Medication info
Rabeprazole Sodium 20 mg Tablets

Rabeprazole Sodium 20 mg Tablets

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

MFDS item code 201905356 · Approved 2019.07.29

Summary

Main use
Relief of symptoms of gastric ulcer and gastroesophageal reflux disease, and treatment of Helicobacter pylori infection
Who takes it
Adults
Adult dose
For gastric ulcer and duodenal ulcer: Typically, 10 mg orally once a day, with a maximum dose of 20 mg per day depending on symptoms. Administer for a maximum of 8 weeks for gastric ulcer and a maximum of 6 weeks for duodenal ulcer. For erosive or ulcerative gastroesophageal reflux disease: Administer either 10 mg or 20 mg once daily for 4 to 8 weeks. If not treated, an additional 8 weeks of 10 mg or 20 mg may be given twice a day.

Ingredients

Manufacturer
독립바이오제약(주)

Efficacy & effects

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

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

This medication is primarily used to treat gastric and duodenal ulcers. It also relieves symptoms of erosive or ulcerative gastroesophageal reflux disease and is effective for long-term maintenance therapy of this condition. It is used in combination with antibiotics to treat patients with digestive ulcers infected by Helicobacter pylori. It is also used in patients with Zollinger-Ellison syndrome to control excessive gastric acid secretion. This medication helps improve symptoms of various digestive-related ulcers and esophageal diseases.

How to take

Adult dose

For gastric ulcer and duodenal ulcer: Typically, 10 mg orally once a day, with a maximum dose of 20 mg per day depending on symptoms. Administer for a maximum of 8 weeks for gastric ulcer and a maximum of 6 weeks for duodenal ulcer. For erosive or ulcerative gastroesophageal reflux disease: Administer either 10 mg or 20 mg once daily for 4 to 8 weeks. If not treated, an additional 8 weeks of 10 mg or 20 mg may be given twice a day.

Precautions

This medication should not be used in patients with certain allergic reactions. For example, it should not be administered to those with hypersensitivity to this medication or its components, or to benzimidazole derivatives. Additionally, caution is needed when using this medication in patients allergic to penicillin or macrolide antibiotics, especially in combination therapy with antibiotics for the eradication of Helicobacter pylori. It should not be used by pregnant or breastfeeding women as it may affect the fetus or newborn. Patients with decreased liver function, the elderly, and those with a history of drug allergies should use this medication with caution. Allergic reactions such as skin rash or itching may occur; if such symptoms arise, stop taking the medication immediately and consult a doctor. Regular blood tests may be necessary as changes in red blood cells, white blood cells, and platelet counts can occur. Liver function abnormalities may also occur; hence, regular liver function tests are advisable. Cardiac symptoms, changes in blood pressure, headaches, and dizziness have also been reported, so attention should be given if these symptoms occur. Digestive symptoms may include diarrhea, abdominal pain, and nausea, and any abnormal symptoms should be reported to a doctor. It may affect the mental and neurological system, leading to anxiety, insomnia, drowsiness, and depression, so caution is needed. Respiratory symptoms, muscle pain, joint pain, and skin adverse reactions have also been reported, so consultation with healthcare personnel is recommended if symptoms arise. Long-term use of this medication may increase the risk of osteoporosis and fractures, hence being cautious during prolonged usage is necessary. Hypomagnesemia may rarely occur, so patients taking this medication long-term or in conjunction with certain drugs should regularly check magnesium levels. As this medication strongly suppresses gastric acid secretion, there is a slightly increased risk of gastrointestinal bacterial infections. Particularly, if diarrhea persists for a long time, consult a doctor. Caution is necessary while driving or operating machinery as drowsiness may occur. There may be interactions with other medications, so especially if taking antibiotics, anticoagulants, or antiviral drugs, it is essential to inform a doctor. This medication should not be chewed or crushed, but taken whole in tablet form, and stored out of reach of children. In case of overdose, there is no specific antidote, but appropriate treatment should be provided based on symptoms, as the medication is not easily dialyzable. Finally, long-term use of this medication may lead to vitamin B12 absorption disorders, so monitoring of this is necessary during prolonged usage.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), chest tightness, breathing difficulties → severe allergic reactions.
  • Fulminant hepatitis, liver dysfunction, jaundice → liver abnormalities (jaundice).
  • Severe rash, blisters, skin peeling, oral/ocular mucosal pain → severe skin abnormalities.
  • Dyspnea, asthma, apneas, respiratory depression → respiratory issues.
  • Severe neurological symptoms: sudden and severe headaches, lightning headaches, seizures, confusion, visual disturbances, paralysis.

Mild side effects

  • Occasionally rash
  • hives
  • itching
  • 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
  • hypochromic anemia
  • pancytopenia
  • agranulocytosis
  • decreased platelets
  • hemolytic anemia
  • elevated ALT
  • elevated AST
  • elevated ALP
  • elevated γ-GTP
  • elevated LDH
  • elevated total bilirubin
  • hypertension
  • myocardial infarction
  • ECG abnormalities
  • migraines
  • syncope
  • angina.

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

Storage

This medication can be sensitive to air and moisture, so it must be stored in a tightly closed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius. Proper storage will ensure the medication's effectiveness.

Appearance and packaging

Appearance

Pale yellow round enteric coated tablets

Package unit

28 tablets (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.