Medication info
Esotec DR Extended Release Capsule 20 mg (Esomeprazole Magnesium Hydrate)

Esotec DR Extended Release Capsule 20 mg (Esomeprazole Magnesium Hydrate)

Prescription medication경구
Ingredient · strength
Esomeprazole Magnesium Dihydrate›10.85mg / 1 capsule
Manufacturer / importer
대원제약(주)
Appearance
A pink upper part and a white lower part extended release hard capsule containing round pellets ranging from white to pale yellow.
Packaging
14 capsules/PTP [7 capsules/PTP X 2], 30 capsules/bottle
Approval status
Active

MFDS item code 202101870 · Approved 2021.02.24 · Insurance code 671807330

Summary

Main use
Treatment and prevention of recurrence of gastroesophageal reflux disease (erosive reflux esophagitis)
Who takes it
Adults · Children
Adult dose
Esotec DR Extended Release Capsule 20 mg can be taken regardless of meals and should be swallowed with liquid such as water; do not chew or crush. For the treatment of erosive reflux esophagitis, 40 mg is administered once daily for 4 weeks; if symptoms persist, continue for an additional 4 weeks. Long-term maintenance therapy to prevent recurrence in patients with esophagitis is 20 mg administered once daily.
Child dose
For adolescents aged 12 years and older, 40 mg is administered once daily for 4 weeks for the treatment of erosive reflux esophagitis; if symptoms persist, continue for an additional 4 weeks. There is no experience in administering this medication to children under 12 years of age.

Ingredients

Manufacturer
대원제약(주)

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 (GERD) is a condition caused by the reflux of stomach acid into the esophagus, and is used for the treatment of erosive reflux esophagitis. It is also used as a long-term maintenance therapy to prevent recurrence in patients with esophagitis. This medication helps to suppress gastric acid secretion, protect the esophageal mucosa, and alleviate symptoms. Patients can expect improvement in symptoms and prevention of recurrence through continuous administration.

How to take

Adult dose

Esotec DR Extended Release Capsule 20 mg can be taken regardless of meals and should be swallowed with liquid such as water; do not chew or crush. For the treatment of erosive reflux esophagitis, 40 mg is administered once daily for 4 weeks; if symptoms persist, continue for an additional 4 weeks. Long-term maintenance therapy to prevent recurrence in patients with esophagitis is 20 mg administered once daily.

Child dose

For adolescents aged 12 years and older, 40 mg is administered once daily for 4 weeks for the treatment of erosive reflux esophagitis; if symptoms persist, continue for an additional 4 weeks. There is no experience in administering this medication to children under 12 years of age.

Precautions

This medication should not be administered to certain patients. For example, patients allergic to this drug, its ingredients, or who have experienced hypersensitivity reactions to benzimidazole derivatives should not use it. Additionally, patients taking certain antiviral agents such as atazanavir, nelfinavir, and rilpivirine or nursing mothers should avoid this medication. Although serious adverse reactions were rarely reported in clinical trials involving patients with gastroesophageal reflux disease, some patients may experience side effects such as diarrhea, headache, dizziness, and increased liver enzyme levels. Long-term use may lead to side effects such as hypomagnesemia, increased risk of fractures, and increased risk of gastrointestinal bacterial infection, necessitating regular testing. If symptoms suggestive of malignant tumors are present, it is essential to confirm their malignancy before taking this medication, and it is crucial to consult a doctor if symptoms change. This drug may interact with other medications, so it is advisable to consult with a healthcare professional if you are taking blood thinners, antiviral agents, antibiotics, or immunosuppressants. While no specific anomalies were found in animal studies during pregnancy, it should be administered cautiously to pregnant women, and nursing mothers should avoid this medication. In the case of overdose, there is no specific antidote, so treatment should be symptomatic, and it should be kept out of reach of children. Furthermore, transferring the medicine to another container can compromise its quality, so care should be taken.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylactic reaction/shock, severe hypomagnesemia, hepatitis, jaundice, hepatic failure, Stevens-Johnson syndrome (skin and mucous membrane syndrome), toxic epidermal necrolysis (Lyell syndrome), acute generalized exanthematous pustulosis, respiratory distress, bronchospasm, rhabdomyolysis, severe allergic reactions, severe skin adverse reactions, skin and systemic lupus erythematosus, systemic lupus erythematosus, severe skin adverse reactions, Clostridium difficile-associated diarrhea

Mild side effects

  • Diarrhea
  • dyspepsia
  • abdominal bloating
  • abdominal pain
  • upper abdominal pain
  • nausea
  • gastric ulcers
  • headache
  • dizziness
  • drowsiness
Show 14 more
  • increased aspartate aminotransferase
  • increased alanine aminotransferase
  • increased creatine phosphokinase
  • increased alkaline phosphatase
  • increased lactate dehydrogenase
  • joint dislocation
  • ligament sprain
  • arthralgia
  • influenza
  • hair loss
  • photosensitivity
  • erythema multiforme
  • dermatitis
  • itching

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air and moisture, and it is advisable to store it at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness and prevents deterioration.

Appearance and packaging

Appearance

A pink upper part and a white lower part extended release hard capsule containing round pellets ranging from white to pale yellow.

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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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.