Medication info
Esprorole 20 mg (Esomeprazole Magnesium Trihydrate)

Esprorole 20 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Esomeprazole Magnesium Trihydrate›22.25mg / 1 tablet
Manufacturer / importer
명문제약(주)
Appearance
Pink round film-coated tablets
Packaging
28 tablets/box (14 tablets/PTP x 2)
Approval status
Active

MFDS item code 201403489 · Approved 2014.07.29 · Insurance code 649806670

Summary

Main use
Treatment and prevention of recurrence of gastroesophageal reflux disease (erosive esophagitis, etc.), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, relief of upper gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs and treatment/prevention of ulcers.
Who uses it
Adults · Children
Adult dosage
This medicine should be swallowed with liquids such as water and should not be chewed or crushed. 1. Adults 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: administer 40 mg once daily for 4 weeks. For patients whose esophagitis is not treated or whose symptoms continue, take for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in esophagitis patients: 20 mg once daily.
Children's dosage
Adolescents aged 12 and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: administer 40 mg once daily for 4 weeks. If esophagitis is not treated or symptoms persist.

Ingredients

Manufacturer
명문제약(주)

Efficacy & effects

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

  • 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 medicine is effective for long-term maintenance therapy to treat gastroesophageal reflux disease and prevent recurrence in patients with erosive esophagitis. It is also used to alleviate symptoms in patients with gastroesophageal reflux disease without esophagitis. It helps treat and prevent recurrence of peptic ulcers caused by Helicobacter pylori infection. It is applicable for treatment and prevention of symptoms or ulcers of the upper gastrointestinal tract caused by non-steroidal anti-inflammatory drugs. Lastly, it also contributes to stabilizing the patient's condition as maintenance therapy after preventing rebleeding from gastric ulcers or duodenal ulcers. Therefore, this medicine is widely used for the treatment and prevention of various gastrointestinal disorders.

Dosage and Administration

Adult dosage

This medicine should be swallowed with liquids such as water and should not be chewed or crushed. 1. Adults 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: administer 40 mg once daily for 4 weeks. For patients whose esophagitis is not treated or whose symptoms continue, take for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in esophagitis patients: 20 mg once daily.

Children's dosage

Adolescents aged 12 and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: administer 40 mg once daily for 4 weeks. If esophagitis is not treated or symptoms persist.

Precautions

This medication should not be administered to certain patients. Patients with allergy to this drug or its components or who have experienced hypersensitivity to benzimidazoles should not use this drug. During Helicobacter pylori eradication therapy, patients allergic to penicillins or macrolide antibiotics should not use this drug in combination with amoxicillin or clarithromycin. Additionally, patients on certain heart-related medications or antivirals, and those with a history of myocardial infarction or breastfeeding should avoid this drug. Various adverse reactions may occur while taking this medicine, including headaches, abdominal pain, diarrhea, skin rash, muscle pain, etc. Rarely, serious blood abnormalities, hypersensitivity reactions, liver dysfunction, or severe skin reactions may occur, so immediate consultation with a healthcare professional is necessary if symptoms arise. Long-term use may require regular examinations, as there may be a slight increase in the risk of gastrointestinal infections. Electrolyte imbalances such as hypomagnesemia may also occur with prolonged use, so caution is needed. This drug has a high potential for drug interactions, so inform your doctor or pharmacist about any other medications you are taking. Particularly, caution is needed when combined with anticoagulants, antivirals, antibiotics, etc. During pregnancy, the safety of this drug has not been firmly established, so it should be used cautiously under the guidance of a physician, and it is advisable not to administer it while breastfeeding. In case of overdose, as there is no specific antidote, immediately go to a hospital for appropriate treatment. This medication should be stored out of reach of children and care should be taken not to transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, shock, skin peeling, pain in oral/ocular mucosa, Stevens-Johnson syndrome (skin mucous membrane syndrome), toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), hepatic failure, jaundice, encephalopathy, severe edema, hypertension, sudden and severe headaches, seizures, altered consciousness, visual disturbances, paralysis

Mild side effects

Headaches, dizziness, sensory disturbances, drowsiness, taste disorder, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, increased liver enzymes, hepatitis, dermatitis, itching, rash, hair loss, photosensitivity, fractures, arthralgia, myalgia, muscular weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal distension, allergic reactions,

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

Storage

This medicine should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

28 tablets/box (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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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.