Medication info
CMG Rabeprazole Tablet 20 mg (Rabeprazole Sodium)

CMG Rabeprazole Tablet 20 mg (Rabeprazole Sodium)

Prescription medicationTablet경구
Ingredient · strength
Rabeprazole Sodium›20mg / 1 tablet
Manufacturer / importer
(주)씨엠지제약
Appearance
Light yellow round enteric-coated tablet
Packaging
28 tablets/PTP [28 tablets (14 tablets/PTP x 2)]
Approval status
Active

MFDS item code 200702551 · Approved 2007.02.28 · Insurance code 648600930

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 Helicobacter pylori infection gastrointestinal ulcers, treatment of Zollinger-Ellison syndrome.
Who takes it
Adults · Children
Adult dose
The usual adult dosage of rabeprazole sodium is 10 mg taken orally once a day. Depending on symptoms, it may be increased to 20 mg taken orally once a day. For gastric ulcers, treatment is for up to 8 weeks, and for duodenal ulcers, up to 6 weeks. For erosive or ulcerative gastroesophageal reflux disease, it is administered as 10 mg or 20 mg once daily for 4 to 8 weeks. If treatment is not successful after 8 weeks of PPI use, an additional 8 weeks of treatment at 10 mg or 20 mg two times a day may be considered, but the 20 mg twice daily is only for patients with severe mucosal injury diagnosed. For relief of symptoms of gastroesophageal reflux disease, 10 mg is administered once daily. If symptoms are not controlled after 4 weeks, additional medical consultation is necessary. After symptoms have resolved, on-demand therapy can be implemented if needed with 10 mg taken once daily to control any re-emerging symptoms. For long-term maintenance therapy of gastroesophageal reflux disease, it is administered orally as 10 mg or 20 mg once daily depending on the patient. For eradicating Helicobacter pylori, it is recommended that patients with Helicobacter pylori infection undergo eradication therapy with a combination of this medication (20 mg), clarithromycin (500 mg), and amoxicillin (1 g) administered two times a day for 7 days. For Zollinger-Ellison syndrome, the recommended initial dosage for adults is 60 mg taken once a day. The dosage may be adjusted up to 120 mg per day according to the needs of each patient. Doses up to 100 mg may be administered once daily, while the 120 mg dose is divided into 60 mg taken twice daily. There has been experience administering this medication to Zollinger-Ellison syndrome patients for up to one year. Patients with liver impairment: There have been reports of hepatic encephalopathy in patients with cirrhosis; therefore, caution is advised in administration. Pediatric patients: Safety in pediatric patients has not been established. Elderly patients: Caution is advised, as they often have reduced liver function.
Child dose
Safety in pediatric patients has not been established.

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

Treatment of gastric ulcers and duodenal ulcers, relief of symptoms of gastroesophageal reflux disease and maintenance therapy, combination therapy with antibiotics for Helicobacter pylori infection gastrointestinal ulcers, treatment of Zollinger-Ellison syndrome.

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

This medication is used for the treatment of gastric ulcers, duodenal ulcers, and erosive or ulcerative gastroesophageal reflux disease. It also alleviates symptoms caused by gastroesophageal reflux disease and is used for long-term maintenance therapy. For patients with gastrointestinal ulcers infected with Helicobacter pylori, it is combined with antibiotics. Rarely, it may also be helpful in the treatment of Zollinger-Ellison syndrome. Overall, it is effective in improving symptoms related to gastrointestinal diseases.

How to take

Adult dose

The usual adult dosage of rabeprazole sodium is 10 mg taken orally once a day. Depending on symptoms, it may be increased to 20 mg taken orally once a day. For gastric ulcers, treatment is for up to 8 weeks, and for duodenal ulcers, up to 6 weeks. For erosive or ulcerative gastroesophageal reflux disease, it is administered as 10 mg or 20 mg once daily for 4 to 8 weeks. If treatment is not successful after 8 weeks of PPI use, an additional 8 weeks of treatment at 10 mg or 20 mg two times a day may be considered, but the 20 mg twice daily is only for patients with severe mucosal injury diagnosed. For relief of symptoms of gastroesophageal reflux disease, 10 mg is administered once daily. If symptoms are not controlled after 4 weeks, additional medical consultation is necessary. After symptoms have resolved, on-demand therapy can be implemented if needed with 10 mg taken once daily to control any re-emerging symptoms. For long-term maintenance therapy of gastroesophageal reflux disease, it is administered orally as 10 mg or 20 mg once daily depending on the patient. For eradicating Helicobacter pylori, it is recommended that patients with Helicobacter pylori infection undergo eradication therapy with a combination of this medication (20 mg), clarithromycin (500 mg), and amoxicillin (1 g) administered two times a day for 7 days. For Zollinger-Ellison syndrome, the recommended initial dosage for adults is 60 mg taken once a day. The dosage may be adjusted up to 120 mg per day according to the needs of each patient. Doses up to 100 mg may be administered once daily, while the 120 mg dose is divided into 60 mg taken twice daily. There has been experience administering this medication to Zollinger-Ellison syndrome patients for up to one year. Patients with liver impairment: There have been reports of hepatic encephalopathy in patients with cirrhosis; therefore, caution is advised in administration. Pediatric patients: Safety in pediatric patients has not been established. Elderly patients: Caution is advised, as they often have reduced liver function.

Child dose

Safety in pediatric patients has not been established.

Precautions

This medication should not be administered to patients with allergies or hypersensitivity to specific components or benzimidazole drugs. Additionally, it should not be used if there is an allergy to amoxicillin or clarithromycin when combined during Helicobacter pylori eradication therapy. Caution is advised for patients with heart-related medications or antiviral medications, as well as women who are pregnant or breastfeeding. Patients with impaired liver function, elderly patients, or those with a history of drug allergies should use this medication with care. If allergic symptoms such as skin rash or itching occur while taking this medication, it should be stopped immediately. Regular blood tests may be needed as there may be changes in red or white blood cell counts, and appropriate measures should be taken if abnormalities are found. Liver function tests should also be performed regularly, and if symptoms of hepatitis or jaundice appear, medication should be stopped. Various side effects, such as arrhythmias, blood pressure changes, gastrointestinal symptoms, headache, and dizziness, may occur, so monitoring of symptoms is important. If respiratory symptoms or pneumonia symptoms occur, consult a healthcare provider immediately. Long-term use may increase the risk of fractures, and hypomagnesemia may occur due to low magnesium levels, thus regular blood tests are necessary. This medication strongly suppresses gastric acid secretion, which may slightly increase the risk of bacterial infections in the stomach. Caution should be taken as drowsiness may occur when driving or operating machinery. There may be interactions with other medications, so inform the healthcare provider of any other medications being taken, especially when combined with antiviral drugs, antibiotics, or anticoagulants. Pregnant or breastfeeding women should not use this medication. The safety in children or minors has not been established, so it is best not to use it. Do not chew or crush the tablets; swallow them whole, and keep out of reach of children. Long-term use of this medication may lead to vitamin B12 absorption issues, so supplementation should be considered if necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, fulminant hepatitis, liver dysfunction, jaundice, toxic epidermal necrolysis (Lyell syndrome), Stevens-Johnson syndrome, severe neurological symptoms (severe headache, seizures, confusion, visual disturbances, paralysis), severe edema accompanied by increased blood pressure, acute interstitial nephritis, hepatic encephalopathy, anaphylaxis, shock, angioedema, sudden death, coma, hyperammonemia.

Mild side effects

  • Rash
  • hives
  • 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
  • elevated total bilirubin
  • hypertension
  • myocardial infarction
  • electrocardiogram abnormalities
  • migraine
  • syncope
  • angina
  • interval block.

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

Storage

This medication should be stored in a sealed container to avoid exposure to air or moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius to safely preserve the medication's effectiveness.

Appearance and packaging

Appearance

Light yellow round enteric-coated tablet

Package unit

28 tablets/PTP [28 tablets (14 tablets/PTP x 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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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.