Medication info
Zerobi Tablet 120 mg (Orlistat)

Zerobi Tablet 120 mg (Orlistat)

Prescription medicationTabletOral
Ingredient · strength
Orlistat›120mg / 1 tablet
Manufacturer / importer
Daehan New Pharm Co., Ltd.
Appearance
Teal colored rectangular film-coated tablet
Packaging
90 tablets per box [(10 tablets/PTPX9)], 90 tablets per box [(10 tablets/PTP(Alu-Alu)X9)], 84 tablets per box [(7 tablets/PTPX12)], 84 tablets per box [(7 tablets/PTP(Alu-Alu)X12)]
Approval status
Active

MFDS item code 202204145 · Approved 2022.11.18

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 120 mg of orlistat 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 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 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 daily does not increase its effectiveness. Based on measurements of fecal fat, 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 older adults.
Child dose
Studies have not been conducted in children under 12 years of age.

Ingredients

Manufacturer
Daehan New Pharm Co., Ltd.

Efficacy & effects

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

  • Obesity
View approved original text

This medicine is used in patients with a body mass index (BMI) of 30 or more, or in obese patients with a BMI of 27 or more with risk factors such as hypertension, diabetes, or dyslipidemia. It assists in weight loss or maintenance when used in conjunction with a low-calorie diet, and is effective in reducing the risk of weight regain. Therefore, it plays an important role in the treatment of obesity and helps in maintaining a healthy weight.

How to take

Adult dose

The recommended dose of this medicine is 120 mg of orlistat 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 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 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 daily does not increase its effectiveness. Based on measurements of fecal fat, 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 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 patients with biliary obstruction. Additionally, it should not be administered to patients with allergies to this medication or its components, to pregnant women or women who may become pregnant, and to nursing mothers. This medication contains lactose, so individuals with genetic diseases such as galactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption should also avoid using it. Patients with liver damage or symptoms indicating liver dysfunction should have liver function tests while taking this medication, and should consult their doctor immediately if any abnormal symptoms appear. Patients with hyperoxaluria or a history of calcium oxalate kidney stones may have an increased risk of kidney stones while taking this medication, so caution is advised. This medication primarily has gastrointestinal side effects, which may include abdominal pain, abdominal distention, constipation, fatty stools, increased bowel movements, or fecal incontinence. Most of the side effects are mild and transient, typically occurring within three months of starting treatment and tend to decrease over time. Patients may also discontinue treatment due to side effects during the use of this medication, so any severe symptoms should be reported to a healthcare provider. The absorption of fat-soluble vitamins (vitamins A, D, E, K) and beta-carotene may be reduced, so taking vitamin supplements is recommended. Vitamin supplements should be taken at least 2 hours before or 2 hours after using this medication for optimal effect. Taking this medication with high-fat meals can exacerbate gastrointestinal side effects, so it is important to control fat intake and distribute it evenly across three meals. If any symptoms of liver dysfunction (such as reduced appetite, skin itching, jaundice, changes in urine color, abdominal pain, etc.) appear, the medication should be discontinued immediately, and a doctor should be consulted. This medication may affect blood glucose control in diabetic patients, so adjustments to blood sugar medication doses may be necessary. Excessive weight loss can increase the risk of gallstones, so the rate of weight loss should be controlled. This medication may have interactions with certain drugs, particularly in patients taking cyclosporine, anticoagulants, antiepileptic drugs, or antiretroviral agents, caution is required. Pregnant or nursing women should avoid using this medication, and the safety and efficacy in children under 12 years old have not been confirmed. There is not enough clinical trial data for the elderly, so caution should be exercised in their use. In case of overdose, monitoring for 24 hours is necessary, and systemic effects tend to recover quickly. This medication should be stored out of reach of children and protected from light and moisture.

Side effects

  • Fatty stools
  • abdominal distension and flatulence
  • increased frequency of bowel movements
  • fatty stools / fatty defecation
  • increased bowel movements
  • fecal incontinence
  • abdominal pain / discomfort
  • nausea
  • infectious diarrhea
  • rectal pain / discomfort
Show 48 more
  • dental abnormalities
  • gingival abnormalities
  • vomiting
  • influenza
  • upper respiratory infections
  • lower respiratory 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
  • edema of the feet
  • elevation of aminotransferases
  • elevation of ALP
  • hepatitis
  • liver failure
  • itching
  • urticaria
  • angioedema
  • bronchial spasms
  • 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 medication should be stored in a tightly closed container to protect it from air, light, and moisture. Additionally, it is important to keep it in a cool place below 25 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Teal colored rectangular film-coated tablet

Package unit

90 tablets per box [(10 tablets/PTPX9)], 90 tablets per box [(10 tablets/PTP(Alu-Alu)X9)], 84 tablets per box [(7 tablets/PTPX12)], 84 tablets per box [(7 tablets/PTP(Alu-Alu)X12)]

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.