Medication info
Unirabeph Tablet 10 mg (Rabeprazole Sodium)

Unirabeph Tablet 10 mg (Rabeprazole Sodium)

Prescription medicationTablet경구
Ingredient · strength
Rabeprazole Sodium›10mg / 1 tablet
Manufacturer / importer
한국유니온제약(주)
Appearance
Yellow round enteric-coated tablet
Packaging
28 tablets/box [14 tablets/Alu Alu packaging x 2]
Approval status
Active

MFDS item code 201901301 · Approved 2019.03.04 · Insurance code 665507100

Summary

Main use
Treatment of gastric ulcer and duodenal ulcer, alleviation of gastroesophageal reflux disease symptoms and maintenance therapy, antibiotic combination therapy for Helicobacter pylori infection-related gastrointestinal ulcers, treatment of Zollinger-Ellison syndrome
Who takes it
Adults · Children
Adult dose
For gastric ulcer and duodenal ulcer: usually 10 mg orally once daily, possible to increase to 20 mg orally once daily depending on symptoms. Administer for up to 8 weeks for gastric ulcer and up to 6 weeks for duodenal ulcer. For erosive or ulcerative gastroesophageal reflux disease: 10 mg or 20 mg orally once daily for 4 to 8 weeks. If not controlled after 8 weeks of treatment, may be increased additionally for 8 weeks at 10 mg or 20 mg twice daily (severe mucosal damage).
Child dose
Safety in children has not been established.

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

Treatment of gastric ulcer and duodenal ulcer, alleviation of gastroesophageal reflux disease symptoms and maintenance therapy, antibiotic combination therapy for Helicobacter pylori infection-related gastrointestinal ulcers, treatment of Zollinger-Ellison syndrome

  • Gastric ulcer
  • duodenal ulcer
  • erosive gastroesophageal reflux disease
  • ulcerative gastroesophageal reflux disease
  • symptoms of gastroesophageal reflux disease
  • gastrointestinal ulcers from Helicobacter pylori infection
  • Zollinger-Ellison syndrome
View approved original text

This medication is effective for the treatment of gastric ulcers and duodenal ulcers, and helps relieve symptoms of erosive or ulcerative gastroesophageal reflux disease. It is also used for long-term maintenance therapy of gastroesophageal reflux disease, and increases the treatment effectiveness when combined with antibiotics for patients with gastrointestinal ulcers infected with Helicobacter pylori. It is used for diseases related to excessive gastric acid secretion, such as Zollinger-Ellison syndrome. Thus, it is effective in treating various gastrointestinal diseases and improving symptoms.

How to take

Adult dose

For gastric ulcer and duodenal ulcer: usually 10 mg orally once daily, possible to increase to 20 mg orally once daily depending on symptoms. Administer for up to 8 weeks for gastric ulcer and up to 6 weeks for duodenal ulcer. For erosive or ulcerative gastroesophageal reflux disease: 10 mg or 20 mg orally once daily for 4 to 8 weeks. If not controlled after 8 weeks of treatment, may be increased additionally for 8 weeks at 10 mg or 20 mg twice daily (severe mucosal damage).

Child dose

Safety in children has not been established.

Precautions

This medication should not be used in patients allergic to specific ingredients or in women who are pregnant or breastfeeding. Caution is required when using this medication in patients with poor liver function or in the elderly. Allergic reactions such as skin rashes and itching may occur, so if these symptoms appear, the medication should be stopped immediately. Regular blood tests and liver function tests are important, and if abnormalities are found, the medication should be stopped and a doctor consulted. Patients with cardiovascular diseases should use this medication with caution as it may affect the heart or blood pressure. Gastrointestinal symptoms such as diarrhea, abdominal pain, and nausea may occur, so it is important to monitor your physical condition closely. Neurological symptoms such as headaches, dizziness, and insomnia may occur, so caution is necessary when driving or operating machinery. Respiratory symptoms, muscle pain, and joint pain may occur, so notify healthcare professionals if any unusual symptoms arise. Long-term use may increase the risk of osteoporosis-related fractures, so regular examinations are necessary during long-term treatment. This medication may interact with other drugs, so if you are taking other medications, be sure to inform your doctor or pharmacist. There is no specific antidote for overdose, so appropriate treatment should be administered according to symptoms, and do not chew or crush the tablets; swallow whole. Keep out of reach of children, and do not transfer to another container for safety. It is important to consult a specialist immediately if any unusual symptoms occur during the medication period.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, fulminant hepatitis, liver dysfunction, jaundice, angina, myocardial infarction, pulmonary embolism, ventricular tachycardia, thrombophlebitis, rectal bleeding, blood in stool, hepatic encephalopathy, seizures, confusion, disorientation, systemic severe swelling accompanied by increased blood pressure, acute interstitial nephritis, sudden death, coma, anaphylaxis, angioedema, systemic allergic reactions, toxic epidermal necrolysis,

Mild side effects

  • Rash
  • itching
  • decrease in red blood cells
  • decrease in white blood cells
  • increase in white blood cells
  • increase in eosinophils
  • increase in neutrophils
  • decrease in lymphocytes
  • anemia
  • petechial hemorrhage
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  • lymphadenopathy
  • hypochromic anemia
  • pancytopenia
  • agranulocytosis
  • decrease in platelets
  • hemolytic anemia
  • increase in ALT
  • increase in AST
  • increase in ALP
  • increase in γ-GTP
  • increase in LDH
  • increase in total bilirubin
  • hypertension
  • myocardial infarction
  • abnormal ECG
  • migraine
  • syncope
  • angina
  • heart block
  • palpitations

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

Storage

This medication is susceptible to air and humidity, so it must be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Yellow round enteric-coated tablet

Package unit

28 tablets/box [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

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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.