Medication info
Selabec Tablets 20 mg (Rabeprazole Sodium)

Selabec Tablets 20 mg (Rabeprazole Sodium)

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

MFDS item code 201904754 · Approved 2019.07.16

Summary

Main use
Effective in alleviating symptoms of peptic ulcer and gastroesophageal reflux disease and treating Helicobacter pylori infection.
Who takes it
Adults
Adult dose
Peptic ulcer, duodenal ulcer: Normally, 10 mg is orally administered once daily for adults. Depending on symptoms, 20 mg can be orally administered once daily. Generally, it is administered for up to 8 weeks for gastric ulcers and up to 6 weeks for duodenal ulcers. Erosive or ulcerative gastroesophageal reflux disease: 10 mg or 20 mg is administered orally once daily for 4 to 8 weeks. If not resolved, an additional 8 weeks of 10 mg or 20 mg can be taken orally twice daily. However, 20 mg twice daily is only for confirmed severe mucosal damage. Symptom relief for gastroesophageal reflux disease: 10 mg is administered once daily. If symptoms are not controlled after 4 weeks, further medical attention is required. After symptoms are gone, on-demand therapy using 10 mg once daily can be employed to manage any symptoms that appear afterward. Long-term maintenance therapy for gastroesophageal reflux disease: Depending on the patient, 10 mg or 20 mg is orally administered once daily. Helicobacter pylori eradication: Patients with Helicobacter pylori infection should be treated with eradication therapy. It is recommended to administer this drug 20 mg with 500 mg of clarithromycin and 1 g of amoxicillin twice daily for 7 days. Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg once daily. The dose can be adjusted up to 120 mg depending on individual patient needs. Doses up to 100 mg can be given once daily, while 120 mg should be divided into two doses of 60 mg each taken once daily. Patients with Zollinger-Ellison syndrome have been treated with this drug for up to one year. Patients with liver impairment: Adverse reactions of hepatic encephalopathy have been reported in cirrhotic patients. Therefore, it should be administered cautiously. Pediatric: Safety has not been established for use in children. Elderly: Use cautiously as they often have decreased liver function.

Ingredients

Manufacturer
(주)텔콘알에프제약

Efficacy & effects

Effective in alleviating symptoms of peptic ulcer and gastroesophageal reflux disease and treating Helicobacter pylori infection.

  • Peptic ulcer
  • duodenal ulcer
  • erosive gastroesophageal reflux disease
  • ulcerative gastroesophageal reflux disease
  • gastroesophageal reflux disease
  • gastrointestinal ulcer
  • Zollinger-Ellison syndrome.
View approved original text

This drug is effective in the treatment of gastric and duodenal ulcers and is also used to alleviate symptoms in patients with erosive or ulcerative gastroesophageal reflux disease. It aids in long-term maintenance of gastroesophageal reflux disease and is used in combination with antibiotics to treat gastrointestinal ulcers infected with Helicobacter pylori. It is also useful in the treatment of conditions involving excessive gastric acid secretion such as Zollinger-Ellison syndrome. This drug is used to treat various gastrointestinal disorders and improve symptoms.

How to take

Adult dose

Peptic ulcer, duodenal ulcer: Normally, 10 mg is orally administered once daily for adults. Depending on symptoms, 20 mg can be orally administered once daily. Generally, it is administered for up to 8 weeks for gastric ulcers and up to 6 weeks for duodenal ulcers. Erosive or ulcerative gastroesophageal reflux disease: 10 mg or 20 mg is administered orally once daily for 4 to 8 weeks. If not resolved, an additional 8 weeks of 10 mg or 20 mg can be taken orally twice daily. However, 20 mg twice daily is only for confirmed severe mucosal damage. Symptom relief for gastroesophageal reflux disease: 10 mg is administered once daily. If symptoms are not controlled after 4 weeks, further medical attention is required. After symptoms are gone, on-demand therapy using 10 mg once daily can be employed to manage any symptoms that appear afterward. Long-term maintenance therapy for gastroesophageal reflux disease: Depending on the patient, 10 mg or 20 mg is orally administered once daily. Helicobacter pylori eradication: Patients with Helicobacter pylori infection should be treated with eradication therapy. It is recommended to administer this drug 20 mg with 500 mg of clarithromycin and 1 g of amoxicillin twice daily for 7 days. Zollinger-Ellison syndrome: The recommended initial dose for adults is 60 mg once daily. The dose can be adjusted up to 120 mg depending on individual patient needs. Doses up to 100 mg can be given once daily, while 120 mg should be divided into two doses of 60 mg each taken once daily. Patients with Zollinger-Ellison syndrome have been treated with this drug for up to one year. Patients with liver impairment: Adverse reactions of hepatic encephalopathy have been reported in cirrhotic patients. Therefore, it should be administered cautiously. Pediatric: Safety has not been established for use in children. Elderly: Use cautiously as they often have decreased liver function.

Precautions

This drug should not be used by individuals who have experienced allergic reactions to specific components. Additionally, individuals taking certain antibiotics or other medications, as well as pregnant or breastfeeding women, should not take this drug. Patients with liver dysfunction, the elderly, or those with a history of drug allergies should use this drug cautiously. If allergic symptoms such as rash or itching occur after taking this drug, discontinue use immediately. Regular blood tests and liver function tests are necessary, and if abnormalities occur, stop taking the medication and follow medical advice. Various side effects may appear in different parts of the body including cardiovascular, gastrointestinal, neurological, respiratory, muscular, skin, eyes, and urinary system, so consult healthcare professionals if symptoms arise. This drug suppresses gastric acid secretion, helping in the treatment of gastrointestinal diseases, but prolonged use may increase the risk of fractures and electrolyte abnormalities such as hypomagnesemia. Therefore, routine blood tests and monitoring of magnesium levels are needed during long-term use. This drug may slightly increase the risk of bacterial infections in the gastrointestinal tract, so notify a doctor if diarrhea persists for an extended period. Caution is required while driving or operating machinery as it may cause drowsiness, and consultations with a doctor or pharmacist are essential if taken concomitantly with certain medications. It is advisable not to take this drug during pregnancy or while breastfeeding, and the elderly should be cautious as the risk of side effects may be higher due to decreased liver function. Safety for children has not been established, so it should not be used. When taking this medication, do not chew or crush the tablets; swallow them whole. Store the medication out of reach of children and avoid transferring it to another container. If used for a prolonged period, regular monitoring of your condition is required as per doctor's instructions, and report any abnormal symptoms promptly to healthcare professionals.

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 high fever, blisters, skin peeling, mucosal pain in the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, respiratory difficulties accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination.

Mild side effects

  • Rash
  • urticaria
  • itching
  • decreased red blood cells
  • decreased white blood cells
  • increased white blood cells
  • increased eosinophils
  • increased neutrophils
  • decreased lymphocytes
  • anemia
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  • ecchymosis
  • 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
  • heart block.

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius. This helps preserve the effectiveness and safety of the drug over time.

Appearance and packaging

Appearance

Pale yellow round enteric-coated tablet

Package unit

28 tablets / PTYP [(14 tablets / Alu-Alu*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.