Medication info
Rabeprazole Sodium Tablet 20 mg

Rabeprazole Sodium Tablet 20 mg

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

MFDS item code 201904442 · Approved 2019.06.28 · Insurance code 697100840

Summary

Main use
Treatment of gastric ulcers and duodenal ulcers, alleviation of gastroesophageal reflux disease symptoms, and maintenance therapy effects
Who takes it
Adults · Children
Adult dose
Generally, 10 mg of rabeprazole sodium is administered orally once daily to adults. Depending on symptoms, 20 mg may be administered orally once daily. Treatment is usually given for up to 8 weeks for gastric ulcers, and up to 6 weeks for duodenal ulcers. For erosive or ulcerative gastroesophageal reflux disease, 10 mg or 20 mg is administered orally once daily for 4 to 8 weeks. If not treated after 8 weeks of proton pump inhibitor (PPI) therapy, an additional 8-week course of 10 mg or 20 mg may be administered twice daily. However, the 20 mg twice daily dose is limited to patients with severe mucosal damage. For alleviation of gastroesophageal reflux disease symptoms, 10 mg is administered once daily. If symptoms are not controlled after 4 weeks of administration, further medical attention is required. Once symptoms have resolved, on-demand therapy using 10 mg once daily may be used to manage any symptoms that appear later. For long-term maintenance therapy for gastroesophageal reflux disease, 10 mg or 20 mg may be administered orally once daily, depending on the patient. For Helicobacter pylori eradication, patients with Helicobacter pylori infections should undergo eradication therapy. It is recommended to administer this medication 20 mg, along with clarithromycin 500 mg and amoxicillin 1 g, twice daily for 7 days. For Zollinger-Ellison syndrome, the recommended initial dose for adults is 60 mg once daily. The dose may be adjusted up to 120 mg per day as per individual patient necessity. Doses of up to 100 mg may be given once daily, while the 120 mg doses should be divided and administered as 60 mg twice daily. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to 1 year. For liver impairment patients, adverse reactions related to hepatic encephalopathy have been reported in cirrhosis patients, so administration should be done with caution. For elderly patients, administration should be done with caution due to the prevalence of impaired liver function.
Child dose
Safety in pediatric patients has not been established.

Ingredients

Manufacturer
(주)한국피엠지제약

Efficacy & effects

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

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

This medication is used to alleviate symptoms of gastric ulcers, duodenal ulcers, and erosive or ulcerative gastroesophageal reflux disease. It is also effective for long-term maintenance therapy for gastroesophageal reflux disease, and assists in the treatment of gastrointestinal ulcers infected with Helicobacter pylori in combination with antibiotics. It is applicable for rare acid hypersecretion diseases such as Zollinger-Ellison syndrome. This medication is used for the improvement and management of various gastrointestinal diseases.

How to take

Adult dose

Generally, 10 mg of rabeprazole sodium is administered orally once daily to adults. Depending on symptoms, 20 mg may be administered orally once daily. Treatment is usually given for up to 8 weeks for gastric ulcers, and up to 6 weeks for duodenal ulcers. For erosive or ulcerative gastroesophageal reflux disease, 10 mg or 20 mg is administered orally once daily for 4 to 8 weeks. If not treated after 8 weeks of proton pump inhibitor (PPI) therapy, an additional 8-week course of 10 mg or 20 mg may be administered twice daily. However, the 20 mg twice daily dose is limited to patients with severe mucosal damage. For alleviation of gastroesophageal reflux disease symptoms, 10 mg is administered once daily. If symptoms are not controlled after 4 weeks of administration, further medical attention is required. Once symptoms have resolved, on-demand therapy using 10 mg once daily may be used to manage any symptoms that appear later. For long-term maintenance therapy for gastroesophageal reflux disease, 10 mg or 20 mg may be administered orally once daily, depending on the patient. For Helicobacter pylori eradication, patients with Helicobacter pylori infections should undergo eradication therapy. It is recommended to administer this medication 20 mg, along with clarithromycin 500 mg and amoxicillin 1 g, twice daily for 7 days. For Zollinger-Ellison syndrome, the recommended initial dose for adults is 60 mg once daily. The dose may be adjusted up to 120 mg per day as per individual patient necessity. Doses of up to 100 mg may be given once daily, while the 120 mg doses should be divided and administered as 60 mg twice daily. Patients with Zollinger-Ellison syndrome have been treated with this medication for up to 1 year. For liver impairment patients, adverse reactions related to hepatic encephalopathy have been reported in cirrhosis patients, so administration should be done with caution. For elderly patients, administration should be done with caution due to the prevalence of impaired liver function.

Child dose

Safety in pediatric patients has not been established.

Precautions

This medication should not be used in patients with certain allergic reactions. For example, patients with hypersensitivity to this medication, its ingredients, or benzimidazoles should avoid administration. Also, caution is required for patients with allergies to certain antibiotics in combination therapy. It is safest for pregnant or nursing women not to use this medication. Patients with liver function impairment, elderly patients, and those with a history of drug allergies should use this medication with caution. During the use of this medication, hypersensitivity symptoms such as skin rash, urticaria, and itching may occur; if these symptoms arise, discontinue use immediately. Changes in blood cell counts or liver function abnormalities may occur, so regular blood tests and liver function tests are necessary. Patients with heart disease should be careful as it can affect the heart or blood vessels. Gastrointestinal symptoms such as diarrhea, abdominal pain, and nausea may occur; if symptoms are severe, consult healthcare providers. Neurological symptoms such as headache, dizziness, and insomnia have been reported, and in rare cases, confusion or seizures may occur, requiring caution. Respiratory symptoms may include cough or breathing difficulties; in severe cases, notify healthcare providers immediately. Musculoskeletal symptoms such as myalgia or arthralgia may also occur. Serious skin reactions such as rashes or hair loss, and in severe cases, mucous membrane syndrome, may occur, so symptoms should be observed closely. Visual disturbances or eye pain should be discussed with specialists if reported. Urinary symptoms such as dysuria or hematuria may occur, so inform if abnormal symptoms arise. This medication may increase the risk of fractures related to osteoporosis with long-term use, so bone health should be monitored during prolonged administration. In addition, hypomagnesemia may occur rarely with low magnesium levels, so patients on long-term treatment should regularly check their magnesium levels. This medication suppresses gastric acid secretion, which may slightly increase the risk of bacterial infections in the gastrointestinal tract, so if diarrhea persists, notify healthcare providers immediately. Caution is advised as drowsiness may occur when driving or operating machinery. Interactions with other medications may occur, so if you are taking other medications, be sure to inform your doctor or pharmacist. This medication should not be chewed or crushed and should be swallowed whole, and kept out of the reach of children. It is safest for pregnant or nursing women not to use this medication. Elderly patients may exhibit adverse reactions due to decreased liver function, so symptoms should be closely monitored and the medication should be discontinued if necessary. Safety in children has not been established, so it is advisable not to use in pediatric patients. In cases of overdose, there is no specific antidote, and treatment and supportive therapy should be provided according to symptoms. Regular check-ups and consultation with healthcare providers are important for safely using this medication.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (edema)
  • chest tightness
  • breathing difficulties
  • severe rash with fever
  • blistering
  • skin peeling
  • mucous membrane pain in the mouth/eyes
  • liver abnormalities (jaundice)
  • fulminant hepatitis
Show 16 more
  • liver dysfunction
  • severe edema
  • hypertension
  • sudden and severe headache
  • confusion
  • visual disturbances
  • paralysis
  • seizure
  • asthma attack
  • breathlessness
  • pulmonary embolism
  • myocardial infarction
  • ventricular tachycardia
  • thrombophlebitis
  • QT prolongation
  • ventricular fibrillation

Mild side effects

Rash, itching, hematological abnormalities (decreased red blood cells, decreased white blood cells, anemia, etc.), elevated ALT, elevated AST, diarrhea, constipation, abdominal pain, abdominal bloating, dyspepsia, belching, nausea, thirst, vomiting, headache, insomnia, anxiety, dizziness, drowsiness, cough, pharyngitis, rhinitis, nasal bleeding, laryngitis, myalgia, arthralgia, sweating, hair loss, dry eyes, tinnitus, proteinuria, cystitis, increased urination, dysuria, nephrolithiasis, edema, fever, palpitations

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

Storage

Store this medication in a tightly sealed container to protect it from air or moisture. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature. Proper storage will help preserve the effectiveness of the medication for a longer period and ensure safe use.

Appearance and packaging

Appearance

Pale yellow round enteric-coated tablet

Package unit

28 tablets/box [(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.

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.