Medication info
Rabeprazole Sodium 10mg Tablets

Rabeprazole Sodium 10mg Tablets

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

MFDS item code 201904371 · Approved 2019.06.26 · Insurance code 658106470

Summary

Main use
Relief of symptoms of gastric ulcers and gastroesophageal reflux disease, and treatment effect for Helicobacter infection
Who takes it
Adults
Adult dose
Gastric ulcer, duodenal ulcer: Normally give 10 mg orally once daily; based on symptoms, may give 20 mg orally once daily. Treatment duration is 8 weeks for gastric ulcer and 6 weeks for duodenal ulcer.\nErosive or ulcerative gastroesophageal reflux disease: 10 mg or 20 mg orally once daily for 4 to 8 weeks; if not healed after 8 weeks, may add 10 mg or 20 mg orally twice daily based on symptoms. However, 20 mg dosage should be used only in cases of severe mucosal damage.\nRelief of symptoms of gastroesophageal reflux disease: 10 mg given once daily. If symptoms are not controlled after 4 weeks, additional medical consultation is needed. After symptoms have resolved, on-demand therapy can be applied by taking 10 mg once daily to control any subsequent symptoms.\nLong-term maintenance therapy for gastroesophageal reflux disease: May give orally 10 mg or 20 mg daily based on the patient’s needs.\nEradication of Helicobacter pylori: Patients infected with Helicobacter pylori should receive eradication therapy. It is recommended to combine this drug at 20 mg with clarithromycin 500 mg and amoxicillin 1 g, administered twice daily for 7 days.\nZollinger-Ellison syndrome: The recommended starting dose for adults is 60 mg orally once daily. The dosage may be adjusted up to 120 mg based on individual patient needs. A dose of up to 100 mg can be administered once daily, while the 120 mg dose is divided and taken as 60 mg twice daily. Patients with Zollinger-Ellison syndrome have been treated with this drug for up to 1 year.\n◯ Patients with liver impairment: Adverse reactions indicating hepatic encephalopathy have been reported in patients with liver cirrhosis, hence it should be used cautiously.\n◯ Children: Safety for children has not been established.\n◯ Elderly: Caution is needed as they often have reduced liver function.

Ingredients

Manufacturer
(유)한풍제약

Efficacy & effects

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

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

This medication is used for the treatment of peptic ulcers such as gastric ulcer and duodenal ulcer. It also alleviates the symptoms of patients with erosive or ulcerative gastroesophageal reflux disease and is effective for long-term maintenance therapy of such gastroesophageal reflux disease. It can also be used in combination with antibiotics for gastrointestinal ulcer patients infected with Helicobacter pylori. It is applicable for conditions of excessive gastric acid secretion, such as Zollinger-Ellison syndrome, improving the patient's condition. Overall, it is widely used for alleviating and treating symptoms of various gastrointestinal diseases.

How to take

Adult dose

Gastric ulcer, duodenal ulcer: Normally give 10 mg orally once daily; based on symptoms, may give 20 mg orally once daily. Treatment duration is 8 weeks for gastric ulcer and 6 weeks for duodenal ulcer.\nErosive or ulcerative gastroesophageal reflux disease: 10 mg or 20 mg orally once daily for 4 to 8 weeks; if not healed after 8 weeks, may add 10 mg or 20 mg orally twice daily based on symptoms. However, 20 mg dosage should be used only in cases of severe mucosal damage.\nRelief of symptoms of gastroesophageal reflux disease: 10 mg given once daily. If symptoms are not controlled after 4 weeks, additional medical consultation is needed. After symptoms have resolved, on-demand therapy can be applied by taking 10 mg once daily to control any subsequent symptoms.\nLong-term maintenance therapy for gastroesophageal reflux disease: May give orally 10 mg or 20 mg daily based on the patient’s needs.\nEradication of Helicobacter pylori: Patients infected with Helicobacter pylori should receive eradication therapy. It is recommended to combine this drug at 20 mg with clarithromycin 500 mg and amoxicillin 1 g, administered twice daily for 7 days.\nZollinger-Ellison syndrome: The recommended starting dose for adults is 60 mg orally once daily. The dosage may be adjusted up to 120 mg based on individual patient needs. A dose of up to 100 mg can be administered once daily, while the 120 mg dose is divided and taken as 60 mg twice daily. Patients with Zollinger-Ellison syndrome have been treated with this drug for up to 1 year.\n◯ Patients with liver impairment: Adverse reactions indicating hepatic encephalopathy have been reported in patients with liver cirrhosis, hence it should be used cautiously.\n◯ Children: Safety for children has not been established.\n◯ Elderly: Caution is needed as they often have reduced liver function.

Precautions

This medication should not be used by patients who are allergic to specific ingredients or who have hypersensitivity to penicillin or macrolide antibiotics.\nWomen who are pregnant or breastfeeding should also not take this medication, and it should be avoided when taken with certain antiviral drugs.\nPatients with poor liver function or the elderly should exercise extra caution when using this medication, and it should be administered carefully in those with a history of allergies.\nIf allergic symptoms such as skin rash, itching, or hives occur during the use of this medication, discontinue use immediately.\nRegular blood tests are necessary as red or white blood cell counts may change.\nLiver function tests should also be conducted regularly, and if symptoms of hepatitis or jaundice appear, consult a physician immediately.\nIt may affect the heart or blood vessels, so caution is needed as symptoms like hypertension, myocardial infarction, or arrhythmia may occur.\nGastrointestinal symptoms may include diarrhea, constipation, abdominal pain, or nausea, and in severe cases, immediate notification to medical personnel is required.\nAs it may affect the central nervous system, symptoms like headache, dizziness, insomnia, or depression may arise, and consultation is required if symptoms are severe.\nRespiratory symptoms may include cough, pharyngitis, or difficulty breathing, and in rare cases, serious conditions like pneumonia have been reported.\nVarious side effects such as muscle pain, joint pain, skin rash, or hair loss may occur, so inform a physician immediately of any unusual symptoms.\nAs this medication suppresses gastric acid secretion, long-term use may increase the risk of bone fractures and may lead to hypomagnesemia, requiring regular blood tests.\nThe risk of bacterial infection in the gastrointestinal tract may be slightly increased, so if diarrhea persists, consult with medical personnel.\nCaution is necessary when driving or operating machinery as drowsiness may occur.\nIt may interact with other medications, so be sure to inform the doctor or pharmacist if you are taking antibiotics, anticoagulants, antivirals, etc.\nThis medication should not be chewed or crushed, and must be swallowed whole. Keep out of reach of children.\nIt is safest not to take this medication if you are pregnant or breastfeeding, and the elderly should be cautious as liver function may decline and increase the risk of side effects.\nIn the case of overdose, there is no specific antidote, but appropriate treatment is required based on symptoms, so follow the prescribed dosage strictly.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain of oral/ocular mucosa, shortness of breath or difficulty in breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), severe lethargy throughout the body, sudden and very severe headache, thunderclap headache, seizures, altered consciousness, vision abnormalities, paralysis, urinary symptoms

Mild side effects

  • Rash
  • itching
  • hives
  • decreased red blood cells
  • decreased white blood cells
  • increased white blood cells
  • increased eosinophils
  • increased neutrophils
  • decreased lymphocytes
  • anemia
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  • petechial hemorrhage
  • lymphadenopathy
  • hypochromic anemia
  • pancytopenia
  • agranulocytosis
  • thrombocytopenia
  • hemolytic anemia
  • elevated ALT
  • elevated AST
  • elevated ALP
  • elevated γ-GTP
  • elevated LDH
  • elevated total bilirubin
  • hypertension
  • myocardial infarction
  • ECG abnormalities
  • migraine
  • syncope
  • angina
  • heart blockade

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

Storage

This medication may be sensitive to air or moisture, so it is important to store it in a tightly sealed container. The storage temperature should be kept between 1°C and 30°C at room temperature, avoiding direct sunlight or high temperatures.

Appearance and packaging

Appearance

Pale yellow round enteric-coated tablet

Package unit

28 tablets/box [(14 tablets/Alu Alu 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.