Medication info
Zerofat Tablet 60mg (Orlistat)

Zerofat Tablet 60mg (Orlistat)

Prescription medicationTabletOral
Ingredient · strength
Orlistat›60mg / 1 tablet
Manufacturer / importer
Mothers Pharmaceutical Co., Ltd.
Appearance
Yellow oblong film-coated tablet
Packaging
84 tablets/box [7 tablets/PTP x 12], 84 tablets/box [7 tablets/PTP (Alu-Alu) x 12]
Approval status
Active

MFDS item code 202204683 · Approved 2022.12.28

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 medicine is 120mg of orlistat per dose, taken orally 3 times daily with a meal containing fat or within 1 hour after a meal. Patients should continue to follow 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 if the meal 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 120mg per dose 3 times daily does not increase the effectiveness of this medicine. Based on measurements of fat in the stool, the effect of this medicine appears approximately 24 ∼ 48 hours after taking it. After discontinuation, stool 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 of the risk of weight regain

View approved original text

This medicine is used for the treatment of 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 aids in weight loss or weight maintenance when used in conjunction with a low-calorie diet and reduces the risk of weight regain. Therefore, this medicine is effective in overall health improvement related to obesity management.

How to take

Adult dose

The recommended dose of this medicine is 120mg of orlistat per dose, taken orally 3 times daily with a meal containing fat or within 1 hour after a meal. Patients should continue to follow 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 if the meal 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 120mg per dose 3 times daily does not increase the effectiveness of this medicine. Based on measurements of fat in the stool, the effect of this medicine appears approximately 24 ∼ 48 hours after taking it. After discontinuation, stool 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 medicine should not be used in patients with chronic malabsorption syndrome or biliary obstruction. Patients with allergies to this medicine or its ingredients, pregnant women or women who may become pregnant, and nursing mothers should not take this medicine. This medicine contains lactose; therefore, patients with genetic conditions such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicine. If liver damage or symptoms indicating abnormal liver function occur, discontinue use and inform the doctor, and a liver function test should be performed. Patients with hyperoxaluria or a history of calcium oxalate kidney stones should use this medicine with caution. This medicine contains the dye Yellow No. 4 (Tartrazine), so individuals allergic or hypersensitive to this component should take caution. Taking this medicine may frequently result in gastrointestinal symptoms such as oily stools, abdominal bloating, flatulence, constipation, and fecal incontinence. These symptoms are usually mild and decrease over time, but may persist longer in some patients. There may be cases where treatment is discontinued due to adverse reactions during medication, with gastrointestinal adverse reactions being the most common cause. When taking this medicine, dietary guidelines should be strictly followed; combined use with high-fat meals can increase gastrointestinal side effects, so fat intake should be properly managed. This medicine may reduce the absorption of fat-soluble vitamins and beta-carotene, so it is advisable to take vitamin supplements. These supplements should be taken 2 hours before this medicine or after taking this medicine at least 2 hours later. Abnormal liver function may occur, so if symptoms such as decreased appetite, itching, jaundice, changes in urine color, changes in stool color, or pain in the upper right abdomen occur, inform the doctor immediately. Diabetic patients may find that blood sugar control improves with this medicine, necessitating adjustments to the dosage of antidiabetic medications. Interactions with other medications may occur, so particularly if taking cyclosporine, anticoagulants, anticonvulsants, or antiretrovirals, consult a healthcare professional. Pregnant or nursing women should not take this medicine, and its safety and efficacy in children under 12 have not been established, so it should not be used in this population. In cases of overdose, significant toxicity symptoms are rare, but monitoring may be necessary for 24 hours. Store this medicine out of reach of children and preferably in its original packaging to protect it from light and moisture.

Side effects

  • Lipid stools
  • abdominal bloating and gas
  • increased frequency of bowel movements
  • fatty/lipid stools
  • oily bowel movements
  • increased bowel frequency
  • 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 disturbances
  • fatigue
  • rash
  • dry skin
  • menstrual irregularities
  • vaginitis
  • urinary tract infections
  • mental anxiety
  • depression
  • otitis media
  • foot swelling
  • elevated aminotransferases
  • elevated ALP
  • hepatitis
  • liver failure
  • itching
  • urticaria
  • angioedema
  • bronchospasm
  • anaphylaxis
  • vesicular rash
  • decreased prothrombin levels
  • increased INR
  • hypothyroidism
  • pancreatitis
  • hypoglycemia
  • seizures
  • lower gastrointestinal bleeding
  • hyperoxaluria
  • oxalate nephropathy
  • sensory abnormalities of the skin
  • constipation
  • dyspepsia
  • heartburn

Not everyone experiences these, and they can vary from person to person.

Storage

This medicine is sensitive to air, light, and moisture, so it should be stored in a tightly sealed container. It is also advisable to store it in a cool place at or below 25 degrees Celsius.

Appearance and packaging

Appearance

Yellow oblong film-coated tablet

Package unit

84 tablets/box [7 tablets/PTP x 12], 84 tablets/box [7 tablets/PTP (Alu-Alu) x 12]

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.