Medication info

New Bephra Tablet 20 Milligrams (Rabeprazole Sodium)

Prescription medicationApproval withdrawn
Ingredient · strength
Rabeprazole Sodium›Strength being verified
Manufacturer / importer
메딕스제약(주)
Appearance
Pale yellow round enteric-coated tablet
Packaging
28 tablets/box [(14 tablets/PTP×2)]
Approval status
Approval withdrawn

MFDS item code 201901831 · Approved 2019.03.27

This product's status changed to Approval withdrawn on 2023.08.23. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of symptoms of gastric ulcers and gastroesophageal reflux disease, and treatment effect for Helicobacter pylori infection
Who uses it
Adults
Adult dosage
Gastric ulcer, duodenal ulcer: Typically, 10 mg is administered orally once daily. According to symptoms, 20 mg may be taken orally once daily. Typically, treatments are given 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 not treated, an additional 8 weeks of 10 mg or 20 mg may be taken once daily.

Ingredients

Manufacturer
메딕스제약(주)

Efficacy & effects

Relief of symptoms of gastric ulcers and gastroesophageal reflux disease, and treatment effect for Helicobacter pylori infection

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

This medication is used for the treatment of gastric ulcers and duodenal ulcers, and alleviates the symptoms of erosive or ulcerative gastroesophageal reflux disease. It is also effective for long-term maintenance therapy of gastroesophageal reflux disease. For patients with gastrointestinal ulcers caused by Helicobacter pylori infection, it is used in combination with antibiotics to enhance therapeutic effects. It is also used for acid-related disorders such as Zollinger-Ellison syndrome. This medication helps improve the symptoms of various gastrointestinal disorders.

Dosage and Administration

Adult dosage

Gastric ulcer, duodenal ulcer: Typically, 10 mg is administered orally once daily. According to symptoms, 20 mg may be taken orally once daily. Typically, treatments are given 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 not treated, an additional 8 weeks of 10 mg or 20 mg may be taken once daily.

Precautions

This medication should not be administered to patients with allergies to specific components or a history of hypersensitivity. Caution is especially needed for individuals allergic to penicillin or macrolide antibiotics. It is safest not to use this medication during pregnancy or while breastfeeding. Patients with liver function issues or the elderly should use this medication with caution, and those with a history of hypersensitivity should also be cautious. This medication may cause allergic symptoms such as skin rash, hives, and itching, and should be discontinued immediately if these symptoms occur. Regular blood tests are necessary as the red or white blood cell counts may change, and liver function tests should also be performed. Caution is needed for patients with cardiovascular diseases, as this medication may affect the heart or blood pressure. Gastrointestinal symptoms such as diarrhea, constipation, abdominal pain, nausea, and vomiting may occur, and in severe cases, immediate consultation with a doctor is advised. Neurological symptoms such as headache, dizziness, insomnia, and drowsiness may also occur; if symptoms are severe, discontinue use and consult a professional. Respiratory issues or musculoskeletal pain have also been reported, so caution is necessary if related symptoms arise. Serious skin reactions may occur, so inform medical personnel immediately if rashes or changes in the skin appear. Vision or hearing abnormalities may develop, so caution is necessary if symptoms such as blurred vision, tinnitus, or hearing loss occur. This medication can affect blood coagulation, so consult a doctor if consuming blood-coagulation related medications. Long-term use may increase the risk of osteoporosis and fractures, so regular monitoring is needed for long-term use. This medication suppresses gastric acid secretion, potentially increasing the risk of bacterial infections in the gastrointestinal tract; notify medical personnel immediately if diarrhea persists. Drowsiness may occur while driving or operating machinery, so caution is advised. Drug interactions may exist, so inform medical personnel of any other medications being taken. The tablets should be swallowed whole without chewing or crushing, and stored out of reach of children. There is no specific antidote for overdose; appropriate treatment should be sought depending on symptoms.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough+fever, respiratory problems, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and

Mild side effects

  • Rash
  • itching
  • hives
  • 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
  • hypopigmented anemia
  • pancytopenia
  • agranulocytosis
  • decreased platelets
  • hemolytic anemia
  • elevated ALT
  • elevated AST
  • elevated ALP
  • elevated γ-GTP
  • elevated LDH
  • elevated total bilirubin
  • hypertension
  • myocardial infarction
  • abnormal electrocardiogram
  • migraine
  • syncope
  • angina
  • cardiac block

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. It is best to maintain storage temperatures between 1 to 30 degrees Celsius to safely preserve the medication's efficacy.

Appearance and packaging

Appearance

Pale yellow round enteric-coated tablet

Package unit

28 tablets/box [(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.

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.