Medication info
Rabeprazole Sodium 10 mg (Rabeprazole Sodium)

Rabeprazole Sodium 10 mg (Rabeprazole Sodium)

Prescription medicationTablet경구
Ingredient · strength
Rabeprazole Sodium›10mg / 1 tablet
Manufacturer / importer
독립바이오제약(주)
Appearance
Light yellow round enteric-coated tablets
Packaging
28T (14T/1PTP X 2 EA)
Approval status
Active

MFDS item code 201905355 · Approved 2019.07.29

Summary

Main use
Relief of symptoms of gastric ulcers and gastroesophageal reflux disease, and treatment of Helicobacter pylori infection
Who takes it
Adults
Adult dose
For gastric ulcers and duodenal ulcers: Typically, for adults, 10 mg of rabeprazole sodium is administered orally once daily. Depending on symptoms, 20 mg can be administered orally once a day. Duration of administration is generally up to 8 weeks for gastric ulcers and 6 weeks for duodenal ulcers. For erosive or ulcerative gastroesophageal reflux disease: 10 mg or 20 mg should be administered once daily for 4 to 8 weeks. For proton pump inhibitors (PPI), if treatment is not achieved after 8 weeks, an additional dosage of 10 mg or 20 mg can be taken orally twice daily for 8 weeks. However, the administration of 20 mg twice daily is limited to patients with confirmed severe mucosal damage. To relieve symptoms of gastroesophageal reflux disease: 10 mg once daily. If symptoms do not stabilize after 4 weeks of treatment, further consultation is required. Once symptoms have resolved, as needed, 10 mg may be administered once daily for on-demand therapy to control any subsequent symptoms. For long-term maintenance therapy of gastroesophageal reflux disease: Patients can take 10 mg or 20 mg orally once daily depending on individual circumstances. For Helicobacter pylori eradication: Patients infected with Helicobacter pylori should be treated with eradication therapy. It is recommended to combine this medication with 20 mg of clarithromycin 500 mg and amoxicillin 1 g taken twice daily for 7 days. For Zollinger-Ellison syndrome: The recommended initial dosage for adults is 60 mg once daily. The dosage can be adjusted up to 120 mg depending on individual patient needs. Dosage up to 100 mg can be administered once daily, while 120 mg should be divided into 60 mg administered twice daily. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to 1 year. ◯ In patients with liver dysfunction: Adverse reactions of hepatic encephalopathy have been reported in patients with liver cirrhosis. Hence, it should be administered cautiously. ◯ Pediatric patients: Safety in children has not been established. ◯ Elderly: Caution should be exercised as many elderly patients may have impaired liver function.

Ingredients

Manufacturer
독립바이오제약(주)

Efficacy & effects

Relief of symptoms of gastric ulcers and gastroesophageal reflux disease, and treatment of Helicobacter pylori infection

  • Gastric ulcers
  • duodenal ulcers
  • erosive gastroesophageal reflux disease
  • ulcerative gastroesophageal reflux disease
  • gastroesophageal reflux disease
  • gastrointestinal ulcers
  • Zollinger-Ellison syndrome
View approved original text

This medication is used for the treatment of gastric ulcers and duodenal ulcers. It also relieves symptoms of erosive or ulcerative gastroesophageal reflux disease and is effective in long-term maintenance therapy of gastroesophageal reflux disease. In patients with Helicobacter pylori infected gastrointestinal ulcers, it is combined with antibiotics for treatment. Additionally, it helps manage diseases related to excessive gastric acid secretion, such as Zollinger-Ellison syndrome. Overall, it is used for the treatment of gastrointestinal ulcers and diseases related to gastroesophageal conditions.

How to take

Adult dose

For gastric ulcers and duodenal ulcers: Typically, for adults, 10 mg of rabeprazole sodium is administered orally once daily. Depending on symptoms, 20 mg can be administered orally once a day. Duration of administration is generally up to 8 weeks for gastric ulcers and 6 weeks for duodenal ulcers. For erosive or ulcerative gastroesophageal reflux disease: 10 mg or 20 mg should be administered once daily for 4 to 8 weeks. For proton pump inhibitors (PPI), if treatment is not achieved after 8 weeks, an additional dosage of 10 mg or 20 mg can be taken orally twice daily for 8 weeks. However, the administration of 20 mg twice daily is limited to patients with confirmed severe mucosal damage. To relieve symptoms of gastroesophageal reflux disease: 10 mg once daily. If symptoms do not stabilize after 4 weeks of treatment, further consultation is required. Once symptoms have resolved, as needed, 10 mg may be administered once daily for on-demand therapy to control any subsequent symptoms. For long-term maintenance therapy of gastroesophageal reflux disease: Patients can take 10 mg or 20 mg orally once daily depending on individual circumstances. For Helicobacter pylori eradication: Patients infected with Helicobacter pylori should be treated with eradication therapy. It is recommended to combine this medication with 20 mg of clarithromycin 500 mg and amoxicillin 1 g taken twice daily for 7 days. For Zollinger-Ellison syndrome: The recommended initial dosage for adults is 60 mg once daily. The dosage can be adjusted up to 120 mg depending on individual patient needs. Dosage up to 100 mg can be administered once daily, while 120 mg should be divided into 60 mg administered twice daily. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to 1 year. ◯ In patients with liver dysfunction: Adverse reactions of hepatic encephalopathy have been reported in patients with liver cirrhosis. Hence, it should be administered cautiously. ◯ Pediatric patients: Safety in children has not been established. ◯ Elderly: Caution should be exercised as many elderly patients may have impaired liver function.

Precautions

This medication should not be used in patients with allergies to certain drugs or components. Caution is needed when administering to patients allergic to penicillin or macrolide antibiotics. It is safest for pregnant or breastfeeding women to avoid taking this medication. Patients with impaired liver function or the elderly should use this medication cautiously and consult a doctor immediately if any abnormal symptoms occur. This medication may cause allergic reactions such as skin rash, itching, and hives, and should be discontinued if symptoms occur. It is important to have regular blood tests or liver function tests to monitor for any abnormalities. Various side effects may occur in different areas, including the heart, gastrointestinal, and nervous system, so patients should be vigilant about symptoms. This medication suppresses gastric acid secretion, which may increase the risk of fractures with long-term use, requiring periodic examinations. Furthermore, long-term use may lead to hypomagnesemia, necessitating monitoring of magnesium levels. If gastrointestinal infection symptoms such as diarrhea persist during use, immediate consultation with medical staff is advised. Caution is needed as drowsiness may occur while driving or operating machinery. This medication may interact with other drugs, so it is essential to inform about any concomitant medications. Special caution is needed when used with antiviral agents or some antibiotics. This medication should be swallowed whole without chewing or crushing. Keep out of reach of children and do not transfer to other containers. It is safest to avoid this medication during pregnancy or breastfeeding. Safety in pediatric patients has not been established, so usage requires caution. There is no specific antidote for overdose, so appropriate treatment should be provided based on symptoms. It is important to conduct regular examinations to check for side effects in cases of long-term use.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by fever, blisters, peeling skin, pain in the oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attacks, respiratory disturbances accompanied by cough+fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, urinary changes

Mild side effects

  • Rash
  • hives
  • itching
  • decreased red blood cells
  • decreased white blood cells
  • increased white blood cells
  • increased eosinophils
  • increased neutrophils
  • decreased lymphocytes
  • anemia
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  • petechiae
  • lymphadenopathy
  • hypopigmented anemia
  • pancytopenia
  • agranulocytosis
  • decreased platelets
  • hemolytic anemia
  • elevated ALT
  • elevated AST
  • elevated ALP
  • elevated γ-GTP
  • elevated LDH
  • elevated total bilirubin
  • hypertension
  • myocardial infarction
  • abnormal electrocardiogram
  • migraine
  • syncope
  • angina
  • heart block

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

Storage

This medication may be sensitive to air and humidity, so it must be stored in a tightly sealed container. It is recommended to maintain storage at room temperature between 1°C and 30°C. Proper storage will help prolong the efficacy of the medication.

Appearance and packaging

Appearance

Light yellow round enteric-coated tablets

Package unit

28T (14T/1PTP X 2 EA)

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.