Medication info
Samsung Esomeprazole Tablet 20 mg (Esomeprazole Magnesium Dihydrate)

Samsung Esomeprazole Tablet 20 mg (Esomeprazole Magnesium Dihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Dihydrate›21.69mg / 1 tablet
Manufacturer / importer
삼성제약(주)
Appearance
Pink round film-coated tablet
Packaging
28 tablets/box [14 tablets/Alu-Alu×2]
Approval status
Active

MFDS item code 201803141 · Approved 2018.07.30 · Insurance code 642307130

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, relief of gastrointestinal symptoms related to non-steroidal anti-inflammatory analgesics, etc.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquids such as water and should not be chewed or crushed. Dosage for adults: 1) Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If necessary, an additional 4 weeks can be administered. 2) Prevention of recurrence in patients with esophagitis: 20 mg once daily as maintenance therapy. 3) Treatment of symptomatic gastroesophageal reflux disease without esophagitis: 20 mg once daily. Even after symptom relief, 20 mg should be administered once daily.
Children's dosage
Dosage for adolescents aged 12 and older: 1) Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If necessary, an additional 4 weeks can be administered. 2) Treatment of symptomatic gastroesophageal reflux disease without esophagitis:

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, relief of gastrointestinal symptoms related to non-steroidal anti-inflammatory analgesics, etc.

  • Gastroesophageal reflux disease
  • erosive esophagitis
  • esophagitis
  • duodenal ulcers
  • peptic ulcers
  • upper gastrointestinal symptoms
  • pain
  • discomfort
  • burning sensation
  • gastric ulcers
  • duodenal ulcers
  • Zollinger-Ellison syndrome
View approved original text

This medication is used for the treatment of gastroesophageal reflux disease, especially for long-term maintenance therapy to prevent recurrence in patients with erosive esophagitis. It is also effective for relieving symptoms of gastroesophageal reflux disease without esophagitis. It is used in combination with antibiotics for the treatment and prevention of recurrence of Helicobacter pylori positive duodenal ulcers and peptic ulcers. It is also used for the treatment and prevention of symptoms and ulcers related to upper gastrointestinal tract due to non-steroidal anti-inflammatory analgesics. This medication is employed in the treatment of Zollinger-Ellison syndrome and in prevention and maintenance therapy of rebleeding in gastric or duodenal ulcers. Overall, it is effective in improving and treating symptoms of various gastrointestinal-related diseases.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquids such as water and should not be chewed or crushed. Dosage for adults: 1) Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If necessary, an additional 4 weeks can be administered. 2) Prevention of recurrence in patients with esophagitis: 20 mg once daily as maintenance therapy. 3) Treatment of symptomatic gastroesophageal reflux disease without esophagitis: 20 mg once daily. Even after symptom relief, 20 mg should be administered once daily.

Children's dosage

Dosage for adolescents aged 12 and older: 1) Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If necessary, an additional 4 weeks can be administered. 2) Treatment of symptomatic gastroesophageal reflux disease without esophagitis:

Precautions

This medication should not be administered to patients with known allergies to specific ingredients or those who have experienced hypersensitivity reactions. It may interact with certain antibiotics or medications used in conjunction with this medication, so patients taking specific medications should avoid use. It is safest for breastfeeding women to avoid taking this medication. Patients with a history of heart disease or myocardial infarction should use this medication with caution. Various side effects may occur during the use of this medication; therefore, if unusual symptoms such as headache, dizziness, abdominal pain, skin rash, muscle pain, etc., develop, immediate consultation with a physician is necessary. Regular blood tests or other examinations are required during long-term use, especially when taking the medication for more than one year. Since this medication reduces stomach acid, there may be a slight increase in the risk of gastrointestinal infections. Patients with osteoporosis or a high risk of fractures should be cautious as long-term use may increase the risk of fractures. This medication may interact with certain drugs, affecting their efficacy or side effects; patients should inform their doctor or pharmacist if they are taking other medications. Due to limited safety data on this medication during pregnancy, pregnant women should consult their physician for careful use. In the case of overdose, as there is no specific antidote, patients should visit a medical facility immediately for appropriate treatment. This medication should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, shock, fever, angioedema, anaphylaxis, shock, jaundice, hepatitis, hepatic failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), neurological symptoms such as rigidity, arrhythmia, seizures, severe allergic reactions, severe skin abnormalities.

Mild side effects

Headache, dizziness, paresthesia, drowsiness, taste disturbance, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, increased liver enzymes, hepatitis, dermatitis, itching, rash, hair loss, photosensitivity, fractures, arthralgia, myalgia, muscle weakness, nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal distension, allergic reactions, back pain, chest pain, sternum.

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

Storage

This medication may be sensitive to air or moisture; it should be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1°C and 30°C at room temperature to safely preserve the medication's efficacy over time.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets/box [14 tablets/Alu-Alu×2]

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.