Medication info
Esomeprazole Magnesium Trihydrate 20 mg (Esomeprazole Magnesium Trihydrate)

Esomeprazole Magnesium Trihydrate 20 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›22.3mg / 1 tablet
Manufacturer / importer
화일약품(주)
Appearance
Pale pink round film-coated tablet
Packaging
28 tablets (14 tablets/PTP X 2)
Approval status
Active

MFDS item code 201907479 · Approved 2019.10.28 · Insurance code 684501800

Summary

Main use
Treatment and prevention of gastroesophageal reflux disease (erosive reflux esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, treatment and prevention of NSAID-related gastric ulcers
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquids 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 - Treatment of symptoms in gastroesophageal reflux disease without esophagitis: 20 mg once daily, and if symptoms persist, the same
Children's dosage
Adolescents aged 12 years and older - Treatment of gastroesophageal reflux disease: 40 mg once daily for 4 weeks - Treatment of symptoms of gastroesophageal reflux disease without esophagitis: 20 mg once daily

Ingredients

Manufacturer
화일약품(주)

Efficacy & effects

Treatment and prevention of gastroesophageal reflux disease (erosive reflux esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, treatment and prevention of NSAID-related gastric ulcers

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

This medication is used for the treatment of gastroesophageal reflux disease, particularly for long-term maintenance therapy in erosive reflux esophagitis, and is effective for relief of symptoms in gastroesophageal reflux disease without esophagitis. It is also used in combination with antibiotics for the treatment and prevention of recurrence of duodenal ulcers and peptic ulcers caused by Helicobacter pylori infection. Additionally, it is used for the treatment of upper gastrointestinal symptoms and gastric ulcers related to NSAID use, as well as for preventing ulcer recurrence. It helps in treating Zollinger-Ellison syndrome and preventing rebleeding from gastric or duodenal ulcers. Overall, it is used to improve various symptoms and complications related to gastrointestinal diseases.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquids 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 - Treatment of symptoms in gastroesophageal reflux disease without esophagitis: 20 mg once daily, and if symptoms persist, the same

Children's dosage

Adolescents aged 12 years and older - Treatment of gastroesophageal reflux disease: 40 mg once daily for 4 weeks - Treatment of symptoms of gastroesophageal reflux disease without esophagitis: 20 mg once daily

Precautions

This medication should not be administered to specific patients. For example, it should not be used in patients with known allergies to this medication or its components, including benzimidazole derivatives, or those who have previously shown such reactions. Care should also be taken in patients who are taking amoxicillin or clarithromycin for the eradication of Helicobacter pylori, in case of allergies to these antibiotics. This medication should particularly not be given to patients taking specific heart-related medications or those with a history of myocardial infarction, and to nursing mothers. This medication contains the dye E102, and those with sensitivity or allergy history to this component should use it cautiously. Various adverse reactions may occur while taking this medication, with common symptoms including headache, abdominal pain, diarrhea, and nausea; rare occurrences of blood disorders or severe allergic reactions may also arise. Long-term use may result in electrolyte imbalance, such as hypomagnesemia, necessitating regular check-ups. Furthermore, as this medication reduces gastric acid, the risk of bacterial infections in the gastrointestinal tract may increase, and the risk of fractures may heighten, so caution is advised in patients at risk of osteoporosis. There are many drug interactions with this medication; when taken with digoxin, warfarin, methotrexate, etc., strict adherence to the physician's instructions is required, and it is advisable not to use it in conjunction with certain antiviral medications. During pregnancy, the safety has not been fully established, thus it should be used cautiously; it is recommended not to use this medication during breastfeeding. In cases of overdose, as there are no specific antidotes, symptoms should be monitored and proper treatment should be administered. Lastly, this medication should be kept out of the reach of children and should not be transferred to another container to maintain its quality.

Side effects and when to seek care immediately

Serious side effects

Angioedema, anaphylactic reactions, shock, urticaria, severe swelling (edema), difficulty breathing, bronchospasm, fever, jaundice, hepatitis, hepatic failure, encephalopathy, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, eosinophilia and systemic symptoms accompanied drug reactions (DRESS syndrome), severe skin reactions, rhabdomyolysis, seizures, altered consciousness, visual disturbances, paralysis, severe

Mild side effects

  • Headache
  • dizziness
  • confusion
  • insomnia
  • anxiety
  • depression
  • aggressiveness
  • hallucinations
  • drowsiness
  • taste disorder
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  • blurred vision
  • bronchospasm
  • abdominal pain
  • constipation
  • diarrhea
  • abdominal bloating
  • nausea
  • vomiting
  • dry mouth
  • stomatitis
  • gastrointestinal candidiasis
  • increased liver enzymes
  • hepatitis
  • dermatitis
  • itching
  • rash
  • hair loss
  • photosensitivity
  • fracture
  • joint pain
  • muscle pain
  • muscular weakness
  • interstitial nephritis
  • gynecomastia
  • weakness
  • increased sweating
  • Clostridium difficile.

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 or moisture from entering. The storage temperature should be room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale pink round film-coated tablet

Package unit

28 tablets (14 tablets/PTP X 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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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.