Medication info
Midaun Capsule 120mg (Orlistat)

Midaun Capsule 120mg (Orlistat)

Prescription medicationHard capsuleOral
Ingredient · strength
Orlistat›120mg / 1 capsule
Manufacturer / importer
Genupharm Co., Ltd.
Appearance
For domestic use: Hard capsule with upper and lower teal color containing white or whitish powder or granule. For export: Hard capsule with upper and lower teal color containing white or whitish powder.
Packaging
For domestic use: 90 capsules (10 capsules/PTPX9), 300 capsules/bottle, 30 capsules/bottle For export: 84 capsules (21 capsules/PTP X4), 21 capsules/PTP
Approval status
Active

MFDS item code 200903801 · Notified 2009.05.29

Summary

Main use
Treatment of obesity (weight loss and weight maintenance); reduction of the risk of weight regain
Who takes it
Adults
Adult dose
The recommended dose of this medicine is 120 mg of orlistat orally three 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 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. As 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 120 mg of this medicine three times daily does not increase its effectiveness. Measurements of fecal fat indicate that the effect of this medicine 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 medicine 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.

Ingredients

Manufacturer
Genupharm Co., Ltd.

Efficacy & effects

Treatment of obesity (weight loss and weight maintenance); reduction of the risk of weight regain

View approved original text

This medication is indicated for patients with obesity who have a body mass index (BMI) of 30 kg/m² or above or patients with BMI of 27 kg/m² or above who have risk factors such as hypertension, diabetes, or dyslipidemia. It helps effectively reduce or maintain weight when used in conjunction with a low-calorie diet. Additionally, it plays an important role in obesity management by reducing the risk of weight regain. Therefore, this medication is used for overall health improvement related to obesity management.

How to take

Adult dose

The recommended dose of this medicine is 120 mg of orlistat orally three 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 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. As 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 120 mg of this medicine three times daily does not increase its effectiveness. Measurements of fecal fat indicate that the effect of this medicine 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 medicine 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.

Precautions

This medication should not be used in patients with chronic malabsorption syndrome or biliary obstruction. Also, patients with known allergies to this medication or its ingredients, pregnant or potentially pregnant women, and breastfeeding women should not take this medication. Liver damage has been reported rarely, and a doctor should be consulted immediately if there are signs of liver function abnormalities, and a liver function test should be performed. Patients with hyperoxaluria or calcium oxalate nephrolithiasis should use this medication with caution. Taking this medication may commonly cause gastrointestinal symptoms, such as fat in stools, abdominal distension, flatulence, constipation, or diarrhea. These symptoms are usually mild and transient, typically starting within 3 months and resolving within 1 to 4 weeks. However, some patients may experience persistence for more than 6 months. Serious side effects such as hepatitis, liver failure, allergic reactions, pancreatitis, and seizures have been reported, thus symptoms should be reported to a doctor immediately. Taking this medication with a high-fat meal may increase gastrointestinal side effects; therefore, it is important to distribute fat intake evenly over three meals. Additionally, this medication may reduce the absorption of fat-soluble vitamins and beta-carotene, so it is recommended to take vitamin supplements at least 2 hours apart. Women who are pregnant or nursing should not take this medication, and safety and efficacy have not been established for children under 12 years of age. This medication may interact with other medications, especially cyclosporine, oral anticoagulants, and antiepileptics, so it is essential to follow the doctor's instructions when taking them together. In case of overdose, 24-hour observation is required, and storage recommendations include keeping it out of reach of children, protected from light and moisture.

Side effects

  • fatty stools
  • abdominal bloating and flatulence
  • increased frequency of stools
  • fatty / fatty stools
  • increased bowel movements
  • fecal incontinence
  • abdominal pain / discomfort
  • nausea
  • infectious diarrhea
  • rectal pain / discomfort
Show 49 more
  • dental abnormalities
  • gum abnormalities
  • vomiting
  • influenza
  • upper respiratory tract infections
  • lower respiratory tract infections
  • ENT symptoms
  • abdominal pain
  • leg pain
  • arthritis
  • myalgia
  • joint abnormalities
  • tendinitis
  • headache
  • sleep disturbances
  • fatigue
  • rash
  • dry skin
  • irregular menstruation
  • vaginitis
  • urinary tract infections
  • anxiety
  • depression
  • otitis
  • foot edema
  • elevated aminotransferases
  • elevated ALP
  • hepatitis
  • liver failure
  • itching
  • rash
  • hives
  • angioedema
  • bronchospasm
  • anaphylaxis
  • vesicular rash
  • decreased prothrombin levels
  • increased INR
  • hypothyroidism
  • pancreatitis
  • hypoglycemia
  • convulsions
  • lower gastrointestinal bleeding
  • hyperoxaluria
  • oxalate nephropathy
  • sensory abnormalities of the skin
  • constipation
  • dyspepsia
  • heartburn

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

Storage

This medication is sensitive to air, light, and moisture, so it should be stored in a tightly closed container. Additionally, it should be kept in a cool place at or below 25 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

For domestic use: Hard capsule with upper and lower teal color containing white or whitish powder or granule. For export: Hard capsule with upper and lower teal color containing white or whitish powder.

Package unit

For domestic use: 90 capsules (10 capsules/PTPX9), 300 capsules/bottle, 30 capsules/bottle For export: 84 capsules (21 capsules/PTP X4), 21 capsules/PTP

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.

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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.