Medication info
Esomeprazole Tablets 20 mg (Esomeprazole Magnesium Trihydrate)

Esomeprazole Tablets 20 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›22.25mg / 1 tablet
Manufacturer / importer
풍림무약(주)
Appearance
Pale pink round film-coated tablet
Packaging
28 tablets (14 tablets/PTP x 2)
Approval status
Active

MFDS item code 201600209 · Approved 2016.01.12 · Insurance code 649001470

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of peptic ulcers positive for Helicobacter pylori, alleviation of upper gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs and treatment/prevention of ulcers.
Who uses it
Adults · Children
Adult dosage
Esomeprazole Tablets 20 mg should be swallowed with liquid 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, with an additional 4 weeks if untreated. - Maintenance therapy to prevent recurrence: 20 mg once daily. - Treatment of symptoms of gastroesophageal reflux disease without esophagitis: 20 mg once daily, and if symptoms are controlled after 1, further administration may be necessary.
Children's dosage
Adolescents over 12 years - Treatment of gastroesophageal reflux disease Erosive reflux esophagitis: 40 mg once daily for 4 weeks, with an additional 4 weeks if untreated. Treatment of symptoms without esophagitis: 20 mg once daily.

Ingredients

Manufacturer
풍림무약(주)

Efficacy & effects

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

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

This medication is used for the treatment of gastroesophageal reflux disease and erosive reflux esophagitis, and is effective for long-term maintenance therapy to prevent recurrence in patients with esophagitis. It also helps relieve symptoms of gastroesophageal reflux disease without esophagitis. It is used in combination with antibiotics for the eradication of Helicobacter pylori, effectively preventing recurrence in patients with duodenal and peptic ulcers. It is used for short-term treatment of gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug use, as well as for the treatment and prevention of gastric and duodenal ulcers related to non-steroidal anti-inflammatory drugs. It is also used for the treatment of Zollinger-Ellison syndrome and for maintenance therapy after prevention of rebleeding due to gastric and duodenal ulcers.

Dosage and Administration

Adult dosage

Esomeprazole Tablets 20 mg should be swallowed with liquid 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, with an additional 4 weeks if untreated. - Maintenance therapy to prevent recurrence: 20 mg once daily. - Treatment of symptoms of gastroesophageal reflux disease without esophagitis: 20 mg once daily, and if symptoms are controlled after 1, further administration may be necessary.

Children's dosage

Adolescents over 12 years - Treatment of gastroesophageal reflux disease Erosive reflux esophagitis: 40 mg once daily for 4 weeks, with an additional 4 weeks if untreated. Treatment of symptoms without esophagitis: 20 mg once daily.

Precautions

This drug should not be used by patients with allergies to specific ingredients or who have had hypersensitivity reactions. Additionally, it is safe to avoid in patients taking certain antibiotics or antiviral medications, those with a history of heart disease, and breastfeeding women. Caution is needed if there is an allergy to Yellow No. 5 dye when using this drug. Side effects such as headache, dizziness, abdominal pain, diarrhea, and skin rash may occur, so if any abnormal symptoms arise, immediate consultation with a medical professional is necessary. Long-term use may require regular health check-ups, including blood tests or electrolyte tests, as there is a particular risk of low magnesium levels. Since this drug suppresses gastric acid secretion, the risk of bacterial infection in the stomach may increase, so if diarrhea symptoms persist, consult with a physician. Patients at risk for osteoporosis or fractures should periodically check bone health status if taking this drug long-term. There may be interactions with other medications, so patients taking other drugs should inform their healthcare provider, especially if taking medications affecting blood coagulation, antivirals, or antibiotics. Pregnant or breastfeeding women should consult a physician before taking this drug. In case of overdose, there is no specific antidote, so immediate medical treatment is essential, and it is important to store it out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, shock, hypomagnesemia, severe rash, mucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), acute generalised exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), hepatitis, liver failure, encephalopathy, Clostridium difficile-associated diarrhea, jaundice, severe edema, rhabdomyolysis, rigidity, arrhythmia, seizures, severe allergy.

Mild side effects

Headache, insomnia, anxiety, confusion, depression, aggression, hallucinations, dizziness, sensory disturbances, drowsiness, taste disturbances, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, dermatitis, itching, rashes, hair loss, photosensitivity, fractures, arthralgia, myalgia, muscle weakness, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, facial flushing.

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

Storage

Store this medication in a tightly sealed container to prevent air or moisture from entering. It should be kept at room temperature between 1°C and 30°C, away from excessively hot or cold places. This method of storage will help maintain the effectiveness of the medication.

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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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.