Medication info
Esomeprazole 40 mg Tablets (Esomeprazole Magnesium Trihydrate)

Esomeprazole 40 mg Tablets (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›44.5mg / 1 tablet
Manufacturer / importer
풍림무약(주)
Appearance
Pink, round, film-coated tablet
Packaging
28 tablets (14 tablets/PTP X 2)
Approval status
Active

MFDS item code 201600210 · Approved 2016.01.12 · Insurance code 649001480

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), eradication of Helicobacter pylori, prevention of recurrence of peptic ulcers, relief of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, and ulcers treatment and prevention effects.
Who uses it
Adults · Children
Adult dosage
This drug should be swallowed with liquids such as water and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: 20 mg once daily 2) Helicobacter pylori eradication combined therapy
Children's dosage
Adolescents aged 12 and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: once daily,

Ingredients

Manufacturer
풍림무약(주)

Efficacy & effects

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

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

This drug is used for the treatment of gastroesophageal reflux disease, especially for the long-term maintenance therapy to prevent recurrence of erosive esophagitis. It helps in the treatment and prevention of duodenal ulcers and peptic ulcers as part of a combined therapy with antibiotics for the eradication of Helicobacter pylori. Additionally, it is effective for treating upper gastrointestinal symptoms related to the use of non-steroidal anti-inflammatory drugs and for treating and preventing gastric and duodenal ulcers. It is also utilized in the maintenance therapy after prevention of rebleeding due to gastric or duodenal ulcers in Zollinger-Ellison syndrome. Overall, it is used for the treatment of various symptoms and diseases related to gastrointestinal disorders.

Dosage and Administration

Adult dosage

This drug should be swallowed with liquids such as water and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: 20 mg once daily 2) Helicobacter pylori eradication combined therapy

Children's dosage

Adolescents aged 12 and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: once daily,

Precautions

This drug should not be administered to specific patients. Patients with an allergy or hypersensitivity to this drug or any of its components, or to benzimidazole derivatives should not use it. Additionally, it should be avoided in patients with allergy to amoxicillin or clarithromycin when used in combination therapy for eradication of Helicobacter pylori. Patients on cardiac medications or with a history of myocardial infarction, as well as breastfeeding women, should preferably not use this medication. This drug may cause various adverse reactions. Symptoms such as decreased blood cell count, allergic reactions, hypomagnesemia, headache, dizziness, abdominal pain, diarrhea, abnormal liver function, skin rash have been reported. Notably, prolonged use may lead to hypomagnesemia, necessitating regular blood tests. This drug inhibits gastric acid secretion, which lowers stomach acidity, but this may slightly increase the risk of bacterial infections in the gastrointestinal tract. Long-term use may also increase the risk of fractures, so caution is required for patients with osteoporosis. This drug may interact with other medications, so especially when used in combination with antibiotics, antiviral agents, anticoagulants, anticonvulsants, consultation with a doctor or pharmacist is necessary. Changes in drug concentration may require dosage adjustment or monitoring if necessary. Due to limited data on the safety of this drug during pregnancy, pregnant women should use it cautiously, and nursing mothers are advised not to take it. In case of overdose, there is no specific antidote, so treatment should be symptomatic and based on general management. This drug should be stored in a safe place out of reach of children, and transferring it to another container is not advisable as it may affect the quality.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylactic reaction, shock, angioedema, yellowing of the skin or eyes (jaundice), hepatitis, liver failure, encephalopathy in patients with pre-existing liver disease, skin-mucous membrane syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Clostridium difficile-associated diarrhea, respiratory distress, asthma attack

Mild side effects

  • Headache
  • dizziness
  • paresthesia
  • drowsiness
  • taste disturbance
  • blurred vision
  • bronchospasm
  • abdominal pain
  • constipation
  • diarrhea
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  • abdominal bloating
  • nausea
  • vomiting
  • dry mouth
  • stomatitis
  • liver enzyme increase
  • dermatitis
  • itching
  • rash
  • hair loss
  • photosensitivity
  • fractures
  • joint pain
  • muscle pain
  • muscle weakness
  • fatigue
  • sweating
  • allergic reactions
  • back pain
  • chest pain
  • sternal pain
  • facial swelling
  • facial flushing
  • fatigue
  • fever
  • influenza-like illness
  • general swelling

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

Storage

This drug must be stored in a sealed container to prevent exposure to air or moisture. It should be stored at room temperature between 1 degree and 30 degrees Celsius for safe use.

Appearance and packaging

Appearance

Pink, round, film-coated tablet

Package unit

28 tablets (14 tablets/PTP 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.