Medication info
Befzol Tablets 20mg (Rabeprazole Sodium)

Befzol Tablets 20mg (Rabeprazole Sodium)

Prescription medicationTablet경구
Ingredient · strength
Rabeprazole Sodium›20mg / 1 tablet
Manufacturer / importer
경동제약(주)
Appearance
Pale yellow round enteric-coated tablets
Packaging
28 tablets (7 tablets/Alu-Alu X 4)
Approval status
Active

MFDS item code 201403760 · Approved 2014.08.13 · Insurance code 648103440

Summary

Main use
Treatment of gastric and duodenal ulcers, alleviation of symptoms of gastroesophageal reflux disease, and efficacy in maintenance therapy
Who takes it
Adults
Adult dose
Gastric ulcer, duodenal ulcer: Generally administered orally 10 mg of rabeprazole sodium once a day to adults. Depending on symptoms, it may be administered 20 mg orally once a day. Typically, it is given for up to 8 weeks for gastric ulcers and up to 6 weeks for duodenal ulcers. Erosive or ulcerative gastroesophageal reflux disease: Administer 10 mg or 20 mg once a day for 4 to 8 weeks. If proton pump inhibitors (PPIs) have not resolved symptoms after administering for 8 weeks, it may be taken additionally at 10 mg or 20 mg orally twice a day for 8 more weeks. However, administering 20 mg orally twice a day is only for patients with confirmed severe mucosal damage. To alleviate symptoms of gastroesophageal reflux disease: Administer 10 mg once a day. If symptoms are not controlled after 4 weeks of administration, further medical attention is needed. After symptoms resolve, on-demand therapy at 10 mg once a day can be used to control any subsequent symptoms that may appear. Long-term maintenance therapy for gastroesophageal reflux disease: Administer orally 10 mg or 20 mg once a day, depending on the patient. Helicobacter pylori eradication: Patients with Helicobacter pylori infection should be treated with eradication therapy. It is recommended to combine this drug 20 mg with clarithromycin 500 mg and amoxicillin 1 g, taken twice a day for 7 days. Zollinger-Ellison syndrome: The recommended starting dose for adults is 60 mg once a day. Dosage can be adjusted up to 120 mg per day depending on the individual patient's needs. The 100 mg dose can be taken once a day, while the 120 mg dose should be divided and taken as 60 mg twice a day. Patients with Zollinger-Ellison syndrome have experience with this drug for up to 1 year. ○ Patients with liver dysfunction: Adverse reactions of hepatic encephalopathy have been reported in patients with liver cirrhosis. Therefore, it should be administered cautiously. ○ Pediatric patients: Safety in children has not been established. ○ Elderly patients: Caution is needed as liver function may often be impaired.

Ingredients

Manufacturer
경동제약(주)

Efficacy & effects

Treatment of gastric and duodenal ulcers, alleviation of symptoms of gastroesophageal reflux disease, and efficacy in maintenance therapy

  • 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 symptoms of erosive or ulcerative gastroesophageal reflux disease and is effective for long-term maintenance therapy of this condition. It is administered in combination with antibiotics for patients with gastrointestinal ulcers caused by Helicobacter pylori infection. It is also used to improve symptoms in conditions related to excessive gastric acid such as Zollinger-Ellison syndrome. Overall, it helps to effectively treat diseases related to the stomach and esophagus.

How to take

Adult dose

Gastric ulcer, duodenal ulcer: Generally administered orally 10 mg of rabeprazole sodium once a day to adults. Depending on symptoms, it may be administered 20 mg orally once a day. Typically, it is given for up to 8 weeks for gastric ulcers and up to 6 weeks for duodenal ulcers. Erosive or ulcerative gastroesophageal reflux disease: Administer 10 mg or 20 mg once a day for 4 to 8 weeks. If proton pump inhibitors (PPIs) have not resolved symptoms after administering for 8 weeks, it may be taken additionally at 10 mg or 20 mg orally twice a day for 8 more weeks. However, administering 20 mg orally twice a day is only for patients with confirmed severe mucosal damage. To alleviate symptoms of gastroesophageal reflux disease: Administer 10 mg once a day. If symptoms are not controlled after 4 weeks of administration, further medical attention is needed. After symptoms resolve, on-demand therapy at 10 mg once a day can be used to control any subsequent symptoms that may appear. Long-term maintenance therapy for gastroesophageal reflux disease: Administer orally 10 mg or 20 mg once a day, depending on the patient. Helicobacter pylori eradication: Patients with Helicobacter pylori infection should be treated with eradication therapy. It is recommended to combine this drug 20 mg with clarithromycin 500 mg and amoxicillin 1 g, taken twice a day for 7 days. Zollinger-Ellison syndrome: The recommended starting dose for adults is 60 mg once a day. Dosage can be adjusted up to 120 mg per day depending on the individual patient's needs. The 100 mg dose can be taken once a day, while the 120 mg dose should be divided and taken as 60 mg twice a day. Patients with Zollinger-Ellison syndrome have experience with this drug for up to 1 year. ○ Patients with liver dysfunction: Adverse reactions of hepatic encephalopathy have been reported in patients with liver cirrhosis. Therefore, it should be administered cautiously. ○ Pediatric patients: Safety in children has not been established. ○ Elderly patients: Caution is needed as liver function may often be impaired.

Precautions

This medicine should not be used in patients who have had an allergic reaction to this drug or any of its components. Patients allergic to penicillin or macrolide antibiotics should be cautious when using this drug in combination with them. Particularly, serious side effects may occur when used with certain antibiotics, so it is essential to follow a doctor's instructions. It is safer for pregnant or breastfeeding women not to take this medication. Patients with impaired liver function or the elderly should be more cautious when using this drug, and should consult a physician immediately if abnormal symptoms occur. This medicine may cause allergic reactions such as skin rash, itching, or hives, so if these symptoms appear, discontinue use. It is advisable to regularly undergo blood tests and liver function tests during administration. Side effects can occur in various areas, such as the heart, gastrointestinal system, nervous system, respiratory system, muscles, and skin, so notify medical personnel immediately if symptoms occur. Long-term use may increase the risk of bone fractures, so periodic checks on the condition are necessary for prolonged use. This medication strongly inhibits gastric acid secretion, which may slightly increase the risk of gastrointestinal infections. Caution is needed as drowsiness may occur during driving or operating machinery. This drug may interact with other medications, so be sure to inform your healthcare provider about any medications you are taking. Particularly caution is advised when used with drugs affecting blood coagulation due to the risk of bleeding. Safety has not been confirmed during pregnancy or breastfeeding, so it is better not to use it. Safety in children has not been established, so it should not be used in pediatric patients. In cases of overdose, there is no specific antidote, so it is crucial to receive treatment based on the symptoms. This drug should be swallowed whole without chewing or crushing and should be kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, systemic allergic reactions, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucous membranes, severe skin adverse reactions, asthma attacks, respiratory abnormalities accompanied by cough and fever, shortness of breath or difficulty breathing, yellowing of the skin or eyes, jaundice, profound lethargy, liver dysfunction, sudden and very severe headache, seizures, confusion.

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
  • thrombocytopenia
  • hemolytic anemia
  • increased ALT
  • increased AST
  • increased ALP
  • increased γ-GTP
  • increased LDH
  • increased total bilirubin
  • hypertension
  • myocardial infarction
  • abnormal electrocardiogram
  • migraine
  • syncope
  • angina
  • atrioventricular block

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

Storage

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture. It is best stored at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Pale yellow round enteric-coated tablets

Package unit

28 tablets (7 tablets/Alu-Alu X 4)

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.