Medication info
Nelson Rabeprazole Tablet 10mg (Rabeprazole Sodium)

Nelson Rabeprazole Tablet 10mg (Rabeprazole Sodium)

Prescription medicationTablet경구
Ingredient · strength
Rabeprazole Sodium›10mg / 1 tablet
Manufacturer / importer
한국넬슨제약(주)
Appearance
Yellowish round enteric-coated tablet
Packaging
28 tablets/box [14 tablets/Alu-Alu X2]
Approval status
Active

MFDS item code 201906996 · Approved 2019.09.30

Summary

Main use
Improvement of gastrointestinal diseases such as treatment of gastric ulcers and duodenal ulcers, alleviation of gastroesophageal reflux disease symptoms
Who takes it
Adults
Adult dose
For gastric ulcer and duodenal ulcer: Adults take 10 mg of rabeprazole sodium orally once a day. Depending on symptoms, 20 mg may be taken orally once daily. Typically, treatment for gastric ulcer lasts up to 8 weeks, and for duodenal ulcer, up to 6 weeks. For erosive or ulcerative gastroesophageal reflux disease: 10 mg or 20 mg once daily for 4 to 8 weeks. If untreated after 8 weeks of PPI therapy, additional treatment may be necessary. For relief of gastroesophageal reflux disease symptoms: 10 mg is administered once daily. If symptoms are not controlled after 4 weeks, further evaluation is necessary. Once symptoms have resolved, on-demand therapy at a dose of 10 mg once daily may be used to manage any symptoms that arise later. For long-term maintenance therapy of gastroesophageal reflux disease: Patients may take 10 mg or 20 mg orally once a day, depending on their condition. For Helicobacter pylori eradication: Patients infected with Helicobacter pylori should be treated with eradication therapy. It is recommended to combine this drug 20 mg with clarithromycin 500 mg and amoxicillin 1 g taken twice a day for 7 days. For Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg taken once daily. The dosage may be adjusted up to 120 mg daily according to individual patient needs. Doses up to 100 mg may be given once daily, while 120 mg should be divided into two doses of 60 mg each day. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to 1 year. ◯ In patients with liver dysfunction: Adverse reactions of hepatic encephalopathy have been reported in patients with cirrhosis. Therefore, it should be used cautiously. ◯ In children: Safety in pediatric patients has not been established. ◯ In the elderly: Caution is required due to often impaired liver function.

Ingredients

Manufacturer
한국넬슨제약(주)

Efficacy & effects

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

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

This medication is used for the treatment of gastrointestinal ulcers such as gastric ulcers and duodenal ulcers. It also relieves symptoms of erosive or ulcerative gastroesophageal reflux disease and is effective for long-term maintenance therapy. It is used in combination with antibiotics for the treatment of gastrointestinal ulcers in patients infected with Helicobacter pylori. It is also a suitable treatment option for Zollinger-Ellison syndrome. It helps improve and treat symptoms of various gastrointestinal diseases.

How to take

Adult dose

For gastric ulcer and duodenal ulcer: Adults take 10 mg of rabeprazole sodium orally once a day. Depending on symptoms, 20 mg may be taken orally once daily. Typically, treatment for gastric ulcer lasts up to 8 weeks, and for duodenal ulcer, up to 6 weeks. For erosive or ulcerative gastroesophageal reflux disease: 10 mg or 20 mg once daily for 4 to 8 weeks. If untreated after 8 weeks of PPI therapy, additional treatment may be necessary. For relief of gastroesophageal reflux disease symptoms: 10 mg is administered once daily. If symptoms are not controlled after 4 weeks, further evaluation is necessary. Once symptoms have resolved, on-demand therapy at a dose of 10 mg once daily may be used to manage any symptoms that arise later. For long-term maintenance therapy of gastroesophageal reflux disease: Patients may take 10 mg or 20 mg orally once a day, depending on their condition. For Helicobacter pylori eradication: Patients infected with Helicobacter pylori should be treated with eradication therapy. It is recommended to combine this drug 20 mg with clarithromycin 500 mg and amoxicillin 1 g taken twice a day for 7 days. For Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg taken once daily. The dosage may be adjusted up to 120 mg daily according to individual patient needs. Doses up to 100 mg may be given once daily, while 120 mg should be divided into two doses of 60 mg each day. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to 1 year. ◯ In patients with liver dysfunction: Adverse reactions of hepatic encephalopathy have been reported in patients with cirrhosis. Therefore, it should be used cautiously. ◯ In children: Safety in pediatric patients has not been established. ◯ In the elderly: Caution is required due to often impaired liver function.

Precautions

This drug should not be used in patients with allergies to specific ingredients or who have experienced hypersensitivity reactions. Caution is especially needed when combined with penicillin or macrolide antibiotics, particularly during eradication therapy of Helicobacter pylori. It is safer for pregnant or breastfeeding women not to take this medication. Patients with impaired liver function or the elderly should use this medication with caution, and patients with a history of drug hypersensitivity should also be careful. If any allergic symptoms such as rash or itching occur while taking this medication, discontinue use immediately and consult a physician. Regular blood tests and liver function tests should be done, and appropriate measures should be taken if any abnormalities are found. Adverse effects can occur in various areas including heart, gastrointestinal, nervous system, respiratory, and skin, so inform medical personnel if symptoms appear. Caution is needed as long-term use may increase the risk of bone fractures. Hypomagnesemia may occur, so regularly check magnesium levels in the blood when taken long-term or combined with specific medications. This medication inhibits gastric acid secretion and may increase the risk of bacterial infection in the gastrointestinal tract, so if symptoms such as diarrhea persist, consult a physician. There may be drowsiness or dizziness while driving or operating machinery; caution is needed. There may be interactions with other medications, so inform your medical personnel if you are taking any other drugs. Particularly, caution is necessary when combined with antiviral or antibiotic drugs, and some medications should not be taken together. This medication should not be chewed or crushed and should be swallowed whole in tablet form. It should be stored in a safe place out of reach of children and it is advisable not to change containers. Use of this medication is not recommended during pregnancy or breastfeeding, as safety has not been established. Elderly patients may have an increased risk of adverse effects due to decreased liver function, so they should discontinue use and consult if symptoms occur. Safety in children has not been established, so its use is not recommended. There is no specific antidote for overdose, so immediate medical attention should be sought for proper treatment. It is important to regularly monitor liver function and blood status during the use of this medication.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), interstitial pneumonia, fulminant hepatitis, liver dysfunction, jaundice, toxic epidermal necrolysis (Lyell syndrome), mucocutaneous syndrome (Stevens-Johnson syndrome), severe allergic reactions, pulmonary edema, difficulty breathing, asthma, apnea, respiratory depression, acute interstitial nephritis, severe edema, elevated blood pressure, sudden and severe headache, serious neurological symptoms (seizures, confusion, visual disturbances, paralysis),

Mild side effects

  • Rash
  • itching
  • decreased red blood cells
  • decreased white blood cells
  • increased white blood cells
  • increased eosinophils
  • increased neutrophils
  • decreased lymphocytes
  • anemia
  • petechial bleeding
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  • lymphadenopathy
  • hypochromic anemia
  • pancytopenia
  • agranulocytosis
  • decreased platelets
  • hemolytic anemia
  • elevated ALT
  • elevated AST
  • elevated ALP
  • elevated γ-GTP
  • elevated LDH
  • elevated total bilirubin
  • hypertension
  • myocardial infarction
  • electrocardiogram abnormalities
  • migraine
  • syncope
  • angina
  • heart block
  • palpitations

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, avoid excessively hot or cold places, and it is important to store it safely at room temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellowish round enteric-coated tablet

Package unit

28 tablets/box [14 tablets/Alu-Alu X2]

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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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.