Medication info
Esprazol 10 mg (Rabeprazole Sodium)

Esprazol 10 mg (Rabeprazole Sodium)

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

MFDS item code 200702532 · Approved 2007.02.28 · Insurance code 650300370

Summary

Main use
Treatment of gastric ulcers and duodenal ulcers, symptomatic relief of gastroesophageal reflux disease, and other gastrointestinal disorders
Who takes it
Adults
Adult dose
For gastric ulcers and duodenal ulcers: The usual oral dose is 10 mg once daily; depending on symptoms, it may be increased to 20 mg once daily. The duration of treatment is typically 8 weeks for gastric ulcers and 6 weeks for duodenal ulcers. For erosive or ulcerative gastroesophageal reflux disease: Administer 10 mg or 20 mg once daily for 4 to 8 weeks; if symptoms do not improve after 8 weeks of treatment, an additional 8 weeks of 10 mg or 20 mg twice daily may be given. For symptomatic relief of gastroesophageal reflux disease: The dose is 10 mg once daily. Further evaluation is needed if symptoms persist after 4 weeks of treatment. After symptoms have resolved, an on-demand regimen of 10 mg once daily may be utilized for controlling any subsequent symptoms. For long-term maintenance therapy of gastroesophageal reflux disease: This varies between patients and may be administered as 10 mg or 20 mg orally once daily. For Helicobacter pylori eradication: Patients infected with Helicobacter pylori should undergo eradication therapy. It is recommended to administer this drug 20 mg together with clarithromycin 500 mg and amoxicillin 1 g, twice daily for 7 days. For Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg once daily. The dose may be adjusted up to 120 mg daily according to individual patient needs. Doses of up to 100 mg can be given once daily; for 120 mg, it should be divided into 60 mg twice daily. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to 1 year. • Patients with liver dysfunction: Adverse reactions of hepatic encephalopathy have been reported in patients with cirrhosis; therefore, administering cautiously is required. • Pediatrics: Safety in children has not been established. • Elderly: Caution is advised as there may often be impaired liver function.

Ingredients

Manufacturer
진양제약(주)

Efficacy & effects

Treatment of gastric ulcers and duodenal ulcers, symptomatic relief of gastroesophageal reflux disease, and other gastrointestinal disorders

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

This medication treats ulcers that occur in the stomach and duodenum, alleviates symptoms of gastroesophageal reflux disease, and is used for long-term treatment. Additionally, it is used in conjunction with antibiotics for patients with gastrointestinal ulcers caused by Helicobacter pylori infection and is effective for treating conditions associated with excessive gastric acid secretion, such as Zollinger-Ellison syndrome. Thus, it is widely used for various gastrointestinal-related diseases to improve patients' symptoms.

How to take

Adult dose

For gastric ulcers and duodenal ulcers: The usual oral dose is 10 mg once daily; depending on symptoms, it may be increased to 20 mg once daily. The duration of treatment is typically 8 weeks for gastric ulcers and 6 weeks for duodenal ulcers. For erosive or ulcerative gastroesophageal reflux disease: Administer 10 mg or 20 mg once daily for 4 to 8 weeks; if symptoms do not improve after 8 weeks of treatment, an additional 8 weeks of 10 mg or 20 mg twice daily may be given. For symptomatic relief of gastroesophageal reflux disease: The dose is 10 mg once daily. Further evaluation is needed if symptoms persist after 4 weeks of treatment. After symptoms have resolved, an on-demand regimen of 10 mg once daily may be utilized for controlling any subsequent symptoms. For long-term maintenance therapy of gastroesophageal reflux disease: This varies between patients and may be administered as 10 mg or 20 mg orally once daily. For Helicobacter pylori eradication: Patients infected with Helicobacter pylori should undergo eradication therapy. It is recommended to administer this drug 20 mg together with clarithromycin 500 mg and amoxicillin 1 g, twice daily for 7 days. For Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg once daily. The dose may be adjusted up to 120 mg daily according to individual patient needs. Doses of up to 100 mg can be given once daily; for 120 mg, it should be divided into 60 mg twice daily. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to 1 year. • Patients with liver dysfunction: Adverse reactions of hepatic encephalopathy have been reported in patients with cirrhosis; therefore, administering cautiously is required. • Pediatrics: Safety in children has not been established. • Elderly: Caution is advised as there may often be impaired liver function.

Precautions

This medication should not be used by patients who are hypersensitive to this medication or its ingredients, or who have had such reactions in the past. Furthermore, hypersensitivity may occur when used in conjunction with certain antibiotics or other drugs, so patients taking contraindicated medications should not use this drug. It is not recommended for pregnant or breastfeeding women as safety has not been established. Patients with liver function problems or elderly individuals should use this medication with caution, and those with a history of drug hypersensitivity also need to be careful. This medication contains certain dyes; therefore, individuals allergic to these components should take special care before using it. During treatment, adverse reactions such as skin rash, hives, and itching may occur; if these symptoms arise, the medication should be discontinued immediately. Blood tests may show changes in red or white blood cell counts, requiring regular blood testing, and the treatment should be stopped if abnormalities are found. Liver function tests should also be performed regularly, and treatment should be stopped immediately if symptoms of hepatitis or jaundice develop. Symptoms such as hypertension, myocardial infarction, and arrhythmias may rarely occur, so patients should monitor for these symptoms. Gastrointestinal side effects may include diarrhea, abdominal pain, nausea, and vomiting; if severe, consultation with a healthcare provider is necessary. Central nervous system symptoms may include headache, dizziness, insomnia, and anxiety, thus monitoring is required. Respiratory symptoms or side effects such as skin rash and hair loss have also been reported, so any abnormal symptoms should be reported to a healthcare provider immediately. Long-term use of this medication may increase the risk of osteoporosis-related fractures, thus patients taking it long-term should pay attention to bone health. Moreover, magnesium levels may decrease, so regular blood tests for monitoring are necessary during long-term use. This medication suppresses gastric acid secretion, which can increase bacterial growth in the stomach, so if symptoms of infection such as diarrhea persist, a consultation with a healthcare provider is necessary. Caution is advised when driving or operating machinery due to the possibility of drowsiness. There may be interactions with other medications, so patients should inform healthcare providers of any other medications they are taking, especially when used in conjunction with certain antibiotics or antiviral drugs. In cases of overdose, as there are no specific antidotes, appropriate treatment should be performed according to symptoms, and the tablets should be swallowed whole without chewing or crushing. Keep out of reach of children and do not transfer to other containers for safety. During the intake of this medication, it is crucial to have regular examinations as directed by the physician and immediately consult if abnormal symptoms occur.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory difficulties with cough and fever, yellowing of the skin or eyes, extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, and markedly reduced urine output.

Mild side effects

  • Rash
  • itching
  • hives
  • 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 gamma-GTP
  • increased LDH
  • increased total bilirubin
  • hypertension
  • ECG abnormalities
  • migraine
  • fainting
  • angina
  • heart block
  • palpitations

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

Storage

This medication can be sensitive to air or moisture, so it must be stored in a tightly closed container. The storage temperature should be maintained at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will ensure the safety of the drug's efficacy.

Appearance and packaging

Appearance

Light yellow round enteric-coated tablet

Package unit

28 tablets (14 tablets/AluAlu 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.

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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.