Medication info
Resprazolet 10 mg (Rabeprazole Sodium)

Resprazolet 10 mg (Rabeprazole Sodium)

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

MFDS item code 201310362 · Approved 2013.11.28 · Insurance code 651601650

Summary

Main use
Treatment of gastric ulcers and duodenal ulcers, relief of gastroesophageal reflux disease symptoms, etc.
Who takes it
Adults · Children
Adult dose
For gastric ulcer and duodenal ulcer: The usual oral dose for adults is 10 mg once daily of rabeprazole sodium. Depending on symptoms, it may be administered as 20 mg once daily. Usually, treatment for gastric ulcers lasts up to 8 weeks and for duodenal ulcers up to 6 weeks. For erosive or ulcerative gastroesophageal reflux disease: Administer 10 mg or 20 mg once daily for 4 to 8 weeks. If proton pump inhibitors (PPIs) have been administered for 8 weeks without treatment success, an additional 8-week course of 10 mg or 20 mg may be administered twice daily. However, administering 20 mg twice daily is only for patients with severe mucosal damage confirmed. For symptom relief of gastroesophageal reflux disease: Administer 10 mg once daily. If symptoms are not controlled after 4 weeks, further medical evaluation is needed. After symptoms have resolved, on-demand therapy using 10 mg once daily may be utilized to control any subsequent symptoms. For long-term maintenance therapy for gastroesophageal reflux disease: Depending on the patient, administer 10 mg or 20 mg orally once daily. For eradication of Helicobacter pylori: Patients infected with Helicobacter pylori should undergo eradication therapy. It is recommended to combine this medication (20 mg) with clarithromycin (500 mg) and amoxicillin (1 g) administered twice daily for 7 days. For Zollinger-Ellison syndrome: The recommended starting dose for adults is 60 mg once daily. The dosage may be adjusted up to 120 mg daily according to individual patient needs. Doses up to 100 mg may be administered once daily, and a 120 mg dose is divided into two doses of 60 mg each. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to 1 year. ○ Patients with liver impairment: Adverse reactions have been reported in patients with liver cirrhosis related to hepatic encephalopathy. Therefore, it should be administered cautiously. ○ In children: Safety in children has not been established. ○ In elderly: Caution should be exercised as many elderly patients may have decreased liver function.
Child dose
Safety in children has not been established.

Ingredients

Manufacturer
한화제약(주)

Efficacy & effects

Treatment of gastric ulcers and duodenal ulcers, relief of gastroesophageal reflux disease symptoms, etc.

  • 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 effective in the treatment of gastric and duodenal ulcers and is used for relieving symptoms of gastroesophageal reflux disease and maintaining it for long periods. It can also be used in combination with antibiotics to treat patients with gastrointestinal ulcers infected with Helicobacter pylori. It is also applicable to diseases caused by excessive gastric acid secretion, such as Zollinger-Ellison syndrome, to improve symptoms. Overall, this medication is used to treat various ulcers and reflux diseases related to the gastrointestinal tract.

How to take

Adult dose

For gastric ulcer and duodenal ulcer: The usual oral dose for adults is 10 mg once daily of rabeprazole sodium. Depending on symptoms, it may be administered as 20 mg once daily. Usually, treatment for gastric ulcers lasts up to 8 weeks and for duodenal ulcers up to 6 weeks. For erosive or ulcerative gastroesophageal reflux disease: Administer 10 mg or 20 mg once daily for 4 to 8 weeks. If proton pump inhibitors (PPIs) have been administered for 8 weeks without treatment success, an additional 8-week course of 10 mg or 20 mg may be administered twice daily. However, administering 20 mg twice daily is only for patients with severe mucosal damage confirmed. For symptom relief of gastroesophageal reflux disease: Administer 10 mg once daily. If symptoms are not controlled after 4 weeks, further medical evaluation is needed. After symptoms have resolved, on-demand therapy using 10 mg once daily may be utilized to control any subsequent symptoms. For long-term maintenance therapy for gastroesophageal reflux disease: Depending on the patient, administer 10 mg or 20 mg orally once daily. For eradication of Helicobacter pylori: Patients infected with Helicobacter pylori should undergo eradication therapy. It is recommended to combine this medication (20 mg) with clarithromycin (500 mg) and amoxicillin (1 g) administered twice daily for 7 days. For Zollinger-Ellison syndrome: The recommended starting dose for adults is 60 mg once daily. The dosage may be adjusted up to 120 mg daily according to individual patient needs. Doses up to 100 mg may be administered once daily, and a 120 mg dose is divided into two doses of 60 mg each. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to 1 year. ○ Patients with liver impairment: Adverse reactions have been reported in patients with liver cirrhosis related to hepatic encephalopathy. Therefore, it should be administered cautiously. ○ In children: Safety in children has not been established. ○ In elderly: Caution should be exercised as many elderly patients may have decreased liver function.

Child dose

Safety in children has not been established.

Precautions

This medication should not be taken by individuals with hypersensitivity to certain components or benzimidazole derivatives. Caution is also needed if combined with penicillin antibiotics or macrolide antibiotics in those who are allergic. It is safe to avoid this medication for patients taking certain heart-related medications or those who are pregnant or breastfeeding. Caution should be exercised for individuals with impaired liver function or elderly patients, and those with a history of allergies should also be careful. This medication contains a dye called Yellow No. 4, so those allergic to this component should be cautious. If rash, hives, or itching occur during use, discontinue use immediately. Regular blood tests may be necessary as there may be abnormalities in red or white blood cell counts. Liver function tests should also be performed regularly, and if symptoms of hepatitis or jaundice occur, use should be discontinued. Be cautious as heart-related adverse symptoms or blood pressure changes may occur. Gastrointestinal symptoms such as diarrhea, constipation, abdominal pain, or nausea may appear. Neurological symptoms such as headache, insomnia, or dizziness may occur, so monitor the condition carefully. Respiratory symptoms or adverse reactions such as skin rashes or hair loss have also been reported. If any abnormalities in the eyes or ears are felt, consulting a specialist is recommended. It may cause kidney function issues, so if there are abnormalities in urination or blood in urine, be cautious. Long-term use may carry the risk of osteoporosis or hypomagnesemia, so regular check-ups are necessary. As it suppresses gastric acid secretion, there may be a slight increase in the risk of intestinal bacterial infections. Caution is required as drowsiness may occur while driving or operating machinery. It may interact with other medications, so always inform healthcare providers of any medications being taken. Caution is particularly necessary when used in combination with antibiotics, anticoagulants, and antiviral medications. It should be avoided during pregnancy and breastfeeding due to insufficient safety data. Elderly patients may have an increased risk of side effects due to reduced liver function, so if symptoms occur, consult medical personnel immediately. Safety in children has not been established, so use is not recommended. In cases of overdose, there is no specific antidote, and appropriate treatment based on symptoms is required. This medication should be swallowed whole without chewing or crushing and kept out of reach of children. For long-term use, regular check-ups to monitor for abnormalities are important.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, fulminant hepatitis, hepatic dysfunction, jaundice, acute interstitial nephritis, systemic allergic reactions (hypotension, difficulty breathing, facial swelling, etc.), asthma, difficulty breathing, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), sudden death, coma, hyperammonemia, rhabdomyolysis, sensory disturbances, delirium, anaphylaxis, angioedema, hemolytic anemia,

Mild side effects

  • Rash
  • itching
  • decreased red blood cells
  • decreased white blood cells
  • increased white blood cells
  • increased eosinophils
  • increased neutrophils
  • decreased lymphocytes
  • anemia
  • petechiae
Show 20 more
  • lymphadenopathy
  • hypochromic anemia
  • pancytopenia
  • agranulocytosis
  • decreased platelets
  • hemolytic anemia
  • ALT elevation
  • AST elevation
  • ALP elevation
  • γ-GTP elevation
  • LDH elevation
  • total bilirubin elevation
  • hypertension
  • myocardial infarction
  • ECG abnormalities
  • migraine
  • syncope
  • angina
  • heart block
  • palpitations

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture and kept at a temperature between 1 degree and 30 degrees Celsius at room temperature. Storing it this way will help maintain its effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Yellowish round enteric-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alu packaging 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.