Medication info
Esomeprazole Tablet 20/800 mg

Esomeprazole Tablet 20/800 mg

Prescription medicationTablet경구
Ingredient · strength
Esomeprazole Magnesium Trihydrate›22.26mg / 1 tabletSodium Bicarbonate›800mg / 1 tablet
Manufacturer / importer
(주)인트로바이오파마
Appearance
Light pink rectangular film-coated tablet
Packaging
PTP - 28 tablets/PTP [(7 tablets/PTPX4)]
Approval status
Active

MFDS item code 202104752 · Approved 2021.06.18 · Insurance code 052402110

Summary

Main use
Treatment and relapse prevention of erosive reflux esophagitis, alleviation of gastroesophageal reflux disease symptoms
Who takes it
Adults
Adult dose
This medication should be taken at least 1 hour before meals. This medication 20/800mg and 40/800mg contains esomeprazole 20mg and 40mg respectively, but the amount of sodium bicarbonate in 20/800mg (2 tablets) and 40/800mg (1 tablet) is different, so caution is required. 1. Adults - Treatment of erosive reflux esophagitis: Administer 40/800mg once daily for 4 weeks. If not treated, take for an additional 4 weeks.

Ingredients

Manufacturer
(주)인트로바이오파마

Efficacy & effects

Treatment and relapse prevention of erosive reflux esophagitis, alleviation of gastroesophageal reflux disease symptoms

  • Gastroesophageal reflux disease
  • erosive reflux esophagitis
  • esophagitis
  • symptoms of gastroesophageal reflux disease
View approved original text

This medicine is used for treating gastroesophageal reflux disease, specifically erosive reflux esophagitis. It is also effective for long-term maintenance therapy to prevent relapse in patients with esophagitis. It helps alleviate symptoms of gastroesophageal reflux disease, even in patients without esophagitis. Continuous use is necessary as it plays a crucial role in symptom improvement and relapse prevention for patients. It effectively improves discomfort related to gastroesophageal reflux.

How to take

Adult dose

This medication should be taken at least 1 hour before meals. This medication 20/800mg and 40/800mg contains esomeprazole 20mg and 40mg respectively, but the amount of sodium bicarbonate in 20/800mg (2 tablets) and 40/800mg (1 tablet) is different, so caution is required. 1. Adults - Treatment of erosive reflux esophagitis: Administer 40/800mg once daily for 4 weeks. If not treated, take for an additional 4 weeks.

Precautions

This medication should not be administered to certain patients. For example, it should not be used in patients who are allergic to this medication or its ingredients, those taking specific antiviral medications, nursing women, or patients with a history of myocardial infarction. Caution is also needed when administering this medication to patients with poor liver or kidney function, the elderly, patients with heart or lung issues, and those with electrolyte imbalances. Notably, this medication contains sodium bicarbonate, which requires caution in patients needing sodium intake restrictions or those with electrolyte abnormalities. Various adverse reactions may occur when taking this medicine, including headache, abdominal pain, diarrhea, rash, muscle pain, and liver function abnormalities. Rarely, serious skin reactions or hematological abnormalities, and muscle damage may occur, so if severe symptoms or abnormal signs appear, consult a healthcare provider immediately. This medicine suppresses gastric acid secretion, which may increase the risk of gastrointestinal bacterial infections; therefore, if symptoms like diarrhea persist, the possibility of Clostridium difficile infection should be considered. Long-term use of this medication may increase the risk of fractures; therefore, patients at risk of osteoporosis should undergo regular examinations. Additionally, hypomagnesemia may occur, so magnesium levels should be regularly monitored during long-term administration. This medication may interact with other drugs, particularly warfarin, digoxin, some antidepressants, anticonvulsants, and antivirals; caution is necessary when used concurrently, and monitoring by a healthcare professional is required. Data about the safety of this medication during pregnancy is limited, so it should be administered cautiously to pregnant women, while nursing mothers are advised not to take this medication. As there are no specific antidotes for overdose, symptomatic treatment based on the symptoms is required, and it should be kept out of reach of children. Moreover, it is important to store this medication in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (including angioedema), chest tightness, difficulty breathing, cold sweats, paleness → severe allergic reaction
  • Severe rash with high fever, blisters, skin peeling, pain of oral/ocular mucosa → severe skin adverse reactions
  • Shortness of breath or respiratory difficulty, asthma attack, cough + fever accompanied breathing problems → respiratory issues
  • Yellowing of the skin or eyes (jaundice), extreme lethargy → liver issues (jaundice)

Mild side effects

  • Hematologic and lymphatic adverse reactions: leukopenia, thrombocytopenia, agranulocytosis, pancytopenia
  • Immune system adverse reactions: fever, angioedema, anaphylaxis reaction/shock and other hypersensitivity reactions
  • Metabolic/nutritional anomalies: peripheral edema, hyponatremia, hypomagnesemia, hypocalcemia, hypokalemia
  • Psychiatric anomalies: insomnia, agitation, confusion, depression, aggression, hallucinations
  • Nervous system anomalies: headache, dizziness, sensory disturbance, drowsiness, taste disorder
  • Visual

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature. This will help preserve the medication's effectiveness for an extended period.

Appearance and packaging

Appearance

Light pink rectangular film-coated tablet

Package unit

PTP - 28 tablets/PTP [(7 tablets/PTPX4)]

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.