Medication info
Exome Tablet 20 mg (Esomeprazole Magnesium Trihydrate)

Exome Tablet 20 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Dihydrate›21.69mg / 1 tablet
Manufacturer / importer
건일바이오팜주식회사
Appearance
Pale pink, rectangular film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu*2)
Approval status
Active

MFDS item code 201902734 · Approved 2019.04.29 · Insurance code 073001470

Summary

Main use
Treatment and prevention of gastroesophageal reflux disease (erosive reflux esophagitis), eradication of Helicobacter pylori-related benign peptic ulcers, and treatment and prevention effects for NSAIDs-related gastric ulcers.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with water or another liquid and should not be chewed or crushed. 1. Gastroesophageal reflux disease (GERD): - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If esophagitis is untreated or symptoms persist, an additional 4 weeks of treatment is necessary. - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily. - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: 1
Children's dosage
Adolescents over 12 years: - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If treatment is ineffective or symptoms persist, an additional 4 weeks of treatment is required. - Treatment of gastroesophageal reflux disease without esophagitis.

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

Treatment and prevention of gastroesophageal reflux disease (erosive reflux esophagitis), eradication of Helicobacter pylori-related benign peptic ulcers, and treatment and prevention effects for NSAIDs-related gastric ulcers.

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

This medication is used to treat gastroesophageal reflux disease and erosive reflux esophagitis, and is effective for long-term maintenance therapy to prevent recurrence in patients with esophagitis. It is also used in combination with antibiotics for the treatment of duodenal ulcers and peptic ulcers associated with Helicobacter pylori infection and helps prevent recurrence of this bacterium. It is used short-term for relieving upper gastrointestinal pain, discomfort, and burning sensation related to the use of non-steroidal anti-inflammatory drugs (NSAIDs), and is effective for the treatment and prevention of gastric ulcers and duodenal ulcers caused by NSAID use. It is applied in the treatment of Zollinger-Ellison syndrome and for maintenance therapy after preventing rebleeding of gastric ulcers and duodenal ulcers. In summary, it is widely used for the treatment and prevention of various symptoms and diseases related to gastrointestinal disorders.

Dosage and Administration

Adult dosage

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

Children's dosage

Adolescents over 12 years: - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. If treatment is ineffective or symptoms persist, an additional 4 weeks of treatment is required. - Treatment of gastroesophageal reflux disease without esophagitis.

Precautions

This medicine should not be administered to patients with a known allergy to specific ingredients or benzamidazoles or those who have experienced hypersensitivity reactions. Additionally, patients taking certain antibiotics or antiviral agents used in conjunction with this drug for the eradication of Helicobacter pylori should not be treated with this medication. It is also safest not to administer this drug to breastfeeding women or patients with a history of myocardial infarction. This medication contains the dye Erythrosine (Red 3), so patients allergic to this substance should use it with caution. Various side effects may occur during use, including headache, abdominal pain, diarrhea, skin rashes, muscle pain, and hypomagnesemia. Especially with long-term use, regular blood tests or magnesium level checks should be conducted, and if abnormal symptoms appear, consult a doctor immediately. This medication reduces gastric acid secretion, which can increase bacterial growth in the stomach and raise the risk of infection; therefore, notify healthcare personnel if diarrhea persists. Moreover, long-term high-dose use may increase the risk of fractures, so osteoporosis patients need to be cautious. This medication can interact with many other drugs, so if you are taking other medications, be sure to inform your doctor or pharmacist before use. During pregnancy, the safety of this medication is not fully established, so pregnant women should use it cautiously, and it is advisable to avoid taking it while breastfeeding. In cases of overdose, there is no specific antidote, so symptomatic treatment should be provided while monitoring closely. Store out of reach of children and do not transfer to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), anaphylactic reaction/shock, severe rash with high fever, blistering, skin peeling, pain in oral/ocular mucosa, mucosal membrane syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), dyspnea or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever.

Mild side effects

  • Headache
  • dizziness
  • paresthesia
  • drowsiness
  • taste disturbances
  • blurred vision
  • vertigo
  • bronchospasm
  • abdominal pain
  • constipation
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  • diarrhea
  • abdominal fullness
  • nausea
  • vomiting
  • dry mouth
  • stomatitis
  • gastrointestinal candidiasis
  • pancreatitis
  • elevated liver enzymes
  • hepatitis
  • dermatitis
  • itching
  • rash
  • hair loss
  • photosensitivity
  • erythema multiforme
  • fractures
  • arthralgia
  • myalgia
  • muscle weakness
  • interstitial nephritis
  • gynecomastia
  • asthenia
  • increased sweating
  • Clostridium difficile.

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, and the storage temperature should be maintained between 1 to 30 degrees Celsius (room temperature). By storing it this way, the effectiveness of the drug can be maintained for a long time.

Appearance and packaging

Appearance

Pale pink, rectangular 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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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.