Medication info
New Label Tablet 10 mg (Rabeprazole Sodium)

New Label Tablet 10 mg (Rabeprazole Sodium)

Prescription medicationTablet경구
Ingredient · strength
Rabeprazole Sodium›10mg / 1 tablet
Manufacturer / importer
(주)종근당
Appearance
Pale yellow round enteric-coated tablet
Packaging
28 tablets (14 tablets/ALUALUx2), 56 tablets (14 tablets/ALUALUx4)
Approval status
Active

MFDS item code 200800405 · Notified 2008.01.09 · Insurance code 643304530

Summary

Main use
Treatment of gastric ulcers and duodenal ulcers, alleviation of gastroesophageal reflux disease symptoms and maintenance therapy, combination therapy with antibiotics for Helicobacter pylori infection-related gastrointestinal ulcers, treatment of Zollinger-Ellison syndrome.
Who takes it
Adults · Children
Adult dose
For gastric ulcers and duodenal ulcers: Typically, rabeprazole sodium 10 mg is administered orally once daily for adults. Depending on symptoms, it can be administered orally once daily at 20 mg. Administer for up to 8 weeks for gastric ulcers and up to 6 weeks for duodenal ulcers. Erosive or ulcerative gastroesophageal reflux disease: Administer 10 mg or 20 mg once daily for 4 to 8 weeks. If symptoms persist after 8 weeks of treatment, further treatment may be required.
Child dose
Safety for children has not been established.

Ingredients

Manufacturer
(주)종근당

Efficacy & effects

Treatment of gastric ulcers and duodenal ulcers, alleviation of gastroesophageal reflux disease symptoms and maintenance therapy, combination therapy with antibiotics for Helicobacter pylori infection-related gastrointestinal ulcers, treatment of Zollinger-Ellison syndrome.

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

This medication is used to treat gastric ulcers and duodenal ulcers. It also alleviates the symptoms of erosive or ulcerative gastroesophageal reflux disease and is effective for long-term maintenance therapy of gastroesophageal reflux disease. For gastrointestinal ulcer patients infected with Helicobacter pylori, it is combined with antibiotics for treatment. Additionally, it is rarely used for the treatment of Zollinger-Ellison syndrome. This medication helps treat various diseases of the stomach and esophagus.

How to take

Adult dose

For gastric ulcers and duodenal ulcers: Typically, rabeprazole sodium 10 mg is administered orally once daily for adults. Depending on symptoms, it can be administered orally once daily at 20 mg. Administer for up to 8 weeks for gastric ulcers and up to 6 weeks for duodenal ulcers. Erosive or ulcerative gastroesophageal reflux disease: Administer 10 mg or 20 mg once daily for 4 to 8 weeks. If symptoms persist after 8 weeks of treatment, further treatment may be required.

Child dose

Safety for children has not been established.

Precautions

This medication should not be administered to certain patients. For example, patients who have had allergies or hypersensitivity reactions to this medication or its components, and those allergic to specific antibiotics should not take this medication. Also, it is safest not to use this medication during pregnancy or breastfeeding. Patients with liver function issues, the elderly, or those with a history of drug allergies should use this medication with caution. This medication can cause hypersensitivity reactions such as skin rash and itching, so if these symptoms occur, the patient should stop use immediately. Regular blood tests are recommended since red or white blood cell counts may change. Liver function tests should also be conducted regularly, as liver function indicators may increase. Care should be taken as it can affect the heart or blood vessels; if cardiovascular symptoms occur, caution is needed. Gastrointestinal symptoms such as diarrhea, abdominal pain, nausea, or vomiting may occur; if these symptoms arise, consulting a doctor is necessary. Because it can affect the neurological system, headaches, insomnia, and dizziness may occur. If respiratory symptoms such as cough or difficulty breathing occur, medical personnel should be notified immediately. Musculoskeletal issues such as muscle pain or joint pain have also been reported, so caution is advised. Severe skin reactions, including rashes, hair loss, or in severe cases, Stevens-Johnson syndrome, may occur. Vision or hearing problems may arise, so if changes in vision or tinnitus occur, confirmation is necessary. Urological issues may also arise, so if there are difficulties in urination or hematuria, the patient should consult medical personnel. Long-term use of this medication may increase the risk of fractures, so caution is warranted. Additionally, hypomagnesemia, which is a decrease in blood magnesium levels, may occur, necessitating regular tests and supplementation when necessary. This medication can interact with other drugs, so it is important to inform healthcare providers of other medications being taken. Particularly caution is needed when combined with medications that affect blood coagulation, antibiotics, or antivirals. During pregnancy or breastfeeding, it is safest not to use this medication due to insufficient safety data. Elderly patients are at higher risk of side effects due to decreased liver function, so caution is advised when prescribing. Safety for children has not been established, so use is not recommended. In the event of overdose, there is no specific antidote, so treatment should be symptomatic. This medication should be swallowed whole, not chewed or crushed, and kept out of reach of children. When used over a long period, patients should undergo regular examinations as directed by their doctor, and seek immediate consultation if abnormal symptoms appear.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain of oral/ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, liver dysfunction (jaundice), sudden and severe headache, lightning headache, seizures.

Mild side effects

  • Rash
  • itching
  • decreased red blood cells
  • decreased white blood cells
  • increased white blood cells
  • increased eosinophils
  • increased neutrophils
  • decreased lymphocytes
  • anemia
  • purpura
Show 20 more
  • 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
  • electrocardiogram abnormalities
  • migraine
  • syncope
  • angina pectoris
  • 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 tightly sealed container. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. This helps preserve the medication's effectiveness.

Appearance and packaging

Appearance

Pale yellow round enteric-coated tablet

Package unit

28 tablets (14 tablets/ALUALUx2), 56 tablets (14 tablets/ALUALUx4)

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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.