Medication info

Entiprazole Tablet 20mg (Rabeprazole Sodium)

Prescription medicationTablet경구Expired
Ingredient · strength
Rabeprazole Sodium›20mg / 1 tablet
Manufacturer / importer
한국신텍스제약(주)
Appearance
Pale yellow round enteric-coated tablet
Packaging
28 tablets/PTP[(14T/PTP x 2)]
Approval status
Expired

MFDS item code 201907671 · Approved 2019.11.01

This product's status changed to Expired on 2024.11.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of gastric ulcers and duodenal ulcers, symptom relief for gastroesophageal reflux disease, and maintenance therapy effect
Who takes it
Adults
Adult dose
For gastric ulcers and duodenal ulcers: 10 mg orally once daily. Depending on symptoms, 20 mg may be administered orally once daily. Treatment is given for up to 8 weeks for gastric ulcers and up to 6 weeks for duodenal ulcers. For erosive or ulcerative gastroesophageal reflux disease: 10 mg or 20 mg orally once daily for 4-8 weeks. If not resolved after 8 weeks of treatment, an additional 8 weeks of 10 mg or 20 mg may be administered.

Ingredients

Manufacturer
한국신텍스제약(주)

Efficacy & effects

Treatment of gastric ulcers and duodenal ulcers, symptom relief for gastroesophageal reflux disease, and maintenance therapy effect

  • Gastric ulcers
  • duodenal ulcers
  • erosive gastroesophageal reflux disease
  • ulcerative gastroesophageal reflux disease
  • gastroesophageal reflux disease
  • peptic ulcers
  • Zollinger-Ellison syndrome
View approved original text

This medication is used for gastric ulcers, duodenal ulcers, and erosive or ulcerative gastroesophageal reflux disease. It also helps relieve symptoms of gastroesophageal reflux disease and supports long-term maintenance therapy. For patients with peptic ulcers infected with Helicobacter pylori, it is administered in combination with antibiotics, and it is effective for Zollinger-Ellison syndrome as well. This medication is used to restore the health of the stomach and esophagus and improve symptoms.

How to take

Adult dose

For gastric ulcers and duodenal ulcers: 10 mg orally once daily. Depending on symptoms, 20 mg may be administered orally once daily. Treatment is given for up to 8 weeks for gastric ulcers and up to 6 weeks for duodenal ulcers. For erosive or ulcerative gastroesophageal reflux disease: 10 mg or 20 mg orally once daily for 4-8 weeks. If not resolved after 8 weeks of treatment, an additional 8 weeks of 10 mg or 20 mg may be administered.

Precautions

This medication should not be used in patients with a history of specific allergies. For instance, patients who have had hypersensitivity to this medication, its components, or to the benzimidazole class should not be administered. Additionally, it should not be used if there is an allergy to penicillin or macrolide antibiotics during Helicobacter pylori eradication therapy. Women who are pregnant or breastfeeding should not use this medication as it may affect the fetus or newborn. Patients with impaired liver function, elderly patients, and those with a history of drug allergies should use this medication cautiously. This medication contains a dye called Yellow No. 4, and individuals who have had allergic reactions to this component should be cautious. During administration, hypersensitivity reactions may occur, such as skin rashes, hives, and itching, so if such symptoms arise, discontinue use immediately. Regular blood tests and liver function tests are recommended as blood tests may show decreased red or white blood cells or abnormal liver function. Various adverse reactions have been reported, including heart-related issues, digestive symptoms, neurological symptoms, and respiratory symptoms, so consult healthcare professionals if these symptoms appear. Particularly, long-term use may increase the risk of fractures due to osteoporosis, so caution is needed. Also, this medication suppresses gastric acid secretion, which may increase the risk of bacterial infections in the gastrointestinal tract, hence if diarrhea persists, inform healthcare professionals. Be cautious of drowsiness or dizziness when driving or operating machinery. There may be interactions with other medications, so if you are taking other drugs, be sure to inform your healthcare provider. There is no specific antidote for overdose, so it's important to receive treatment for symptoms. This medication should be swallowed whole without chewing or crushing it. Keep this medication out of the reach of children and do not transfer it to other containers. Regular check-ups are advised during long-term use, and it is safest to use the minimum dose for the appropriate duration as directed by a physician.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest discomfort, difficulty breathing, cold sweat, pallor, severe rash accompanied by high fever, blisters, skin peeling, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attack, breathing difficulties accompanied by cough and fever, yellowing of skin or eyes (jaundice), severe lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • 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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  • petechial hemorrhage
  • 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
  • electrocardiogram abnormalities
  • migraine
  • syncope
  • angina
  • heart block

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to keep it at room temperature, between 1 degree and 30 degrees Celsius. This will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Pale yellow round enteric-coated tablet

Package unit

28 tablets/PTP[(14T/PTP 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.