Medication info
Parabazole 20 mg (Rabeprazole Sodium)

Parabazole 20 mg (Rabeprazole Sodium)

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

MFDS item code 201900826 · Approved 2019.02.08 · Insurance code 678601210

Summary

Main use
Treatment of gastric ulcer and duodenal ulcer, alleviation of symptoms of gastroesophageal reflux disease and maintenance therapy effectiveness
Who takes it
Adults
Adult dose
For gastric ulcer and duodenal ulcer: Typically, rabeprazole sodium is taken orally once daily at a dose of 10 mg for adults. Depending on symptoms, the dose may be increased to 20 mg once daily. It is usually administered for up to 8 weeks for gastric ulcers and up to 6 weeks for duodenal ulcers. For erosive or ulcerative gastroesophageal reflux disease: 10 mg or 20 mg once daily for 4 to 8 weeks. After administering a proton pump inhibitor (PPI) for 8 weeks, For alleviation of symptoms of gastroesophageal reflux disease: Administer 10 mg once daily. If symptoms are not controlled after 4 weeks of treatment, further evaluation is necessary. After symptoms have resolved, on-demand therapy with 10 mg once daily may be used to manage any subsequently occurring symptoms. For long-term maintenance therapy for gastroesophageal reflux disease: Administer 10 mg or 20 mg orally once daily, depending on the patient. For eradication of Helicobacter pylori: Patients infected with Helicobacter pylori should be treated with 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 initial dose for adults is 60 mg administered once daily. The dose may be adjusted up to 120 mg per day depending on 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 per day. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to 1 year. For patients with liver impairment: Adverse reactions of hepatic encephalopathy have been reported in patients with liver cirrhosis. Caution should be exercised when administering. For children: Safety and efficacy in pediatric populations have not been established. For elderly patients: Caution should be exercised due to the frequent presence of impaired liver function.

Ingredients

Manufacturer
(주)다산제약

Efficacy & effects

Treatment of gastric ulcer and duodenal ulcer, alleviation of symptoms of gastroesophageal reflux disease and maintenance therapy effectiveness

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

This medication is used for the treatment of gastric ulcers and duodenal ulcers. It also alleviates the symptoms of erosive or ulcerative gastroesophageal reflux disease and is effective for long-term maintenance therapy for gastroesophageal reflux disease. It is used in combination with antibiotics for patients with gastrointestinal ulcers infected with Helicobacter pylori. It also helps in the treatment of Zollinger-Ellison syndrome. Thus, it is used for the treatment and symptomatic improvement of various gastrointestinal diseases.

How to take

Adult dose

For gastric ulcer and duodenal ulcer: Typically, rabeprazole sodium is taken orally once daily at a dose of 10 mg for adults. Depending on symptoms, the dose may be increased to 20 mg once daily. It is usually administered for up to 8 weeks for gastric ulcers and up to 6 weeks for duodenal ulcers. For erosive or ulcerative gastroesophageal reflux disease: 10 mg or 20 mg once daily for 4 to 8 weeks. After administering a proton pump inhibitor (PPI) for 8 weeks, For alleviation of symptoms of gastroesophageal reflux disease: Administer 10 mg once daily. If symptoms are not controlled after 4 weeks of treatment, further evaluation is necessary. After symptoms have resolved, on-demand therapy with 10 mg once daily may be used to manage any subsequently occurring symptoms. For long-term maintenance therapy for gastroesophageal reflux disease: Administer 10 mg or 20 mg orally once daily, depending on the patient. For eradication of Helicobacter pylori: Patients infected with Helicobacter pylori should be treated with 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 initial dose for adults is 60 mg administered once daily. The dose may be adjusted up to 120 mg per day depending on 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 per day. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to 1 year. For patients with liver impairment: Adverse reactions of hepatic encephalopathy have been reported in patients with liver cirrhosis. Caution should be exercised when administering. For children: Safety and efficacy in pediatric populations have not been established. For elderly patients: Caution should be exercised due to the frequent presence of impaired liver function.

Precautions

This medication requires caution in patients with specific allergic reactions or when used with certain antibiotics. Pregnant or breastfeeding women should not take this medication. Patients with poor liver function or elderly patients should use this medication more cautiously. If allergic reactions such as skin rash or itching occur during medication, discontinue use immediately. Regular blood tests and liver function tests should be carried out, and appropriate measures should be taken if abnormalities are found. Adverse effects may appear in various areas such as the heart, gastrointestinal tract, and nervous system, so symptoms should be monitored carefully. Long-term use may lead to issues such as osteoporosis or hypomagnesemia, necessitating regular check-ups. Due to the mechanism of reducing gastric acid secretion, the risk of gastrointestinal infections may increase, so if diarrhea persists, consult a medical professional. Caution is advised while driving or operating machinery as drowsiness may occur. There may be interactions with other medications, so it is essential to consult a doctor or pharmacist. This medication should not be chewed or crushed but swallowed whole, and should be stored out of the reach of children. Long-term use should be avoided, and if symptoms do not improve or worsen, immediate consultation with medical professionals is necessary.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, paralysis, urine

Mild side effects

  • Rash
  • urticaria
  • itching
  • decreased erythrocyte count
  • decreased leukocyte count
  • increased leukocyte count
  • increased eosinophils
  • increased neutrophils
  • decreased lymphocyte count
  • anemia
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  • purpura
  • lymphadenopathy
  • hypopigmented anemia
  • pancytopenia
  • agranulocytosis
  • thrombocytopenia
  • hemolytic anemia
  • elevated ALT
  • elevated AST
  • elevated ALP
  • elevated γ-GTP
  • elevated LDH
  • elevated total bilirubin
  • hypertension
  • myocardial infarction
  • electrocardiogram abnormalities
  • migraine
  • syncope
  • angina
  • ventricular block

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. It is recommended to maintain storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale yellow round enteric-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alu 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.