Medication info
Esome Tablet 40 mg (Esomeprazole Magnesium Trihydrate)

Esome Tablet 40 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Dihydrate›43.38mg / 1 tablet
Manufacturer / importer
대화제약(주)
Appearance
Pink, round film-coated tablet
Packaging
14 tablets/blister × 2
Approval status
Active

MFDS item code 201603653 · Approved 2016.06.21 · Insurance code 645604770

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive reflux esophagitis), treatment of Helicobacter pylori-positive peptic ulcers, relief of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs.
Who uses it
Adults · Children
Adult dosage
This medication must be swallowed with liquid, such as water, and should not be chewed or crushed. 1) Gastroesophageal Reflux Disease (GERD) - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks - If symptoms persist or are not treated, continue for an additional 4 weeks - Maintenance therapy to prevent recurrence: 20 mg once daily - Treatment of gastroesophageal reflux disease symptoms without esophagitis.
Children's dosage
Adolescents 12 years and older - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks - If symptoms persist or are not treated, continue for an additional 4 weeks - Treatment of gastroesophageal reflux disease symptoms without esophagitis.

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

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

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

This medication is used for the treatment of erosive reflux esophagitis in gastroesophageal reflux disease (GERD) and for long-term maintenance therapy to prevent recurrence in patients with esophagitis. It is also helpful in alleviating symptoms of gastroesophageal reflux disease even when there is no esophagitis. When used in combination with antibiotics for the eradication of Helicobacter pylori, it is effective in treating duodenal ulcers and peptic ulcers and preventing relapses. It is also used for the treatment of upper gastrointestinal symptoms caused by non-steroidal anti-inflammatory drugs (both non-selective and selective COX-2 inhibitors), as well as for the treatment of gastric ulcers and prevention of ulcers. Additionally, it is applicable for the treatment of Zollinger-Ellison syndrome and maintenance therapy after the prevention of rebleeding in gastric ulcers and duodenal ulcers due to intravenous administration. It is widely used for the treatment of various gastrointestinal diseases and symptoms.

Dosage and Administration

Adult dosage

This medication must be swallowed with liquid, such as water, and should not be chewed or crushed. 1) Gastroesophageal Reflux Disease (GERD) - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks - If symptoms persist or are not treated, continue for an additional 4 weeks - Maintenance therapy to prevent recurrence: 20 mg once daily - Treatment of gastroesophageal reflux disease symptoms without esophagitis.

Children's dosage

Adolescents 12 years and older - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks - If symptoms persist or are not treated, continue for an additional 4 weeks - Treatment of gastroesophageal reflux disease symptoms without esophagitis.

Precautions

This medication should not be administered to certain patients. Care should be taken for individuals with allergies to this medication or its ingredients, or those who are hypersensitive to penicillin or macrolide antibiotics. It should not be used in combination with certain heart medications or antivirals, and should also not be taken by breastfeeding women. This medication may cause various side effects; thus, immediate consultation with a doctor is necessary if unusual symptoms such as headaches, abdominal pain, diarrhea, skin rashes, or muscle pain occur. Regular examinations are required for long-term use, particularly as electrolyte abnormalities like low magnesium levels may occur. This medication can interact with other drugs; therefore, it is essential to inform healthcare providers of any medications currently being taken. Its safety has not been fully confirmed during pregnancy; thus, it should be used with caution, and should be avoided during breastfeeding. In case of overdose, there is no specific antidote, so appropriate treatment should be administered based on symptoms. Keep this medication out of the reach of children, and avoid transferring it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis reaction/shock, angioedema, severe rash with high fever, blistering, skin peeling, pain of the mucous membranes in the mouth/eyes, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough + fever, skin.

Mild side effects

Headache, dizziness, sensory disturbances, drowsiness, taste disorders, 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, muscle weakness, increased sweating, Clostridium difficile-associated diarrhea, allergic reactions, chest pain, facial swelling, facial flushing, fatigue, fever, influenza-like symptoms.

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, and it should be kept at temperatures between 1°C and 30°C at room temperature. Storing under appropriate temperature and environmental conditions helps maintain its efficacy and prevents degradation.

Appearance and packaging

Appearance

Pink, round film-coated tablet

Package unit

14 tablets/blister × 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.