Medication info
Rabeprazole Sodium 20 mg Tablets

Rabeprazole Sodium 20 mg Tablets

Prescription medicationTablet경구
Ingredient · strength
Rabeprazole Sodium›20mg / 1 tablet
Manufacturer / importer
엔비케이제약(주)
Appearance
Pale yellow, round, enteric-coated tablet
Packaging
Domestic use - 28 tablets/Alu-Alu [(14 tablets/Alu-Alu x 2)]
Approval status
Active

MFDS item code 202001722 · Approved 2020.03.12 · Insurance code 054800800

Summary

Main use
Treatment of gastric ulcers and duodenal ulcers, relief of symptoms of gastroesophageal reflux disease and maintenance therapy, combination therapy with antibiotics for Helicobacter pylori infected gastric ulcers, etc.
Who takes it
Adults · Children
Adult dose
Typically, Rabeprazole Sodium 10 mg is administered orally once daily to adults. Depending on symptoms, it may be increased to 20 mg once daily. Gastric ulcers are treated for up to 8 weeks, and duodenal ulcers for up to 6 weeks. For erosive or ulcerative gastroesophageal reflux disease, 10 mg or 20 mg is given orally once daily for 4 to 8 weeks. If not resolved after 8 weeks, it may be continued for another 8 weeks at 10 mg or 20 mg.
Child dose
Safety in children has not been established.

Ingredients

Manufacturer
엔비케이제약(주)

Efficacy & effects

Treatment of gastric ulcers and duodenal ulcers, relief of symptoms of gastroesophageal reflux disease and maintenance therapy, combination therapy with antibiotics for Helicobacter pylori infected gastric ulcers, etc.

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

This medication is used to treat digestive ulcers such as gastric ulcers and duodenal ulcers. It also improves symptoms in patients with erosive or ulcerative gastroesophageal reflux disease, and is effective for long-term maintenance therapy of this condition. In patients with Helicobacter pylori infected gastric ulcers, it is used in conjunction with antibiotics to enhance treatment efficacy. It is also beneficial for the treatment of Zollinger-Ellison syndrome. Overall, it is widely used for relief and treatment of various gastrointestinal-related conditions.

How to take

Adult dose

Typically, Rabeprazole Sodium 10 mg is administered orally once daily to adults. Depending on symptoms, it may be increased to 20 mg once daily. Gastric ulcers are treated for up to 8 weeks, and duodenal ulcers for up to 6 weeks. For erosive or ulcerative gastroesophageal reflux disease, 10 mg or 20 mg is given orally once daily for 4 to 8 weeks. If not resolved after 8 weeks, it may be continued for another 8 weeks at 10 mg or 20 mg.

Child dose

Safety in children has not been established.

Precautions

This medication should not be used in patients who have had hypersensitivity to certain ingredients or benzimidazole derivatives. Patients who are allergic to penicillin or macrolide antibiotics should also be cautious when using this drug. Especially, patients taking terfenadine, cisapride, pimodizole, or astemizole should not use this medication in combination. It is also safer for patients receiving atazanavir or rilpivirine, and women who are pregnant or breastfeeding should not use this medication. Patients with poor liver function or elderly individuals should use this drug cautiously, as should those with a history of drug allergies. During use, hypersensitivity reactions may occur, such as skin rash, hives, and itching, and if these symptoms appear, use should be stopped immediately. Blood tests are recommended to monitor for abnormalities like decreases in red or white blood cells. Regular liver function tests should be conducted to check for increased liver enzymes, hepatitis or jaundice symptoms, and the medication should be stopped if they arise. Cardiovascular-side effects like elevated blood pressure, myocardial infarction, and arrhythmias may rarely occur, and symptoms should be consulted with a healthcare professional. Gastrointestinal symptoms can include diarrhea, abdominal pain, dyspepsia, nausea, and vomiting. Neuropsychiatric side effects like headache, insomnia, dizziness, and depression have been reported, and rarely neurological symptoms may arise. Respiratory issues can include cough, asthma, and shortness of breath, and if pneumonia symptoms appear, use of the medication should be stopped immediately and a diagnosis sought. Musculoskeletal symptoms such as myalgia and arthralgia can also occur. Dermatological side effects include rashes, itching, hives, hair loss, and in severe cases, serious skin reactions such as Stevens-Johnson syndrome. Ocular side effects reported include blurred vision, tinnitus, and dry eyes. Urinary side effects can include proteinuria, cystitis, and difficulty urinating. Long-term use of this medication may increase the risk of fractures related to osteoporosis, so caution is advised. Hypomagnesemia may rarely occur, and magnesium levels should be monitored periodically during long-term use or when used with certain medications. This medication can increase the risk of bacterial overgrowth in the gastrointestinal tract by suppressing gastric acid secretion, so if diarrhea persists, a doctor should be consulted. Caution is required when driving or operating machinery as drowsiness may occur. There may be interactions with other medications, so particularly with warfarin, methotrexate, antibiotics, advice from a doctor is recommended during combination use. Safety has not been established during pregnancy or lactation, hence it should not be used. Elderly individuals may have higher risks of adverse effects due to declining liver function, so discontinuing the medication should be considered if symptoms arise. Safety in children has not been established, so it is recommended not to use it. In cases of overdose, there are no specific antidotes, so treatment according to symptoms is important. This medication should be swallowed whole without chewing or crushing, and kept out of the reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, fulminant hepatitis, liver dysfunction, jaundice, headache, seizure, confusion, visual abnormalities, paralysis, severe swelling with elevated blood pressure, thrombocytopenia, agranulocytosis, hemolytic anemia, nephritis, toxic epidermal necrolysis (Lyell syndrome), mucocutaneous syndrome (Stevens-Johnson syndrome), Clostridium difficile associated diarrhea, anaphylactic reaction, shock, vascular accidents

Mild side effects

  • Rash
  • itching
  • reduced red blood cells
  • reduced 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 γ-GTP
  • elevated LDH
  • abdominal pain
  • abdominal distension
  • dyspepsia
  • burping
  • nausea
  • diarrhea
  • constipation
  • headache
  • insomnia
  • anxiety
  • dizziness
  • tremor

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

Storage

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture. It is also safe to store at room temperature, ideally between 1 and 30 degrees Celsius, avoiding extreme heat or cold.

Appearance and packaging

Appearance

Pale yellow, round, enteric-coated tablet

Package unit

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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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.