Medication info
Exosium Tablet 40 mg (Esomeprazole Magnesium Trihydrate)

Exosium Tablet 40 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›44.5mg / 1 tablet
Manufacturer / importer
고려제약(주)
Appearance
Pink, round film-coated tablet
Packaging
28 tablets/box [14 tablets/Alu-Alu×2], 28 tablets/box [7 tablets/Alu-Alu×4]
Approval status
Active

MFDS item code 202007780 · Approved 2020.11.12 · Insurance code 642803300

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis) and eradication of Helicobacter pylori-positive peptic ulcers, prevention of gastric and duodenal ulcers
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquid such as water and must not be chewed or crushed. 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40mg once daily for 4 weeks. If symptoms persist after treatment, continue for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20mg once daily. - For symptoms of gastroesophageal reflux disease without esophagitis:
Children's dosage
Adolescents aged 12 years and older 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40mg once daily for 4 weeks - Treatment of symptoms of gastroesophageal reflux disease without esophagitis:

Ingredients

Manufacturer
고려제약(주)

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive esophagitis) and eradication of Helicobacter pylori-positive peptic ulcers, prevention of gastric and duodenal ulcers

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

This medication is used for the treatment and prevention of gastroesophageal reflux disease and erosive esophagitis. It is also helpful in alleviating symptoms of gastroesophageal reflux disease without esophagitis. Additionally, it is effective in treating and preventing recurrence of duodenal ulcers and peptic ulcers as part of a combination therapy with antibiotics for Helicobacter pylori eradication. It provides short-term relief of upper gastrointestinal symptoms (pain, discomfort, burning) related to non-steroidal anti-inflammatory drug use, and is used for the treatment and prevention of gastric ulcers. It is included in maintenance therapy for Zollinger-Ellison syndrome and to prevent rebleeding from gastric or duodenal ulcers. Overall, it helps improve symptoms and supports treatment in various gastrointestinal conditions.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquid such as water and must not be chewed or crushed. 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40mg once daily for 4 weeks. If symptoms persist after treatment, continue for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20mg once daily. - For symptoms of gastroesophageal reflux disease without esophagitis:

Children's dosage

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

Precautions

This medication should not be used in patients with known allergies to specific components or who have had hypersensitivity reactions. Also, patients taking certain antibiotics or antivirals, those with a history of myocardial infarction, or nursing mothers should avoid this medication. This medication may cause various adverse reactions, with common occurrences being headaches, abdominal pain, diarrhea, skin rash, and muscle pain. Rarely, serious blood abnormalities, liver function impairment, and severe allergic reactions have been reported, necessitating caution. Regular monitoring is needed during long-term use, especially since magnesium levels may drop. This medication reduces stomach acid and may increase the risk of infections due to increased bacterial growth in the gastrointestinal tract, so if diarrhea persists, consult a physician. Additionally, patients with osteoporosis should be cautious as the risk of fractures may increase. This medication interacts with many other drugs, so follow a doctor's instructions when co-administering. Some drugs are contraindicated for use together. Use with caution during pregnancy, and it is preferable not to use it while nursing. There are no specific antidotes in case of overdose, so supportive treatment for symptoms is necessary, and it should be kept out of reach of children. Be cautious with transferring medication to different containers, as it may not be good for maintaining quality.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylactic reaction, shock, hypomagnesemia (severe hypomagnesemia may induce hypocalcemia and hypokalemia), pancreatitis, jaundice, hepatitis, liver failure, encephalopathy, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), muscle weakness, interstitial nephritis

Mild side effects

Headache, insomnia, anxiety, confusion, depression, aggression, hallucinations, dizziness, altered perception, drowsiness, taste disturbances, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal distension, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, dermatitis, itching, rash, hair loss, photosensitivity, fractures, arthralgia, myalgia, gynecomastia, weakness, increased sweating, Clostridium difficile-associated diarrhea, allergic reactions, back 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, at room temperature between 1°C and 30°C. Storing it this way will maintain the effectiveness of the medication and ensure its safety.

Appearance and packaging

Appearance

Pink, round film-coated tablet

Package unit

28 tablets/box [14 tablets/Alu-Alu×2], 28 tablets/box [7 tablets/Alu-Alu×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.