Medication info
EPIUM Tablets 40 mg (Esomeprazole Magnesium Trihydrate)

EPIUM Tablets 40 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›44.5mg / 1 tablet
Manufacturer / importer
(주)메디카코리아
Appearance
Pink round film-coated tablet
Packaging
28 tablets/box [14 tablets/PTP (Alu-Alu)*2]
Approval status
Active

MFDS item code 201508477 · Approved 2015.12.29 · Insurance code 646004080

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis) and Helicobacter pylori positive peptic ulcer, alleviation of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed whole with liquids such as water and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg daily once for 4 weeks. If unresponsive or symptoms persist, an additional 4 weeks is recommended. - Long-term maintenance therapy to prevent the recurrence of esophagitis: 20 mg daily once. - Treatment of gastroesophageal reflux symptoms without esophagitis:
Children's dosage
Adolescents over 12 years of age 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg daily once for 4 weeks. If unresponsive or symptoms continue, an additional 4 weeks of treatment.

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

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

  • Gastroesophageal reflux disease
  • erosive esophagitis
  • esophagitis
  • duodenal ulcers
  • peptic ulcers
  • upper gastrointestinal tract pain
  • upper gastrointestinal tract discomfort
  • upper gastrointestinal tract burning
  • gastric ulcers
  • duodenal ulcers
  • Zollinger-Ellison syndrome
  • rebleeding of gastric ulcers
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 recurrence of esophagitis. It also helps treat duodenal ulcers and peptic ulcers confirmed to be positive for Helicobacter pylori and prevents recurrence. It provides short-term relief from symptoms such as pain, discomfort, and burning in the upper gastrointestinal tract associated with the use of non-steroidal anti-inflammatory drugs. It is effective in treating and preventing gastric ulcers in patients on continuous non-steroidal anti-inflammatory drug therapy. Additionally, it is used for the treatment of Zollinger-Ellison syndrome and for maintenance therapy after preventing bleeding from gastric ulcers and duodenal ulcers.

Dosage and Administration

Adult dosage

This medication should be swallowed whole with liquids such as water and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg daily once for 4 weeks. If unresponsive or symptoms persist, an additional 4 weeks is recommended. - Long-term maintenance therapy to prevent the recurrence of esophagitis: 20 mg daily once. - Treatment of gastroesophageal reflux symptoms without esophagitis:

Children's dosage

Adolescents over 12 years of age 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg daily once for 4 weeks. If unresponsive or symptoms continue, an additional 4 weeks of treatment.

Precautions

This medication should not be administered to certain patients. For instance, individuals who have allergies or have experienced hypersensitivity reactions to this medication or its ingredients, or to benzimidazole derivatives, should not take it. Additionally, those allergic to penicillin antibiotics or macrolide antibiotics should avoid concurrent use. It is also safe not to use this medication for patients currently taking certain cardiovascular medications, those with a history of myocardial infarction, and lactating women. While taking this medication, caution is necessary as various adverse reactions may occur. Gastrointestinal symptoms such as headaches, abdominal pain, diarrhea, nausea, and vomiting can commonly occur, and rarely hematological abnormalities, skin rashes, and liver function abnormalities may appear. Electrolyte imbalances such as muscle pain or hypomagnesemia can occur infrequently; consult a healthcare professional immediately if symptoms arise. If this medication is taken for a long period, regular testing is necessary, particularly monitoring magnesium levels and fracture risk when used for more than a year. This medication can reduce stomach acid, which may increase bacterial proliferation in the gastrointestinal tract, slightly raising the risk of infection; notify healthcare professionals immediately if diarrhea persists. This medication may have interactions with other drugs, so it is essential to inform your doctor or pharmacist if you are currently taking any medications. Caution is particularly needed when used alongside anticoagulants, antibiotics, antiviral medications, and anticonvulsants due to the risk of adverse effects from changes in blood concentration. Safety data for this medication during pregnancy is limited; hence, consult a doctor if you are pregnant or planning to become pregnant before using this medication. It is recommended that nursing mothers do not take this medication. In case of overdose, there is no specific antidote; therefore, appropriate treatment should be provided based on symptoms, and it should be kept out of reach of children in a safe place. This medication must be stored in its original container, and transferring it to another container should be avoided to maintain quality and safety.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylactic reaction/shock, hypomagnesemia, mental confusion, jaundice, hepatitis, hepatic failure, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), interstitial nephritis, Clostridium difficile-associated diarrhea, sudden and severe headaches (warning symptoms), hypertension.

Mild side effects

Headache, dizziness, sensory disturbances, drowsiness, taste disturbances, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, pancreatitis, increased liver enzymes, hepatitis, dermatitis, itching, rash, alopecia, photosensitivity, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, allergic reactions, back pain, chest pain

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, ideally at a temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness for an extended period.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets/box [14 tablets/PTP (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.