Medication info

Esomeprazole Magnesium 40 mg Tablets

Prescription medicationTablet경구 · 정맥Expired
Ingredient · strength
Esomeprazole Magnesium Dihydrate›43.38mg / 1 tablet
Manufacturer / importer
독립바이오제약(주)
Appearance
Pink oblong film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu * 2)
Approval status
Expired

MFDS item code 201905068 · Approved 2019.07.19

This product's status changed to Expired on 2024.07.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment and prevention of recurrence of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, alleviation of upper gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquid, and it must not be chewed or crushed. 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily. - Treatment of symptoms associated with gastroesophageal reflux disease without esophagitis: 20 mg once daily as needed. 2. For eradication of Helicobacter pylori.
Children's dosage
Children aged 12 and older 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. - Treatment of symptoms without esophagitis: 20 mg once daily.

Ingredients

Manufacturer
독립바이오제약(주)

Efficacy & effects

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

  • Gastroesophageal reflux disease
  • erosive esophagitis
  • esophagitis
  • Helicobacter pylori positive 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 for the treatment of gastroesophageal reflux disease and erosive esophagitis, as well as for long-term maintenance therapy to prevent the recurrence of esophagitis. It is also effective in combination therapy with antibiotics for the treatment and prevention of recurrence of duodenal ulcers and peptic ulcers caused by Helicobacter pylori infection. It provides short-term treatment for upper gastrointestinal symptoms such as pain and burning sensation caused by the use of non-steroidal anti-inflammatory drugs and also helps in the treatment and prevention of gastric ulcers and duodenal ulcers related to non-steroidal anti-inflammatory drug use. Furthermore, it is used for the treatment of Zollinger-Ellison syndrome, maintenance therapy after prevention of rebleeding from gastric and duodenal ulcers, thus improving overall gastric health.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquid, and it must not be chewed or crushed. 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily. - Treatment of symptoms associated with gastroesophageal reflux disease without esophagitis: 20 mg once daily as needed. 2. For eradication of Helicobacter pylori.

Children's dosage

Children aged 12 and older 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. - Treatment of symptoms without esophagitis: 20 mg once daily.

Precautions

This drug should not be administered to certain patients. For example, patients with hypersensitivity to this drug or any of its components, or a history of hypersensitivity to benzimidazoles should not use it. Additionally, patients with hypersensitivity to penicillin antibiotics or macrolide antibiotics, patients taking specific cardiovascular medications, nursing mothers, patients with a history of myocardial infarction, and patients taking specific antiviral medications should not take this drug. There may be various adverse reactions while taking this medication, so caution is needed. Commonly reported reactions may include headache, abdominal pain, diarrhea, constipation, nausea, and vomiting, while rare reactions can include blood abnormalities, hypersensitivity reactions, hypomagnesemia, mental changes, skin rashes, and liver function abnormalities. Regular check-ups are necessary for long-term use of this drug, and in case of symptoms suggesting malignancy, consulting a doctor is essential. This medication suppresses gastric acid secretion, which may slightly increase the risk of bacterial infections in the gastrointestinal tract; therefore, if diarrhea persists, it is important to consult a medical professional immediately. Long-term use may increase the risk of osteoporosis-related fractures, so proper monitoring is needed for patients at risk of osteoporosis. Furthermore, this medication has many drug interactions, so caution is required when used in conjunction with other medications. Especially when taken with blood thinners, antibiotics, antiviral medications, and anticonvulsants, physician's guidance should be followed. Data regarding the safety of this drug during pregnancy is limited; therefore, pregnant women should use it cautiously, and it is recommended that nursing women avoid this medication. In case of overdose, there are no specific antidotes, so treatment should be symptomatic, and it should be stored in a safe place out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, shock, hypomagnesemia, mental confusion, jaundice, hepatitis, liver failure, encephalopathy, mucocutaneous syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Lyell's syndrome, acute generalized exanthematous pustulosis, drug reactions with eosinophilia and systemic symptoms, erythema multiforme, interstitial nephritis, gynecomastia, rhabdomyolysis, severe allergic reactions, severe skin reactions, respiratory issues, liver.

Mild side effects

Headache, dizziness, sensory disturbances, drowsiness, taste disorders, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, pancreatitis, elevated liver enzymes, dermatitis, itching, rash, hair loss, photosensitivity, fractures, arthralgia, myalgia, muscle weakness, fatigue, increased sweating, Clostridium difficile-associated diarrhea, abdominal bloating, allergic reactions, back pain, chest pain, retrosternal discomfort.

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. The storage temperature should be maintained between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink oblong film-coated tablet

Package unit

28 tablets (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.