Medication info

Exoduo Tablet 20/800 mg

Prescription medicationTablet경구
Ingredient · strength
Esomeprazole Magnesium Trihydrate›22.26mg / 1 tabletSodium Bicarbonate›650mg / 1 tablet
Manufacturer / importer
건일바이오팜주식회사
Appearance
Pale pink oval film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202107644 · Approved 2021.11.25

Summary

Main use
Treatment and prevention of reflux esophagitis, alleviation of gastroesophageal reflux disease symptoms
Who takes it
Adults
Adult dose
This medication should be taken on an empty stomach at least 1 hour before meals. Swallow the tablet whole with at least half a cup of water. Do not take with any other beverages except water. Do not chew or crush the tablet. Treatment for gastroesophageal reflux disease (GERD): - Erosive reflux esophagitis: Administer 40/800 mg once daily for 4 weeks. If symptoms persist, continue for another 4 weeks. - Long-term maintenance therapy to prevent recurrence in esophagitis patients: 20/800 mg once daily. - Symptomatic treatment for GERD without esophagitis: 20/800 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is needed. Once symptoms are alleviated, continuation of symptoms can be managed with 20/800 mg once daily. In adults, 20/800 mg can be administered as needed once daily. For patients at high risk of gastric ulcers and duodenal ulcers due to nonsteroidal anti-inflammatory drug use, it is not recommended to use this dosage repetitively for symptom management. 2. In cases of hepatic impairment: There is no need to adjust the dose in patients with mild to moderate liver impairment. In patients with severe liver impairment, do not exceed the dose of 20/800 mg.

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

Treatment and prevention of reflux esophagitis, alleviation of gastroesophageal reflux disease symptoms

  • Gastroesophageal reflux disease
  • erosive reflux esophagitis
  • esophagitis
View approved original text

This medication is used for the treatment of gastroesophageal reflux disease (GERD) and erosive reflux esophagitis. Additionally, it is utilized for long-term maintenance therapy to prevent recurrence in patients with esophagitis. It is also effective in alleviating symptoms in patients with GERD who do not have esophagitis. The drug regulates stomach acid to protect the esophageal mucosa and improve symptoms. Overall, it helps gastrointestinal health and improves the quality of life of patients.

How to take

Adult dose

This medication should be taken on an empty stomach at least 1 hour before meals. Swallow the tablet whole with at least half a cup of water. Do not take with any other beverages except water. Do not chew or crush the tablet. Treatment for gastroesophageal reflux disease (GERD): - Erosive reflux esophagitis: Administer 40/800 mg once daily for 4 weeks. If symptoms persist, continue for another 4 weeks. - Long-term maintenance therapy to prevent recurrence in esophagitis patients: 20/800 mg once daily. - Symptomatic treatment for GERD without esophagitis: 20/800 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is needed. Once symptoms are alleviated, continuation of symptoms can be managed with 20/800 mg once daily. In adults, 20/800 mg can be administered as needed once daily. For patients at high risk of gastric ulcers and duodenal ulcers due to nonsteroidal anti-inflammatory drug use, it is not recommended to use this dosage repetitively for symptom management. 2. In cases of hepatic impairment: There is no need to adjust the dose in patients with mild to moderate liver impairment. In patients with severe liver impairment, do not exceed the dose of 20/800 mg.

Precautions

This medication should not be administered to patients who are allergic to this drug or its components, or those who have experienced hypersensitivity reactions. Patients taking certain antiviral medications such as Atazanavir or Nelfinavir, nursing women, and those taking medications containing rilpivirine should also avoid using this drug. Patients with a history of myocardial infarction or those who have suffered from myocardial infarction should avoid this medication. Patients with impaired liver function, elderly individuals, patients with severe gastrointestinal ulcers, individuals with decreased kidney function, and those with reduced heart or lung function, or electrolyte imbalances should use this drug cautiously. Particular caution is needed for patients with hypokalemia, hypocalcemia, or acid-base imbalances due to the sodium bicarbonate component in this medication. Patients with conditions such as hypertension, edema, or preeclampsia, where sodium intake must be restricted, should also exercise caution when taking this drug. This medication may cause a variety of side effects, including headache, dizziness, abdominal pain, diarrhea, skin rash, liver function abnormalities, and myalgia. Rarely, serious allergic reactions or severe skin reactions may occur, so patients should consult a doctor immediately if symptoms develop. Long-term use of this drug may lead to hypomagnesemia, and regular blood tests are recommended. This medication suppresses stomach acid secretion, which may increase the number of bacteria in the stomach; therefore, if diarrhea persists, the possibility of infection should be evaluated. Additionally, this drug may interact with other medications, so caution is advised when used in conjunction with anticoagulants, antiviral drugs, antidepressants, anticonvulsants, etc. The safety of this drug during pregnancy has not been fully established, hence it should be administered cautiously under a doctor's guidance. Nursing mothers are advised not to take this medication. In cases of overdose, there is no specific antidote, so appropriate treatment should be administered based on symptoms, and the drug should be stored out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylaxis, shock, severe allergic reactions, severe rash with fever, blisters, skin shedding, oral/ocular mucosal pain, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), jaundice, liver failure, encephalopathy, difficulty breathing, asthma attacks, respiratory difficulties accompanied by cough and fever, severe skin reactions

Mild side effects

  • Leukopenia
  • thrombocytopenia
  • agranulocytosis
  • pancytopenia
  • fever
  • angioedema
  • peripheral edema
  • hyponatremia
  • hypomagnesemia
  • insomnia
Show 24 more
  • anxiety
  • mental confusion
  • depression
  • aggression
  • hallucinations
  • headache
  • dizziness
  • perception abnormalities
  • drowsiness
  • taste disturbance
  • blurred vision
  • vertigo
  • bronchospasm
  • pancreatitis
  • abdominal pain
  • constipation
  • diarrhea
  • abdominal bloating
  • nausea
  • vomiting
  • dry mouth
  • stomatitis
  • gastrointestinal candidiasis
  • hyperemia

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

Storage

This medication must be stored in a tightly sealed container to protect it from air and moisture. Additionally, it should be kept at normal room temperature (between 1°C and 30°C) away from extreme heat or cold.

Appearance and packaging

Appearance

Pale pink oval film-coated tablet

Package unit

30 tablets/bottle

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.