Medication info
Omeprazole 20 mg (Esomeprazole Magnesium Trihydrate)

Omeprazole 20 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›22.25mg / 1 tablet
Manufacturer / importer
(주)비보존제약
Appearance
Pale pink, round, film-coated tablets
Packaging
28 tablets/box [14 tablets/Alu-Alu X 2], 28 tablets/box [7 tablets/Alu-Alu X 4]
Approval status
Active

MFDS item code 201507071 · Approved 2015.10.08 · Insurance code 658202930

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, relief of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, treatment and prevention of gastric and duodenal ulcers, treatment of Zollinger-Ellison syndrome, effective maintenance therapy to prevent rebleeding of gastric ulcers.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with fluids such as water and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If not resolved or symptoms persist, an additional 4 weeks of treatment is required. - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily. - Treatment of symptoms of gastroesophageal reflux disease without esophagitis: 20 mg once daily.
Children's dosage
Adolescents aged 12 and older - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If not resolved or symptoms persist, an additional 4 weeks of treatment is required. - Treatment of gastroesophageal reflux disease symptoms without esophagitis.

Ingredients

Manufacturer
(주)비보존제약

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, relief of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, treatment and prevention of gastric and duodenal ulcers, treatment of Zollinger-Ellison syndrome, effective maintenance therapy to prevent rebleeding of gastric ulcers.

  • Gastroesophageal reflux disease
  • erosive esophagitis
  • esophagitis
  • symptoms of gastroesophageal reflux disease without esophagitis
  • Helicobacter pylori positive duodenal ulcers
  • peptic ulcers
  • upper gastrointestinal pain
  • upper gastrointestinal discomfort
  • upper gastrointestinal burning sensation
  • gastric ulcers related to non-steroidal anti-inflammatory drug use
  • duodenal ulcers related to non-steroidal anti-inflammatory drug use
  • Zollinger-Ellison syndrome
View approved original text

This medication is used not only to treat gastroesophageal reflux disease and erosive esophagitis but also for long-term maintenance therapy to prevent recurrence in patients with esophagitis. Additionally, it is effective in alleviating symptoms of gastroesophageal reflux disease without esophagitis. As part of the antibiotic combination therapy to eradicate Helicobacter pylori infection, it is also utilized to prevent recurrence in patients with Helicobacter pylori positive duodenal and peptic ulcers. It provides short-term treatment for pain or discomfort in the upper gastrointestinal tract caused by the use of non-steroidal anti-inflammatory drugs (NSAIDs) and aids in the treatment of gastric ulcers and prevention of gastric and duodenal ulcers in patients requiring continuous NSAID therapy. Furthermore, it is used in the treatment of Zollinger-Ellison syndrome and maintenance therapy after initiating prevention against rebleeding of gastric or duodenal ulcers. Overall, it is utilized effectively to treat and prevent various gastrointestinal-related diseases and symptoms.

Dosage and Administration

Adult dosage

This medication should be swallowed with fluids such as water and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If not resolved or symptoms persist, an additional 4 weeks of treatment is required. - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily. - Treatment of symptoms of gastroesophageal reflux disease without esophagitis: 20 mg once daily.

Children's dosage

Adolescents aged 12 and older - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If not resolved or symptoms persist, an additional 4 weeks of treatment is required. - Treatment of gastroesophageal reflux disease symptoms without esophagitis.

Precautions

This medication should not be administered to certain patients. First, patients who are allergic to this drug or have a history of hypersensitivity reactions should not take it. Second, patients who have hypersensitivity to penicillin or macrolide antibiotics among the antibiotics combined for eradication of Helicobacter pylori should also avoid this medication. Third, patients taking certain heart-related medications, antiviral drugs, and breastfeeding women should not take this medication. This drug contains the pigment Yellow No. 5, so those with allergies or hypersensitivity to this component should use it cautiously. Various adverse reactions may occur during treatment. For instance, blood cell count reduction, allergic reactions, electrolyte imbalance, headache, dizziness, gastrointestinal symptoms, skin rash, muscle pain, etc., have been reported. Rarely, serious skin disorders or liver function impairment may also occur, so consult a doctor immediately if symptoms arise. This medication suppresses gastric acid secretion, which may promote bacterial growth in the gastrointestinal tract, slightly increasing the risk of infections such as diarrhea. Furthermore, long-term use may increase the risk of fractures, so patients at risk for osteoporosis require regular check-ups. This medication can interact with several drugs, so inform your doctor or pharmacist if you are taking other medications. Caution is especially needed when used with anticoagulants, antiviral drugs, certain antibiotics, and anticonvulsants. Its safety during pregnancy has not been fully established, so it should be administered cautiously under a doctor's judgment, and it is advisable that breastfeeding women do not take it. In case of overdose, no specific antidote exists, so appropriate treatment should be provided according to symptoms, and keep it out of the reach of children. It is important to avoid transferring the medication to another container as it may not be good for maintaining quality.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylactic reaction, shock, severe allergic reactions with high fever, severe rash, blisters, skin peeling, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), severe cutaneous adverse reactions, difficulty breathing, asthma attacks, dyspnea, laryngeal edema.

Mild side effects

Headache, dizziness, paresthesia, drowsiness, taste disturbance, blurred vision, vertigo, bronchospasm, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, elevated liver enzymes, hepatitis, dermatitis, itching, rash, hair loss, photosensitivity, fractures, arthralgia, myalgia, myasthenia, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal.

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

Storage

This medication should be stored in a tightly closed container, protected from air and moisture, and kept at a temperature between 1 and 30 degrees Celsius. By storing it this way, the efficacy of the medication can be maintained for a longer period.

Appearance and packaging

Appearance

Pale pink, round, film-coated tablets

Package unit

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