Medication info
Esomeprazole Magnesium Trihydrate 40 mg Tablets

Esomeprazole Magnesium Trihydrate 40 mg Tablets

Prescription medicationTablet
Ingredient · strength
Esomeprazole Magnesium Trihydrate›44.5mg / 1 tablet
Manufacturer / importer
제이더블유중외제약(주)
Appearance
Pink round film-coated tablets
Packaging
28 tablets (14 tablets/PTPX2)
Approval status
Active

MFDS item code 201403573 · Approved 2014.07.31 · Insurance code 644913770

Summary

Main use
Treatment of gastroesophageal reflux disease (erosive reflux esophagitis, symptoms) and eradication of Helicobacter pylori associated with peptic ulcers, relief of gastrointestinal symptoms related to non-steroidal anti-inflammatory drug use.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquids 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. For patients whose esophagitis is untreated or whose symptoms persist, an additional 4 weeks of treatment is required. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily. - Treatment of symptoms in gastroesophageal reflux disease without esophagitis: 20 mg once daily. If symptoms are not controlled after 4 weeks, additional medical attention is needed. - Once symptoms improve, ongoing symptoms may be controlled with 20 mg once daily. - In adults, 20 mg may be given as needed once daily. For patients at high risk of developing gastric or duodenal ulcers due to non-steroidal anti-inflammatory drug administration, it is not recommended to administer as needed for controlling ongoing symptoms.
Children's dosage
Adolescents 12 years and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If symptoms persist or are untreated, an additional 4 weeks of treatment is necessary.

Ingredients

Manufacturer
제이더블유중외제약(주)

Efficacy & effects

Treatment of gastroesophageal reflux disease (erosive reflux esophagitis, symptoms) and eradication of Helicobacter pylori associated with peptic ulcers, relief of gastrointestinal symptoms related to non-steroidal anti-inflammatory drug use.

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

This medication is used for the treatment of gastroesophageal reflux disease, particularly erosive reflux esophagitis, and for long-term maintenance therapy to prevent recurrence in patients with esophagitis. It also helps relieve symptoms in patients with gastroesophageal reflux disease without esophagitis. It is included in combination therapy with antibiotics for eradication of Helicobacter pylori and is effective for the treatment and prevention of recurrence in patients with duodenal or peptic ulcers confirmed to be positive for Helicobacter pylori. The medication is also used to treat upper gastrointestinal symptoms from non-steroidal anti-inflammatory drug administration, as well as for the treatment and prevention of gastric ulcers in patients who require such medications. It is utilized in the treatment of Zollinger-Ellison syndrome and as maintenance therapy to prevent rebleeding from gastric or duodenal ulcers induced by intravenous administration. This drug plays a significant role in alleviating various gastrointestinal diseases and associated symptoms.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquids 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. For patients whose esophagitis is untreated or whose symptoms persist, an additional 4 weeks of treatment is required. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily. - Treatment of symptoms in gastroesophageal reflux disease without esophagitis: 20 mg once daily. If symptoms are not controlled after 4 weeks, additional medical attention is needed. - Once symptoms improve, ongoing symptoms may be controlled with 20 mg once daily. - In adults, 20 mg may be given as needed once daily. For patients at high risk of developing gastric or duodenal ulcers due to non-steroidal anti-inflammatory drug administration, it is not recommended to administer as needed for controlling ongoing symptoms.

Children's dosage

Adolescents 12 years and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If symptoms persist or are untreated, an additional 4 weeks of treatment is necessary.

Precautions

This drug should not be administered to certain patients. Do not take this medication if you are allergic to this drug or its components, or have a history of hypersensitivity to benzimidazole derivatives. Caution is also needed when co-administering with penicillin or macrolide antibiotics for the eradication of Helicobacter pylori, if you are allergic to those antibiotics. Patients taking certain medications that affect the heart, those with a history of myocardial infarction, and breastfeeding women should avoid this medication. Various adverse reactions may occur while taking this medication. For example, decreased blood cell counts, allergic reactions, electrolyte imbalances such as hyponatremia or hypomagnesemia, headaches, dizziness, abdominal pain, diarrhea, liver function abnormalities, and skin rashes have been reported. In particular, long-term use may lead to hypomagnesemia, thus regular blood tests are necessary. This medication suppresses gastric acid secretion, which may increase the risk of gastrointestinal bacterial infections during long-term use. Additionally, prolonged use may increase the risk of osteoporotic fractures, so patients at risk of fractures should be cautious. This drug has numerous drug interactions, and those taking other medications should consult with a physician or pharmacist. Special caution is needed when taken with anticoagulants, anticonvulsants, certain antidepressants, antiviral agents, and antibiotics, as side effects may occur due to changes in drug concentration. During pregnancy, data on the safety of this medication is limited, and pregnant women should take it cautiously under a physician's guidance. Nursing women are advised to avoid taking this medication as it is uncertain whether it is passed into breast milk. In case of overdose, there are no specific antidotes, and appropriate symptomatic treatment should be administered, as this medication is not removed by dialysis. Finally, this medication should be kept out of reach of children, and it is important not to transfer it to other containers to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylactic reactions/shock, hypomagnesemia, mental confusion, aggression, hallucinations, taste disturbances, pancreatitis, 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), fractures, muscle weakness, renal failure, gynecomastia, Clostridium.

Mild side effects

Headache, dizziness, paresthesia, drowsiness, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal distension, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, increased liver enzymes, dermatitis, itching, rash, hair loss, photosensitivity, arthralgia, myalgia, gynecomastia, weakness, increased sweating, Clostridium difficile-associated diarrhea, abdominal distension, allergic reactions, facial swelling, flushing, fatigue, fever, flu-like symptoms.

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Avoid places that are too hot or too cold, and store it at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

28 tablets (14 tablets/PTPX2)

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.