Medication info
Rabeprazole Sodium 10 mg (Rabeprazole Sodium)

Rabeprazole Sodium 10 mg (Rabeprazole Sodium)

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

MFDS item code 202001721 · Approved 2020.03.12 · Insurance code 054800760

Summary

Main use
Relief of symptoms of gastric ulcer, duodenal ulcer, and gastroesophageal reflux disease, and treatment of Helicobacter pylori infection
Who takes it
Adults · Children
Adult dose
Typically, 10 mg of rabeprazole sodium is administered orally once daily to adults. Depending on the symptoms, it may be given as 20 mg orally once daily. Typically, it is administered for up to 8 weeks for gastric ulcers and up to 6 weeks for duodenal ulcers. For erosive or ulcerative gastroesophageal reflux disease, it is administered once daily as 10 mg or 20 mg for 4 to 8 weeks. If untreated, an additional 8 weeks of 10 mg or 20 mg may be given.
Child dose
Safety in children has not been established.

Ingredients

Manufacturer
엔비케이제약(주)

Efficacy & effects

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

  • Gastric ulcer
  • duodenal ulcer
  • 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 gastric ulcer, duodenal ulcer, and erosive or ulcerative gastroesophageal reflux disease. It also helps alleviate symptoms of gastroesophageal reflux disease and assists in the long-term maintenance therapy of this condition. It is effective when used in combination with antibiotics for patients with gastrointestinal ulcers infected with Helicobacter pylori. It is also applicable for Zollinger-Ellison syndrome, helping to control excessive gastric acid secretion. It is widely used in the treatment and management of major gastrointestinal diseases.

How to take

Adult dose

Typically, 10 mg of rabeprazole sodium is administered orally once daily to adults. Depending on the symptoms, it may be given as 20 mg orally once daily. Typically, it is administered for up to 8 weeks for gastric ulcers and up to 6 weeks for duodenal ulcers. For erosive or ulcerative gastroesophageal reflux disease, it is administered once daily as 10 mg or 20 mg for 4 to 8 weeks. If untreated, an additional 8 weeks of 10 mg or 20 mg may be given.

Child dose

Safety in children has not been established.

Precautions

This medication should not be used in patients with specific allergic reactions or hypersensitivity to this drug or its components. It is safer for women who are pregnant or breastfeeding not to take this medication. Patients with liver function issues or elderly individuals should use this drug carefully, and caution is needed in those with a history of drug hypersensitivity. If symptoms of hypersensitivity such as rash, urticaria, or itching occur during the use of this drug, it should be discontinued immediately, and a doctor should be consulted. It is important to regularly monitor for adverse reactions through blood tests or liver function tests. This drug may cause various side effects such as gastrointestinal symptoms, cardiac-related anomalies, and neurological symptoms; if any symptoms occur, inform medical personnel. Long-term use may increase the risk of osteoporosis and fractures, so management of bone health is necessary if used for an extended period. This medication may interact with other drugs; if other medications are being taken, it must be reported to the medical staff. Particular caution is needed when used in conjunction with certain antibiotics, antivirals, and anticoagulants, and it should not be combined with some medications. Caution is advised when driving or operating machinery, as drowsiness may occur during the use of this drug. While taking this medication, do not chew or crush the tablet; it should be swallowed whole. It should be kept out of reach of children, and transferring to another container is not recommended. In case of overdose, there is no specific antidote, so treatment and supportive therapy based on symptoms should be undertaken.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, fulminant hepatitis, liver dysfunction, jaundice, headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, severe edema accompanied by elevated blood pressure, hematuria, thrombocytopenia, agranulocytosis, hemolytic anemia, erythema multiforme, systemic lupus erythematosus, toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, hepatic encephalopathy, acute interstitial nephritis

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
  • hypochromic anemia
  • pancytopenia
  • agranulocytosis
  • thrombocytopenia
  • hemolytic anemia
  • elevated ALT
  • elevated AST
  • elevated ALP
  • elevated GTP
  • elevated LDH
  • elevated total bilirubin
  • hypertension
  • myocardial infarction
  • ECG abnormalities
  • migraine
  • syncope
  • angina
  • heart block
  • palpitations

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 or moisture. The optimal storage temperature is between 1 and 30 degrees Celsius, to maintain the efficacy and safety of the drug for a long time.

Appearance and packaging

Appearance

Pale yellow, round enteric-coated tablet

Package unit

For domestic use - 28 tablets/Alu-Alu [(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.

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.