Medication info
Rabeprazole Sodium 10 mg Tablet (Rabeprazole Sodium)

Rabeprazole Sodium 10 mg Tablet (Rabeprazole Sodium)

Prescription medicationTablet경구
Ingredient · strength
Rabeprazole Sodium›10mg / 1 tablet
Manufacturer / importer
동화약품(주)
Appearance
Pale yellow round enteric-coated tablets
Packaging
28 tablets (14 tablets/AluAlu packaging x 2)
Approval status
Active

MFDS item code 201601059 · Approved 2016.02.26 · Insurance code 642706690

Summary

Main use
Treatment of gastric ulcers and duodenal ulcers, relief of symptoms of gastroesophageal reflux disease and maintenance therapy, combination therapy with antibiotics for gastrointestinal ulcers caused by Helicobacter pylori infection.
Who takes it
Adults
Adult dose
For gastric ulcers and duodenal ulcers: The usual dosage for adults is to take 10 mg of rabeprazole sodium orally once a day. Depending on the symptoms, it may be administered at a dosage of 20 mg orally once a day. Generally, it is given for up to 8 weeks for gastric ulcers and 6 weeks for duodenal ulcers. For erosive or ulcerative gastroesophageal reflux disease: 10 mg or 20 mg is to be taken orally once a day for 4 to 8 weeks. If proton pump inhibitors (PPIs) have not resolved the situation after 8 weeks, an additional 8-week course of 10 mg or 20 mg may be taken orally twice a day. Note that the 20 mg twice a day dose is limited to patients with confirmed severe mucosal damage. For relief of symptoms of gastroesophageal reflux disease: 10 mg is to be taken once a day. If symptoms are not controlled after 4 weeks, further consultation is necessary. Once symptoms have subsided, on-demand therapy may be used with 10 mg taken once a day to manage any subsequent symptoms. For long-term maintenance therapy of gastroesophageal reflux disease: 10 mg or 20 mg may be administered orally once a day, depending on the patient. For eradication of Helicobacter pylori: Patients with Helicobacter pylori infection should undergo eradication therapy. It is recommended to take this drug 20 mg with clarithromycin 500 mg and amoxicillin 1 g, orally twice a day for 7 days. For Zollinger-Ellison syndrome: The recommended starting dosage for adults is 60 mg once daily. The dosage may be adjusted up to 120 mg according to the individual patient’s needs. Dosages up to 100 mg may be administered once daily, and 120 mg should be split into two doses of 60 mg each, taken twice daily. Patients with Zollinger-Ellison syndrome have been treated with this drug for up to 1 year. ○ In patients with liver dysfunction: Adverse reactions of hepatic encephalopathy have been reported in patients with liver cirrhosis; hence, it should be used cautiously. ○ In children: Safety has not been established for use in children. ○ In the elderly: Caution is required due to potential impairment of liver function.

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

Treatment of gastric ulcers and duodenal ulcers, relief of symptoms of gastroesophageal reflux disease and maintenance therapy, combination therapy with antibiotics for gastrointestinal ulcers caused by Helicobacter pylori infection.

  • Gastric ulcer
  • duodenal ulcer
  • erosive gastroesophageal reflux disease
  • ulcerative gastroesophageal reflux disease
  • symptoms of gastroesophageal reflux disease
  • gastrointestinal ulcers due to Helicobacter pylori infection
  • Zollinger-Ellison syndrome.
View approved original text

This medication is effective not only in treating ulcers formed in the stomach and duodenum but also in alleviating symptoms of erosive and ulcerative gastroesophageal reflux disease. It is also used for long-term management of chronic gastroesophageal reflux disease and is administered with antibiotics to enhance therapeutic effects for patients with gastrointestinal ulcers caused by Helicobacter pylori infection. It aids in the treatment of Zollinger-Ellison syndrome. Overall, it is used to improve various gastrointestinal-related conditions.

How to take

Adult dose

For gastric ulcers and duodenal ulcers: The usual dosage for adults is to take 10 mg of rabeprazole sodium orally once a day. Depending on the symptoms, it may be administered at a dosage of 20 mg orally once a day. Generally, it is given for up to 8 weeks for gastric ulcers and 6 weeks for duodenal ulcers. For erosive or ulcerative gastroesophageal reflux disease: 10 mg or 20 mg is to be taken orally once a day for 4 to 8 weeks. If proton pump inhibitors (PPIs) have not resolved the situation after 8 weeks, an additional 8-week course of 10 mg or 20 mg may be taken orally twice a day. Note that the 20 mg twice a day dose is limited to patients with confirmed severe mucosal damage. For relief of symptoms of gastroesophageal reflux disease: 10 mg is to be taken once a day. If symptoms are not controlled after 4 weeks, further consultation is necessary. Once symptoms have subsided, on-demand therapy may be used with 10 mg taken once a day to manage any subsequent symptoms. For long-term maintenance therapy of gastroesophageal reflux disease: 10 mg or 20 mg may be administered orally once a day, depending on the patient. For eradication of Helicobacter pylori: Patients with Helicobacter pylori infection should undergo eradication therapy. It is recommended to take this drug 20 mg with clarithromycin 500 mg and amoxicillin 1 g, orally twice a day for 7 days. For Zollinger-Ellison syndrome: The recommended starting dosage for adults is 60 mg once daily. The dosage may be adjusted up to 120 mg according to the individual patient’s needs. Dosages up to 100 mg may be administered once daily, and 120 mg should be split into two doses of 60 mg each, taken twice daily. Patients with Zollinger-Ellison syndrome have been treated with this drug for up to 1 year. ○ In patients with liver dysfunction: Adverse reactions of hepatic encephalopathy have been reported in patients with liver cirrhosis; hence, it should be used cautiously. ○ In children: Safety has not been established for use in children. ○ In the elderly: Caution is required due to potential impairment of liver function.

Precautions

This drug should not be used by patients who are allergic to specific ingredients. Especially when there is a hypersensitivity reaction to benzimidazoles, penicillin antibiotics, or macrolide antibiotics, it should not be administered. Additionally, this drug should not be used in females who are pregnant or breastfeeding, or in patients taking certain heart-related medications. Caution is required when using it in patients with impaired liver function, the elderly, or those with a history of drug allergies. If there is any allergy to the pigments included in this drug, precautions are also necessary. This drug may cause allergic reactions such as skin rash, hives, and itching, and if such symptoms appear, usage should be immediately discontinued. Changes in blood cell counts or liver function abnormalities may occur, so regular blood tests and liver function tests are recommended. Various adverse reactions may occur in several body parts such as the heart, gastrointestinal tract, nervous system, respiratory system, and skin; if any abnormal signs occur, consult a physician. Long-term use may increase the risk of fractures and magnesium deficiency may occur, so supplementation and monitoring are necessary if required. This drug inhibits gastric acid secretion, which may slightly increase the risk of bacterial infections in the gastrointestinal tract. It may cause drowsiness when driving or operating machinery; hence, caution is required. There may be interactions with other medications, so if you are taking any other drugs, you must inform your doctor or pharmacist. It is safest not to use this drug during pregnancy or breastfeeding. This drug should be swallowed whole without chewing or crushing, and stored out of reach of children. If this drug is used for a long time or if abnormal symptoms appear, consult healthcare professionals to receive appropriate care.

Storage

This drug may be sensitive to air or moisture; thus, it should be stored in a sealed container. The recommended storage temperature is between 1 to 30 degrees Celsius at room temperature. Doing so will help maintain the drug's effectiveness and safety over time.

Appearance and packaging

Appearance

Pale yellow round enteric-coated tablets

Package unit

28 tablets (14 tablets/AluAlu packaging x 2)

Same-ingredient medicines

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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.