Medication info
Zerobik Capsule 120 mg (Orlistat)

Zerobik Capsule 120 mg (Orlistat)

Prescription medicationHard capsuleOral
Ingredient · strength
Orlistat›120mg / 1 capsule
Manufacturer / importer
Daehan New Pharm Co., Ltd.
Appearance
Hard capsules with a white or whitish powder or granules and greenish-blue upper and lower surfaces.
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 201908237 · Approved 2019.12.04

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 is 120 mg of orlistat orally 3 times daily, taken with a meal containing fat 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 the three meals. This medicine may be omitted if a meal is skipped 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 elderly patients.
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
  • risk of weight regain.
View approved original text

This medication is suitable for obese patients with a body mass index (BMI) of 30 kg/m² or higher, or with risk factors such as hypertension, diabetes, or dyslipidemia with a BMI of 27 kg/m² or higher. It is effective in aiding weight loss and maintenance when used alongside a low-calorie diet, and reducing the risk of weight regain. This supports healthy weight management through obesity treatment.

How to take

Adult dose

The recommended dose is 120 mg of orlistat orally 3 times daily, taken with a meal containing fat 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 the three meals. This medicine may be omitted if a meal is skipped 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 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 complete biliary obstruction. Individuals with allergies to this medication or its ingredients should also avoid taking it. Pregnant or breastfeeding women should not take this medication. Liver damage has been rarely reported, so if any symptoms of liver dysfunction appear, it is important to immediately inform a doctor and discontinue use. Liver enzyme levels should be monitored through liver function tests. Additionally, patients with hyperoxaluria or calcium oxalate kidney stones should use it with caution. When taking this medication, gastrointestinal-related side effects may often appear, with symptoms including oily stools, abdominal distension, and constipation. These side effects are usually mild and transient, mostly appearing within 3 months and improving within 1-4 weeks. However, in some patients, they may persist for more than 6 months. There may be instances where medication is discontinued due to adverse reactions during treatment, particularly gastrointestinal symptoms, which are the most common reasons. Rarely, severe side effects such as hepatitis, allergic reactions, pancreatitis, and seizures have also been reported. This medication may reduce the absorption of fat-soluble vitamins (vitamins A, D, E, K) and beta-carotene, hence taking vitamin supplements is recommended. Vitamin supplements should be taken at least 2 hours before or after taking this medication for efficacy. The risk of gastrointestinal side effects may increase when taken with high-fat meals; thus, it is advisable to distribute fat intake evenly across three meals a day. Furthermore, excessive weight loss can increase the risk of gallstones, so caution is warranted. If symptoms of liver dysfunction (loss of appetite, itching, jaundice, dark urine, pale stools, upper abdominal pain) occur, immediate consultation with a doctor is necessary. This medication may interact with certain drugs, so inform your doctor or pharmacist if you are taking other medications. Extra caution is needed when taken alongside anticoagulants, cyclosporine, anticonvulsants, and antiretroviral medications. This medication is not recommended during pregnancy or breastfeeding. Its safety and efficacy have not been established in children under 12 years of age, therefore it should not be used. In cases of overdose, no specific adverse reactions have been reported, but monitoring for 24 hours is required.

Side effects

  • Fatty stools
  • abdominal bloating and flatulence
  • frequency of stool
  • fatty/stools with fat
  • oily stools
  • increased bowel movements
  • bowel 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
  • muscle pain
  • joint abnormalities
  • tendinitis
  • headache
  • sleep disorders
  • fatigue
  • rash
  • dry skin
  • menstrual irregularities
  • vaginitis
  • urinary tract infections
  • anxiety
  • depression
  • otitis
  • edema of the feet
  • elevated aminotransferases
  • elevated ALP
  • hepatitis
  • liver failure
  • itching
  • rash
  • hives
  • angioedema
  • bronchospasm
  • anaphylaxis
  • vesicular rash
  • decreased prothrombin levels
  • elevated INR
  • hypothyroidism
  • pancreatitis
  • hypoglycemia
  • seizures
  • lower gastrointestinal bleeding
  • hyperoxaluria
  • oxalate nephropathy
  • sensory disturbances in 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 sealed container to protect it from air, light, and moisture, with a recommended temperature below 25 degrees Celsius. Proper storage will maintain the effectiveness of the medication over time and prevent degradation.

Appearance and packaging

Appearance

Hard capsules with a white or whitish powder or granules and greenish-blue upper and lower surfaces.

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.