Medication info
Esomeprazole Magnesium Hydrate 20 mg (Esomeprazole Magnesium Dihydrate)

Esomeprazole Magnesium Hydrate 20 mg (Esomeprazole Magnesium Dihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Dihydrate›21.69mg / 1 tablet
Manufacturer / importer
(주)셀릭스
Appearance
Pale pink, oblong film-coated tablet
Packaging
28 tablets/box [(14 tablets/Alu-Alu x 2)]
Approval status
Active

MFDS item code 201600760 · Approved 2016.02.05 · Insurance code 646204200

Summary

Main use
Effective for the treatment of gastroesophageal reflux disease and Helicobacter pylori infection, and prevention of recurrence of gastric ulcers
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquids such as water, and should not be chewed or crushed. 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. Extend for another 4 weeks if necessary. - Maintenance therapy for prevention of recurrence: 20 mg once daily. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: 20 mg once daily. If symptoms persist after 4 weeks, further consultation is needed.
Children's dosage
Adolescents over 12 years of age should take the same as adults. There is no experience in administering to children under 12 years of age.

Ingredients

Manufacturer
(주)셀릭스

Efficacy & effects

Effective for the treatment of gastroesophageal reflux disease and Helicobacter pylori infection, and prevention of recurrence of gastric ulcers

  • Gastroesophageal reflux disease
  • erosive esophagitis
  • esophagitis
  • Helicobacter pylori positive 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, particularly for the long-term maintenance therapy of erosive esophagitis. It also helps relieve symptoms of gastroesophageal reflux disease without esophagitis. It is effective in the treatment and prevention of recurrence of duodenal ulcers and peptic ulcers in combination with antibiotics for the eradication of Helicobacter pylori. It short-term treats upper gastrointestinal symptoms, discomfort, burning sensation associated with the use of non-steroidal anti-inflammatory drugs, and is also used for the treatment and prevention of gastric ulcers and duodenal ulcers. It is also effective in the treatment of Zollinger-Ellison syndrome and maintenance therapy after the prevention of rebleeding from gastric or duodenal ulcers. Overall, it is used for the improvement of various gastrointestinal diseases and symptoms.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquids such as water, and should not be chewed or crushed. 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. Extend for another 4 weeks if necessary. - Maintenance therapy for prevention of recurrence: 20 mg once daily. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: 20 mg once daily. If symptoms persist after 4 weeks, further consultation is needed.

Children's dosage

Adolescents over 12 years of age should take the same as adults. There is no experience in administering to children under 12 years of age.

Precautions

This medication should not be used in certain patients. For example, patients who have had an allergic reaction to this drug or any of its components, those allergic to penicillin antibiotics or macrolide antibiotics, patients taking certain heart-related medications, patients with a history of myocardial infarction, and breastfeeding women should not take this medication. This drug contains the dye Tartrazine, so patients with an allergy or hypersensitivity to this dye should use it cautiously. Caution is advised while taking this medication as various side effects may occur. Common side effects include headache, abdominal pain, diarrhea, constipation, nausea, and vomiting, while rare but serious symptoms may include blood abnormalities, hypomagnesemia, confusion, skin rashes, and myalgia. Particularly, if myalgia or weakness occurs, it could be a serious muscle damage condition known as rhabdomyolysis, so immediate consultation with a doctor is advised. Long-term use of this medication may increase the risk of gastrointestinal bacterial infections and the risk of fractures, so patients at risk for osteoporosis require regular examinations. Pregnant or breastfeeding women should consult a doctor before using this medication, and it is advisable not to take it while breastfeeding. This medication has many drug interactions, so caution is needed when taking it with antibiotics, antiviral medications, anticoagulants, antiepileptics, etc. Always consult with a doctor or pharmacist regarding other medications being taken. In the case of overdose, there is no specific antidote, so appropriate treatment should be administered based on symptoms, and keep this medication out of reach of children. Additionally, avoid transferring the medication to different containers to prevent quality degradation or risk of accidents.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis reaction/shock, severe hypomagnesemia, jaundice, hepatitis, hepatic failure, encephalopathy, skin and mucous membrane syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), interstitial nephritis, rhabdomyolysis, serious arrhythmia (QT prolongation, ventricular tachycardia, ventricular fibrillation, Torsades de Pointes)

Mild side effects

Headache, dizziness, drowsiness, taste disorders, blurred vision, dizziness, bronchospasm, abdominal pain, constipation, diarrhea, abdominal distension, nausea, vomiting, dry mouth, stomatitis, elevated liver enzymes, dermatitis, itching, rash, hair loss, photosensitivity, fractures, arthralgia, myalgia, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, facial swelling, facial flushing, fatigue, fever, influenza-like illness, general swelling, leg swelling,

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 air or moisture from entering. Additionally, it should be stored at room temperature between 1°C to 30°C. This will help maintain the medication's efficacy and safety.

Appearance and packaging

Appearance

Pale pink, oblong film-coated tablet

Package unit

28 tablets/box [(14 tablets/Alu-Alu x 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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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.