Medication info
Rabeprazole Sodium 20mg Tablets

Rabeprazole Sodium 20mg Tablets

Prescription medicationTablet경구
Ingredient · strength
Rabeprazole Sodium›20mg / 1 tablet
Manufacturer / importer
메딕스제약(주)
Appearance
Pale yellow round enteric-coated tablets
Packaging
28 tablets/box [(14 tablets/PTP×2)]
Approval status
Active

MFDS item code 201901829 · Approved 2019.03.27 · Insurance code 625801610

Summary

Main use
Relief of symptoms of gastric ulcer and gastroesophageal reflux disease, and suppression of Helicobacter pylori infection
Who takes it
Adults · Children
Adult dose
Gastric Ulcer, Duodenal Ulcer: The usual adult dosage of rabeprazole sodium is 10 mg orally once daily. Depending on symptoms, it may be taken at a dose of 20 mg orally once daily. Treatment is usually given for up to 8 weeks for gastric ulcer and up to 6 weeks for duodenal ulcer. Erosive or Ulcerative Gastroesophageal Reflux Disease: Administer 10 mg or 20 mg once daily for 4 to 8 weeks. If proton pump inhibitors are not effective after 8 weeks of treatment, additional treatment for another 8 weeks with 10 mg or 20 mg taken twice daily may be considered, but 20 mg administered twice daily should only be in patients with severe mucosal damage. Symptom relief for gastroesophageal reflux disease: Administer 10 mg once daily. If symptoms are not managed after 4 weeks, further medical evaluation is required. Once symptoms resolve, on-demand therapy of 10 mg once daily can be employed to control recurring symptoms. Long-term maintenance therapy for gastroesophageal reflux disease: Patient-specific doses of 10 mg or 20 mg orally once daily may be warranted. Helicobacter pylori eradication: Patients infected with Helicobacter pylori should undergo eradication therapy. It is recommended to combine this medication (20 mg) with clarithromycin (500 mg) and amoxicillin (1 g), administered twice daily for 7 days. Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg once daily. The dosage may be adjusted up to 120 mg daily according to individual patient needs. Doses up to 100 mg may be given once daily, whereas 120 mg should be divided into two doses of 60 mg taken twice daily. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to one year. ○ In patients with liver dysfunction: Adverse reactions have been reported in cirrhotic patients showing hepatic encephalopathy. Therefore, it should be administered with caution. ○ Children: Safety and efficacy in children have not been established. ○ Elderly: Administer with caution, as liver function is often impaired in older adults.
Child dose
Safety and efficacy in children have not been established.

Ingredients

Manufacturer
메딕스제약(주)

Efficacy & effects

Relief of symptoms of gastric ulcer and gastroesophageal reflux disease, and suppression of Helicobacter pylori infection

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

This medication is effective in treating gastric ulcers and duodenal ulcers, as well as in alleviating symptoms of erosive or ulcerative gastroesophageal reflux disease. It is also used for long-term maintenance therapy of gastroesophageal reflux disease and in combination with antibiotics for gastrointestinal ulcer patients infected with Helicobacter pylori. It is helpful in treating Zollinger-Ellison syndrome. This medication is widely used to improve and treat symptoms of various gastrointestinal disorders.

How to take

Adult dose

Gastric Ulcer, Duodenal Ulcer: The usual adult dosage of rabeprazole sodium is 10 mg orally once daily. Depending on symptoms, it may be taken at a dose of 20 mg orally once daily. Treatment is usually given for up to 8 weeks for gastric ulcer and up to 6 weeks for duodenal ulcer. Erosive or Ulcerative Gastroesophageal Reflux Disease: Administer 10 mg or 20 mg once daily for 4 to 8 weeks. If proton pump inhibitors are not effective after 8 weeks of treatment, additional treatment for another 8 weeks with 10 mg or 20 mg taken twice daily may be considered, but 20 mg administered twice daily should only be in patients with severe mucosal damage. Symptom relief for gastroesophageal reflux disease: Administer 10 mg once daily. If symptoms are not managed after 4 weeks, further medical evaluation is required. Once symptoms resolve, on-demand therapy of 10 mg once daily can be employed to control recurring symptoms. Long-term maintenance therapy for gastroesophageal reflux disease: Patient-specific doses of 10 mg or 20 mg orally once daily may be warranted. Helicobacter pylori eradication: Patients infected with Helicobacter pylori should undergo eradication therapy. It is recommended to combine this medication (20 mg) with clarithromycin (500 mg) and amoxicillin (1 g), administered twice daily for 7 days. Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg once daily. The dosage may be adjusted up to 120 mg daily according to individual patient needs. Doses up to 100 mg may be given once daily, whereas 120 mg should be divided into two doses of 60 mg taken twice daily. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to one year. ○ In patients with liver dysfunction: Adverse reactions have been reported in cirrhotic patients showing hepatic encephalopathy. Therefore, it should be administered with caution. ○ Children: Safety and efficacy in children have not been established. ○ Elderly: Administer with caution, as liver function is often impaired in older adults.

Child dose

Safety and efficacy in children have not been established.

Precautions

This medication should not be used in patients who have had allergies or hypersensitivity to any of its components. Warnings should be exercised in cases of allergic reactions to penicillin or macrolide antibiotics during treatment with this medication. Patients taking certain heart-related medications, as well as pregnant or breastfeeding women, should not use this medication. Caution is advised in patients with impaired liver function, elderly patients, and those with a history of allergies. This medication may cause allergic reactions such as skin rashes and itching; if symptoms occur, use should be discontinued immediately. Regular monitoring should be conducted as blood test results may show abnormalities during treatment. Liver function tests should also be conducted periodically and the medication should be discontinued if liver problems arise. Because it can also affect the heart and blood vessels, caution is needed for patients with a history of heart disease. Gastrointestinal symptoms such as diarrhea, abdominal pain, and nausea may occur and severe cases should consult a doctor. Neurological side effects such as headaches, dizziness, and insomnia have also been reported, so caution is necessary. Respiratory symptoms or side effects such as skin rashes and hair loss may also occur. This medication may affect the eyes and ears, so any changes in vision or hearing should be reported. It may also affect the kidneys and urinary system, requiring evaluation for abnormal symptoms. Long-term use may increase the risk of osteoporosis and fractures, so bone density tests may be advisable if necessary. This medication suppresses gastric acid secretion, which may increase bacterial growth in the stomach, potentially raising the risk of infections with long-term use. Caution is advised as drowsiness may occur when driving or operating machinery. There may be interactions with other medications; inform your doctor if you are taking any other medications. It is safest to avoid this medication during pregnancy or while breastfeeding. Safety has not been established for children, so it is advisable not to use it in this age group. In case of overdose, specific antidotes are not available, so appropriate treatment should be provided based on symptoms. This medication should be swallowed whole as a tablet, not chewed or crushed. Store in a tightly closed container, out of the reach of children, and do not transfer to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, severe rash with fever, blisters, peeling skin, mouth/eye mucosal pain, yellowing of skin or eyes (jaundice), profound weakness, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, marked decrease in urination, severe swelling and increased blood pressure, fulminant hepatitis, liver dysfunction,

Mild side effects

  • Rash
  • itching
  • urticaria
  • 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
  • thrombocytopenia
  • hemolytic anemia
  • increased ALT
  • increased AST
  • increased ALP
  • increased γ-GTP
  • increased LDH
  • elevated total bilirubin
  • hypertension
  • myocardial infarction
  • ECG abnormalities
  • migraine
  • syncope
  • angina
  • heart block

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air and moisture. It is advisable to maintain storage temperatures between 1°C and 30°C to prolong the medication’s effectiveness.

Appearance and packaging

Appearance

Pale yellow round enteric-coated tablets

Package unit

28 tablets/box [(14 tablets/PTP×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.