Medication info

Antiprazole Tablets 10 mg (Rabeprazole Sodium)

Prescription medicationTablet경구Expired
Ingredient · strength
Rabeprazole Sodium›10mg / 1 tablet
Manufacturer / importer
한국신텍스제약(주)
Appearance
Pale yellow round enteric-coated tablets
Packaging
28 Tablets/PTP [(14 tablets/PTP x 2)]
Approval status
Expired

MFDS item code 201907670 · Approved 2019.11.01

This product's status changed to Expired on 2024.11.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of gastric ulcers and duodenal ulcers, relief of symptoms of gastroesophageal reflux disease and improvement of digestive diseases
Who takes it
Adults
Adult dose
Gastric ulcer, duodenal ulcer: Usually for adults, 10 mg of rabeprazole sodium is taken orally once a day. Depending on symptoms, 20 mg can be taken orally once daily. Usually administered for gastric ulcers up to 8 weeks, and for duodenal ulcers up to 6 weeks. Erosive or ulcerative gastroesophageal reflux disease: Administer 10 mg or 20 mg once daily for 4 to 8 weeks. If proton pump inhibitors (PPI) is not effective after 8 weeks, an additional 10 mg or 20 mg can be taken orally twice a day for another 8 weeks. However, the 20 mg twice daily dosage is only for patients confirmed to have severe mucosal damage. Symptom relief for gastroesophageal reflux disease: 10 mg is administered once daily. If symptoms are not controlled after 4 weeks, additional medical assessment is required. Once symptoms have resolved, on-demand therapy can be used to manage later symptoms by taking 10 mg once daily if necessary. Long-term maintenance therapy for gastroesophageal reflux disease: Depending on the patient, administer 10 mg or 20 mg orally once daily. Helicobacter pylori eradication: Patients infected with Helicobacter pylori should be treated with eradication therapy. A combination of 20 mg of this medication, 500 mg of clarithromycin, and 1 g of amoxicillin is recommended to be taken orally twice daily for 7 days. Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg once daily. The dosage can be adjusted up to 120 mg daily according to individual patient needs. Up to 100 mg can be taken once daily, and the 120 mg dosage should be divided into 60 mg twice daily. Patients with Zollinger-Ellison syndrome have experience with this medication for up to one year. ◯ Liver impaired patients Adverse reactions of hepatic encephalopathy have been reported in patients with cirrhosis. Therefore, careful administration is required. ◯ Pediatrics Safety in children has not been established. ◯ Elderly Due to frequently reduced liver function, careful administration is warranted.

Ingredients

Manufacturer
한국신텍스제약(주)

Efficacy & effects

Treatment of gastric ulcers and duodenal ulcers, relief of symptoms of gastroesophageal reflux disease and improvement of digestive diseases

  • Gastric ulcers
  • duodenal ulcers
  • 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 effective in treating gastric ulcers and duodenal ulcers and is used to alleviate symptoms of erosive or ulcerative gastroesophageal reflux disease. It is also suitable for long-term maintenance therapy of gastroesophageal reflux disease and is used in combination with antibiotics for treating gastrointestinal ulcer patients infected with Helicobacter pylori. It helps in treating Zollinger-Ellison syndrome. In short, it is used to improve and treat various gastrointestinal-related diseases.

How to take

Adult dose

Gastric ulcer, duodenal ulcer: Usually for adults, 10 mg of rabeprazole sodium is taken orally once a day. Depending on symptoms, 20 mg can be taken orally once daily. Usually administered for gastric ulcers up to 8 weeks, and for duodenal ulcers up to 6 weeks. Erosive or ulcerative gastroesophageal reflux disease: Administer 10 mg or 20 mg once daily for 4 to 8 weeks. If proton pump inhibitors (PPI) is not effective after 8 weeks, an additional 10 mg or 20 mg can be taken orally twice a day for another 8 weeks. However, the 20 mg twice daily dosage is only for patients confirmed to have severe mucosal damage. Symptom relief for gastroesophageal reflux disease: 10 mg is administered once daily. If symptoms are not controlled after 4 weeks, additional medical assessment is required. Once symptoms have resolved, on-demand therapy can be used to manage later symptoms by taking 10 mg once daily if necessary. Long-term maintenance therapy for gastroesophageal reflux disease: Depending on the patient, administer 10 mg or 20 mg orally once daily. Helicobacter pylori eradication: Patients infected with Helicobacter pylori should be treated with eradication therapy. A combination of 20 mg of this medication, 500 mg of clarithromycin, and 1 g of amoxicillin is recommended to be taken orally twice daily for 7 days. Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg once daily. The dosage can be adjusted up to 120 mg daily according to individual patient needs. Up to 100 mg can be taken once daily, and the 120 mg dosage should be divided into 60 mg twice daily. Patients with Zollinger-Ellison syndrome have experience with this medication for up to one year. ◯ Liver impaired patients Adverse reactions of hepatic encephalopathy have been reported in patients with cirrhosis. Therefore, careful administration is required. ◯ Pediatrics Safety in children has not been established. ◯ Elderly Due to frequently reduced liver function, careful administration is warranted.

Precautions

This medication should not be administered to patients with hypersensitivity to certain components or benzimidazole derivatives. Caution is required when using in patients allergic to penicillin and macrolide antibiotics, particularly when used in combination for Helicobacter pylori eradication therapy. Cardiac side effects may occur when taken with certain cardiac-related medications, so co-administration should be avoided. It is safer for pregnant or breastfeeding women not to use this medication. Patients with impaired liver function or the elderly should be administered with caution due to the higher risk of side effects. This medication contains Yellow No. 4 dye, so those allergic to this ingredient should use it with caution. If any adverse reactions such as skin rash, hives, or itching occur during use, the medication should be discontinued immediately. Regular hematological tests are required as abnormalities may be detected in blood tests. Liver function tests should also be conducted regularly; if any abnormalities are found, immediate action must be taken. Symptoms related to cardiovascular issues or gastrointestinal symptoms may occur, and consulting with a healthcare provider is advised if any such symptoms arise. Symptoms related to the central nervous system or respiratory symptoms have also been reported, so caution is necessary. Long-term use may increase the risk of fractures related to osteoporosis, and therefore, careful monitoring is required during prolonged therapy. Magnesium levels may decrease, so regular monitoring is necessary when used for extended periods or in combination with certain drugs. Due to inhibition of gastric acid secretion, there may be a slight increase in the risk of gastrointestinal bacterial infections; if diarrhea persists, inform a healthcare provider. Drowsiness or other effects may occur when driving or operating machinery, so caution is required. There may be potential interactions with other medications, so it is essential to consult with a healthcare provider regarding any co-administered drugs. Use during pregnancy is contraindicated, and it is also safer not to use during breastfeeding. Elderly patients may have a higher likelihood of experiencing side effects due to decreased liver function; careful administration is advised in case symptoms occur. Safety in pediatric patients has not been established, and experience with its use is limited. Do not chew or crush the tablets; swallow them whole. Keep out of reach of children and it is advisable not to transfer to another container. Long-term use of this medication may cause vitamin B12 absorption disorders, so regular checks are necessary if required. Autoimmune conditions such as erythema multiforme or systemic lupus erythematosus may develop, so consult a specialist immediately if any unusual symptoms occur. Kidney-related side effects such as acute interstitial nephritis can occur, so discontinue use immediately if any signs of kidney dysfunction appear. There is no specific antidote for overdose; treatment should be symptomatic and supportive.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in the mucous membranes of the mouth/eyes, difficulty or shortness of breath, asthma attacks, abnormal respiratory symptoms with cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urine abnormalities.

Mild side effects

  • Occasionally
  • rash
  • hives
  • itching
  • decreased red blood cells
  • decreased white blood cells
  • increased white blood cells
  • increased eosinophils
  • increased neutrophils
  • decreased lymphocytes
Show 21 more
  • anemia
  • petechiae
  • lymphadenopathy
  • hypochromic anemia
  • pancytopenia
  • agranulocytosis
  • thrombocytopenia
  • hemolytic anemia
  • ALT elevation
  • AST elevation
  • ALP elevation
  • γ-GTP elevation
  • LDH elevation
  • total bilirubin elevation
  • hypertension
  • migraine
  • fainting
  • angina
  • arrhythmia
  • palpitations
  • bradycardia.

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

Storage

This medication should be stored in a sealed container as it may be sensitive to air or moisture. It is also advisable to keep it at room temperature between 1 and 30 degrees Celsius to maintain its efficacy for an extended period.

Appearance and packaging

Appearance

Pale yellow round enteric-coated tablets

Package unit

28 Tablets/PTP [(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

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.