Medication info

Esoditi Oral Disintegra Tablet 20mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥Approval withdrawn
Ingredient · strength
Esomeprazole Magnesium Trihydrate›21.69mg / 1 tablet
Manufacturer / importer
(주)태준제약
Appearance
Round white tablet with gray spots
Packaging
28 tablets/box [7 tablets/PTP x 4]
Approval status
Approval withdrawn

MFDS item code 201902348 · Approved 2019.04.16

This product's status changed to Approval withdrawn on 2024.01.09. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis) and treatment of peptic ulcers associated with Helicobacter pylori infection, prevention of gastric and duodenal ulcers
Who uses it
Adults · Children
Adult dosage
This medication should be placed on the tongue and swallowed with saliva without chewing or crushing. 1) Gastroesophageal Reflux Disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If not resolved, extend treatment for another 4 weeks. - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily. - Symptomatic treatment for GERD without esophagitis: 20 mg once daily. If symptoms persist after 4 weeks, further treatment is necessary.
Children's dosage
For adolescents aged 12 and older: - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If not resolved, extend treatment for another 4 weeks. - Symptomatic treatment without esophagitis: 20 mg once daily.

Ingredients

Manufacturer
(주)태준제약

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive esophagitis) and treatment of peptic ulcers associated with Helicobacter pylori infection, prevention of gastric and duodenal ulcers

  • Gastroesophageal reflux disease
  • erosive reflux esophagitis
  • esophagitis
  • duodenal ulcer
  • peptic ulcer
  • upper gastrointestinal symptoms
  • pain
  • discomfort
  • burning sensation
  • gastric ulcer
View approved original text

This medication is used for the treatment of gastroesophageal reflux disease and erosive reflux esophagitis, and is also effective for long-term maintenance therapy to prevent recurrence in patients with esophagitis. It also helps treat duodenal ulcers and peptic ulcers caused by Helicobacter pylori infection, and prevents the recurrence of ulcers caused by this bacterium. It is used for the short-term treatment of gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug use and to prevent and treat gastric and duodenal ulcers that may occur due to long-term use. It is also effective for the treatment of Zollinger-Ellison syndrome and maintenance therapy after preventing rebleeding of ulcers. With these efficacies, it is widely used for the treatment and prevention of gastrointestinal diseases.

Dosage and Administration

Adult dosage

This medication should be placed on the tongue and swallowed with saliva without chewing or crushing. 1) Gastroesophageal Reflux Disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If not resolved, extend treatment for another 4 weeks. - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily. - Symptomatic treatment for GERD without esophagitis: 20 mg once daily. If symptoms persist after 4 weeks, further treatment is necessary.

Children's dosage

For adolescents aged 12 and older: - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If not resolved, extend treatment for another 4 weeks. - Symptomatic treatment without esophagitis: 20 mg once daily.

Precautions

This medication should not be used in patients with specific allergic reactions or hypersensitivity. It should also not be administered if there is an allergy to certain antibiotics used in combination with this medication. Additionally, it is contraindicated for patients taking certain heart-related medications, breastfeeding women, and patients on specific antiviral medications. Various side effects such as a decrease in blood cell counts, allergic reactions, electrolyte imbalances, neurological and psychiatric symptoms, gastrointestinal disturbances, liver function abnormalities, skin rashes may occur while taking this medication, albeit rarely. Regular health check-ups are necessary during long-term use, and immediate consultation with a physician is required in the event of any changes in symptoms. This medication reduces stomach acid, which may increase the risk of certain bacterial infections, and long-term use may increase the risk of fractures, so caution is advised. This medication may not be suitable for patients with certain genetic diseases, and checking before taking it is essential. Due to many drug interactions, consultation with a doctor or pharmacist is required when taking this medication with others, especially with anticoagulants, antibiotics, antiviral agents, and anticonvulsants. During pregnancy, safety data for this medication is limited, so it should only be used based on a physician's judgment when absolutely necessary and it is recommended not to take it while breastfeeding. In case of overdose, specific antidotes are not available; recommended treatment is based on symptoms, and it should be kept out of reach of children. This medication should be stored in its original container, and transferring it to another container should be avoided.

Side effects and when to seek care immediately

Serious side effects

Angioedema, anaphylactic reaction/shock, urticaria, rarely angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, very rarely hepatitis with or without jaundice, acute liver failure, acute liver abnormalities, severe edema, sudden and severe headache, seizure, confusion, visual disturbances, paralysis, thrombocytopenia, leukopenia.

Mild side effects

  • Occasionally peripheral edema
  • rarely hyponatremia
  • very rarely hypomagnesemia
  • occasionally insomnia
  • rarely anxiety
  • confusion
  • depression
  • very rarely aggression
  • hallucination
  • frequent headache
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  • occasionally dizziness
  • paresthesia
  • drowsiness
  • rarely taste disorder
  • rarely blurred vision
  • occasionally dizziness
  • rarely bronchospasm
  • frequent abdominal pain
  • constipation
  • diarrhea
  • abdominal bloating
  • nausea
  • vomiting
  • occasionally dry mouth
  • rarely stomatitis
  • gastrointestinal.

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

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture exposure, and it is recommended to store it at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the efficacy of the medication over time.

Appearance and packaging

Appearance

Round white tablet with gray spots

Package unit

28 tablets/box [7 tablets/PTP x 4]

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.