Medication info
Orlistat Capsule 60 mg (Orlistat)

Orlistat Capsule 60 mg (Orlistat)

Prescription medicationHard capsuleOral
Ingredient · strength
Orlistat›60mg / 1 capsule
Manufacturer / importer
Huons Co., Ltd.
Appearance
Hard capsules with a white or off-white powder or granules, and yellow-colored upper and lower parts.
Packaging
90 capsules/PTP [90 capsules (10 capsules/PTPX9)], 300 capsules/bottle [300 capsules/bottle]
Approval status
Active

MFDS item code 201900855 · Approved 2019.02.11

Summary

Main use
Treatment of obesity (weight reduction and weight maintenance); prevention to reduce the risk of weight regain
Who takes it
Adults · Children
Adult dose
○ Adults The recommended dose is 120mg of orlistat orally 3 times daily, taken with a fat-containing meal or within 1 hour after a meal. Patients should continue to follow a nutritionally balanced, mildly hypocaloric 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 medicine may be omitted if a meal is missed 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 this medicine or at least 2 hours after it, such as at bedtime. Taking more than 120mg per dose 3 times daily does not increase the efficacy of this medicine. Based on measurements of fecal fat, the effect of this medicine appears 24 ∼ 48 hours after dosing. After discontinuation, fecal fat content generally returns to pretreatment levels within 48 ∼ 72 hours. The efficacy and safety of this medicine have not been evaluated for periods exceeding 4 years. No studies have been conducted in patients with hepatic and/or renal impairment or in older adults.
Child dose
No studies have been conducted in children under 12 years of age.

Ingredients

Manufacturer
Huons Co., Ltd.

Efficacy & effects

Treatment of obesity (weight reduction and weight maintenance); prevention to reduce the risk of weight regain

View approved original text

This medication is used for obese patients with a body mass index (BMI) of 30 kg/m² or higher, or with a BMI of 27 kg/m² or higher who have risk factors such as hypertension, diabetes, or dyslipidemia. It is prescribed along with a low-calorie diet to assist in weight loss or maintenance. Additionally, it is effective in treating obesity by reducing the risk of weight regain. This drug is used to help maintain a healthy weight and improve obesity-related risk factors.

How to take

Adult dose

○ Adults The recommended dose is 120mg of orlistat orally 3 times daily, taken with a fat-containing meal or within 1 hour after a meal. Patients should continue to follow a nutritionally balanced, mildly hypocaloric 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 medicine may be omitted if a meal is missed 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 this medicine or at least 2 hours after it, such as at bedtime. Taking more than 120mg per dose 3 times daily does not increase the efficacy of this medicine. Based on measurements of fecal fat, the effect of this medicine appears 24 ∼ 48 hours after dosing. After discontinuation, fecal fat content generally returns to pretreatment levels within 48 ∼ 72 hours. The efficacy and safety of this medicine have not been evaluated for periods exceeding 4 years. No studies have been conducted in patients with hepatic and/or renal impairment or in older adults.

Child dose

No studies have been conducted in children under 12 years of age.

Precautions

This medication should not be used in patients with chronic malabsorption syndrome or cholestasis. Individuals who are allergic to this medication or its components should also avoid taking it. Pregnant women, women who may become pregnant, and breastfeeding women should not take this medication. Patients with liver function issues should use this medication with caution, and they must inform their doctor and stop taking the medication if symptoms of liver impairment occur. Furthermore, caution is required in patients with hyperoxaluria or calcium oxalate nephrolithiasis due to increased urinary oxalate excretion. Taking this medication may frequently result in gastrointestinal symptoms, such as abdominal pain, changes in bowel habits, fatty stools, oily discharge, increased bowel movements, fecal incontinence, oily stools, nausea, vomiting, upper respiratory infections, lower respiratory infections, influenza, headache, sleep disturbances, fatigue, rash, dry skin, menstrual irregularities, vaginitis, urinary tract infections, anxiety, depression, ear infections, swelling of the feet, abdominal pain, leg pain, arthritis, muscle pain, joint pain, and tendinitis. When taken with a high-fat meal, this medication may increase gastrointestinal side effects, so it is recommended to distribute fat intake evenly across three meals daily. Additionally, this medication can interfere with the absorption of fat-soluble vitamins, so it is advisable to take multivitamin supplements containing vitamins A, D, E, K, and beta-carotene. Vitamin supplements should be taken at least two hours before or after taking this medication. If symptoms of liver dysfunction (decreased appetite, itching, jaundice, changes in urine color, changes in stool color, right upper abdominal pain) occur, immediate medical attention is required, and liver function tests should be conducted. This medication may affect blood sugar control in diabetic patients, so monitoring blood glucose and adjusting medication dosage may be necessary. Excessive weight loss can increase the risk of gallstones, which should be taken into consideration. It may also affect blood coagulation; therefore, patients on oral anticoagulants must regularly monitor coagulation parameters. This medication may interact with some drugs, so patients taking immunosuppressants, antiepileptics, antiretrovirals, or anticoagulants should consult their physician before use and monitor drug concentrations or effects. It is safer not to use this medication during pregnancy or breastfeeding, and it is not recommended for children under 12 years old. In case of overdose, 24-hour observation is needed, and generally, the effects of the drug recover quickly. This medication should be stored out of reach of children and kept in its original packaging to protect it from light and moisture.

Side effects

  • fatty stools
  • abdominal bloating and gas
  • frequency of stools
  • fatty/frothy stools
  • fatty bowel movements
  • increased bowel movements
  • fecal incontinence
  • abdominal pain/discomfort
  • nausea
  • infectious diarrhea
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  • rectal pain/discomfort
  • dental abnormalities
  • gum abnormalities
  • vomiting
  • influenza
  • upper respiratory tract infections
  • lower respiratory tract infections
  • otolaryngological symptoms
  • abdominal pain
  • leg pain
  • arthritis
  • myalgia
  • joint abnormalities
  • tendonitis
  • headache
  • sleep disturbances
  • fatigue
  • rash
  • dry skin
  • menstrual irregularities
  • vaginitis
  • urinary tract infections
  • anxiety
  • depression
  • otitis
  • foot swelling
  • increased amino transferase levels
  • elevated ALP
  • hepatitis
  • liver failure
  • itching
  • rash
  • hives
  • angioedema
  • bronchial spasm
  • anaphylaxis
  • vesicular rash
  • decreased prothrombin levels
  • elevated INR
  • hypothyroidism
  • pancreatitis
  • hypoglycemia
  • seizures
  • lower gastrointestinal bleeding
  • hyperoxaluria
  • oxalate nephropathy
  • sensory disturbances of the skin
  • constipation
  • dyspepsia
  • heartburn

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from air, light, and moisture. It is important to store it at a cool temperature below 25 degrees Celsius to maintain the medication's effectiveness.

Appearance and packaging

Appearance

Hard capsules with a white or off-white powder or granules, and yellow-colored upper and lower parts.

Package unit

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

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.