Medication info

Rabeprazole Sodium Tablet 10 mg (Rabeprazole Sodium)

Prescription medicationExpired
Ingredient · strength
Rabeprazole Sodium›Strength being verified
Manufacturer / importer
미래바이오제약(주)
Appearance
Light yellow round delayed-release film-coated tablet
Packaging
28 tablets (14 tablets/PTP packaging * 2) 28 tablets (14 tablets/AluAlu packaging * 2)
Approval status
Expired

MFDS item code 201307381 · Approved 2013.05.20

This product's status changed to Expired on 2023.05.20. 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, alleviation and maintenance of gastroesophageal reflux disease symptoms, antibiotic combination therapy for Helicobacter pylori infection digestive ulcers
Who uses it
Adults · Children
Adult dosage
For ulcers, duodenal ulcers: Typically, for adults, Rabeprazole sodium is administered orally once daily at 10 mg. Depending on symptoms, it can be administered orally at 20 mg once daily. Typically, treatment for gastric ulcers lasts up to 8 weeks, and for duodenal ulcers up to 6 weeks. Erosive or ulcerative gastroesophageal reflux disease: 10 mg or 20 mg is administered once daily for 4 to 8 weeks. If proton pump inhibitors (PPIs) are not effective after 8 weeks, it may be possible to take an additional 10 mg or 20 mg orally twice daily for another 8 weeks, but 20 mg twice daily is limited to patients with confirmed severe mucosal damage. Gastroesophageal reflux disease symptom relief: 10 mg is administered once daily. If symptoms are not controlled after 4 weeks of treatment, further medical attention is needed. Once symptoms have resolved, on-demand therapy can be used, administering 10 mg once daily as needed to manage subsequent symptoms. Long-term maintenance therapy for gastroesophageal reflux disease: Administer 10 mg or 20 mg orally once daily according to the patient’s needs. Helicobacter pylori eradication: Patients infected with Helicobacter pylori should be treated with eradication therapy. The recommended regimen is to combine this drug 20 mg with clarithromycin 500 mg and amoxicillin 1 g, administered orally twice daily for 7 days. Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg once daily. The dose can be adjusted up to 120 mg per day based on individual patient needs. Doses up to 100 mg may be given once daily, while 120 mg should be divided into 60 mg administered twice daily. Patients with Zollinger-Ellison syndrome have been treated with this drug for up to 1 year. ○ Patients with liver dysfunction: Adverse reactions of hepatic encephalopathy have been reported in cirrhotic patients. Therefore, it should be administered cautiously. ○ Pediatric patients: Safety in pediatric patients has not been established. ○ Older adults: Should be administered cautiously due to frequently reduced liver function.
Children's dosage
Safety in pediatric patients has not been established.

Ingredients

Manufacturer
미래바이오제약(주)

Efficacy & effects

Treatment of gastric ulcers and duodenal ulcers, alleviation and maintenance of gastroesophageal reflux disease symptoms, antibiotic combination therapy for Helicobacter pylori infection digestive ulcers

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

This drug treats gastric ulcers and duodenal ulcers, and is also used for patients with erosive or ulcerative gastroesophageal reflux disease. It is effective for the alleviation of gastroesophageal reflux disease symptoms and long-term maintenance therapy. It may be prescribed in combination with antibiotics for patients with digestive ulcers infected with Helicobacter pylori. It is also used for the treatment of Zollinger-Ellison syndrome. This drug helps in the treatment and symptom improvement of various digestive diseases.

Dosage and Administration

Adult dosage

For ulcers, duodenal ulcers: Typically, for adults, Rabeprazole sodium is administered orally once daily at 10 mg. Depending on symptoms, it can be administered orally at 20 mg once daily. Typically, treatment for gastric ulcers lasts up to 8 weeks, and for duodenal ulcers up to 6 weeks. Erosive or ulcerative gastroesophageal reflux disease: 10 mg or 20 mg is administered once daily for 4 to 8 weeks. If proton pump inhibitors (PPIs) are not effective after 8 weeks, it may be possible to take an additional 10 mg or 20 mg orally twice daily for another 8 weeks, but 20 mg twice daily is limited to patients with confirmed severe mucosal damage. Gastroesophageal reflux disease symptom relief: 10 mg is administered once daily. If symptoms are not controlled after 4 weeks of treatment, further medical attention is needed. Once symptoms have resolved, on-demand therapy can be used, administering 10 mg once daily as needed to manage subsequent symptoms. Long-term maintenance therapy for gastroesophageal reflux disease: Administer 10 mg or 20 mg orally once daily according to the patient’s needs. Helicobacter pylori eradication: Patients infected with Helicobacter pylori should be treated with eradication therapy. The recommended regimen is to combine this drug 20 mg with clarithromycin 500 mg and amoxicillin 1 g, administered orally twice daily for 7 days. Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg once daily. The dose can be adjusted up to 120 mg per day based on individual patient needs. Doses up to 100 mg may be given once daily, while 120 mg should be divided into 60 mg administered twice daily. Patients with Zollinger-Ellison syndrome have been treated with this drug for up to 1 year. ○ Patients with liver dysfunction: Adverse reactions of hepatic encephalopathy have been reported in cirrhotic patients. Therefore, it should be administered cautiously. ○ Pediatric patients: Safety in pediatric patients has not been established. ○ Older adults: Should be administered cautiously due to frequently reduced liver function.

Children's dosage

Safety in pediatric patients has not been established.

Precautions

This drug should not be used in patients who have had allergic reactions to specific ingredients or benzimidazole derivatives. Caution is required in cases of hypersensitivity to penicillin-based antibiotics or macrolide antibiotics, especially when combined with treatment for Helicobacter pylori eradication. Patients taking certain cardiac-related medications or antivirals should be careful as side effects may occur when co-administered with these medications. Pregnant or breastfeeding women should not take this drug. Patients with impaired liver function or elderly patients should be particularly careful when administering this drug, and caution is also needed in those with a history of allergies. This drug contains Yellow No. 4 (Tartrazine), so patients who are sensitive to it should be careful. If allergic symptoms such as rash, urticaria, or itching occur during treatment, discontinue use immediately. Regular blood tests and liver function tests are recommended due to possible changes in blood cell counts or liver function abnormalities. Symptoms related to cardiac issues, digestive system problems, or neurological symptoms may occur, and if symptoms develop, consult medical personnel. Long-term use may increase the risk of side effects such as osteoporosis or hypomagnesemia, so regular monitoring is required. This drug reduces gastric acid secretion, which can lead to bacterial overgrowth in the stomach; therefore, inform medical personnel if diarrhea persists. Caution is needed when driving or operating machinery as drowsiness or dizziness may occur. There may be potential interactions with other medications, so if you are taking other medications, be sure to inform medical personnel. There is no specific antidote for overdose, so appropriate treatment based on symptoms is necessary. This drug should not be chewed or crushed, and should be swallowed whole, keeping it out of reach of children. When taken for a long time, it is safest to use the minimum dose while receiving regular check-ups according to a doctor's instructions.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, shortness of breath, asthma, fulminant hepatitis, liver dysfunction, jaundice, sudden and severe headache, seizures, confusion, visual disturbances, paralysis, markedly reduced urine output, generalized severe edema, elevated blood pressure, toxic epidermal necrolysis (Lyell syndrome), mucocutaneous syndrome (Stevens-Johnson syndrome), shock, anaphylaxis, angioedema, hepatic encephalopathy, rhabdomyolysis, delirium

Mild side effects

Rash, itching, blood abnormalities (decrease in red blood cells, decrease in white blood cells, increase in white blood cells, increase in eosinophils, increase in neutrophils, decrease in lymphocytes, anemia, petechiae, lymphadenopathy, hypochromic anemia, pancytopenia, agranulocytosis, thrombocytopenia, hemolytic anemia), ALT/AST/ALP/γ-GTP/LDH/elevated total bilirubin, hypertension, myocardial infarction, electrocardiogram abnormalities, migraines, syncope, angina, atrioventricular block, palpitations, tachycardia, bradycardia,

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

Storage

This drug must be stored in a tightly sealed container to prevent air and moisture ingress, and it is important to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. Storing in this manner helps to maintain the drug's effectiveness.

Appearance and packaging

Appearance

Light yellow round delayed-release film-coated tablet

Package unit

28 tablets (14 tablets/PTP packaging * 2) 28 tablets (14 tablets/AluAlu packaging * 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.

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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.