Medication info
Esomeprazole Magnesium Trihydrate 20/800 mg Tablets

Esomeprazole Magnesium Trihydrate 20/800 mg Tablets

Prescription medicationTablet경구
Ingredient · strength
Esomeprazole Magnesium Trihydrate›22.26mg / 1 tabletSodium Bicarbonate›800mg / 1 tablet
Manufacturer / importer
진양제약(주)
Appearance
Light pink, rectangular film-coated tablets
Packaging
28 tablets/box [(7 tablets/PTP × 4)]
Approval status
Active

MFDS item code 202104835 · Approved 2021.06.24 · Insurance code 650304270

Summary

Main use
Treatment of erosive reflux esophagitis and prevention of recurrence, improvement of gastroesophageal reflux disease symptoms
Who takes it
Adults
Adult dose
This medicine should be taken on an empty stomach at least 1 hour before meals. When taking this medicine, it should be swallowed whole with at least half a cup of water. Do not take with any beverages other than water. This medicine should not be chewed or crushed. For treatment of erosive reflux esophagitis: Administer 40/800 mg once daily for 4 weeks. In patients whose esophagitis is not resolved or whose symptoms persist, it may be taken for another 4 weeks.

Ingredients

Manufacturer
진양제약(주)

Efficacy & effects

Treatment of erosive reflux esophagitis and prevention of recurrence, improvement of gastroesophageal reflux disease symptoms

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

This medicine is used in the treatment of gastroesophageal reflux disease, particularly erosive reflux esophagitis. It can also be utilized as a long-term maintenance therapy to prevent recurrence in patients with esophagitis. Additionally, it helps relieve various symptoms of gastroesophageal reflux disease in patients without esophagitis. It is a medicine that is appropriately used for symptom improvement and long-term management.

How to take

Adult dose

This medicine should be taken on an empty stomach at least 1 hour before meals. When taking this medicine, it should be swallowed whole with at least half a cup of water. Do not take with any beverages other than water. This medicine should not be chewed or crushed. For treatment of erosive reflux esophagitis: Administer 40/800 mg once daily for 4 weeks. In patients whose esophagitis is not resolved or whose symptoms persist, it may be taken for another 4 weeks.

Precautions

It is essential not to use this medicine in certain patients. Patients who are allergic to this medicine or its ingredients, or who have had hypersensitivity reactions in the past, should not use this medicine. Furthermore, it is contraindicated for pregnant women, women who are breastfeeding, patients taking the antiviral drugs Atazanavir or Nelfinavir, and those with a history of myocardial infarction. Use with caution in patients with liver or kidney dysfunction, elderly patients, patients with impaired heart or lung function, patients with severe gastrointestinal ulcers, patients with electrolyte imbalances, and patients who need to restrict sodium intake. Particularly, the Sodium Bicarbonate component in this medicine may cause alkalosis or edema due to sodium accumulation, so the patient's condition should be closely monitored. This medicine can cause various side effects. Blood-related issues such as leukopenia or thrombocytopenia may occur, along with hypersensitivity reactions such as fever, angioedema, or anaphylactic shock. Electrolyte imbalances including hyponatremia and hypomagnesemia have been reported, while psychological symptoms may include insomnia, anxiety, depression, and hallucinations. Neurological symptoms such as headaches, dizziness, and drowsiness are common, whereas gastrointestinal symptoms such as abdominal pain, diarrhea, constipation, nausea, and vomiting occur relatively frequently. Rarely, liver dysfunction, skin rash, hair loss, or severe skin reactions (such as Stevens-Johnson syndrome) have also been reported. Since this medicine inhibits gastric acid secretion, bacterial overgrowth in the gastrointestinal tract may increase, raising the risk of specific bacterial infections. Long-term use may increase the risk of osteoporosis-related fractures, so patients at high risk of fractures require regular examinations. This medicine can interact with other medications, so when taken with anticoagulants, antiviral drugs, anticonvulsants, antidepressants, etc., it is crucial to closely monitor drug concentrations and effects under a doctor's guidance. The safety of this medicine during pregnancy has not been entirely confirmed, so caution is advised when using it. It is recommended not to take this medicine while breastfeeding. In case of overdose, there are no specific antidotes, so it is crucial to receive symptomatic treatment, and keep it out of reach of children. During treatment with this medicine, if symptoms change or adverse reactions occur, it is necessary to consult a doctor immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylaxis reaction/shock, severe allergic reaction, severe skin adverse reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, eosinophilia and systemic symptoms drug reaction, liver failure, jaundice, liver dysfunction, severe neurological symptoms, seizures, altered consciousness, visual disturbances, paralysis, severe edema, urination abnormalities

Mild side effects

  • Headache
  • dizziness
  • paresthesia
  • drowsiness
  • blurred vision
  • bronchospasm
  • abdominal pain
  • constipation
  • diarrhea
  • abdominal distension
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  • nausea
  • vomiting
  • dry mouth
  • stomatitis
  • jaundice
  • elevated liver enzymes
  • hepatitis
  • dermatitis
  • itching
  • rash
  • hair loss
  • photosensitivity
  • fractures
  • arthralgia
  • myalgia
  • interstitial nephritis
  • gynecomastia
  • weakness
  • increased sweating
  • diarrhea
  • abdominal swelling
  • belching
  • allergic reactions
  • back pain
  • chest pain
  • sub-sternal pain
  • facial swelling
  • facial flushing

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

Storage

This medicine must be stored in a tightly sealed container to protect it from air and moisture. It is best to keep it at room temperature between 1 and 30 degrees Celsius to maintain the medicine's efficacy.

Appearance and packaging

Appearance

Light pink, rectangular film-coated tablets

Package unit

28 tablets/box [(7 tablets/PTP × 4)]

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.