Medication info
Zerobecapsule 60mg (Orlistat)

Zerobecapsule 60mg (Orlistat)

Prescription medicationHard capsuleOral
Ingredient · strength
Orlistat›60mg / 1 capsule
Manufacturer / importer
Daehan New Pharm Co., Ltd.
Appearance
A hard capsule with a white or off-white powder or granules and a yellowish hard shell.
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 201908236 · Approved 2019.12.04

Summary

Main use
Treatment of obesity (weight loss and weight maintenance); prevention 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 weight maintenance); prevention of weight regain

  • Obesity
View approved original text

This medication is used for patients with obesity who have a body mass index (BMI) of 30 kg/m² or higher, or a BMI of 27 kg/m² or higher with risk factors such as hypertension, diabetes, or dyslipidemia. It helps reduce weight or maintain weight in conjunction with a low-calorie diet. It also reduces the risk of weight regain. Therefore, it is effective for the treatment of obesity and for reducing the risk of weight regain.

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 with conditions involving cessation of bile secretion. Patients allergic to this medication or its components, pregnant women or those who may become pregnant, and breastfeeding women should also refrain from taking it. Liver damage has been reported rarely, so if symptoms of liver dysfunction occur, promptly inform a doctor and discontinue use of this medication. It is important to check liver enzyme levels through liver function tests. Additionally, since urinary excretion of oxalates may increase, patients with hyperoxaluria or calcium oxalate kidney stones should use this medication with caution. Gastrointestinal adverse effects may occur frequently with this medication, including abdominal distension, flatulence, constipation, oily stools, increased bowel movements, or fecal incontinence. These symptoms usually appear within 3 months of starting treatment and most improve within 4 weeks, but in some patients, may persist for more than 6 months. There may be cases where treatment is discontinued due to adverse reactions while taking this medication, primarily due to gastrointestinal issues. Occasionally, serious liver damage such as hepatitis or liver failure may occur, so liver function should be monitored. The risk of gastrointestinal adverse effects increases when taken with a high-fat meal, so it is recommended to distribute fat intake evenly across three meals a day. Additionally, this medication may reduce the absorption of fat-soluble vitamins and beta-carotene, so it is advised to take vitamin supplements at least 2 hours before or after taking this medication. Pregnant or breastfeeding women should not take this medication, and its safety and efficacy in children under 12 have not been established. This medication may interact with other drugs, so it is important to follow a doctor's instructions when taking it alongside cyclosporine, anticoagulants, anticonvulsants, antiretrovirals, etc., and to periodically check blood coagulation status or drug concentration. In case of overdose, serious side effects are rare, but monitoring the patient's condition for 24 hours is necessary. For storage, keep it out of the reach of children, protect it from light and moisture, and maintain its original packaging.

Side effects

  • Fatty stool
  • abdominal distension and flatulence
  • increased frequency of bowel movements
  • fatty/stool with fat
  • increased bowel movements
  • bowel incontinence
  • abdominal pain/discomfort
  • nausea
  • infectious diarrhea
  • rectal pain/discomfort
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  • abnormal teeth
  • abnormal gums
  • 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
  • ear infection
  • foot edema
  • elevated aminotransferases
  • elevated ALP
  • hepatitis
  • liver failure
  • itching
  • rash
  • hives
  • angioedema
  • bronchial asthma
  • anaphylaxis
  • vesicular rash
  • decreased prothrombin levels
  • elevated INR
  • hypothyroidism
  • pancreatitis
  • hypoglycemia
  • seizures
  • lower gastrointestinal bleeding
  • hyperoxaluria
  • oxalate nephropathy
  • sensory abnormalities in the skin
  • 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. Furthermore, it is important to keep it in a cool place below 25 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

A hard capsule with a white or off-white powder or granules and a yellowish hard shell.

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.

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.