Medication info
Paribene Tablet 20 mg (Rabeprazole Sodium)

Paribene Tablet 20 mg (Rabeprazole Sodium)

Prescription medicationTablet경구
Ingredient · strength
Rabeprazole Sodium›20mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Pale yellow round enteric-coated tablet
Packaging
Domestic: 28 tablets (28 tablets/PTP X 1) Export: 28 tablets (14 tablets/PTP X 2)
Approval status
Active

MFDS item code 200611053 · Notified 2006.11.20 · Insurance code 671800330

Summary

Main use
Relief of symptoms of gastric ulcers and gastroesophageal reflux disease, and effective treatment for Helicobacter pylori infection
Who takes it
Adults
Adult dose
Gastric ulcer, duodenal ulcer: typically administered orally as 10 mg once daily, can be increased to 20 mg once daily based on symptoms. Gastric ulcers are treated for up to 8 weeks, and duodenal ulcers for up to 6 weeks. Erosive or ulcerative gastroesophageal reflux disease: administer 10 mg or 20 mg once daily for 4 to 8 weeks; if not resolved after 8 weeks, can administer 10 mg or 20 mg orally twice daily (for severe cases). Relief of symptoms of gastroesophageal reflux disease: administer 10 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention is required. After the symptoms resolve, on-demand therapy using 10 mg once daily can be utilized to control subsequent symptoms. Long-term maintenance therapy for gastroesophageal reflux disease: administer 10 mg or 20 mg orally once daily depending on the patient. Helicobacter pylori eradication: Patients infected with Helicobacter pylori should receive eradication therapy. A combination of this medication at 20 mg, clarithromycin 500 mg, and amoxicillin 1 g is recommended to be administered twice daily for 7 days. Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg once daily. The dosage can be adjusted based on individual patient needs up to 120 mg per day. The 100 mg dose can be administered once daily, and the 120 mg dose should be divided into 60 mg administered twice daily. Experience with administering this medication for Zollinger-Ellison syndrome has been reported for up to 1 year. For patients with liver dysfunction, adverse reactions of hepatic encephalopathy have been reported in cirrhotic patients. Therefore, it should be administered with caution. For pediatric patients, safety has not been established. Elderly patients should administer it cautiously as they often have decreased liver function.

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

Relief of symptoms of gastric ulcers and gastroesophageal reflux disease, and effective treatment for Helicobacter pylori infection

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

This medicine is used for the treatment of gastric ulcers, duodenal ulcers, and erosive or ulcerative gastroesophageal reflux disease. It also relieves the symptoms of gastroesophageal reflux disease and is applicable for long-term maintenance therapy. It is effective as part of a combination therapy with antibiotics for patients with gastrointestinal ulcers infected by Helicobacter pylori. Furthermore, it is used for Zollinger-Ellison syndrome to improve symptoms. It is utilized in the treatment of various gastrointestinal disorders, effectively alleviating symptoms.

How to take

Adult dose

Gastric ulcer, duodenal ulcer: typically administered orally as 10 mg once daily, can be increased to 20 mg once daily based on symptoms. Gastric ulcers are treated for up to 8 weeks, and duodenal ulcers for up to 6 weeks. Erosive or ulcerative gastroesophageal reflux disease: administer 10 mg or 20 mg once daily for 4 to 8 weeks; if not resolved after 8 weeks, can administer 10 mg or 20 mg orally twice daily (for severe cases). Relief of symptoms of gastroesophageal reflux disease: administer 10 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention is required. After the symptoms resolve, on-demand therapy using 10 mg once daily can be utilized to control subsequent symptoms. Long-term maintenance therapy for gastroesophageal reflux disease: administer 10 mg or 20 mg orally once daily depending on the patient. Helicobacter pylori eradication: Patients infected with Helicobacter pylori should receive eradication therapy. A combination of this medication at 20 mg, clarithromycin 500 mg, and amoxicillin 1 g is recommended to be administered twice daily for 7 days. Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg once daily. The dosage can be adjusted based on individual patient needs up to 120 mg per day. The 100 mg dose can be administered once daily, and the 120 mg dose should be divided into 60 mg administered twice daily. Experience with administering this medication for Zollinger-Ellison syndrome has been reported for up to 1 year. For patients with liver dysfunction, adverse reactions of hepatic encephalopathy have been reported in cirrhotic patients. Therefore, it should be administered with caution. For pediatric patients, safety has not been established. Elderly patients should administer it cautiously as they often have decreased liver function.

Precautions

This medication should not be used in patients who have specific allergic reactions or hypersensitivity to certain antibiotics. Pregnant or breastfeeding women should not take this medication. Patients with liver dysfunction or the elderly should use this medication with caution, and caution is also necessary if there is a history of drug allergies. If any allergic reactions such as rash or itching occur while taking this medication, discontinue use immediately. Regular blood tests and liver function tests should be conducted, and if any abnormal signs are detected, consult a healthcare provider immediately. Since various adverse reactions may occur in the heart, gastrointestinal system, nervous system, respiratory system, muscles, and skin, careful observation is required in case any symptoms arise. Long-term use may increase the risk of osteoporosis and fractures; therefore, regular examinations are recommended for long-term treatment. This medication suppresses gastric acid secretion, which may slightly increase the risk of gastrointestinal bacterial infections, so if symptoms like diarrhea persist, consult a healthcare provider. Caution is needed when driving or operating machinery as drowsiness or dizziness may occur. There may be interactions with other medications; therefore, it is essential to inform healthcare providers of any concurrent medications being taken. Particularly, caution should be exercised when combined with certain antibiotics, antivirals, and anticoagulants, and dosing adjustments or monitoring may be necessary. This medication should be swallowed whole without chewing or crushing and kept out of the reach of children. In the case of overdose, since no specific antidote exists, treatment should be based on symptoms and according to medical advice.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, fulminant hepatitis, liver dysfunction, jaundice, severe allergic reactions, skin adverse reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome), respiratory distress, asthma, pulmonary embolism, deep vein thrombosis, ventricular tachycardia, ventricular fibrillation, Torsades de pointes, serious neurological symptoms (seizures, altered consciousness, visual disturbances, paralysis,

Mild side effects

  • Rash
  • itching
  • decreased red blood cells
  • decreased white blood cells
  • increased white blood cells
  • increased eosinophils
  • increased neutrophils
  • decreased lymphocytes
  • anemia
  • petechial hemorrhage
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  • lymphadenopathy
  • hypochromic anemia
  • pancytopenia
  • agranulocytosis
  • thrombocytopenia
  • hemolytic anemia
  • elevated ALT
  • elevated AST
  • elevated ALP
  • elevated gamma-glutamyl transpeptidase
  • elevated LDH
  • elevated total bilirubin
  • hypertension
  • myocardial infarction
  • abnormal electrocardiogram
  • 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 closed container to protect it from air and moisture. It is recommended to keep the storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Pale yellow round enteric-coated tablet

Package unit

Domestic: 28 tablets (28 tablets/PTP X 1) Export: 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.

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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.