Medication info
Orlistat Capsule 120 mg (Orlistat)

Orlistat Capsule 120 mg (Orlistat)

Prescription medicationHard capsuleOral
Ingredient · strength
Orlistat›120mg / 1 capsule
Manufacturer / importer
Eden Pharma Co., Ltd.
Appearance
A hard capsule with upper and lower teal colors containing white or whitish powder or granules
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 202001614 · Approved 2020.03.09

Summary

Main use
Treatment of obesity (weight loss and maintenance); reduction and prevention of the risk of weight regain
Who takes it
Adults · Children
Adult dose
The recommended dose of this medicine 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 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 per dose, 3 times daily, does not increase the effectiveness of this medicine. Based on measurements of fecal fat, the effect of this medicine appears 24 ∼ 48 hours after taking the medicine. After treatment is discontinued, fecal fat content usually 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 or older adults.
Child dose
Studies have not been conducted in children under 12 years of age.

Ingredients

Manufacturer
Eden Pharma Co., Ltd.

Efficacy & effects

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

  • Obesity
  • risk of weight regain
View approved original text

This medication helps patients with a body mass index (BMI) of 30 kg/m² or greater, or patients with a BMI of 27 kg/m² or greater who also have risk factors such as hypertension, diabetes, or dyslipidemia, to lose weight and maintain weight. It is used in conjunction with a low-calorie diet to enhance the effects of obesity treatment and reduce the risk of weight regain. Thus, it is effective in improving weight control and health management.

How to take

Adult dose

The recommended dose of this medicine 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 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 per dose, 3 times daily, does not increase the effectiveness of this medicine. Based on measurements of fecal fat, the effect of this medicine appears 24 ∼ 48 hours after taking the medicine. After treatment is discontinued, fecal fat content usually 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 or older adults.

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. Additionally, it should not be taken by patients who are allergic to this medicine or its components, pregnant or potentially pregnant women, and nursing mothers. Liver damage has been reported rarely, so any signs of liver dysfunction should be reported to a physician immediately, and this medication should be discontinued. It is important to monitor liver enzyme levels through liver function tests. Patients with hyperoxaluria or calcium oxalate nephrolithiasis should use this medication with caution. Use of this medication may affect the gastrointestinal tract, with symptoms such as abdominal distension, flatus, constipation, and oily stools frequently occurring. These symptoms are usually mild and transient and often occur within 3 months of starting treatment. However, in some patients, symptoms may persist for more than 6 months. This medication may reduce the absorption of fat-soluble vitamins and beta-carotene, so it is recommended to take vitamin supplements. Vitamin supplements should be taken at least 2 hours before or after taking this medication. If symptoms of liver dysfunction (loss of appetite, itching, jaundice, dark urine, pale stools, upper abdominal pain) occur while taking this medication, medical personnel must be notified immediately, and this medication should be stopped. Taking this medication with a high-fat meal may increase gastrointestinal side effects, so it is advisable to distribute daily fat intake evenly across three meals. If taken with oral anticoagulants, blood coagulation parameters should be checked regularly, and it is advisable not to take it with cyclosporine. This medication is not recommended for children under 12 years of age, and there is insufficient clinical data regarding the elderly. In cases of overdose, observation for 24 hours is needed, and generally, the action of this medication recovers quickly. Finally, this medication should be stored out of the reach of children and protected from light and moisture.

Side effects

  • Fatty stools
  • abdominal bloating and flatulence
  • increased frequency of stools
  • fatty/greasy stools
  • fecal urgency
  • fecal incontinence
  • abdominal pain/discomfort
  • nausea
  • infectious diarrhea
  • rectal pain/discomfort
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  • dental abnormalities
  • gum abnormalities
  • vomiting
  • influenza
  • upper respiratory tract infection
  • lower respiratory tract infection
  • ENT symptoms
  • abdominal pain
  • leg pain
  • arthritis
  • myalgia
  • joint abnormalities
  • tendinitis
  • headache
  • sleep disorders
  • fatigue
  • rash
  • dry skin
  • menstrual irregularities
  • vaginitis
  • urinary tract infection
  • mental anxiety
  • depression
  • otitis
  • pedal edema
  • elevated aminotransferases
  • elevated ALP
  • hepatitis
  • itching
  • rash
  • urticaria
  • angioedema
  • bronchospasm
  • anaphylaxis
  • vesicular rash
  • decreased prothrombin level
  • elevated INR
  • hypothyroidism
  • pancreatitis
  • hypoglycemia
  • seizures
  • lower gastrointestinal bleeding
  • hyperoxaluria
  • oxalate nephropathy
  • sensory disturbances
  • constipation
  • dyspepsia
  • heartburn
  • hepatocellular necrosis
  • acute liver failure

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 recommended to store it in a cool place at temperatures below 25 degrees Celsius.

Appearance and packaging

Appearance

A hard capsule with upper and lower teal colors containing white or whitish powder or granules

Package unit

30 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.