Medication info
Unirabeph Tablet 20 mg (Rabeprazole Sodium)

Unirabeph Tablet 20 mg (Rabeprazole Sodium)

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

MFDS item code 201901302 · Approved 2019.03.04 · Insurance code 665507090

Summary

Main use
Treatment of gastric ulcers and duodenal ulcers, relief of symptoms of gastroesophageal reflux disease and maintenance therapy, combination therapy with antibiotics for Helicobacter pylori infection, etc.
Who takes it
Adults
Adult dose
Gastric Ulcer, Duodenal Ulcer: Administer 10 mg by mouth once daily as Rabeprazole Sodium. Depending on symptoms, 20 mg may be administered once daily. Treatment duration for gastric ulcer is up to 8 weeks, and for duodenal ulcer is 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 treated, may additionally administer 10 mg or 20 mg for another 8 weeks.

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

Treatment of gastric ulcers and duodenal ulcers, relief of symptoms of gastroesophageal reflux disease and maintenance therapy, combination therapy 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 used for the treatment of gastrointestinal ulcers such as gastric and duodenal ulcers. It also helps in the treatment and symptom relief of erosive or ulcerative gastroesophageal reflux disease. It is effective for long-term maintenance therapy of gastroesophageal reflux disease and is used in combination with antibiotics for patients infected with Helicobacter pylori. It is also used for conditions of excessive gastric acid secretion such as Zollinger-Ellison syndrome. Overall, it helps improve gastrointestinal and esophageal-related conditions.

How to take

Adult dose

Gastric Ulcer, Duodenal Ulcer: Administer 10 mg by mouth once daily as Rabeprazole Sodium. Depending on symptoms, 20 mg may be administered once daily. Treatment duration for gastric ulcer is up to 8 weeks, and for duodenal ulcer is 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 treated, may additionally administer 10 mg or 20 mg for another 8 weeks.

Precautions

This medication should not be used in patients with allergies to specific ingredients or a history of hypersensitivity to benzimidazoles. Furthermore, when used in combination with amoxicillin or clarithromycin for the eradication of Helicobacter pylori, it should be avoided in patients with hypersensitivity to penicillin or macrolide antibiotics. It should also be avoided in patients taking specific drugs such as terfenadine, cisapride, pimodipine, astemizole, atazanavir, and rilpivirine. Pregnant or breastfeeding women should not take this medication. Patients with impaired liver function, the elderly, and those with a history of drug hypersensitivity should use this medication cautiously. This medication may cause hypersensitivity reactions such as skin rash, urticaria, and itching; if these symptoms occur, use should be stopped immediately. Regular blood tests are required as there may be changes in red or white blood cell counts. Periodic liver function tests should be conducted as signs of liver dysfunction may appear, and treatment should be stopped if abnormalities are found. Cardiovascular adverse reactions have been reported, so caution is required in cases of hypertension, myocardial infarction, or arrhythmias. Various symptoms such as diarrhea, abdominal pain, nausea, and vomiting may occur, so consult a doctor if such symptoms arise. Neurological symptoms may include headache, insomnia, anxiety, and dizziness; thus, caution is advised. Respiratory symptoms such as cough or dyspnea may also occur, and rarely, interstitial pneumonia may develop, requiring immediate medical attention if fever and dyspnea appear. Musculoskeletal and skin-related side effects may also occur; therefore, consult a healthcare professional if any unusual symptoms arise. This medication suppresses gastric acid secretion and may increase the risk of gastrointestinal bacterial infections, so caution is needed for long-term use. There may be effects such as drowsiness when driving or operating machinery. Interactions with other medications may occur, especially with warfarin, methotrexate, and antibiotics; consult a doctor when using these in combination. This medication should not be used during pregnancy and breastfeeding, and caution should be exercised in the elderly due to the potential for increased side effects from decreased liver function. Safety in children has not been established, so it is advisable not to use it in this population. There are no specific antidotes for overdose, but treatment and supportive therapy according to symptoms are needed. Tablets should not be chewed or crushed and should be swallowed whole, and should be kept out of reach of children. This medication may mask symptoms of malignant tumors, so if malignancies such as gastric cancer are suspected, it must be confirmed before use. During prolonged treatment, especially for more than one year, regular monitoring for adverse effects is necessary. There may be malabsorption of vitamin B12 when taking this medication, so caution is required for long-term use. Autoimmune diseases such as skin and systemic lupus erythematosus may develop or worsen, so consult a healthcare professional immediately if related symptoms occur. If kidney function impairment is suspected, treatment should be stopped, and appropriate measures should be taken.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling, tightness in the chest, difficulty breathing, severe rash with fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, yellowing of the skin or eyes (jaundice), generalized malaise, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, numbness, significantly reduced urine output, severe edema, elevated blood pressure, severe allergic reactions, severe skin reactions, respiratory problems, liver

Mild side effects

  • Rash
  • itching
  • reduction in red blood cells
  • reduction in white blood cells
  • increase in white blood cells
  • increase in eosinophils
  • increase in neutrophils
  • decrease in lymphocytes
  • anemia
  • petechiae
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  • lymphadenopathy
  • hypochromic anemia
  • panhypopenia
  • agranulocytosis
  • thrombocytopenia
  • hemolytic anemia
  • ALT elevation
  • AST elevation
  • ALP elevation
  • γ-GTP elevation
  • LDH elevation
  • total bilirubin elevation
  • hypertension
  • myocardial infarction
  • electrocardiogram abnormalities
  • migraine
  • syncope
  • angina pectoris
  • heart block
  • palpitations

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. Additionally, it is important to store it at room temperature between 1 degree and 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Light yellow round enteric-coated tablet

Package unit

28 tablets/box [14 tablets/Alu Alu packaging 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.