Medication info
Orlistat 120 mg Capsules

Orlistat 120 mg Capsules

Prescription medicationHard capsuleOral
Ingredient · strength
Orlistat›120mg / 1 capsule
Manufacturer / importer
Huvis Pharmaceutical Co., Ltd.
Appearance
Ahard capsule with a white or off-white powder or granules, with a greenish-blue upper and lower part.
Packaging
Bottled packaging - 300 capsules/bottle, Bottled packaging - 30 capsules/bottle
Approval status
Active

MFDS item code 202000480 · Approved 2020.01.30

Summary

Main use
Treatment of obesity (weight loss and maintenance); reduction of the risk of weight regain
Who takes it
Adults · Children
Adult dose
○ Adults The recommended dose of this medicine is 120 mg of orlistat per dose, taken orally 3 times daily 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 the 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 efficacy of this medicine. Measurements of fecal fat indicate that the effect of this medicine appears 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.

Ingredients

Manufacturer
Huvis Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Obesity
  • Hypertension
  • Diabetes
  • Dyslipidemia
View approved original text

This medication is used for obese patients with a body mass index (BMI) of 30 or higher, or a BMI of 27 or higher with other risk factors such as hypertension, diabetes, or dyslipidemia. It is intended to be used alongside a low-calorie diet to assist with weight loss and effectively support weight maintenance. It significantly contributes to obesity treatment by reducing the risk of weight regain.

How to take

Adult dose

○ Adults The recommended dose of this medicine is 120 mg of orlistat per dose, taken orally 3 times daily 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 the 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 efficacy of this medicine. Measurements of fecal fat indicate that the effect of this medicine appears 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.

Precautions

This medication should not be used in patients with chronic malabsorption syndrome or cholestasis. It is also contraindicated for individuals who are allergic to this medication or any of its ingredients, pregnant women or those who may become pregnant, and breastfeeding women. Liver damage has been reported rarely, so if there are signs of liver dysfunction, the doctor should be contacted immediately and the medication should be discontinued. It is important to check liver enzyme levels through liver function tests. Patients with hyperoxaluria or a history of calcium oxalate nephrolithiasis should exercise caution while taking this medication, as urinary oxalate excretion may increase. The most common side effects when taking this medication are gastrointestinal symptoms, including abdominal distension, flatulence, constipation, fatty stools, oily stools, increased bowel movements, and fecal incontinence. Most adverse reactions are mild and transient, typically occurring within three months. However, in some patients, they may persist for more than six months. Severe liver damage, such as hepatitis or hepatic failure, has been reported, so if symptoms of liver dysfunction develop, it is crucial to stop the medication immediately and consult a healthcare professional. This medication can reduce the absorption of fat-soluble vitamins and beta-carotene, so vitamin A, D, E, K, or beta-carotene supplements are recommended to be taken alongside it. Vitamin supplements should be taken at least two hours before or two hours after taking this medication. Patients should adhere strictly to dietary guidelines, especially ensuring that fat intake does not exceed 30% of total daily calories. A high fat intake may increase gastrointestinal side effects. This medication may interact with patients who have impaired liver function, hypothyroidism, or those taking specific drugs, so consultation with healthcare professionals is necessary. When taken together with oral anticoagulants, blood coagulation markers should be closely monitored, and co-administration with cyclosporine is not recommended. Pregnant or breastfeeding women should avoid taking this medication, and safety and efficacy have not been established in children under 12 years old. In the event of overdose, monitoring for 24 hours is necessary, and it is important to inform healthcare professionals immediately if any adverse reactions occur. This medication should be kept out of the reach of children, and stored away from light and moisture.

Side effects

  • Fatty stools
  • abdominal bloating and flatulence
  • increased frequency of stools
  • greasy stools
  • oily bowel movements
  • increased bowel movements
  • fecal incontinence
  • abdominal pain/discomfort
  • nausea
  • infectious diarrhea
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  • rectal pain/discomfort
  • dental abnormalities
  • gingival abnormalities
  • vomiting
  • influenza
  • upper respiratory tract infection
  • lower respiratory tract infection
  • ENT symptoms
  • abdominal pain
  • leg pain
  • arthritis
  • myalgia
  • joint abnormalities
  • tendinitis
  • headache
  • sleep disturbances
  • fatigue
  • rash
  • dry skin
  • menstrual irregularities
  • vaginitis
  • urinary tract infections
  • anxiety
  • depression
  • ear infection
  • foot swelling
  • elevated aminotransferases
  • elevated ALP
  • hepatitis
  • liver failure
  • itching
  • urticaria
  • angioedema
  • bronchospasm
  • anaphylaxis
  • bullous rash
  • decreased prothrombin levels
  • increased INR
  • hypothyroidism
  • pancreatitis
  • hypoglycemia
  • seizures
  • lower gastrointestinal bleeding
  • hyperoxaluria
  • oxalate nephropathy
  • skin sensory disturbances
  • 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 sealed container to prevent degradation. Additionally, it is important to store it in a cool place below 25 degrees Celsius to maintain the medication's effectiveness.

Appearance and packaging

Appearance

Ahard capsule with a white or off-white powder or granules, with a greenish-blue upper and lower part.

Package unit

Bottled packaging - 300 capsules/bottle, Bottled packaging - 30 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.