Medication info
Orlistat Capsule 120 mg

Orlistat Capsule 120 mg

Prescription medicationHard capsuleOral
Ingredient · strength
Orlistat›120mg / 1 capsule
Manufacturer / importer
Chong Kun Dang Pharm.
Appearance
A turquoise hard capsule containing white or whitish pellets.
Packaging
Packaging type: PTP packaging, Packaging unit: 84 capsules (21 capsules/PTP packaging x 4)
Approval status
Active

MFDS item code 200008801 · Approved 2000.11.20

Summary

Main use
Treatment of obesity (weight loss and maintenance); reduction of the risk of weight regain
Who takes it
Adults · Children
Adult dose
The recommended dose of this medicine is orlistat 120 mg orally 3 times daily, with a meal 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 derived from fat. Daily intake of fat, carbohydrates, and protein should be distributed evenly among 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 this medicine or at least 2 hours after it, such as at bedtime. Taking more than 120 mg of this medicine 3 times daily does not increase its efficacy. Based on measurements of fecal fat, the effect of this medicine becomes apparent about 24 ∼ 48 hours after taking the medicine. 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.

Ingredients

Importer
Chong Kun Dang Pharm.

Efficacy & effects

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

View approved original text

This medication is developed for obese patients with a body mass index (BMI) of 30 kg/m² or higher, or those with a BMI of 27 kg/m² or higher with other risk factors such as hypertension, diabetes, and dyslipidemia. It assists in weight loss or maintenance when used in conjunction with a low-calorie diet and is used not only for obesity treatment but also to reduce the risk of weight regain.

How to take

Adult dose

The recommended dose of this medicine is orlistat 120 mg orally 3 times daily, with a meal 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 derived from fat. Daily intake of fat, carbohydrates, and protein should be distributed evenly among 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 this medicine or at least 2 hours after it, such as at bedtime. Taking more than 120 mg of this medicine 3 times daily does not increase its efficacy. Based on measurements of fecal fat, the effect of this medicine becomes apparent about 24 ∼ 48 hours after taking the medicine. 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.

Precautions

This medication should not be used in patients with chronic malabsorption syndrome or cholestasis. People allergic to this drug or its components should not take it. Pregnant or potentially pregnant women and breastfeeding women should avoid this medication. Since there may be liver damage, any symptoms of liver dysfunction should lead to immediate notification to a doctor and discontinuation of the medication. Regular liver function tests to check liver enzyme levels are required. Patients with hyperoxaluria or a history of calcium oxalate renal stones should be cautious, as kidney problems may arise when taking this medication. This medication primarily causes gastrointestinal side effects, which may include abdominal distension, flatulence, constipation, and fatty stools. Such symptoms usually occur within 3 months of starting treatment and are mostly temporary. If severe side effects or persistent symptoms occur, consultation with a doctor is necessary. During treatment, absorption of fat-soluble vitamins and beta-carotene may be reduced, so taking vitamin supplements is recommended. Vitamin supplements should be taken at least 2 hours after taking this medication or 2 hours before taking it. This medication can exacerbate gastrointestinal side effects when taken with high-fat meals, so it is important to control fat intake and maintain a balanced diet. Severe liver damage such as hepatitis or liver failure may occasionally occur, so special attention to liver health is necessary. This medication may affect blood coagulation status when taken with anticoagulants; therefore, regular blood tests should be performed. Women using oral contraceptives are advised to use additional contraceptive methods in the event of diarrhea while taking this medication, as the contraceptive effect may be reduced. Caution is advisable when taken with anticonvulsants due to an increased risk of seizures. This medication may reduce the effectiveness of HIV treatments; therefore, patients with HIV should have their viral load checked frequently. It is safe to avoid using this medication during pregnancy or breastfeeding. The safety and efficacy of this medication have not been established for children under 12 years of age. There is no specific treatment for overdose, but monitoring of the patient's condition for 24 hours is necessary. This medication should be kept out of reach of children and stored away from light and moisture.

Side effects

  • Fatty stools
  • abdominal bloating and flatulence
  • increased frequency of bowel movements
  • fat/greasy stool
  • greasy bowel movement
  • increased bowel movements
  • fecal incontinence
  • abdominal pain/discomfort
  • nausea
  • infectious diarrhea
Show 60 more
  • rectal pain/discomfort
  • dental abnormalities
  • gingival abnormalities
  • vomiting
  • influenza
  • upper respiratory tract infections
  • lower respiratory tract infections
  • ENT symptoms
  • abdominal pain
  • leg pain
  • arthritis
  • myalgia
  • joint abnormalities
  • tendonitis
  • headache
  • sleep disorders
  • fatigue
  • rash
  • dry skin
  • menstrual irregularities
  • vulvovaginitis
  • urinary tract infections
  • mental anxiety
  • depression
  • otitis media
  • leg edema
  • elevated aminotransferases
  • elevated ALP
  • hepatitis
  • itching
  • urticaria
  • angioedema
  • bronchospasm
  • anaphylaxis
  • vesicular rash
  • decreased prothrombin levels
  • elevated INR
  • hypothyroidism
  • pancreatitis
  • hypoglycemia
  • seizures
  • lower gastrointestinal bleeding
  • hyperoxaluria
  • oxalate nephropathy
  • renal failure
  • diverticulitis
  • cholelithiasis
  • dysesthesia
  • constipation
  • dyspepsia
  • heartburn
  • hepatocyte necrosis
  • acute liver failure
  • loss of appetite
  • jaundice
  • dark urine
  • pale stool
  • right upper abdominal pain
  • rectal bleeding
  • severe diarrhea

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 keep it in a cool place at or below 25 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

A turquoise hard capsule containing white or whitish pellets.

Package unit

Packaging type: PTP packaging, Packaging unit: 84 capsules (21 capsules/PTP packaging x 4)

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.