Medication info
ZeroFat Capsule (Orlistat)

ZeroFat Capsule (Orlistat)

Prescription medicationHard capsuleOral
Ingredient · strength
Orlistat›120mg / 1 capsule
Manufacturer / importer
Mothers Pharmaceutical Co., Ltd.
Appearance
A hard capsule with upper and lower teal green containing white or off-white powder or granules.
Packaging
90 capsules/box [(10 capsules/PTP) * 9], 30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 200903802 · Notified 2009.05.29

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 a day, taken with a fat-containing meal or within 1 hour after a meal. Patients should continue to follow a nutritionally balanced, mildly hypocaloric diet in which approximately 30 % of calories come 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 missed 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 a day does not increase its effectiveness. Based on measurements of fecal fat, the effect of this medicine appears 24 ∼ 48 hours after administration. After discontinuation, fecal fat content generally 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 in elderly patients.
Child dose
Studies have not been conducted in children under 12 years of age.

Ingredients

Manufacturer
Mothers Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is beneficial for patients with a body mass index (BMI) of 30 kg/m² or higher or overweight patients with risk factors such as hypertension, diabetes, or dyslipidemia with a BMI of 27 kg/m² or higher. It is effective in reducing or maintaining body weight when used in conjunction with a low-calorie diet. It also contributes to reducing the risk of weight regain. Therefore, it plays an important role in obesity treatment and weight management.

How to take

Adult dose

The recommended dose of this medicine is 120 mg of orlistat orally 3 times a day, taken with a fat-containing meal or within 1 hour after a meal. Patients should continue to follow a nutritionally balanced, mildly hypocaloric diet in which approximately 30 % of calories come 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 missed 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 a day does not increase its effectiveness. Based on measurements of fecal fat, the effect of this medicine appears 24 ∼ 48 hours after administration. After discontinuation, fecal fat content generally 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 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 patients with biliary obstruction. Furthermore, it should not be administered to patients with allergies to this drug or its ingredients, to women who are pregnant or may become pregnant, and to nursing mothers. If liver damage is suspected, the doctor should be informed immediately, and the medication should be discontinued, while liver function tests should be performed to check the liver condition. Patients with hyperoxaluria or calcium oxalate kidney stones should be cautious when taking this medication. Taking this medication may frequently cause gastrointestinal symptoms, such as abdominal distension, flatulence, constipation, and oily stools, which are generally mild and transient. Gastrointestinal adverse reactions mainly occur within 3 months after the start of treatment and mostly improve within 1 to 4 weeks. Treatment may be discontinued due to adverse reactions, so patients should consult a doctor if symptoms are severe. This medication can increase gastrointestinal adverse reactions when a high amount of fat is consumed during meals, so it is important to distribute fat intake evenly throughout the three meals a day. Absorption of fat-soluble vitamins and beta-carotene may be reduced, so taking vitamin supplements is recommended, spaced at least 2 hours before or after taking this medication. If signs of liver dysfunction appear, the medication should be discontinued immediately, and medical attention should be sought, as severe liver damage like hepatitis or liver failure has been reported rarely. For diabetic patients, this medication may improve blood glucose control, necessitating adjustments to the doses of hypoglycemic agents. Excessive weight loss may increase the risk of gallstones, so caution is necessary. This medication may interact with certain drugs, so patients on cyclosporine, anticoagulants, antiepileptics, or antiretrovirals should consult healthcare professionals. Pregnant or nursing women should not take this medication, and safety in children under 12 years has not been established. This medication should be kept out of the reach of children and stored away from light and moisture.

Side effects

  • Fatty stool
  • abdominal bloating and flatulence
  • frequency of stools
  • oily/fatty stools
  • oily bowel movements
  • 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
  • tendonitis
  • headache
  • sleep disturbances
  • fatigue
  • rash
  • dry skin
  • irregular menstruation
  • vaginitis
  • urinary tract infections
  • anxiety
  • depression
  • otitis
  • foot swelling
  • elevation of aminotransferases
  • elevation of ALP
  • hepatitis
  • liver failure
  • itching
  • urticaria
  • angioedema
  • bronchospasm
  • anaphylaxis
  • vesicular rash
  • decrease in prothrombin levels
  • increase in INR
  • hypothyroidism
  • pancreatitis
  • hypoglycemia
  • convulsions
  • lower gastrointestinal bleeding
  • hyperoxaluria
  • oxalate nephropathy
  • skin sensory disturbance
  • 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 sealed container. It is also important to keep it in a cool place below 25 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

A hard capsule with upper and lower teal green containing white or off-white powder or granules.

Package unit

90 capsules/box [(10 capsules/PTP) * 9], 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.