Medication info
Esomeprazole Magnesium Delayed Release Capsule 20 mg (Esomeprazole Magnesium Trihydrate)

Esomeprazole Magnesium Delayed Release Capsule 20 mg (Esomeprazole Magnesium Trihydrate)

Prescription medication경구
Ingredient · strength
Esomeprazole Magnesium Dihydrate›10.85mg / 1 capsule
Manufacturer / importer
(주)유영제약
Appearance
A controlled-release hard capsule with a pink upper part and a white lower part containing white to light yellow round pellets.
Packaging
14 capsules/PTP [7 capsules/PTPX2], 30 capsules/bottle
Approval status
Active

MFDS item code 202101872 · Approved 2021.02.24 · Insurance code 648204420

Summary

Main use
Treatment and prevention of recurrence of gastroesophageal reflux disease (erosive reflux esophagitis)
Who takes it
Adults · Children
Adult dose
Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis does not improve or symptoms persist, take for an additional 4 weeks. Long-term maintenance therapy for preventing recurrence in esophagitis patients: 20 mg once daily. No dose adjustment is needed for patients with renal impairment and the elderly. Severe liver impairment patients should not exceed 20 mg.
Child dose
Treatment of erosive reflux esophagitis in adolescents aged 12 years and older: Administer 40 mg once daily for 4 weeks. If esophagitis does not improve or symptoms persist, take for an additional 4 weeks. 12 years

Ingredients

Manufacturer
(주)유영제약

Efficacy & effects

Treatment and prevention of recurrence of gastroesophageal reflux disease (erosive reflux esophagitis)

  • Gastroesophageal reflux disease
  • erosive reflux esophagitis
  • esophagitis
View approved original text

Gastroesophageal reflux disease is a condition that causes discomfort due to the regurgitation of stomach contents into the esophagus. This medication is used for the treatment of erosive reflux esophagitis and improves symptoms by alleviating damage to the esophageal mucosa. Furthermore, it is utilized as a long-term maintenance therapy to prevent recurrence after treatment. This helps effectively manage symptoms and improve patients' quality of life. Therefore, it is used for the treatment and prevention of recurrence of gastroesophageal reflux disease.

How to take

Adult dose

Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis does not improve or symptoms persist, take for an additional 4 weeks. Long-term maintenance therapy for preventing recurrence in esophagitis patients: 20 mg once daily. No dose adjustment is needed for patients with renal impairment and the elderly. Severe liver impairment patients should not exceed 20 mg.

Child dose

Treatment of erosive reflux esophagitis in adolescents aged 12 years and older: Administer 40 mg once daily for 4 weeks. If esophagitis does not improve or symptoms persist, take for an additional 4 weeks. 12 years

Precautions

This medication should not be used in certain patients. Patients with allergies to this medication or its components, those who have had hypersensitivity reactions to benzimidazoles, patients taking specific antiviral drugs such as atazanavir and nelfinavir, nursing women, and patients taking drugs containing rilpivirine should not use this medication. This medication can cause side effects such as gastrointestinal disturbances, headache, dizziness, etc. Rarely, serious reactions such as blood abnormalities, liver dysfunction, and skin rashes have been reported. Prolonged use may lead to electrolyte abnormalities, such as hypomagnesemia, requiring regular monitoring. As this medication suppresses gastric acid, the risk of gastrointestinal bacterial infections may slightly increase. In particular, hospitalized patients may have an increased risk of diarrhea due to Clostridium difficile; therefore, consultation with a doctor is necessary if diarrhea persists. Patients taking this medication long-term may have an increased risk of fractures; hence, monitoring and preventive measures are essential if there is a risk of osteoporosis. This medication can interact with other drugs; thus, if taking other medications, especially anticoagulants, antiviral drugs, anticonvulsants, or antidepressants, it is crucial to inform your physician or pharmacist. Co-administration can alter the effectiveness of the drugs or increase the risk of side effects. During pregnancy, data on the safety of this drug is limited; therefore, it should be used with caution during pregnancy, and it is advisable for nursing women not to take this medication. In the event of overdose, there are no specific antidotes, and symptomatic relief and supportive care are required. This medication is not removed by dialysis, so immediate consultation with healthcare professionals is necessary in the case of overdose. Store this medication out of the reach of children; transferring it to another container may not maintain quality and should be avoided.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria, angioedema, anaphylactic reaction/shock, severe allergic reactions
  • Blood and lymphatic system abnormalities (leukopenia, thrombocytopenia, agranulocytosis, pancytopenia)
  • Liver abnormalities (jaundice, liver failure, hepatitis, encephalopathy)
  • Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, mucocutaneous syndrome, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)

Mild side effects

  • Diarrhea
  • indigestion
  • abdominal distension
  • abdominal pain
  • epigastric pain
  • nausea
  • headache
  • dizziness
  • drowsiness
  • increased aspartate aminotransferase
Show 12 more
  • increased alanine aminotransferase
  • increased blood creatine phosphokinase
  • increased blood alkaline phosphatase
  • increased blood lactate dehydrogenase
  • joint dislocation
  • ligament sprain
  • arthralgia
  • influenza
  • hair loss
  • phototoxicity
  • polymorphic erythema
  • Stevens-Johnson syndrome

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly closed container. It is essential to maintain the storage temperature between 1 and 30 degrees Celsius to preserve the medication's effectiveness and safety.

Appearance and packaging

Appearance

A controlled-release hard capsule with a pink upper part and a white lower part containing white to light yellow round pellets.

Package unit

14 capsules/PTP [7 capsules/PTPX2], 30 capsules/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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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.