Medication info
Esomeprazole Magnesium 20 mg Tablets

Esomeprazole Magnesium 20 mg Tablets

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

MFDS item code 201905067 · Approved 2019.07.19 · Insurance code 057700160

Summary

Main use
Treatment of gastroesophageal reflux disease (such as erosive reflux esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcer, relief of gastrointestinal symptoms associated with non-steroidal anti-inflammatory drugs, treatment and prevention of gastric and duodenal ulcers, treatment of Zollinger-Ellison syndrome, effective maintenance therapy to prevent rebleeding from gastric ulcers.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquid, such as water, and not chewed or crushed. 1. Gastroesophageal reflux disease (GERD). - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. - For patients where esophagitis is untreated or symptoms persist, take for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in esophagitis patients: 20 mg once daily. - Gastroesophageal reflux disease treatment without esophagitis symptoms: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention may be needed. · Once symptoms are alleviated, the subsequent symptoms can be controlled at 20 mg once daily. · In adults, 20 mg once daily can be administered as needed. It is not recommended for patients at high risk of developing gastric and duodenal ulcers due to the use of NSAIDs to control continuous symptoms. 2. Combination therapy with antibiotics for Helicobacter pylori eradication. This medication 20 mg should be administered in combination with amoxicillin 1 g and clarithromycin 500 mg, twice daily for 7 days. 3. Short-term therapy for upper gastrointestinal symptoms (pain, discomfort, burning sensation) related to non-steroidal anti-inflammatory drug (COX-2 non-selective, selective) treatment. - 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention may be needed. Clinical trials exceeding 4 weeks have not been conducted. 4. Patients requiring ongoing non-steroidal anti-inflammatory drug treatment. - Treatment for gastric ulcers related to non-steroidal anti-inflammatory drug treatment: 20 mg once daily. Treatment duration is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers related to non-steroidal anti-inflammatory drug treatment: 20 mg once daily. 5. Treatment of Zollinger-Ellison syndrome. The recommended initial dose is 40 mg twice daily. Subsequent doses should be adjusted according to the individual patient, and treatment should continue as long as there are clinical signs. According to clinical data, most patients can be adjusted at a dose of 80 to 160 mg daily. Doses exceeding 80 mg daily should be divided into two doses. 6. Maintenance therapy after intravenous prevention of rebleeding from gastric or duodenal ulcers. After intravenous prevention of rebleeding, 40 mg once daily for 4 weeks.
Children's dosage
Adolescents aged 12 years and above. - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. - Treatment of gastroesophageal reflux disease symptoms without esophagitis: 20 mg once daily.

Ingredients

Manufacturer
독립바이오제약(주)

Efficacy & effects

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

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

This medicine is used for the long-term maintenance therapy of gastroesophageal reflux disease and erosive reflux esophagitis to prevent recurrence in patients with esophagitis. It is also effective in treating and preventing recurrence of duodenal ulcers and peptic ulcers caused by Helicobacter pylori infection. Additionally, it aids in the short-term treatment of upper gastrointestinal symptoms that may occur due to the use of non-steroidal anti-inflammatory drugs, as well as in the treatment and prevention of related ulcers. It is used for the treatment of Zollinger-Ellison syndrome and for maintenance therapy after preventing rebleeding from gastric or duodenal ulcers. Therefore, it contributes to the health recovery of patients by being effective in the treatment and improvement of various gastrointestinal diseases.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquid, such as water, and not chewed or crushed. 1. Gastroesophageal reflux disease (GERD). - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. - For patients where esophagitis is untreated or symptoms persist, take for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in esophagitis patients: 20 mg once daily. - Gastroesophageal reflux disease treatment without esophagitis symptoms: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention may be needed. · Once symptoms are alleviated, the subsequent symptoms can be controlled at 20 mg once daily. · In adults, 20 mg once daily can be administered as needed. It is not recommended for patients at high risk of developing gastric and duodenal ulcers due to the use of NSAIDs to control continuous symptoms. 2. Combination therapy with antibiotics for Helicobacter pylori eradication. This medication 20 mg should be administered in combination with amoxicillin 1 g and clarithromycin 500 mg, twice daily for 7 days. 3. Short-term therapy for upper gastrointestinal symptoms (pain, discomfort, burning sensation) related to non-steroidal anti-inflammatory drug (COX-2 non-selective, selective) treatment. - 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention may be needed. Clinical trials exceeding 4 weeks have not been conducted. 4. Patients requiring ongoing non-steroidal anti-inflammatory drug treatment. - Treatment for gastric ulcers related to non-steroidal anti-inflammatory drug treatment: 20 mg once daily. Treatment duration is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers related to non-steroidal anti-inflammatory drug treatment: 20 mg once daily. 5. Treatment of Zollinger-Ellison syndrome. The recommended initial dose is 40 mg twice daily. Subsequent doses should be adjusted according to the individual patient, and treatment should continue as long as there are clinical signs. According to clinical data, most patients can be adjusted at a dose of 80 to 160 mg daily. Doses exceeding 80 mg daily should be divided into two doses. 6. Maintenance therapy after intravenous prevention of rebleeding from gastric or duodenal ulcers. After intravenous prevention of rebleeding, 40 mg once daily for 4 weeks.

Children's dosage

Adolescents aged 12 years and above. - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. - Treatment of gastroesophageal reflux disease symptoms without esophagitis: 20 mg once daily.

Precautions

This medication should not be administered to specific patients. First, patients with allergies or hypersensitivity to this drug or its components should not use it. Second, if this medication is to be used with amoxicillin or clarithromycin for Helicobacter pylori eradication, it should not be administered to those with allergies to those antibiotics. Third, patients taking certain heart-related medications or antiviral agents, breastfeeding mothers, and patients with a history of myocardial infarction should not take this medication. This drug contains a coloring agent called Yellow 5, so patients with a history of allergy to this ingredient should use it with caution. Various adverse reactions may occur when using this drug. For example, blood abnormalities, immune system reactions, electrolyte imbalances, neurological symptoms, gastrointestinal symptoms, skin reactions, etc., have been reported. In particular, rare but serious skin disorders, muscle-related problems, and liver dysfunction may occur, so if symptoms appear, immediate consultation with medical personnel is advised. Long-term use of this medication may require regular check-ups and may slightly increase the risk of gastrointestinal infections; thus, if diarrhea symptoms persist, patients should inform their healthcare provider. Moreover, long-term use of this medication may increase the risk of bone fractures, so patients at risk of osteoporosis should be cautious. This medication may interact with other medications; therefore, especially when taken with anticoagulants, antibiotics, antiviral agents, or anticonvulsants, it is essential to follow the expert's instructions. Due to limited safety data regarding use during pregnancy, pregnant women should use this medication with caution, and breastfeeding mothers are advised not to take this drug. In case of overdose, as there is no specific antidote, appropriate treatment should be administered according to the symptoms, and it is crucial to keep it out of reach of children. When using this medication, it is safe to administer the minimum dose and appropriate duration as directed by a healthcare provider.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria, angioedema, anaphylactic reaction/shock, severe allergic reaction.
  • Jaundice, hepatitis, liver failure, liver abnormalities (jaundice).
  • Severe skin reactions: Urticaria, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).
  • Severe skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis.

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • insomnia
  • agitation
  • mental confusion
  • depression
  • aggression
  • hallucinations
  • taste disorders
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  • blurred vision
  • bronchospasm
  • abdominal pain
  • constipation
  • diarrhea
  • abdominal distension
  • nausea
  • vomiting
  • dry mouth
  • stomatitis
  • gastrointestinal candidiasis
  • pancreatitis
  • increased liver enzymes
  • hepatitis
  • hair loss
  • photosensitivity
  • erythema multiforme
  • fractures
  • arthralgia
  • myalgia
  • muscular weakness
  • kidney diseases
  • gynecomastia
  • asthenia
  • increased sweating
  • Clostridium difficile infection.

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

Storage

This medication can be sensitive to air and moisture, so it should be stored in a tightly closed container. Additionally, it is advisable to keep the drug at normal room temperature, between 1 and 30 degrees Celsius, and not in excessively hot or cold places.

Appearance and packaging

Appearance

Pale pink oval film-coated tablets

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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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.