Medication info
Esome 40 mg (Esomeprazole Magnesium Trihydrate)

Esome 40 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›44.5mg / 1 tablet
Manufacturer / importer
(주)엘앤씨바이오
Appearance
Pink round film-coated tablet
Packaging
28 tablets/box [28 tablets (14 tablets/PTP x 2)], 30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 202001244 · Approved 2020.02.21 · Insurance code 060500540

Summary

Main use
Treatment of gastroesophageal reflux disease (erosive reflux esophagitis), eradication of Helicobacter pylori associated with benign peptic ulcers and prevention of recurrence, treatment and prevention of NSAID-related gastric ulcers
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 - Additional 4 weeks if esophagitis is untreated - Maintenance therapy for prevention of recurrence: 20 mg once daily - Treatment of symptoms without esophagitis: 20 mg once daily - As needed, 1 dose per day
Children's dosage
Adolescents aged 12 and older - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks - Treatment of symptoms without esophagitis: 20 mg once daily - Continuous symptoms after symptom relief

Ingredients

Manufacturer
(주)엘앤씨바이오

Efficacy & effects

Treatment of gastroesophageal reflux disease (erosive reflux esophagitis), eradication of Helicobacter pylori associated with benign peptic ulcers and prevention of recurrence, treatment and prevention of NSAID-related gastric ulcers

  • Gastroesophageal reflux disease
  • erosive reflux esophagitis
  • esophagitis
  • duodenal ulcers
  • peptic ulcers
  • upper gastrointestinal symptoms such as pain
  • discomfort
  • burning sensation
  • gastric ulcer
View approved original text

This medication is used for the treatment and maintenance therapy of gastroesophageal reflux disease, especially erosive reflux esophagitis. It is also used in combination with antibiotics effective in treating Helicobacter pylori infection-related duodenal and peptic ulcers. It helps in the short-term treatment of gastrointestinal symptoms associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs) and also aids in the treatment and prevention of gastric and duodenal ulcers. It is utilized for maintenance therapy to prevent rebleeding in patients with Zollinger-Ellison syndrome and gastric or duodenal ulcers, improving patient symptoms. It is effective in treating and preventing various conditions related to gastrointestinal diseases.

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 - Additional 4 weeks if esophagitis is untreated - Maintenance therapy for prevention of recurrence: 20 mg once daily - Treatment of symptoms without esophagitis: 20 mg once daily - As needed, 1 dose per day

Children's dosage

Adolescents aged 12 and older - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks - Treatment of symptoms without esophagitis: 20 mg once daily - Continuous symptoms after symptom relief

Precautions

This medication should not be administered to certain patients. For instance, individuals with an allergy or previous hypersensitivity reaction to this medication or its components, as well as certain antibiotics or medications used in Helicobacter pylori eradication therapy, should not take this product. It is also not recommended for breastfeeding women and those with a history of myocardial infarction. This medication can cause various side effects, commonly headaches, abdominal pain, diarrhea, and nausea. Rarely, serious side effects such as blood abnormalities, hypersensitivity reactions, mental symptoms, liver function abnormalities, and skin rashes have been reported. Regular monitoring is necessary for electrolyte imbalances such as hypomagnesemia, especially with long-term use. This drug may interact with other medications; therefore, it is essential to discuss concurrent medications with a physician or pharmacist. Care is needed when used with medications affecting blood coagulation, antiviral agents, antibiotics, antiepileptics, etc., and when starting or stopping this medication, blood concentration or effects must be closely observed. Data on the safety of this medication during pregnancy is limited; thus, it should be administered with caution to pregnant women, and it is recommended not to take this medication while breastfeeding. In case of overdose, no specific antidote is available; thus, treatment and general management based on symptoms are required. This medication should be kept out of reach of children, and transferring it to other containers should be avoided to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylaxis reaction/shock, severe hypomagnesemia, mental confusion, leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, pancreatitis, increased liver enzymes, hepatitis with or without jaundice, liver failure, encephalopathy, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, eosinophilia with systemic symptoms

Mild side effects

  • Headache
  • dizziness
  • sensory disturbances
  • drowsiness
  • taste disorders
  • blurred vision
  • vertigo
  • bronchospasm
  • abdominal pain
  • constipation
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  • diarrhea
  • abdominal bloating
  • nausea
  • vomiting
  • dry mouth
  • stomatitis
  • gastrointestinal candidiasis
  • dermatitis
  • itching
  • rash
  • hair loss
  • photosensitivity
  • fractures
  • arthralgia
  • myalgia
  • weakness
  • increased sweating
  • fatigue
  • pain
  • flushing
  • hypertension
  • tachycardia
  • goiter
  • irritable bowel syndrome
  • dyspepsia
  • diarrhea

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture and should be kept at a temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets/box [28 tablets (14 tablets/PTP x 2)], 30 tablets/bottle, 300 tablets/bottle

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.