Medication info

Ursodeoxycholic Acid 300 mg Tablets

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Ursodeoxycholic Acid›300mg / 1 tablet
Manufacturer / importer
(주)한국팜비오
Appearance
White round tablets
Packaging
Bottle packaging - 30 tablets/bottle, Bottle packaging - 300 tablets/bottle, PTP packaging - 100 tablets/box [10 tablets/PTP x 10]
Approval status
Approval withdrawn

MFDS item code 202005686 · Notified 2020.08.06

This product's status changed to Approval withdrawn on 2023.12.14. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of liver function in patients with primary biliary cirrhosis and prevention of gallstones in patients with obesity and gastric cancer
Who takes it
Adults
Adult dose
For improvement of liver function in primary biliary cirrhosis, ursodeoxycholic acid is administered orally as 300 mg three times a day with meals. For prevention of gallstones in patients with rapid weight loss, 300 mg is taken twice a day. For gastric cancer patients who have undergone gastrectomy, 300 mg is taken once a day.

Ingredients

Manufacturer
(주)한국팜비오

Efficacy & effects

Improvement of liver function in patients with primary biliary cirrhosis and prevention of gallstones in patients with obesity and gastric cancer

View approved original text

This medication helps improve liver function in patients with primary biliary cirrhosis. It is also used to prevent gallstones in obese patients who have experienced rapid weight loss and in gastric cancer patients who have undergone gastrectomy.

How to take

Adult dose

For improvement of liver function in primary biliary cirrhosis, ursodeoxycholic acid is administered orally as 300 mg three times a day with meals. For prevention of gallstones in patients with rapid weight loss, 300 mg is taken twice a day. For gastric cancer patients who have undergone gastrectomy, 300 mg is taken once a day.

Precautions

This medication is used for the prevention or treatment of gallstones. Firstly, this medication should not be used in certain patients. For example, individuals who are allergic to the ingredients of this medication or bile acids, those with severely obstructed bile ducts, acute hepatitis patients, individuals with certain types of gallstones, patients without a functioning gallbladder, those with severe cholecystitis or cholangitis, pregnant or nursing women, children, kidney disease patients, and individuals with inflammation in the stomach or intestines should not take this medication. Additionally, patients with severe pancreatic diseases or gallstones in the bile ducts, and those with very poor liver function should exercise greater caution when taking this medication. Taking this medication may occasionally cause gastrointestinal and skin symptoms such as diarrhea, nausea, vomiting, abdominal pain, constipation, heartburn, itching, and rash. Rarely, serious side effects such as interstitial pneumonia, liver function abnormalities, and leukopenia may occur, so if symptoms worsen, immediate consultation with medical personnel is necessary. While taking this medication, regular liver function tests and blood tests should be done, and overdose typically presents with diarrhea, so treatment corresponding to symptoms is needed. This medication can enhance the effects of certain diabetes medications, and when taken with antacids or certain lipid-lowering medications, it may interfere with the absorption of this medication. It is also advisable not to take it with medications that may cause liver damage. It is safest for pregnant women and nursing mothers not to take this medication, and for children, the safety and efficacy of this medication have not been established, hence it is not used. Elderly individuals require special care, and this medication should be stored out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Interstitial pneumonia (fever, cough, difficulty breathing, abnormal chest X-ray), elevated serum bilirubin levels (suspected symptoms of jaundice), potential worsening of jaundice in advanced cirrhosis

Mild side effects

  • Diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • constipation
  • heartburn
  • discomfort in the upper abdomen
  • itching
  • rash
  • general fatigue
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  • dizziness
  • calcification of gallstones
  • increase in liver enzyme levels
  • leukopenia
  • fatigue
  • viral infections
  • influenza-like symptoms
  • abdominal pain
  • bloating
  • nausea
  • back pain
  • musculoskeletal pain
  • headache
  • pharyngitis
  • sinusitis
  • upper respiratory tract infections
  • hair loss
  • dysmenorrhea
  • pruritus
  • chest discomfort

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Moreover, avoid storing it in excessively hot or cold locations and keep it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White round tablets

Package unit

Bottle packaging - 30 tablets/bottle, Bottle packaging - 300 tablets/bottle, PTP packaging - 100 tablets/box [10 tablets/PTP x 10]

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.