Medication info
Rabeprazole Sodium 10 mg Tablet

Rabeprazole Sodium 10 mg Tablet

Prescription medicationTablet경구
Ingredient · strength
Rabeprazole Sodium›10mg / 1 tablet
Manufacturer / importer
한국코러스(주)
Appearance
Yellowish round enteric-coated tablet
Packaging
(Domestic) 28 tablets (14 tablets/AluAluX2) (Export) 10 tablets/PTP,
Approval status
Active

MFDS item code 201403528 · Approved 2014.07.31 · Insurance code 647203690

Summary

Main use
Treatment of gastric ulcers and duodenal ulcers, alleviation of symptoms and maintenance therapy for gastroesophageal reflux disease, antibiotic combination therapy for gastrointestinal ulcers infected by Helicobacter pylori, treatment for Zollinger-Ellison syndrome.
Who takes it
Adults
Adult dose
For gastric ulcers and duodenal ulcers: 10 mg is administered orally once daily, and depending on symptoms, may be increased to 20 mg once daily. Treatment duration is 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 is administered once daily for 4 to 8 weeks. If treatment is unsuccessful, an additional 8 weeks of 10 mg or 20 mg may be taken twice daily orally. For the maintenance therapy of gastroesophageal reflux disease symptoms: 10 mg is administered once daily. If symptoms do not improve after 4 weeks, further evaluation is needed. After symptoms are resolved, on-demand therapy can be utilized with 10 mg taken once daily as needed. For long-term maintenance therapy of gastroesophageal reflux disease: patients may take 10 mg or 20 mg orally once daily, depending on individual needs. For Helicobacter pylori eradication: patients infected with Helicobacter pylori should undergo eradication therapy. It is recommended to combine this drug 20 mg with clarithromycin 500 mg and amoxicillin 1 g, administered twice daily for 7 days. For 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 needs. Up to 100 mg can be taken once daily, and the 120 mg dose should be divided into two doses of 60 mg each day. Patients with Zollinger-Ellison syndrome have been treated with this drug for up to one year. ◯ In patients with liver disease There have been reports of adverse reactions related to hepatic encephalopathy in patients with liver cirrhosis; therefore, administration should be done with caution. ◯ In pediatric patients Safety in pediatric patients has not been established. ◯ In the elderly Caution is needed due to frequently diminished liver function.

Ingredients

Manufacturer
한국코러스(주)

Efficacy & effects

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

  • 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, as well as erosive and ulcerative gastroesophageal reflux disease. It is also effective in alleviating symptoms of gastroesophageal reflux disease and long-term maintenance therapy. In patients with gastrointestinal ulcers infected by Helicobacter pylori, it is used in combination with antibiotics to enhance therapeutic effects. It also helps in the treatment of Zollinger-Ellison syndrome. Overall, this medication is used for the treatment of various diseases of the stomach and esophagus.

How to take

Adult dose

For gastric ulcers and duodenal ulcers: 10 mg is administered orally once daily, and depending on symptoms, may be increased to 20 mg once daily. Treatment duration is 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 is administered once daily for 4 to 8 weeks. If treatment is unsuccessful, an additional 8 weeks of 10 mg or 20 mg may be taken twice daily orally. For the maintenance therapy of gastroesophageal reflux disease symptoms: 10 mg is administered once daily. If symptoms do not improve after 4 weeks, further evaluation is needed. After symptoms are resolved, on-demand therapy can be utilized with 10 mg taken once daily as needed. For long-term maintenance therapy of gastroesophageal reflux disease: patients may take 10 mg or 20 mg orally once daily, depending on individual needs. For Helicobacter pylori eradication: patients infected with Helicobacter pylori should undergo eradication therapy. It is recommended to combine this drug 20 mg with clarithromycin 500 mg and amoxicillin 1 g, administered twice daily for 7 days. For 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 needs. Up to 100 mg can be taken once daily, and the 120 mg dose should be divided into two doses of 60 mg each day. Patients with Zollinger-Ellison syndrome have been treated with this drug for up to one year. ◯ In patients with liver disease There have been reports of adverse reactions related to hepatic encephalopathy in patients with liver cirrhosis; therefore, administration should be done with caution. ◯ In pediatric patients Safety in pediatric patients has not been established. ◯ In the elderly Caution is needed due to frequently diminished liver function.

Precautions

This medication should not be used in certain patients. First, individuals who have a history of allergic reactions to this medication or its ingredients, or to benzimidazoles, should not take it. Caution is also necessary for those allergic to penicillin or macrolide antibiotics when used in Helicobacter pylori eradication therapy. Furthermore, individuals taking certain heart medications or antiviral drugs, as well as pregnant or breastfeeding women, should avoid this medication. Patients with liver dysfunction, the elderly, or those with a history of drug allergies should use this medication with caution. This medication contains the dye Yellow No. 4, so those sensitive to this ingredient should also exercise caution. During treatment, allergic symptoms such as skin rash, hives, and itching may occur, and if these symptoms arise, the medication should be discontinued immediately. Regular blood tests are recommended as abnormalities in red or white blood cell counts may occur. There may also be signs of liver dysfunction, so liver function tests should be conducted periodically. Various side effects may occur in different body areas including the heart, blood vessels, gastrointestinal tract, nervous system, respiratory system, muscles and joints, skin, eyes, and urinary tract; consult a healthcare professional if unusual symptoms develop. If this medication is taken long term, especially for more than one year, regular examinations are required, and caution should be taken regarding the risk of side effects such as osteoporosis or hypomagnesemia. Additionally, because this medication suppresses gastric acid secretion, the risk of certain bacterial infections may increase slightly, and if diarrhea persists, inform a healthcare professional. Caution is necessary as drowsiness may occur when driving or operating machinery. There may be interactions with other medications, especially antibiotics, anticoagulants, antiviral drugs, and antifungal agents; always consult a physician or pharmacist when taking them together. It is safest to avoid this medication during pregnancy or breastfeeding, and safety in children has not been established. In cases of overdose, there is no specific antidote, so treatment should be symptomatic. This medication should be swallowed whole and not chewed or crushed. Store this medication out of reach of children, and it is best not to transfer it to another container. Finally, if symptoms of autoimmune diseases such as skin or systemic lupus erythematosus appear during treatment, the medication should be discontinued immediately, and a specialist should be consulted.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, fulminant hepatitis, liver dysfunction, jaundice, migraine, seizures, confusion, visual disturbances, paralysis, elevated blood pressure, kidney dysfunction, decreased platelets, agranulocytosis, hemolytic anemia, severe allergic reactions, severe skin reactions, respiratory problems, liver abnormalities (jaundice), severe neurological symptoms, severe swelling or urinary disturbances, toxic epidermal necrolysis (Lyell's syndrome),

Mild side effects

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

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a sealed container. It is best kept at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellowish round enteric-coated tablet

Package unit

(Domestic) 28 tablets (14 tablets/AluAluX2) (Export) 10 tablets/PTP,

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.