Medication info
Newbera Tablet 20 mg (Rabeprazole Sodium)

Newbera Tablet 20 mg (Rabeprazole Sodium)

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

MFDS item code 201603479 · Approved 2016.06.15 · Insurance code 053600340

Summary

Main use
Treatment of gastric ulcers and duodenal ulcers, alleviation of symptoms and maintenance therapy for gastroesophageal reflux disease
Who takes it
Adults · Children
Adult dose
For gastric ulcers and duodenal ulcers: Administer 10 mg orally once daily. Depending on symptoms, 20 mg may be administered orally once daily. Typically administered for up to 8 weeks for gastric ulcers and 6 weeks for duodenal ulcers. For erosive or ulcerative gastroesophageal reflux disease: Administer 10 mg or 20 mg once daily for 4 to 8 weeks. If not resolved after 8 weeks of proton pump inhibitor therapy, an additional 8 weeks of 10 mg or 20 mg may be administered orally twice daily, but 20 mg twice daily is for patients with severe mucosal damage confirmed. For alleviation of symptoms of gastroesophageal reflux disease: Administer 10 mg once daily. If symptoms are not controlled after 4 weeks of administration, additional medical care is required. Once symptoms have resolved, on-demand therapy using 10 mg once daily may be used to control any symptoms that appear later. For long-term maintenance therapy of gastroesophageal reflux disease: Administer 10 mg or 20 mg orally once daily, depending on the patient. For eradication of Helicobacter pylori: Patients infected with Helicobacter pylori should receive eradication therapy. It is recommended to administer this medication 20 mg along with Clarithromycin 500 mg and Amoxicillin 1 g, twice daily for 7 days. For Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg once daily. The dosage may be adjusted up to 120 mg daily, depending on patients' needs. A dosage of 100 mg may be administered once daily, while 120 mg should be divided into 60 mg doses taken twice daily. Patients with Zollinger-Ellison syndrome have been administered this medication for up to 1 year. ◯ Patients with liver disease Adverse reactions have been reported in patients with liver cirrhosis. Therefore, it should be administered cautiously. ◯ Children The safety of this medication has not been established in children. ◯ Elderly Caution is needed in the elderly as liver function may be impaired.
Child dose
The safety of this medication has not been established in children.

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

Treatment of gastric ulcers and duodenal ulcers, alleviation of symptoms and maintenance therapy for gastroesophageal reflux disease

  • Gastric ulcers
  • duodenal ulcers
  • 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 to treat gastric ulcers and duodenal ulcers. It also alleviates symptoms of erosive or ulcerative gastroesophageal reflux disease and is effective for long-term maintenance therapy of gastroesophageal reflux disease. It is used in combination with antibiotics for the treatment of gastrointestinal ulcers infected with Helicobacter pylori. Additionally, it is applied in Zollinger-Ellison syndrome to improve symptoms. This medication helps maintain the health of the stomach and esophagus and effectively treats symptoms.

How to take

Adult dose

For gastric ulcers and duodenal ulcers: Administer 10 mg orally once daily. Depending on symptoms, 20 mg may be administered orally once daily. Typically administered for up to 8 weeks for gastric ulcers and 6 weeks for duodenal ulcers. For erosive or ulcerative gastroesophageal reflux disease: Administer 10 mg or 20 mg once daily for 4 to 8 weeks. If not resolved after 8 weeks of proton pump inhibitor therapy, an additional 8 weeks of 10 mg or 20 mg may be administered orally twice daily, but 20 mg twice daily is for patients with severe mucosal damage confirmed. For alleviation of symptoms of gastroesophageal reflux disease: Administer 10 mg once daily. If symptoms are not controlled after 4 weeks of administration, additional medical care is required. Once symptoms have resolved, on-demand therapy using 10 mg once daily may be used to control any symptoms that appear later. For long-term maintenance therapy of gastroesophageal reflux disease: Administer 10 mg or 20 mg orally once daily, depending on the patient. For eradication of Helicobacter pylori: Patients infected with Helicobacter pylori should receive eradication therapy. It is recommended to administer this medication 20 mg along with Clarithromycin 500 mg and Amoxicillin 1 g, twice daily for 7 days. For Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg once daily. The dosage may be adjusted up to 120 mg daily, depending on patients' needs. A dosage of 100 mg may be administered once daily, while 120 mg should be divided into 60 mg doses taken twice daily. Patients with Zollinger-Ellison syndrome have been administered this medication for up to 1 year. ◯ Patients with liver disease Adverse reactions have been reported in patients with liver cirrhosis. Therefore, it should be administered cautiously. ◯ Children The safety of this medication has not been established in children. ◯ Elderly Caution is needed in the elderly as liver function may be impaired.

Child dose

The safety of this medication has not been established in children.

Precautions

This medication should not be used by individuals who are allergic to specific components or have a history of hypersensitivity. The safety of this medication has not been established in pregnant or breastfeeding women, and its use should be avoided. Patients with impaired liver function or the elderly should use this medication cautiously, and those with a history of allergic reactions to medications should also be careful. If symptoms of allergy such as skin rash or itching occur while taking this medication, it must be stopped immediately. It is advisable to have regular blood tests and liver function tests while taking this medication, and if any unusual symptoms are observed, consult a healthcare professional immediately. Because it may affect the heart or blood vessels, precaution is advised for individuals with cardiovascular disease. Gastrointestinal symptoms such as diarrhea, abdominal pain, and nausea may occur, so if these symptoms persist, inform a healthcare professional. Psychological symptoms such as headaches, dizziness, and insomnia may occur, and drowsiness may result, so caution is necessary when driving or operating machinery. Various side effects such as respiratory symptoms, muscle pain, and skin rash have been reported, so unusual symptoms should be monitored closely. This medication may interact with other drugs, so if you are taking other medications, it is important to inform your healthcare provider. Particularly when used with antibiotics, antivirals, anticoagulants, etc., follow the instructions of a healthcare professional. Long-term use may increase the risk of bone fractures, so regular check-ups are necessary for long-term users. Hypomagnesemia, which is a decrease in blood magnesium levels, can occur rarely, so for those using this medication long term or in combination with certain drugs, blood magnesium levels should be monitored periodically. This medication suppresses gastric acid secretion, which may somewhat increase the risk of bacterial infections in the stomach, so if diarrhea persists, consult a healthcare professional. There is no specific antidote in case of overdose, so receive treatment according to the symptoms, and do not chew or crush the tablets; swallow them whole. Keep this medication out of reach of children, and it is advisable not to transfer it to another container. During the use of this medication, it is important to adhere to the minimum dosage and duration as directed by a physician.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling
  • chest tightness
  • difficulty breathing
  • fever
  • blisters
  • skin peeling
  • pain in oral/ocular mucosa
  • severe allergic reactions
  • severe skin adverse reactions
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  • asthma
  • dyspnea
  • difficulty breathing
  • abnormal lung sounds
  • jaundice
  • liver abnormalities
  • sudden and severe headache
  • thunderclap headache
  • seizures
  • confusion
  • visual disturbances
  • paralysis
  • severe neurological symptoms
  • significant decrease in urine output
  • full-body severe

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
  • ALT elevation
  • AST elevation
  • ALP elevation
  • γ-GTP elevation
  • LDH elevation
  • total bilirubin elevation
  • hypertension
  • myocardial infarction
  • abnormal electrocardiogram
  • 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 prevent air or moisture from entering. The storage temperature should be maintained between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow round enteric-coated tablets

Package unit

28 tablets (28 tablets/PTP × 1)

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.