoring. In cases of overdose, the patient should be observed for 24 hours; while serious adverse reactions are not common, caution is advised. Lastly, this medication should be stored out of reach of children and protected from light and moisture.

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

This medication is sensitive to air, light, and moisture; therefore, it must be stored in a tightly closed container. Additionally, it should be stored in a cool place below 25 degrees Celsius to maintain its effectiveness.

Appearance

A hard capsule filled with white or off-white powder or granules with a yellowish hard capsule shell.

Package unit

300 capsules/bottle, 30 capsules/bottle