Medication info
LipiX Capsule 60 mg (Orlistat)

LipiX Capsule 60 mg (Orlistat)

Prescription medicationHard capsuleOral
Ingredient · strength
Orlistat›60mg / 1 capsule
Manufacturer / importer
Dongkook Pharmaceutical Co., Ltd.
Appearance
A yellow hard capsule containing white or off-white powder or granules
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 202003728 · Approved 2020.05.21

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 drug is 120mg of orlistat orally 3 times daily, with a fat-containing meal or within 1 hour after a meal. Patients should continue to eat 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 among three meals. This drug may be omitted if a meal is skipped or if a meal contains no fat. Because this drug 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 nutrient intake. The vitamin supplement should be taken at least 2 hours before this drug or at least 2 hours after it, such as at bedtime. Taking more than 120mg of this drug 3 times daily does not increase its effectiveness. Based on measurements of fecal fat, the effect of this drug becomes apparent approximately 24 ∼ 48 hours after taking the drug. After treatment is discontinued, fecal fat content generally returns to pretreatment levels within 48 ∼ 72 hours. The efficacy and safety of this drug for periods exceeding 4 years have not been evaluated. Studies have not been conducted in patients with hepatic and/or renal impairment or in older adults.
Child dose
Studies have not been conducted in children under 12 years of age.

Ingredients

Manufacturer
Dongkook Pharmaceutical Co., Ltd.

Efficacy & effects

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

View approved original text

This medication is used for obese patients with a body mass index (BMI) of 30 or greater, or a BMI of 27 or greater with risk factors such as hypertension, diabetes, or dyslipidemia. It helps to reduce or maintain weight in conjunction with a low-calorie diet and is effective in reducing the risk of weight regain. Thus, this drug plays a significant role in the treatment of obesity and weight management.

How to take

Adult dose

The recommended dose of this drug is 120mg of orlistat orally 3 times daily, with a fat-containing meal or within 1 hour after a meal. Patients should continue to eat 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 among three meals. This drug may be omitted if a meal is skipped or if a meal contains no fat. Because this drug 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 nutrient intake. The vitamin supplement should be taken at least 2 hours before this drug or at least 2 hours after it, such as at bedtime. Taking more than 120mg of this drug 3 times daily does not increase its effectiveness. Based on measurements of fecal fat, the effect of this drug becomes apparent approximately 24 ∼ 48 hours after taking the drug. After treatment is discontinued, fecal fat content generally returns to pretreatment levels within 48 ∼ 72 hours. The efficacy and safety of this drug for periods exceeding 4 years have not been evaluated. Studies have not been conducted in patients with hepatic and/or renal impairment or in 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 biliary obstruction. Patients with an allergy to this drug or its components should also avoid taking it. This drug is not to be administered to pregnant women or those who may become pregnant, as well as nursing mothers. Liver damage has been reported rarely, so anyone with signs of liver dysfunction should consult a doctor immediately and discontinue use of this drug. It is important to monitor liver enzyme levels through liver function tests. Patients with hyperoxaluria or calcium oxalate kidney stones should exercise caution when taking this drug. This drug blocks the absorption of fat, which may lead to various gastrointestinal symptoms. Abdominal distension, flatulence, constipation, fatty stools, and fecal incontinence are frequently reported symptoms, which typically arise within the first three months of treatment and may diminish over time. If gastrointestinal adverse reactions are severe or persistent, treatment may need to be discontinued. During treatment with this drug, the absorption of fat-soluble vitamins (vitamins A, D, E, K) and beta-carotene may be reduced, so taking vitamin supplements is recommended, and vitamins should be administered at least 2 hours before or after taking this drug. Taking this drug with high-fat meals may increase gastrointestinal adverse reactions, so it is advisable to spread fat intake evenly across three meals. Signs of liver dysfunction include loss of appetite, itching, jaundice, dark urine, pale stools, and pain in the right upper quadrant; such symptoms should be reported to a doctor immediately. Due to the weight loss effect, blood glucose control may change for diabetic patients, which may necessitate adjustments to the dosage of hypoglycemic agents. Excessive weight loss can increase the risk of cholelithiasis, so caution is warranted. This drug may interact with certain medications, so patients taking cyclosporine, anticoagulants, antiepileptics, antiretrovirals, etc., should definitely consult their physician. Use in pregnancy is not recommended, and nursing mothers should avoid taking this drug. The safety and efficacy of this drug have not been established in children under 12 years old. No specific serious adverse reactions have been reported for overdose, but monitoring for 24 hours may be required in cases of overdose. This drug should be stored out of the reach of children and protected from light and moisture.

Side effects

  • Lipid stool
  • abdominal bloating and flatulence
  • frequency of bowel movements
  • fatty/stool with fat
  • fecal incontinence
  • 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
  • ENT symptoms
  • abdominal pain
  • leg pain
  • arthritis
  • myalgia
  • joint abnormalities
  • tendinitis
  • headache
  • sleep disorders
  • fatigue
  • rash
  • dry skin
  • menstrual irregularities
  • vaginitis
  • urinary tract infections
  • anxiety
  • depression
  • otitis
  • edema of the foot
  • elevated amino transfer enzymes
  • elevated ALP
  • hepatitis
  • liver failure
  • itching
  • rash
  • urticaria
  • angioedema
  • bronchial constriction
  • anaphylaxis
  • vesicular rash
  • decreased prothrombin levels
  • increased 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 drug 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 below 25 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

A yellow hard capsule containing white or off-white 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.

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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.