Zerodown Capsule 120 mg (Orlistat)

Adult dose

○ Adults The recommended dose of this medicine is 120 mg of orlistat orally three times daily with meals containing fat or within 1 hour after a meal. Patients should continue a nutritionally balanced, mildly hypocaloric diet in which approximately 30 % of calories are from fat. Daily intake of fat, carbohydrates, and protein should be distributed evenly across three meals. This medicine may be omitted if a meal is skipped or contains no fat. Because this medicine may reduce the absorption of some fat-soluble vitamins and beta-carotene, patients are advised to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition. The vitamin supplement should be taken at least 2 hours before or at least 2 hours after this medicine, such as at bedtime. Taking more than 120 mg of this medicine three times daily does not increase its effectiveness. Based on measurement of fecal fat, the effect of this medicine appears approximately 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 medicine for periods exceeding 4 years have not been evaluated. ○ 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 biliary obstruction. Furthermore, individuals allergic to this medication or its components, pregnant women or those who may become pregnant, and breastfeeding women should avoid taking it. Caution is advised for those with liver dysfunction or suspected liver damage; liver function tests should be performed. Patients with hyperoxaluria or calcium oxalate kidney stones need to be cautious as this medication may increase urinary oxalate excretion. Commonly, gastrointestinal adverse reactions may occur with this medication, including abdominal distension, flatulence, constipation, and fatty stools. These symptoms typically appear within three months of starting treatment and are mostly transient and mild, but may persist in some patients for more than six months. Some patients may discontinue treatment due to adverse reactions, primarily gastrointestinal symptoms. This medication may cause more severe gastrointestinal side effects when taken with a high-fat meal, so it is important to distribute fat intake evenly across three meals a day. This medication may reduce the absorption of fat-soluble vitamins (vitamins A, D, E, K) and beta-carotene, so taking vitamin supplements is recommended. Vitamin supplements should be taken at least two hours before or after taking this medication to maintain effectiveness. If symptoms of liver damage, such as loss of appetite, itching, jaundice, dark urine, pale stools, or pain in the right upper abdomen occur, inform a physician immediately. This medication may affect blood sugar control in diabetic patients, necessitating dosage adjustments for blood sugar medications. Excessive weight loss may increase the risk of gallstones, so the rate of weight loss should be controlled. This medication may interact with certain drugs, so patients taking cyclosporine, anticoagulants, anticonvulsants, or antiretroviral agents should consult their doctor. Pregnant or breastfeeding women should not take this medication, and it is not used in children under 12 years of age due to unconfirmed safety and efficacy. It should be stored out of reach of children and protected from direct sunlight and moisture.

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

This medication should be stored in a tightly closed container to prevent exposure to air, light, and moisture. Additionally, it is important to store it in a cool place, below 25 degrees Celsius, to maintain the medication's efficacy.

Appearance

Hard capsules with white or light white powder or granules in the upper and lower teal green color

Package unit

90 capsules (10 capsules/PTPX9), 300 capsules/bottle, 30 capsules/bottle