Medication info

Il-Dong Esomeprazole Magnesium Trihydrate 40 mg Tablet

Prescription medicationTablet경구 · 정맥Approval withdrawn
Ingredient · strength
Esomeprazole Magnesium Trihydrate›44.5mg / 1 tablet
Manufacturer / importer
일동제약(주)
Appearance
Pink, oblong film-coated tablet
Packaging
28 tablets/box [14 tablets/Alu-Alu*2]
Approval status
Approval withdrawn

MFDS item code 202003749 · Approved 2020.05.22

This product's status changed to Approval withdrawn on 2024.07.30. 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 reflux esophagitis), eradication of Helicobacter pylori, prevention of relapse of peptic ulcers, and alleviation of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquid, such as water, and should not be chewed or crushed. 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: 20 mg once daily - If necessary, 20 mg once daily.
Children's dosage
Adolescents aged 12 and older - Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks - Treatment of symptoms of gastroesophageal reflux disease without esophagitis

Ingredients

Manufacturer
일동제약(주)

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive reflux esophagitis), eradication of Helicobacter pylori, prevention of relapse of peptic ulcers, and alleviation of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs.

  • Gastroesophageal reflux disease
  • erosive reflux esophagitis
  • esophagitis
  • duodenal ulcers
  • peptic ulcers
  • upper gastrointestinal symptoms
  • pain
  • discomfort
  • burning sensation
  • gastric ulcers
  • duodenal ulcers
  • Zollinger-Ellison syndrome
View approved original text

This medication is used to treat gastroesophageal reflux disease and erosive reflux esophagitis, and it is also effective for long-term maintenance therapy to prevent recurrence in patients with esophagitis. It is also helpful in alleviating symptoms of gastroesophageal reflux disease without esophagitis. It is used in combination with antibiotics for the treatment and prevention of relapse in patients with duodenal ulcers and peptic ulcers associated with Helicobacter pylori infection. It is used short-term for the treatment of upper gastrointestinal symptoms related to the use of non-steroidal anti-inflammatory drugs, and is effective for the treatment and prevention of gastric ulcers and duodenal ulcers due to continuous use of non-steroidal anti-inflammatory drugs. It is also applied for maintenance therapy for Zollinger-Ellison syndrome and prevention of rebleeding from gastric and duodenal ulcers. Thus, it is widely used for the treatment and prevention of various gastrointestinal diseases.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquid, such as water, and should not be chewed or crushed. 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: 20 mg once daily - If necessary, 20 mg once daily.

Children's dosage

Adolescents aged 12 and older - Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks - Treatment of symptoms of gastroesophageal reflux disease without esophagitis

Precautions

This medication should not be administered to patients with specific allergic reactions. For example, patients who are allergic to this medication, its components, or benzimidazole derivatives, or who have previously experienced such reactions should avoid its use. Additionally, patients allergic to penicillin or macrolide antibiotics, which are used in conjunction for the eradication treatment of Helicobacter pylori, should also refrain from using this medication. Patients taking specific heart-related medications, such as terfenadine, cisapride, pimodine, or astemizole, should not use this medication in conjunction. Patients receiving antiviral drugs such as atazanavir or nelfinavir, nursing women, patients with a history of myocardial infarction, and patients taking rilpivirine should also avoid this medication. During the use of this medication, various adverse reactions may occur. Digestive symptoms such as headache, abdominal pain, diarrhea, nausea, and vomiting are frequently reported, and in rare cases, serious side effects such as blood abnormalities, skin rashes, liver dysfunction, and hypomagnesemia may occur. Particularly, long-term use may lead to hypomagnesemia, so it's important to regularly monitor magnesium levels in the blood. Additionally, because this medication suppresses gastric acid secretion, it may slightly increase the risk of bacterial infections in the gastrointestinal tract. If diarrhea persists, consultation with a physician is recommended. Long-term use, especially beyond one year, may increase the risk of fractures, so patients at risk for osteoporosis should have regular monitoring such as bone density tests. This medication may interact with other medications, so it should be taken as directed by a physician, especially in conjunction with anticoagulants, antiviral medications, antibiotics, and antidepressants. During pregnancy, the safety of this medication has not been fully confirmed, so it should only be used cautiously when necessary. It is recommended that nursing women not take this medication. In case of overdose, there is no specific antidote, so appropriate treatment should be sought based on symptoms. Finally, this medication should be kept out of reach of children and should not be transferred to another container, ensuring attention to the preservation of the medication's quality.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria, angioedema, anaphylaxis, shock, fever, angioedema, anaphylaxis, shock, angioedema, urticaria → severe allergic reactions
  • Severe rashes accompanied by high fever, blisters, skin shedding, mucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), acute generalized pustular eruption, eosinophilia, and systemic symptoms associated with drug response (DRESS syndrome) → severe skin reactions.

Mild side effects

Headache, dizziness, paresthesia, drowsiness, taste disturbance, blurred vision, dizziness, bronchospasm, abdominal pain, constipation, diarrhea, abdominal distension, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, increased liver enzymes, dermatitis, itching, rash, hair loss, photosensitivity, fractures, arthralgia, myalgia, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, allergic reactions, back pain, chest pain, sternal pain

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

Storage

This medication should be stored in a tightly closed container to prevent air and moisture from entering. It should be kept at room temperature between 1°C and 30°C, away from extremely hot or cold environments.

Appearance and packaging

Appearance

Pink, oblong film-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.