Medication info
AlliCapsule 60 mg (Orlistat)

AlliCapsule 60 mg (Orlistat)

Prescription medicationHard capsuleOral
Ingredient · strength
Orlistat›60mg / 1 capsule
Manufacturer / importer
CMG Pharmaceutical Co., Ltd.
Appearance
Hard capsules with white to whitish powder or granules, with yellow upper and lower halves.
Packaging
300 capsules/bottle, 30 capsules/bottle
Approval status
Active

MFDS item code 202000825 · Approved 2020.02.11

Summary

Main use
Treatment of obesity (weight loss and maintenance), suppression of the risk of weight regain
Who takes it
Adults · Children
Adult dose
Adults: The recommended dose is orlistat 120 mg 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 about 30 % of calories are derived from fat. Daily intake of fat, carbohydrates, and protein should be distributed evenly among the three meals. This drug may be omitted if a meal is skipped or contains no fat. Since 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 nutrition. 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 120 mg of this drug per dose, 3 times daily, does not increase its effectiveness. Measurements of fecal fat indicate that the effect of this drug 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 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 elderly patients.
Child dose
Children younger than 12 years: No studies have been conducted.

Ingredients

Manufacturer
CMG Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of obesity (weight loss and maintenance), suppression of the risk of weight regain

  • Obesity
  • hypertension
  • diabetes
  • dyslipidemia
View approved original text

This medication is used in obese patients with a body mass index (BMI) of 30 kg/m² or greater, or in patients with a BMI of 27 kg/m² or greater who have other risk factors such as hypertension, diabetes, or dyslipidemia. It helps with weight loss or maintenance in conjunction with a low-calorie diet and reduces the risk of weight regain, thus preventing complications associated with obesity and supporting healthy weight management.

How to take

Adult dose

Adults: The recommended dose is orlistat 120 mg 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 about 30 % of calories are derived from fat. Daily intake of fat, carbohydrates, and protein should be distributed evenly among the three meals. This drug may be omitted if a meal is skipped or contains no fat. Since 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 nutrition. 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 120 mg of this drug per dose, 3 times daily, does not increase its effectiveness. Measurements of fecal fat indicate that the effect of this drug 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 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 elderly patients.

Child dose

Children younger than 12 years: No studies have been conducted.

Precautions

This medication should not be used in certain patients. Patients with chronic malabsorption syndrome, biliary obstruction, those allergic to this medication or its ingredients, and pregnant, potentially pregnant, or breastfeeding women should not take it. Patients with liver damage should exercise caution when taking this medication. There have been rare reports of abnormal liver function, so if any symptoms of liver dysfunction occur, the patient should immediately inform a doctor and discontinue use of this medication. In addition, patients with hyperoxaluria or existing kidney stones should use this medication cautiously as it may increase the risk of kidney stones. Gastrointestinal adverse reactions can occur frequently while taking this medication, including oily stools, abdominal distension, flatulence, constipation, increased bowel movements, or fecal incontinence, most of which are mild and temporary. These symptoms usually appear within 3 months of starting treatment and tend to diminish over time. However, some patients may experience these symptoms for more than 6 months. While taking this medication, the absorption of fat-soluble vitamins such as vitamins A, D, E, K, and beta-carotene may be reduced; therefore, it is advisable to take a multivitamin supplement. Vitamin supplements should be taken at least 2 hours after taking this medication or at least 2 hours before it. Due to weight loss, blood sugar control may improve in diabetic patients, which may require adjustments in antihyperglycemic agents or insulin dosage. Rapid weight loss can also increase the risk of gallstones, so caution is advised. This medication may interact with various other drugs. Specifically, when taken with cyclosporine, it may reduce the blood concentration of cyclosporine, diminishing its effectiveness; therefore, when using both medications, administration timing should be adjusted and blood levels monitored frequently. Regular monitoring of coagulation status is also necessary when used in combination with anticoagulants such as warfarin. Pregnant or breastfeeding women should not use this medication, and its safety and effectiveness in children under 12 years old have not been established. Serious adverse reactions are infrequent in cases of overdose, but patients should be monitored for at least 24 hours if overdose occurs. This medication should be stored in a sealed container protected from light and moisture, and it is advisable not to transfer it to another container.

Side effects

  • Fatty stools
  • abdominal bloating and flatulence
  • frequency of stools
  • fatty/stearrich stools
  • steatorrhea
  • 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 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
  • hearing loss
  • foot edema
  • elevated aminotransferases
  • elevated ALP
  • hepatitis
  • liver failure
  • itching
  • rash
  • urticaria
  • angioedema
  • bronchospasm
  • anaphylaxis
  • vesicular rash
  • decreased prothrombin levels
  • elevated 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 medication should be stored in a sealed container to protect it from air, light, and moisture, and it is important to keep the temperature below 25 degrees Celsius. Proper storage will help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Hard capsules with white to whitish powder or granules, with yellow upper and lower halves.

Package unit

300 capsules/bottle, 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.

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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.