Medication info
Entiome Tablet 40mg (Esomeprazole Magnesium Trihydrate)

Entiome Tablet 40mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Dihydrate›43.38mg / 1 tablet
Manufacturer / importer
(주)셀비온
Appearance
Pink oblong film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu * 2)
Approval status
Active

MFDS item code 201907047 · Approved 2019.10.04

Summary

Main use
Treatment of gastroesophageal reflux disease (e.g., erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, relief of gastrointestinal symptoms related to nonsteroidal anti-inflammatory drugs, treatment and prevention of gastric and duodenal ulcers, treatment of Zollinger-Ellison syndrome, and effective maintenance therapy for preventing rebleeding.
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. In patients where esophagitis does not resolve or symptoms persist, continue for another 4 weeks. - Long-term maintenance therapy for preventing recurrence in esophagitis patients: 20 mg once daily. - Symptomatic therapy for gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further consultation is needed. · Once symptoms are alleviated, any subsequent symptoms should be controlled with 20 mg once daily. · For adults, 20 mg may be administered as needed once daily when needed. Continuous administration to control symptoms is not recommended in patients at high risk of peptic and duodenal ulcer due to NSAID use.
Children's dosage
Teens aged 12 and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If symptoms persist, continue for another 4 weeks.

Ingredients

Manufacturer
(주)셀비온

Efficacy & effects

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

  • Gastroesophageal reflux disease
  • erosive reflux esophagitis
  • esophagitis
  • Helicobacter pylori positive 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 in the treatment of gastroesophageal reflux disease and erosive esophagitis, helping to prevent recurrence of esophagitis through long-term maintenance therapy. It is also effective for alleviating symptoms in patients with gastroesophageal reflux disease without esophagitis. It is included in antibiotic combination therapy for the eradication of Helicobacter pylori, used for the treatment and prevention of duodenal and peptic ulcers. It aids in short-term treatment for alleviating gastrointestinal symptoms associated with nonsteroidal anti-inflammatory drug use, and it is utilized for the treatment of gastric ulcers and prevention of ulcers in long-term users. It is effectively used in the treatment of Zollinger-Ellison syndrome and in maintaining prevention of rebleeding from gastric or duodenal ulcers. This medication is broadly used for treating various gastrointestinal diseases, improving patients' 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. In patients where esophagitis does not resolve or symptoms persist, continue for another 4 weeks. - Long-term maintenance therapy for preventing recurrence in esophagitis patients: 20 mg once daily. - Symptomatic therapy for gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further consultation is needed. · Once symptoms are alleviated, any subsequent symptoms should be controlled with 20 mg once daily. · For adults, 20 mg may be administered as needed once daily when needed. Continuous administration to control symptoms is not recommended in patients at high risk of peptic and duodenal ulcer due to NSAID use.

Children's dosage

Teens aged 12 and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If symptoms persist, continue for another 4 weeks.

Precautions

This medication should not be used in certain patients. Patients allergic to this drug, its ingredients, or benzimidazole derivatives, or those with a history of hypersensitivity, should not receive it. When used in combination with amoxicillin or clarithromycin for Helicobacter pylori eradication therapy, those allergic to penicillin antibiotics or macrolide antibiotics should not use it. Additionally, patients taking certain heart-related medications or antivirals, breastfeeding women, or those with a history of myocardial infarction should not take this medication. This medication may have various side effects. Reduced blood cell counts, allergic reactions, electrolyte imbalances, changes in mental state, headaches, dizziness, blurred vision, gastrointestinal disturbances, liver function abnormalities, skin rashes, muscle weakness, and other adverse reactions have been reported. Particularly rare but serious skin reactions or severe muscle damage such as rhabdomyolysis may occur, and symptoms should be discussed with a physician immediately. This medication may mask symptoms of malignant tumors; it is essential to check for cancer if gastric ulcers are present or suspected. Regular check-ups are necessary for long-term use, and any changes in symptoms should be discussed with a physician. Furthermore, interactions with antibiotics or other medications used concurrently should be checked thoroughly in the package insert. This medication suppresses gastric acid secretion, lowering the acidity in the stomach, which may increase the risk of bacterial infections within the gastrointestinal tract. Long-term use may also increase the risk of fractures, requiring caution in patients with osteoporosis. Prolonged use beyond 3 months may lead to hypomagnesemia, necessitating periodic checks and possible supplementation of magnesium levels. This medication can interact with several other drugs. Particularly when taken with anticoagulants, antidepressants, anticonvulsants, and antivirals, changes in drug concentrations or risks of side effects may occur necessitating physician guidance. Additionally, caution is advised as the blood concentration of this medication may increase or decrease when taken with specific drugs. Data regarding the safety of this medication during pregnancy is limited, and it should be used cautiously during pregnancy; it is recommended that breastfeeding women do not take this medication. In cases of overdose, there are no specific antidotes, and general treatment according to symptoms should be carried out. Because this medication binds strongly to proteins, it is not removed by dialysis. This medication should be kept out of the reach of children and should not be transferred to other containers, aiding in accident prevention and maintaining drug quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis reactions/shock, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), difficulty breathing (bronchospasm), jaundice, liver failure, sudden and severe headache.

Mild side effects

Headache, dizziness, altered perception, drowsiness, taste disturbances, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal bloating, nausea/vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, elevated liver enzymes, dermatitis, itching, rash, hair loss, photosensitivity, fractures, arthralgia, myalgia, interstitial nephritis, gynecomastia, weakness, increased sweating, Clostridium difficile-associated diarrhea, allergic reactions, back pain, chest pain, sternal pain, facial pain.

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to keep storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink oblong 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.

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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.