Medication info
Esomeprazole Magnesium Trihydrate 40 mg Tablets

Esomeprazole Magnesium Trihydrate 40 mg Tablets

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›21.69mg / 1 tablet
Manufacturer / importer
(주)킵스바이오파마
Appearance
Pink round film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu×2)
Approval status
Active

MFDS item code 201508511 · Approved 2015.12.30 · Insurance code 693201670

Summary

Main use
Improvement of gastrointestinal diseases, including treatment and prevention of recurrence of gastroesophageal reflux disease (erosive esophagitis) and positive Helicobacter pylori associated peptic ulcer.
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: 40 mg once daily for 4 weeks - Maintenance therapy to prevent relapse of esophagitis: 20 mg once daily - Treatment of gastroesophageal reflux disease symptoms without esophagitis: 20 mg once daily 2) Combination therapy for Helicobacter pylori eradication
Children's dosage
Adolescents aged 12 years and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks - Treatment of gastroesophageal reflux disease without esophagitis symptoms:

Ingredients

Manufacturer
(주)킵스바이오파마

Efficacy & effects

Improvement of gastrointestinal diseases, including treatment and prevention of recurrence of gastroesophageal reflux disease (erosive esophagitis) and positive Helicobacter pylori associated peptic ulcer.

  • Gastroesophageal reflux disease
  • erosive reflux esophagitis
  • esophagitis
  • positive Helicobacter pylori-associated duodenal ulcers
  • peptic ulcers
  • upper gastrointestinal pain
  • upper gastrointestinal discomfort
  • upper gastrointestinal burning sensation
  • gastric ulcers associated with nonsteroidal anti-inflammatory drug use
  • duodenal ulcers associated with nonsteroidal anti-inflammatory drug use
  • Zollinger-Ellison syndrome
  • gastric ulcers
View approved original text

This medication is used for the treatment of gastroesophageal reflux disease and erosive reflux esophagitis and for long-term maintenance therapy to prevent relapse in patients with esophagitis. It also helps with the treatment and prevention of recurrence of duodenal ulcers and peptic ulcers caused by Helicobacter pylori infection. It is effective for the short-term treatment of gastrointestinal symptoms resulting from nonsteroidal anti-inflammatory drug use and for the treatment and prevention of gastric ulcers in patients using these drugs long-term. It is also used for the treatment of Zollinger-Ellison syndrome and maintenance therapy to prevent rebleeding from gastric and duodenal ulcers after intravenous infusion, aiding in the improvement and treatment of symptoms across various gastrointestinal diseases.

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: 40 mg once daily for 4 weeks - Maintenance therapy to prevent relapse of esophagitis: 20 mg once daily - Treatment of gastroesophageal reflux disease symptoms without esophagitis: 20 mg once daily 2) Combination therapy for Helicobacter pylori eradication

Children's dosage

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

Precautions

This medication should not be used in patients who are allergic to specific components or have had hypersensitive reactions to benzimidazoles. Also, caution is necessary when used in combination with amoxicillin or clarithromycin for Helicobacter pylori eradication if there is an allergy to those antibiotics. Adverse reactions may occur when taken with certain heart-related medications or antivirals, so this medication should be avoided if you are taking such drugs. It is safest for nursing women not to take this medication. Patients with heart disease or those who have experienced a myocardial infarction in the past should also avoid using this medication. This medication may cause various adverse reactions, with common symptoms including headache, abdominal pain, diarrhea, and constipation, while rare side effects may include blood disorders or severe allergic reactions. Long-term use may result in decreased serum magnesium levels requiring regular monitoring. There’s a slightly increased risk of gastrointestinal infections, so consult a doctor if diarrhea persists. Long-term use of this medication may increase fracture risk, so caution is advised for patients at risk for osteoporosis. Additionally, this medication has a high potential for drug interactions; it is essential to consult with a doctor or pharmacist if taking other medications. The safety during pregnancy has not been sufficiently verified, so pregnant women should use it cautiously, and nursing mothers are advised not to take it. In case of overdose, there are no specific antidotes available, so symptomatic treatment should be sought, and keep out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylactic reactions/shock, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, severe allergic reactions, severe skin adverse reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory difficulties associated with cough and fever, yellowing of the skin or eyes (jaundice), severe malaise, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache, seizures.

Mild side effects

Headache, dizziness, sensory disturbances, drowsiness, taste disturbance, 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, fractures, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, malaise, 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 must be stored in a tightly closed container to avoid exposure to air and moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius to ensure the drug's efficacy and safety.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets (14 tablets/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.