Medication info
J-Dawn Capsule 60mg (Orlistat)

J-Dawn Capsule 60mg (Orlistat)

Prescription medicationHard capsuleOral
Ingredient · strength
Orlistat›60mg / 1 capsule
Manufacturer / importer
JW Pharmaceutical Co., Ltd.
Appearance
Hard capsules with a white or off-white powder or granule filled, with yellow upper and lower parts.
Packaging
90 capsules (10 capsules/PTPx9)
Approval status
Active

MFDS item code 202000760 · Approved 2020.02.10

Summary

Main use
Treatment of obesity (weight loss and maintenance), and prevention of the risk of weight regain
Who takes it
Adults · Children
Adult dose
◯ Adults The recommended dose of this medication 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 hypocaloric diet in which approximately 30% of calories are derived from fat. Daily intake of fat, carbohydrates, and protein should be distributed evenly across the three meals. This medication may be omitted if a meal is skipped or contains no fat. Because this medication 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 medication 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 medication. Based on measurements of fecal fat, the effect of this medication 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 medication 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
Children under 12 years of age: No studies have been conducted.

Ingredients

Manufacturer
JW Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of obesity (weight loss and maintenance), and prevention of the risk of weight regain

  • Obesity
View approved original text

This medication helps reduce or maintain weight in obese patients with a body mass index (BMI) of 30 or higher, or those with risk factors such as hypertension, diabetes, or dyslipidemia, when used along with a low-calorie diet. It also effectively supports obesity management by reducing the risk of weight regain.

How to take

Adult dose

◯ Adults The recommended dose of this medication 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 hypocaloric diet in which approximately 30% of calories are derived from fat. Daily intake of fat, carbohydrates, and protein should be distributed evenly across the three meals. This medication may be omitted if a meal is skipped or contains no fat. Because this medication 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 medication 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 medication. Based on measurements of fecal fat, the effect of this medication 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 medication 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

Children under 12 years of age: No studies have been conducted.

Precautions

This drug should not be used in patients with chronic malabsorption syndrome or those who have impaired bile secretion. Additionally, patients who have allergic reactions to this drug or its components, pregnant women, women who may become pregnant, and nursing mothers should not take this medication. Caution is required when administering to patients with liver dysfunction, and any signs of liver damage should be reported to a doctor immediately. This drug should also be used cautiously in patients with hyperoxaluria or calcium oxalate kidney stones. During treatment, gastrointestinal symptoms may frequently occur, which can be exacerbated by consuming high-fat foods; therefore, dietary control is important. This drug helps with weight loss by blocking fat absorption, which may reduce the absorption of fat-soluble vitamins A, D, E, K, and beta-carotene, so it is advisable to take vitamin supplements. Vitamin supplements should be taken at least 2 hours before or 2 hours after taking this medication. If symptoms of liver dysfunction appear while taking this medication, dosing should be stopped immediately, and liver function tests should be conducted. Additionally, diabetic patients may experience improved blood sugar control due to this medication, so dosage adjustments of hypoglycemic agents might be necessary. Rapid weight loss may increase the risk of gallstones, necessitating caution. This medication may interact with other drugs; therefore, patients currently taking cyclosporine, anticoagulants, antiepileptic medications, or antiretroviral medications should consult their doctor. Pregnant or nursing women should not take this drug, and it is not recommended for children under 12 years due to lack of safety and efficacy data. There is insufficient research on the elderly, so caution is needed. No serious adverse reactions have been reported with overdose, but monitoring for 24 hours is required in such cases. This drug should be kept out of the reach of children and protected from light and moisture.

Side effects

  • Fatty stools
  • abdominal bloating and flatulence
  • increased frequency of defecation
  • fatty/greasy stools
  • oily stools
  • increased bowel movements
  • 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
  • otolaryngological symptoms
  • abdominal pain
  • leg pain
  • arthritis
  • myalgia
  • joint abnormalities
  • tendonitis
  • headache
  • sleep disorders
  • fatigue
  • rash
  • dry skin
  • menstrual irregularities
  • vaginitis
  • urinary tract infections
  • anxiety
  • depression
  • otitis
  • pedal edema
  • elevated aminotransferases
  • elevated ALP
  • hepatitis
  • itching
  • rash
  • urticaria
  • angioedema
  • bronchospasm
  • anaphylaxis
  • vesicular rash
  • decreased prothrombin levels
  • elevated INR
  • hypothyroidism
  • pancreatitis
  • hypoglycemia
  • seizures
  • lower gastrointestinal bleeding
  • hyperoxaluria
  • oxalate nephropathy
  • altered skin sensations
  • constipation
  • dyspepsia
  • heartburn

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

Storage

This medication should be protected from air, light, and moisture and should be stored in a cool place below 25 degrees Celsius. This will help maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Hard capsules with a white or off-white powder or granule filled, with yellow upper and lower parts.

Package unit

90 capsules (10 capsules/PTPx9)

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.