Medication info
Esotec DR Extended Release Capsules 40 mg (Esomeprazole Magnesium Trihydrate)

Esotec DR Extended Release Capsules 40 mg (Esomeprazole Magnesium Trihydrate)

Prescription medication경구
Ingredient · strength
Esomeprazole Magnesium Dihydrate›21.69mg / 1 capsule
Manufacturer / importer
대원제약(주)
Appearance
A pink upper and lower pink extended-release hard capsule containing white to pale yellow round pellets.
Packaging
14 capsules/PTP [7 capsules/PTP X 2], 30 capsules/bottle
Approval status
Active

MFDS item code 202101869 · Approved 2021.02.24 · Insurance code 671807320

Summary

Main use
Effect for the treatment and prevention of gastroesophageal reflux disease (erosive reflux esophagitis)
Who takes it
Adults · Children
Adult dose
For the treatment of gastroesophageal reflux disease (GERD) with erosive reflux esophagitis, administer 40 mg once daily for 4 weeks. If esophagitis is not resolved or symptoms persist, continue for another 4 weeks. For long-term maintenance therapy to prevent relapse in patients with esophagitis, administer 20 mg once daily.
Child dose
Adolescents over 12 years old are administered 40 mg once daily for 4 weeks for the treatment of gastroesophageal reflux disease (GERD) with erosive reflux esophagitis. There is no experience in administering this medication to children under 12 years old.

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

Effect for the treatment and prevention of gastroesophageal reflux disease (erosive reflux esophagitis)

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

This medication treats erosive reflux esophagitis, a form of gastroesophageal reflux disease (GERD), and is also used for long-term maintenance therapy to prevent relapse in patients with esophagitis.

How to take

Adult dose

For the treatment of gastroesophageal reflux disease (GERD) with erosive reflux esophagitis, administer 40 mg once daily for 4 weeks. If esophagitis is not resolved or symptoms persist, continue for another 4 weeks. For long-term maintenance therapy to prevent relapse in patients with esophagitis, administer 20 mg once daily.

Child dose

Adolescents over 12 years old are administered 40 mg once daily for 4 weeks for the treatment of gastroesophageal reflux disease (GERD) with erosive reflux esophagitis. There is no experience in administering this medication to children under 12 years old.

Precautions

This medication should not be used in patients with a history of allergic reactions to this drug or its ingredients, patients taking certain antiviral agents (atazanavir, nelfinavir, rilpivirine), and nursing mothers. Some patients may experience various side effects such as headaches, dizziness, abdominal pain, diarrhea, skin rashes, etc. If any abnormal symptoms occur, please consult a healthcare professional immediately. It is important to have regular check-ups when taking this medication for a long time, especially for over one year, to monitor your health condition. Since this medication reduces stomach acid, the risk of bacterial overgrowth in the gastrointestinal tract may be slightly increased; if infection symptoms persist, you should consult a physician. Patients at risk of osteoporosis or fractures should be cautious, as the risk of fractures may increase with long-term use of this medication. This medication may interact with other drugs; if you are taking other medications, you must inform your physician or pharmacist, and caution is advised if used in combination with drugs affecting blood coagulation or antiviral agents. There is limited data on the safety of this medication during pregnancy, so if you are pregnant, you should consult a doctor before taking it. This medication is not recommended for nursing mothers, and breastfeeding women should avoid taking it. In case of overdose, there is no specific antidote, and appropriate treatment should be administered according to symptoms. It is important to keep this medication out of the reach of children. Additionally, transferring this medication to another container may affect its quality, so it should be stored in its original packaging.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylactic reaction, shock, angioedema, erythema multiforme, systemic lupus erythematosus, hives, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reactions with eosinophilia and systemic symptoms, jaundice, hepatitis, liver failure, encephalopathy, difficulty breathing, respiratory distress, asthma exacerbation, severe allergic reactions, severe hypomagnesemia (potentially causing hypocalcemia), rhabdomyolysis

Mild side effects

  • Diarrhea
  • dyspepsia
  • abdominal distension
  • abdominal pain
  • epigastric pain
  • nausea
  • gastric ulcer
  • headache
  • dizziness
  • drowsiness
Show 14 more
  • increase in aspartate aminotransferase
  • increase in alanine aminotransferase
  • increase in blood creatine phosphokinase
  • increase in blood alkaline phosphatase
  • increase in blood lactate dehydrogenase
  • joint dislocation
  • ligament sprain
  • arthralgia
  • influenza
  • dermatitis
  • itching
  • rash
  • hair loss
  • photosensitivity

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

Storage

This medication should be stored in a tightly closed container, protected from air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. Proper storage will help maintain the medication's effectiveness and safety.

Appearance and packaging

Appearance

A pink upper and lower pink extended-release hard capsule containing white to pale yellow round pellets.

Package unit

14 capsules/PTP [7 capsules/PTP X 2], 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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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.