Medication info
Lipisrim Capsule 60 mg (Orlistat)

Lipisrim Capsule 60 mg (Orlistat)

Prescription medicationHard capsuleOral
Ingredient · strength
Orlistat›60mg / 1 capsule
Manufacturer / importer
Nova M Healthcare Co., Ltd.
Appearance
A hard capsule containing a white or whitish powder or granules, with a yellow hard capsule body.
Packaging
Case - 90 capsules/box [10 capsules/PTP X 9], Bottle - 300 capsules/bottle
Approval status
Active

MFDS item code 202008845 · Approved 2020.12.16

Summary

Main use
Treatment of obesity (weight reduction and weight maintenance); reduction of the risk of weight regain
Who takes it
Adults · Children
Adult dose
The recommended dose is 120 mg of orlistat per dose, taken orally 3 times daily with a fat-containing meal or within 1 hour after a meal. Patients should continue a nutritionally balanced, mildly calorie-restricted 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 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 nutritional intake. 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 per dose 3 times daily does not increase the effectiveness of this medicine. Based on measurements of fecal fat, the effect of this medicine appears 24 ∼ 48 hours after taking it. After treatment is discontinued, 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
Nova M Healthcare Co., Ltd.

Efficacy & effects

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

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

This medication is indicated for obese patients with a Body Mass Index (BMI) of 30 kg/m² or greater, or for those with a BMI of 27 kg/m² or greater who have risk factors such as hypertension, diabetes, or dyslipidemia. It helps to reduce or maintain body weight when used in conjunction with a low-calorie diet. It is also effective in reducing the risk of weight regain, therefore it is used for the treatment of obesity and weight management.

How to take

Adult dose

The recommended dose is 120 mg of orlistat per dose, taken orally 3 times daily with a fat-containing meal or within 1 hour after a meal. Patients should continue a nutritionally balanced, mildly calorie-restricted 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 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 nutritional intake. 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 per dose 3 times daily does not increase the effectiveness of this medicine. Based on measurements of fecal fat, the effect of this medicine appears 24 ∼ 48 hours after taking it. After treatment is discontinued, 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 by individuals with chronic malabsorption syndrome or cholestasis. Individuals allergic to this drug or its ingredients, pregnant women, women who may become pregnant, and nursing mothers should also avoid using this medication. Liver damage has been rarely reported; therefore, if there are signs of liver dysfunction, notify a doctor immediately and discontinue use. It is important to check liver enzyme levels through liver function tests. Additionally, patients with hyperoxaluria or calcium oxalate kidney stones should use this medication cautiously. This medication may lead to gastrointestinal adverse reactions more frequently than a placebo, primarily including abdominal pain, abdominal distension, flatulence, constipation, and oily stools. These symptoms are usually mild and transient, occurring within 3 months and improving within 4 weeks. However, in some patients, they may persist for more than 6 months. There could be instances where treatment is discontinued due to adverse reactions from this medication, primarily due to gastrointestinal side effects. Rarely, hypersensitivity reactions such as hepatitis and anaphylaxis have been reported. When taken with a high-fat meal, gastrointestinal adverse reactions may increase, so dietary guidelines should be followed to control fat intake and distribute it evenly across three meals. Furthermore, this medication can decrease the absorption of fat-soluble vitamins and beta-carotene; therefore, it is recommended to take a multivitamin supplement, and it should be taken at least 2 hours before or after taking this medication. During pregnancy, it is advised not to take this medication, and nursing women should also avoid its use. For children, use is recommended only for adolescents aged 12 years and older, as safety and efficacy have not been established for children under 12 years of age. Due to insufficient clinical data on the elderly, caution is required. This medication may interact with other drugs; therefore, patients who are taking immunosuppressants, anticoagulants, antiepileptics, or antiretrovirals should consult their doctors. Careful monitoring of blood coagulation status is necessary when used in conjunction with oral anticoagulants. In case of overdose, 24-hour observation is needed, and serious adverse reactions are rarely observed. When storing the medication, keep it out of the reach of children, protect it from light and moisture, and maintain it in its original packaging.

Side effects

  • Fatty stools
  • abdominal bloating and gas
  • increased frequency of stool
  • steatorrhea
  • increased bowel movements
  • fecal incontinence
  • abdominal pain/discomfort
  • nausea
  • infectious diarrhea
  • rectal pain/discomfort
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  • dental abnormalities
  • gingival abnormalities
  • vomiting
  • influenza
  • upper respiratory tract infections
  • lower respiratory tract infections
  • otolaryngological symptoms
  • abdominal pain
  • limb pain
  • arthritis
  • myalgia
  • joint abnormalities
  • tendinitis
  • headache
  • sleep disorders
  • fatigue
  • rash
  • dry skin
  • menstrual irregularities
  • vaginitis
  • urinary tract infections
  • anxiety
  • depression
  • otitis
  • foot edema
  • elevated aminotransferases
  • increased ALP
  • hepatitis
  • liver failure
  • itching
  • rash
  • hives
  • angioedema
  • bronchospasm
  • anaphylaxis
  • vesicular rash
  • decreased prothrombin levels
  • increased INR
  • hypothyroidism
  • pancreatitis
  • hypoglycemia
  • seizures
  • lower gastrointestinal bleeding
  • hyperoxaluria
  • oxalate nephropathy
  • sensory disturbances of 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. Additionally, it should be kept in a cool place below 25 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

A hard capsule containing a white or whitish powder or granules, with a yellow hard capsule body.

Package unit

Case - 90 capsules/box [10 capsules/PTP X 9], 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.