Medication info

Raberit Tablet 20 mg (Rabeprazole Sodium)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Rabeprazole Sodium›20mg / 1 tablet
Manufacturer / importer
신일제약(주)
Appearance
Yellowish round enteric-coated tablet
Packaging
28 tablets (14 tablets/PTP x 2)
Approval status
Approval withdrawn

MFDS item code 200702690 · Notified 2007.03.05

This product's status changed to Approval withdrawn on 2024.08.22. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of symptoms of gastric ulcer and gastroesophageal reflux disease and treatment effect on Helicobacter pylori infection
Who takes it
Adults · Children
Adult dose
For gastric ulcers and duodenal ulcers: In adults, the usual dose of Rabeprazole sodium is 10 mg orally once daily. Depending on symptoms, it may be taken as 20 mg orally once daily. Typically, it's given for up to 8 weeks for gastric ulcers and 6 weeks for duodenal ulcers. For erosive or ulcerative gastroesophageal reflux disease: Administer 10 mg or 20 mg once daily for 4 to 8 weeks. If there is no treatment response after 8 weeks, further treatment for 8 weeks with 10 mg or 20 mg orally twice daily may be considered, but 20 mg twice daily is limited to patients with severe mucosal damage. For symptom relief in gastroesophageal reflux disease: Administer 10 mg once daily. If symptoms remain unmanageable after 4 weeks, further medical evaluation is required. After symptoms have resolved, on-demand therapy with 10 mg once daily can be used to manage symptoms that occur later. For long-term maintenance therapy for gastroesophageal reflux disease: Administer 10 mg or 20 mg orally once daily, depending on the patient. For Helicobacter pylori eradication: Patients with Helicobacter pylori infection should be treated with eradication therapy. It is recommended to administer this medication 20 mg in combination with Clarithromycin 500 mg and Amoxicillin 1 g, twice daily for 7 days. For Zollinger-Ellison syndrome: The recommended initial dose in adults is 60 mg once daily. The dosage can be adjusted up to 120 mg daily according to individual patient needs. Doses up to 100 mg can be given once daily, while 120 mg should be divided into two doses of 60 mg each. Patients with Zollinger-Ellison syndrome have experience with this medication for up to one year. 🏥 In patients with liver dysfunction, adverse effects of hepatic encephalopathy have been reported in cirrhotic patients. Therefore, it should be administered carefully. 🏥 In children, safety has not been established. 🏥 In the elderly, caution should be exercised as they often have impaired liver function.
Child dose
Safety in children has not been established.

Ingredients

Manufacturer
신일제약(주)

Efficacy & effects

Relief of symptoms of gastric ulcer and gastroesophageal reflux disease and treatment effect on Helicobacter pylori infection

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

This medication is used for the treatment of ulcers in the stomach and duodenum and helps alleviate the symptoms of erosive or ulcerative gastroesophageal reflux disease. It is also effective for long-term maintenance therapy of gastroesophageal reflux disease. Combined with antibiotics for patients with gastrointestinal ulcers caused by Helicobacter pylori infection, it enhances the treatment effect. It is also applied in diseases of excessive gastric acid secretion like Zollinger-Ellison syndrome. Thus, it is widely used for various gastrointestinal disorders.

How to take

Adult dose

For gastric ulcers and duodenal ulcers: In adults, the usual dose of Rabeprazole sodium is 10 mg orally once daily. Depending on symptoms, it may be taken as 20 mg orally once daily. Typically, it's given for up to 8 weeks for gastric ulcers and 6 weeks for duodenal ulcers. For erosive or ulcerative gastroesophageal reflux disease: Administer 10 mg or 20 mg once daily for 4 to 8 weeks. If there is no treatment response after 8 weeks, further treatment for 8 weeks with 10 mg or 20 mg orally twice daily may be considered, but 20 mg twice daily is limited to patients with severe mucosal damage. For symptom relief in gastroesophageal reflux disease: Administer 10 mg once daily. If symptoms remain unmanageable after 4 weeks, further medical evaluation is required. After symptoms have resolved, on-demand therapy with 10 mg once daily can be used to manage symptoms that occur later. For long-term maintenance therapy for gastroesophageal reflux disease: Administer 10 mg or 20 mg orally once daily, depending on the patient. For Helicobacter pylori eradication: Patients with Helicobacter pylori infection should be treated with eradication therapy. It is recommended to administer this medication 20 mg in combination with Clarithromycin 500 mg and Amoxicillin 1 g, twice daily for 7 days. For Zollinger-Ellison syndrome: The recommended initial dose in adults is 60 mg once daily. The dosage can be adjusted up to 120 mg daily according to individual patient needs. Doses up to 100 mg can be given once daily, while 120 mg should be divided into two doses of 60 mg each. Patients with Zollinger-Ellison syndrome have experience with this medication for up to one year. 🏥 In patients with liver dysfunction, adverse effects of hepatic encephalopathy have been reported in cirrhotic patients. Therefore, it should be administered carefully. 🏥 In children, safety has not been established. 🏥 In the elderly, caution should be exercised as they often have impaired liver function.

Child dose

Safety in children has not been established.

Precautions

This medication should not be taken by individuals allergic to certain components or with a history of hypersensitivity to benzimidazoles. Furthermore, caution is necessary for those allergic to penicillin or macrolide antibiotics, especially when used in combination during Helicobacter pylori eradication therapy. Patients taking Atazanavir or Rilpivirine or those who are pregnant or breastfeeding should not use this medication. This medication contains the pigment Yellow #5, so individuals allergic to this component should exercise caution. Additionally, patients with poor liver function, elderly individuals, and those with a history of drug allergies should use it carefully. During treatment, hypersensitivity reactions such as skin rash and itching can occur, so if such symptoms arise, discontinue use immediately. Blood tests may show abnormalities in red or white blood cell counts, liver function, therefore regular checks are recommended. Cardiac issues, blood pressure irregularities, and digestive symptoms (abdominal pain, diarrhea, nausea, etc.) may also occur, so medical consultation is advisable if symptoms arise. Nervous system side effects like headaches, dizziness, insomnia, as well as respiratory issues, muscle pain, and skin rashes have been reported, thus caution is warranted. If liver dysfunction, kidney issues, or severe allergic reactions are suspected, discontinue the medication immediately and visit a healthcare facility. This medication may increase the risk of bone fractures with long-term use, so regular check-ups are necessary during prolonged treatment. Additionally, as this medication suppresses gastric acid secretion, there may be a slight increase in the risk of gastrointestinal bacterial infections; if diarrhea persists, consult a doctor. This medication may cause drowsiness during driving or operating machinery, so caution is advised. There is potential for drug interactions, so when taking it with other medications, especially antibiotics, antivirals, and anticoagulants, it is essential to inform healthcare professionals. Pregnant or breastfeeding women should not use this medication, and caution is advised for the elderly due to the possibility of side effects from liver function decline. Safety in children has not been established, so it is best not to use it. In case of overdose, there is no specific antidote, so appropriate treatment should be administered according to symptoms, and the tablets should be swallowed whole without chewing or crushing.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, fever, interstitial pneumonia, abnormal lung sounds, fulminant hepatitis, liver dysfunction, jaundice, headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, agranulocytosis, hemolytic anemia, acute interstitial nephritis, thrombocytopenia, severe edema with increased blood pressure, severe allergic reactions, skin rash, blisters, skin peeling, pain in oral/ocular mucosa, severe

Mild side effects

Occasionally, rash, itching, hives, blood-related issues (anemia, leukopenia, leukocytosis, eosinophilia, neutrophilia, lymphocyte reduction, thrombocytopenia, hemolytic anemia), increased liver enzymes (ALT, AST, ALP, γ-GTP, LDH, total bilirubin), high blood pressure, myocardial infarction, abnormal electrocardiograms, migraine, syncope, and angina.

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture. A storage temperature between 1 and 30 degrees Celsius at room temperature is recommended to maintain the medication's efficacy for a long time.

Appearance and packaging

Appearance

Yellowish round enteric-coated tablet

Package unit

28 tablets (14 tablets/PTP 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.

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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.