Medication info
Raepra Tablet 10 mg (Rabeprazole Sodium)

Raepra Tablet 10 mg (Rabeprazole Sodium)

Prescription medicationTablet경구
Ingredient · strength
Rabeprazole Sodium›10mg / 1 tablet
Manufacturer / importer
위더스제약(주)
Appearance
Yellowish round enteric-coated tablet
Packaging
28 tablets/box [(14 tablets/Alu-Alu)×2]
Approval status
Active

MFDS item code 200702536 · Approved 2007.02.28 · Insurance code 660700980

Summary

Main use
Improvement of gastrointestinal diseases such as treatment of gastric ulcers and duodenal ulcers, relief of gastroesophageal reflux disease symptoms.
Who takes it
Adults · Children
Adult dose
Typically, for adults, rabeprazole sodium is administered orally once a day at 10 mg. Depending on symptoms, it can be administered orally once a day at 20 mg. Typically, it is used for up to 8 weeks for gastric ulcers and up to 6 weeks for duodenal ulcers. For erosive or ulcerative gastroesophageal reflux disease: Administer orally 10 mg or 20 mg once a day for 4 to 8 weeks. If not resolved after 8 weeks of proton pump inhibitor (PPI) therapy, additional treatment may be necessary. For relief of gastroesophageal reflux disease symptoms: Administer 10 mg once a day. If symptoms are not controlled after 4 weeks, further medical attention is needed. Once symptoms have resolved, on-demand treatment can be used with 10 mg taken once a day to control any subsequent symptoms that arise. Long-term maintenance therapy for gastroesophageal reflux disease: Administer orally 10 mg or 20 mg daily depending on the patient. Helicobacter pylori eradication: Helicobacter pylori infected patients should be treated with eradication therapy. It is recommended to administer this medication (20 mg) in combination with clarithromycin (500 mg) and amoxicillin (1 g) twice daily for 7 days. For Zollinger-Ellison syndrome: A recommended initial dose for adults is 60 mg once daily. The dosage can be adjusted up to 120 mg daily according to individual patient needs. Doses up to 100 mg can be administered once daily, while the 120 mg dosage should be divided into two doses of 60 mg taken twice daily. There has been experience administering this medication for up to a year for patients with Zollinger-Ellison syndrome. ◯ Liver impairment patients: Adverse reactions of hepatic encephalopathy have been reported in patients with cirrhosis; thus, it should be administered cautiously. ◯ Pediatric patients: Safety for pediatric use has not been established. ◯ Elderly: Patients often have impaired liver function, so it should be administered with caution.
Child dose
Safety for pediatric use has not been established.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

Improvement of gastrointestinal diseases such as treatment of gastric ulcers and duodenal ulcers, relief of gastroesophageal reflux disease symptoms.

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

This medication is used for the relief and long-term management of symptoms associated with gastric and duodenal ulcers, as well as erosive and ulcerative gastroesophageal reflux disease. Additionally, it is used in conjunction with antibiotics for patients with gastrointestinal ulcers accompanying Helicobacter pylori infection to enhance treatment effects. It is also applicable to diseases caused by excessive gastric acid secretion, such as Zollinger-Ellison syndrome. It is widely used to treat various gastrointestinal-related diseases and improve symptoms.

How to take

Adult dose

Typically, for adults, rabeprazole sodium is administered orally once a day at 10 mg. Depending on symptoms, it can be administered orally once a day at 20 mg. Typically, it is used for up to 8 weeks for gastric ulcers and up to 6 weeks for duodenal ulcers. For erosive or ulcerative gastroesophageal reflux disease: Administer orally 10 mg or 20 mg once a day for 4 to 8 weeks. If not resolved after 8 weeks of proton pump inhibitor (PPI) therapy, additional treatment may be necessary. For relief of gastroesophageal reflux disease symptoms: Administer 10 mg once a day. If symptoms are not controlled after 4 weeks, further medical attention is needed. Once symptoms have resolved, on-demand treatment can be used with 10 mg taken once a day to control any subsequent symptoms that arise. Long-term maintenance therapy for gastroesophageal reflux disease: Administer orally 10 mg or 20 mg daily depending on the patient. Helicobacter pylori eradication: Helicobacter pylori infected patients should be treated with eradication therapy. It is recommended to administer this medication (20 mg) in combination with clarithromycin (500 mg) and amoxicillin (1 g) twice daily for 7 days. For Zollinger-Ellison syndrome: A recommended initial dose for adults is 60 mg once daily. The dosage can be adjusted up to 120 mg daily according to individual patient needs. Doses up to 100 mg can be administered once daily, while the 120 mg dosage should be divided into two doses of 60 mg taken twice daily. There has been experience administering this medication for up to a year for patients with Zollinger-Ellison syndrome. ◯ Liver impairment patients: Adverse reactions of hepatic encephalopathy have been reported in patients with cirrhosis; thus, it should be administered cautiously. ◯ Pediatric patients: Safety for pediatric use has not been established. ◯ Elderly: Patients often have impaired liver function, so it should be administered with caution.

Child dose

Safety for pediatric use has not been established.

Precautions

This medication should not be used in patients with specific allergic reactions or hypersensitivity to its ingredients. Patients allergic to penicillin or macrolide antibiotics should also be cautious when using antibiotics with this medication. It is safest for pregnant or breastfeeding women to avoid taking this medication. Patients with impaired liver function or the elderly should use it carefully, and those with a history of drug allergies should also be cautious. This medication may cause allergic symptoms such as skin rash and itching; thus, if symptoms appear, it should be discontinued immediately. Regular blood tests and liver function tests should be conducted, and if abnormalities are found, medical consultation should be sought promptly. Side effects may occur in various areas, including the heart, gastrointestinal tract, nervous system, respiratory system, muscles, and skin, so quick response is necessary if symptoms occur. Long-term use may increase the risk of fractures, so caution is required. Hypomagnesemia may occasionally occur, so regularly checking magnesium levels during long-term use is important. This medication can increase the risk of bacterial infections in the stomach due to suppression of gastric acid secretion, so if abnormal symptoms such as diarrhea persist, inform medical staff. Symptoms such as drowsiness may occur when driving or operating machinery, so caution is advised. There may be interactions with other medications; therefore, inform healthcare providers about any medications being taken. This tablet should be swallowed whole without chewing or crushing, and should be kept out of the reach of children. It is advisable to inform medical staff about taking this medication before clinical tests, as it may affect test results.

Side effects and when to seek care immediately

Serious side effects

Urticaria, tightness in the chest, difficulty breathing, yellowing of the skin (jaundice), extreme lethargy, acute hepatitis, liver dysfunction, jaundice, severe allergic reactions, severe skin adverse reactions, toxic epidermal necrolysis (Lyell syndrome), Stevens-Johnson syndrome, dyspnea, asthma attacks, hepatic encephalopathy, sudden and very severe headaches, seizures, confusion, visual disturbances, paralysis, severe edema, elevated blood pressure.

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
  • increased ALT
  • increased AST
  • increased ALP
  • increased γ-GTP
  • increased LDH
  • elevated total bilirubin
  • hypertension
  • myocardial infarction
  • ECG abnormalities
  • migraine
  • syncope
  • angina
  • heart blocking
  • palpitations.

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture. It is also safe to store at a temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellowish round enteric-coated tablet

Package unit

28 tablets/box [(14 tablets/Alu-Alu)×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.