Medication info
Rabeprazole Sodium Tablet 20mg

Rabeprazole Sodium Tablet 20mg

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

MFDS item code 201400354 · Approved 2014.01.27 · Insurance code 649604290

Summary

Main use
Improvement of digestive diseases, including treatment of gastric ulcers and duodenal ulcers, and alleviation of symptoms of gastroesophageal reflux disease.
Who takes it
Adults · Children
Adult dose
For gastric ulcer and duodenal ulcer: Adults typically receive 10 mg of rabeprazole sodium orally once daily. Depending on symptoms, 20 mg may be administered once daily. It is typically administered 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 once daily for 4 to 8 weeks. If proton pump inhibitor (PPI) treatment for 8 weeks is ineffective, an additional 10 mg or 20 mg orally twice daily for another 8 weeks may be administered, with 20 mg twice daily reserved for patients with confirmed severe mucosal damage. For alleviating symptoms of gastroesophageal reflux disease: 10 mg is administered once daily. If symptoms are not controlled after 4 weeks, further evaluation is needed. After symptoms resolve, on-demand therapy may be employed by administering 10 mg once daily as needed for any subsequent symptoms. For long-term maintenance therapy of gastroesophageal reflux disease: Administer 10 mg or 20 mg orally once daily depending on the patient. For Helicobacter pylori eradication: Patients with Helicobacter pylori infection should undergo eradication therapy. It is recommended to combine this medication 20 mg with clarithromycin 500 mg and amoxicillin 1 g, taken twice daily for 7 days. For Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg once daily, with the dosage adjustable up to 120 mg depending on the needs of individual patients. Doses up to 100 mg can be taken once daily, while the 120 mg dose should be divided into two doses of 60 mg taken daily. Experience has shown that patients with Zollinger-Ellison syndrome have been treated with this medication for up to one year. For patients with liver disease: Adverse reactions related to hepatic encephalopathy have been reported in cirrhotic patients, so caution is required. For children: The safety for children has not been established. For the elderly: Since liver function is often impaired, caution should be exercised.
Child dose
The safety for children has not been established.

Ingredients

Manufacturer
대우제약(주)

Efficacy & effects

Improvement of digestive diseases, including treatment of gastric ulcers and duodenal ulcers, and alleviation of symptoms of gastroesophageal reflux disease.

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

This medication is used to treat ulcers that form in the stomach and duodenum. It is also effective in alleviating the symptoms of erosive gastroesophageal reflux disease and ulcerative gastroesophageal reflux disease. It is utilized as a long-term maintenance therapy for gastroesophageal reflux disease, and it is used in combination with antibiotics to treat patients with gastrointestinal ulcers associated with Helicobacter pylori infection. It is also applicable for Zollinger-Ellison syndrome to improve symptoms. Overall, it is used for the treatment and symptom relief of gastrointestinal disorders.

How to take

Adult dose

For gastric ulcer and duodenal ulcer: Adults typically receive 10 mg of rabeprazole sodium orally once daily. Depending on symptoms, 20 mg may be administered once daily. It is typically administered 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 once daily for 4 to 8 weeks. If proton pump inhibitor (PPI) treatment for 8 weeks is ineffective, an additional 10 mg or 20 mg orally twice daily for another 8 weeks may be administered, with 20 mg twice daily reserved for patients with confirmed severe mucosal damage. For alleviating symptoms of gastroesophageal reflux disease: 10 mg is administered once daily. If symptoms are not controlled after 4 weeks, further evaluation is needed. After symptoms resolve, on-demand therapy may be employed by administering 10 mg once daily as needed for any subsequent symptoms. For long-term maintenance therapy of gastroesophageal reflux disease: Administer 10 mg or 20 mg orally once daily depending on the patient. For Helicobacter pylori eradication: Patients with Helicobacter pylori infection should undergo eradication therapy. It is recommended to combine this medication 20 mg with clarithromycin 500 mg and amoxicillin 1 g, taken twice daily for 7 days. For Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg once daily, with the dosage adjustable up to 120 mg depending on the needs of individual patients. Doses up to 100 mg can be taken once daily, while the 120 mg dose should be divided into two doses of 60 mg taken daily. Experience has shown that patients with Zollinger-Ellison syndrome have been treated with this medication for up to one year. For patients with liver disease: Adverse reactions related to hepatic encephalopathy have been reported in cirrhotic patients, so caution is required. For children: The safety for children has not been established. For the elderly: Since liver function is often impaired, caution should be exercised.

Child dose

The safety for children has not been established.

Precautions

This medication should not be used by individuals with allergies to certain drugs or substances, especially if there is hypersensitivity to benzimidazole derivatives, penicillin antibiotics, or macrolide antibiotics. Furthermore, it should not be taken with certain cardiac medications or antiviral agents, and it is not recommended for use in pregnant or nursing women. Patients with impaired liver function, elderly patients, or those with a history of drug allergies should use this medication cautiously. During treatment, symptoms such as skin rash, itching, blood abnormalities, liver function abnormalities, and cardiovascular and gastrointestinal symptoms may occur; in such cases, the medication should be stopped immediately, and a physician should be consulted. Caution is required while driving or operating machinery, as drowsiness may occur. Long-term use may increase the risk of fractures, hypomagnesemia, and vitamin B12 absorption disorders, so regular testing is necessary. There may be drug interactions; therefore, especially when taking antibiotics, antiviral agents, warfarin, or methotrexate, consultation with a doctor or pharmacist is advised. This medication should not be chewed or crushed and should be swallowed whole, and it should be kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction, severe rash with high fever, blisters, skin shedding, pain in oral/eye mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthma attack, cough with fever and respiratory abnormalities, respiratory problems, jaundice (yellowing of skin or eyes), severe malaise, liver abnormalities (jaundice), sudden and

Mild side effects

  • Rash
  • urticaria
  • itching
  • 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
  • increased ALT
  • increased AST
  • increased ALP
  • increased γ-GTP
  • increased LDH
  • increased total bilirubin
  • hypertension
  • myocardial infarction
  • electrocardiogram abnormalities
  • migraine
  • syncope
  • angina
  • and atrioventricular block.

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

Storage

This medication may be sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve the medication's effect.

Appearance and packaging

Appearance

Pale yellow, round, enteric-coated tablet

Package unit

28 tablets/PTP

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.