Medication info

Urazole Tablets 20mg (Rabeprazole Sodium)

Prescription medicationTablet경구Expired
Ingredient · strength
Rabeprazole Sodium›20mg / 1 tablet
Manufacturer / importer
(주)유유제약
Appearance
Pale yellow round enteric-coated tablet
Packaging
28 tablets (14 tablets/PTP packaging x 2), 28 tablets (14 tablets/Alu Alu packaging x 2)
Approval status
Expired

MFDS item code 201902329 · Approved 2019.04.16

This product's status changed to Expired on 2024.04.16. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of gastric and duodenal ulcers, alleviation of gastroesophageal reflux disease symptoms, and maintenance therapy
Who takes it
Adults
Adult dose
Adults should take 10 mg of rabeprazole sodium orally once daily. Depending on symptoms, 20 mg may be taken orally once daily. Treatment for gastric ulcers is up to 8 weeks, and for duodenal ulcers, up to 6 weeks. For erosive or ulcerative gastroesophageal reflux disease, 10 mg or 20 mg should be taken once daily for 4-8 weeks. If after 8 weeks symptoms persist, an additional 8 weeks of 10 mg or 20 mg may be given. The recommended starting dose for Zollinger-Ellison syndrome in adults is 60 mg orally once daily. The dosage can be adjusted based on the needs of individual patients, up to 120 mg per day. A dose of up to 100 mg may be taken once daily, while a 120 mg dose should be divided into 60 mg doses, taken twice daily. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to one year.

Ingredients

Manufacturer
(주)유유제약

Efficacy & effects

Treatment of gastric and duodenal ulcers, alleviation of gastroesophageal reflux disease symptoms, and maintenance therapy

  • Gastric ulcer
  • duodenal ulcer
  • erosive gastroesophageal reflux disease
  • ulcerative gastroesophageal reflux disease
  • symptoms of gastroesophageal reflux disease
  • peptic ulcer due to Helicobacter pylori infection
  • Zollinger-Ellison syndrome
View approved original text

This medication is effective for the treatment of gastric ulcers and duodenal ulcers, as well as erosive or ulcerative gastroesophageal reflux disease. It also alleviates symptoms of gastroesophageal reflux disease and is used for long-term maintenance therapy. It is administered in combination with antibiotics for patients with peptic ulcers associated with Helicobacter pylori infection. Additionally, it helps improve symptoms in patients with Zollinger-Ellison syndrome. Overall, it is widely used for the treatment of various diseases of the stomach and esophagus.

How to take

Adult dose

Adults should take 10 mg of rabeprazole sodium orally once daily. Depending on symptoms, 20 mg may be taken orally once daily. Treatment for gastric ulcers is up to 8 weeks, and for duodenal ulcers, up to 6 weeks. For erosive or ulcerative gastroesophageal reflux disease, 10 mg or 20 mg should be taken once daily for 4-8 weeks. If after 8 weeks symptoms persist, an additional 8 weeks of 10 mg or 20 mg may be given. The recommended starting dose for Zollinger-Ellison syndrome in adults is 60 mg orally once daily. The dosage can be adjusted based on the needs of individual patients, up to 120 mg per day. A dose of up to 100 mg may be taken once daily, while a 120 mg dose should be divided into 60 mg doses, taken twice daily. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to one year.

Precautions

This medication should not be administered to patients with specific allergic reactions or those hypersensitive to certain antibiotics. Women who are pregnant or breastfeeding should also avoid using this medication. Patients with impaired liver function or the elderly should use it cautiously, and it should be administered carefully in those with a history of hypersensitivity reactions to the drug. If symptoms of allergy such as rash or itching occur during use, treatment should be discontinued immediately. Regular blood tests and liver function tests should be performed, and if any abnormal symptoms are found, administration should be stopped and appropriate measures taken. Patients with heart or vascular issues should also use caution, as digestive symptoms or neuropsychiatric symptoms may occur. Abnormal reactions may occur in various organs including the respiratory, musculoskeletal, skin, eyes, and urinary tract; thus, consult a doctor if symptoms arise. Long-term use may increase the risk of osteoporosis and hypomagnesemia, so regular testing is necessary and supplements should be taken as needed. This medication suppresses gastric acid secretion, hence the risk of gastrointestinal bacterial infections may slightly increase. Caution is advised when driving or operating machinery as drowsiness may occur; inform your healthcare provider of any other medications being used, as interactions may be possible. It is contraindicated during pregnancy and should also not be used while breastfeeding. The elderly may have an increased risk of adverse reactions due to decreased liver function, so administration should be stopped and consultation sought if symptoms occur. The safety in pediatric patients has not been established, so it is preferable not to use it in this population. There is no specific antidote in case of overdose; treatment and supportive therapy according to symptoms is necessary. This medication should be swallowed whole without chewing or crushing the tablet, and should be kept out of reach of children. Monitor closely for symptoms suggestive of malignancy with long-term use, and necessary examinations should be conducted. Regular blood tests and liver function tests are required, and immediate consultation with healthcare professionals is necessary if abnormal symptoms occur.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, fulminant hepatitis, liver dysfunction, jaundice, angina, pulmonary embolism, rarely, apnea, respiratory depression, interstitial pneumonia, toxic epidermal necrolysis (Lyell syndrome), Stevens-Johnson syndrome, severe neurologic symptoms (seizures, confusion, visual disturbances, paralysis), severe edema with elevated blood pressure, acute interstitial nephritis, anaphylaxis, shock

Mild side effects

  • Rash
  • urticaria
  • itching
  • decreased red blood cells
  • decreased white blood cells
  • increased white blood cells
  • increased eosinophils
  • increased neutrophils
  • decreased lymphocytes
  • anemia
Show 23 more
  • petechiae
  • lymphadenopathy
  • hypochromic anemia
  • pancytopenia
  • agranulocytosis
  • thrombocytopenia
  • hemolytic anemia
  • elevated ALT
  • AST
  • ALP
  • GGT
  • LDH
  • total bilirubin
  • hypertension
  • myocardial infarction
  • abnormal electrocardiogram
  • migraine
  • syncope
  • angina
  • heart block
  • palpitations
  • bradycardia
  • emptiness

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to safely preserve the efficacy of the drug.

Appearance and packaging

Appearance

Pale yellow round enteric-coated tablet

Package unit

28 tablets (14 tablets/PTP packaging x 2), 28 tablets (14 tablets/Alu Alu packaging x 2)

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

No questions yet.

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

Related searches

Search tags

Suggested searches

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.