Medication info

Rabeprazole Sodium 20 mg Tablets

Prescription medicationExpired
Ingredient · strength
Rabeprazole Sodium›Strength being verified
Manufacturer / importer
(주)중헌제약
Appearance
Light yellow, round, enteric-coated tablet
Packaging
28 tablets (14 tablets x 2 PTP packs)
Approval status
Expired

MFDS item code 201801439 · Approved 2018.03.30

This product's status changed to Expired on 2023.03.30. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of gastric ulcer and duodenal ulcer, symptomatic relief of gastroesophageal reflux disease and maintenance therapy, treatment of gastrointestinal ulcer in combination with antibiotics for Helicobacter pylori infection, etc.
Who uses it
Adults · Children
Adult dosage
Typically, for adults, rabeprazole sodium is administered orally at a dosage of 10 mg once daily. Depending on symptoms, it may be taken as 20 mg once daily. Typically, gastric ulcers are treated for up to 8 weeks, and duodenal ulcers for up to 6 weeks. For erosive or ulcerative gastroesophageal reflux disease, 10 mg or 20 mg is taken once daily for 4 to 8 weeks. If not treated after 8 weeks of PPI therapy, an additional 8 weeks of 10 mg or 20 mg may be taken twice daily orally. However, a dosage of 20 mg twice daily is reserved for patients with severe mucosal damage confirmed. For symptomatic relief of gastroesophageal reflux disease: 10 mg is administered once daily. If symptoms are not controlled after four weeks, further medical consultation is needed. Once symptoms have resolved, on-demand therapy with 10 mg once daily can be used to manage any symptoms that may arise afterward. For long-term maintenance therapy of gastroesophageal reflux disease: 10 mg or 20 mg is taken orally once daily based on patient requirements. For eradication of Helicobacter pylori: Patients with Helicobacter pylori infection should receive eradication therapy. It is recommended to use this medication 20 mg alongside 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 once daily. The dosage can be adjusted up to 120 mg daily based on individual patient needs. Dosages up to 100 mg may be taken once daily, while the 120 mg dosage is divided into 60 mg twice daily. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to one year. ◯ Patients with liver dysfunction: Adverse reactions of hepatic encephalopathy have been reported in patients with liver cirrhosis; therefore, caution should be exercised in administration. ◯ Pediatrics: The safety in pediatric use has not been established. ◯ The elderly: Caution should be taken as liver function may often be impaired.
Children's dosage
The safety in pediatric use has not been established.

Ingredients

Manufacturer
(주)중헌제약

Efficacy & effects

Treatment of gastric ulcer and duodenal ulcer, symptomatic relief of gastroesophageal reflux disease and maintenance therapy, treatment of gastrointestinal ulcer in combination with antibiotics for Helicobacter pylori infection, etc.

  • 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 effective for the treatment of ulcers in the stomach and duodenum. It also relieves symptoms of erosive or ulcerative gastroesophageal reflux disease and is used for long-term maintenance therapy. In patients with gastrointestinal ulcers caused by Helicobacter pylori infection, it enhances therapeutic effect when used in combination with antibiotics. Additionally, it is helpful for treating Zollinger-Ellison syndrome. In other words, it is widely used for the treatment and symptom improvement of various gastrointestinal diseases.

Dosage and Administration

Adult dosage

Typically, for adults, rabeprazole sodium is administered orally at a dosage of 10 mg once daily. Depending on symptoms, it may be taken as 20 mg once daily. Typically, gastric ulcers are treated for up to 8 weeks, and duodenal ulcers for up to 6 weeks. For erosive or ulcerative gastroesophageal reflux disease, 10 mg or 20 mg is taken once daily for 4 to 8 weeks. If not treated after 8 weeks of PPI therapy, an additional 8 weeks of 10 mg or 20 mg may be taken twice daily orally. However, a dosage of 20 mg twice daily is reserved for patients with severe mucosal damage confirmed. For symptomatic relief of gastroesophageal reflux disease: 10 mg is administered once daily. If symptoms are not controlled after four weeks, further medical consultation is needed. Once symptoms have resolved, on-demand therapy with 10 mg once daily can be used to manage any symptoms that may arise afterward. For long-term maintenance therapy of gastroesophageal reflux disease: 10 mg or 20 mg is taken orally once daily based on patient requirements. For eradication of Helicobacter pylori: Patients with Helicobacter pylori infection should receive eradication therapy. It is recommended to use this medication 20 mg alongside 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 once daily. The dosage can be adjusted up to 120 mg daily based on individual patient needs. Dosages up to 100 mg may be taken once daily, while the 120 mg dosage is divided into 60 mg twice daily. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to one year. ◯ Patients with liver dysfunction: Adverse reactions of hepatic encephalopathy have been reported in patients with liver cirrhosis; therefore, caution should be exercised in administration. ◯ Pediatrics: The safety in pediatric use has not been established. ◯ The elderly: Caution should be taken as liver function may often be impaired.

Children's dosage

The safety in pediatric use has not been established.

Precautions

This medication should not be administered to patients allergic to specific components or benzimidazoles. Also, patients with allergies to certain antibiotics such as amoxicillin or clarithromycin during treatment to eradicate Helicobacter pylori should avoid using it. It should not be given to patients taking certain heart-related medications or drugs such as atazanavir, rilpivirine, pregnant or breastfeeding women. Caution should be exercised in administering to patients with impaired liver function, the elderly, and those with a history of drug allergies. During the use of this medication, hypersensitivity reactions such as skin rashes and itching may occur; if symptoms appear, the medication should be discontinued immediately. There may be various abnormalities such as decreased red or white blood cells and elevated liver enzymes noted in blood tests, so regular examinations are necessary. Adverse reactions in various body parts including the heart, digestive system, nervous system, respiratory system, musculoskeletal system, skin, eyes, and urinary system can occur; any unusual symptoms should be discussed with a physician. Long-term use may increase the risk of fractures due to osteoporosis, so caution is needed. This medication suppresses gastric acid secretion, which may increase the risk of bacterial infections in the gastrointestinal tract; if diarrhea or fever persists, visiting a hospital promptly is necessary. Caution should be taken as drowsiness or dizziness may occur while driving or operating machinery. This medication can interact with various drugs, so if other medications are being taken, it is essential to inform the healthcare provider. The safety of this medication has not been established for use during pregnancy or breastfeeding, so it is advisable not to use it. The safety for children has not been established, so it should not be administered to pediatric patients. This medication should be swallowed whole; it should not be chewed or crushed. When storing, keep it out of the reach of children, and do not transfer it to another container. There is no specific antidote for overdose; appropriate treatment should be given based on symptoms. Long-term use of this medication may result in impaired absorption of vitamin B12, so testing and supplementation may be necessary if needed. Autoimmune diseases may manifest as skin or systemic rashes resembling lupus erythematosus; if related symptoms occur, prompt medical attention is necessary. Use of this medication may affect the results of neuroendocrine tumor tests, so discontinuation before testing may be necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Rash
  • itching
  • hives
  • erythrocytopenia
  • leukopenia
  • leukocytosis
  • eosinophilia
  • neutrophilia
  • lymphocytopenia
  • anemia
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  • petechial hemorrhage
  • lymphadenopathy
  • hypochromic anemia
  • pancytopenia
  • agranulocytosis
  • thrombocytopenia
  • hemolytic anemia
  • elevated ALT
  • elevated AST
  • elevated ALP
  • elevated γ-GTP
  • elevated LDH
  • elevated total bilirubin
  • hypertension
  • myocardial infarction
  • ECG abnormalities
  • migraine
  • syncope
  • angina pectoris
  • conduction block

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

Storage

This medication should be stored in a tightly sealed container that can block light and moisture, at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Light yellow, round, enteric-coated tablet

Package unit

28 tablets (14 tablets x 2 PTP packs)

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.

Questions about this medicine

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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.