Medication info
Esomedin Tablet 20mg (Esomeprazole Magnesium Trihydrate)

Esomedin Tablet 20mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›21.69mg / 1 tablet
Manufacturer / importer
지엘파마(주)
Appearance
Pale pink, round film-coated tablet
Packaging
28 tablets (14 tablets/PTP x 2)
Approval status
Active

MFDS item code 201907455 · Approved 2019.10.25 · Insurance code 649702370

Summary

Main use
Treatment and prevention of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of Helicobacter pylori positive peptic ulcers, and relief of upper gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquid such as water and should not be chewed or crushed. 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: administer 40 mg once daily for 4 weeks. - If esophagitis is not resolved or symptoms persist, take for another 4 weeks. - Long-term maintenance therapy for preventing recurrence in patients with esophagitis: 20 mg once daily. - For symptoms of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is needed. · Once symptoms improve, manage any subsequent symptoms with 20 mg once daily. · In adults, 20 mg once daily can be administered as needed. Continuous management is not advised for patients at high risk of gastric and duodenal ulcers due to the use of non-steroidal anti-inflammatory drugs. 2) Combination therapy with antibiotics for eradication of Helicobacter pylori Administer this medication 20 mg with 1 g of amoxicillin and 500 mg of clarithromycin, twice daily for 7 days. 3) Short-term treatment of upper gastrointestinal symptoms (pain, discomfort, burning sensations) related to the use of non-steroidal anti-inflammatory drugs (non-selective COX-2 or selective) - 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is required. Clinical trials exceeding 4 weeks have not been conducted. 4) For patients requiring continuous use of non-steroidal anti-inflammatory drugs - Treatment of gastric ulcers related to the use of non-steroidal anti-inflammatory drugs: 20 mg once daily. Treatment duration is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers related to the use of non-steroidal anti-inflammatory drugs: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg administered twice daily. Subsequent doses should be adjusted according to individual patient needs and treatment should continue during symptomatic periods. Clinical data suggest that most patients can be managed at doses of 80 to 160 mg per day. Doses exceeding 80 mg daily should be divided into two doses. 6) Maintenance therapy following intravenous induction of prevention of rebleeding from gastric or duodenal ulcers. Administer 40 mg once daily for 4 weeks following intravenous induction for prevention of rebleeding from gastric or duodenal ulcers. 2. 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 resolved or symptoms persist, continue for another 4 weeks. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is necessary. · Once symptoms improve, manage any subsequent symptoms with 20 mg once daily. · In adults, 20 mg once daily can be administered as needed. Continuous management is not advised for patients at high risk of gastric and duodenal ulcers due to non-steroidal anti-inflammatory drugs. 3. Children under 12 years There is no experience in administering this medication to children under the age of 12. 4. Renal impairment No dosage adjustment is necessary. Cases of administration in severe renal failure are limited, so it must be used with caution. 5. Hepatic impairment No dosage adjustment is necessary in patients with mild to moderate liver impairment. In patients with severe liver impairment, the dose should not exceed 20 mg. 6. Elderly No dosage adjustment is necessary.
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 resolved or symptoms persist, extend treatment for another 4 weeks.

Ingredients

Manufacturer
지엘파마(주)

Efficacy & effects

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

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

This medication is used for long-term maintenance therapy to treat gastroesophageal reflux disease, particularly erosive esophagitis, and to prevent its recurrence. It is also helpful in alleviating symptoms of gastroesophageal reflux disease without esophagitis. It is effective for the treatment and prevention of duodenal ulcers and peptic ulcers when used in combination with antibiotics for the eradication of Helicobacter pylori. It is used for short-term treatment of upper gastrointestinal symptoms related to the use of non-steroidal anti-inflammatory drugs, as well as for the treatment of gastric ulcers due to prolonged use, and for the prevention of gastric and duodenal ulcers. It is applied for the treatment of Zollinger-Ellison syndrome and maintenance therapy to prevent rebleeding from gastric or duodenal ulcers, improving patients' symptoms.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquid such as water and should not be chewed or crushed. 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: administer 40 mg once daily for 4 weeks. - If esophagitis is not resolved or symptoms persist, take for another 4 weeks. - Long-term maintenance therapy for preventing recurrence in patients with esophagitis: 20 mg once daily. - For symptoms of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is needed. · Once symptoms improve, manage any subsequent symptoms with 20 mg once daily. · In adults, 20 mg once daily can be administered as needed. Continuous management is not advised for patients at high risk of gastric and duodenal ulcers due to the use of non-steroidal anti-inflammatory drugs. 2) Combination therapy with antibiotics for eradication of Helicobacter pylori Administer this medication 20 mg with 1 g of amoxicillin and 500 mg of clarithromycin, twice daily for 7 days. 3) Short-term treatment of upper gastrointestinal symptoms (pain, discomfort, burning sensations) related to the use of non-steroidal anti-inflammatory drugs (non-selective COX-2 or selective) - 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is required. Clinical trials exceeding 4 weeks have not been conducted. 4) For patients requiring continuous use of non-steroidal anti-inflammatory drugs - Treatment of gastric ulcers related to the use of non-steroidal anti-inflammatory drugs: 20 mg once daily. Treatment duration is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers related to the use of non-steroidal anti-inflammatory drugs: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg administered twice daily. Subsequent doses should be adjusted according to individual patient needs and treatment should continue during symptomatic periods. Clinical data suggest that most patients can be managed at doses of 80 to 160 mg per day. Doses exceeding 80 mg daily should be divided into two doses. 6) Maintenance therapy following intravenous induction of prevention of rebleeding from gastric or duodenal ulcers. Administer 40 mg once daily for 4 weeks following intravenous induction for prevention of rebleeding from gastric or duodenal ulcers. 2. 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 resolved or symptoms persist, continue for another 4 weeks. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is necessary. · Once symptoms improve, manage any subsequent symptoms with 20 mg once daily. · In adults, 20 mg once daily can be administered as needed. Continuous management is not advised for patients at high risk of gastric and duodenal ulcers due to non-steroidal anti-inflammatory drugs. 3. Children under 12 years There is no experience in administering this medication to children under the age of 12. 4. Renal impairment No dosage adjustment is necessary. Cases of administration in severe renal failure are limited, so it must be used with caution. 5. Hepatic impairment No dosage adjustment is necessary in patients with mild to moderate liver impairment. In patients with severe liver impairment, the dose should not exceed 20 mg. 6. Elderly No dosage adjustment is necessary.

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 resolved or symptoms persist, extend treatment for another 4 weeks.

Precautions

This medication should not be used in certain patients. For example, those who have had an allergic reaction or hypersensitivity to this medication or its ingredients should avoid taking it. Caution is needed for patients taking certain antibiotics or medications, especially when combined with some antibiotics. It is advisable for pregnant or breastfeeding women not to use this medication. This medication may cause various side effects such as blood-related abnormalities, allergic reactions, gastrointestinal disturbances, and neurological symptoms, so if symptoms occur, patients should consult healthcare professionals immediately. Regular check-ups are necessary during prolonged use, particularly regarding magnesium levels and fracture risk. This medication can interact with other drugs, so it is important to inform healthcare professionals of any other medications being taken. Pregnant women should use this medication cautiously and it is safer not to use it while breastfeeding. In cases of overdose, there is no specific antidote, so patients should visit a hospital immediately for appropriate treatment. When storing this medication, keep it out of reach of children and do not transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), angioedema, anaphylaxis, shock, severe rash with fever, blisters, skin peeling, mucosal pain in mouth/eyes, severe hypomagnesemia, hepatitis, jaundice, liver failure, encephalopathy, mucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), rhabdomyolysis.

Mild side effects

  • Headache
  • dizziness
  • paresthesia
  • drowsiness
  • taste disturbances
  • blurred vision
  • bronchospasm
  • abdominal pain
  • constipation
  • diarrhea
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  • abdominal bloating
  • nausea
  • vomiting
  • dry mouth
  • stomatitis
  • increased liver enzymes
  • hepatitis
  • dermatitis
  • itching
  • rash
  • hair loss
  • photosensitivity
  • fractures
  • joint pain
  • muscle pain
  • muscle weakness
  • interstitial nephritis
  • gynecomastia
  • asthenia
  • increased sweating
  • abdominal bloating
  • allergic reactions
  • back pain
  • chest pain
  • substernal pain
  • facial swelling
  • facial flushing

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

Storage

This medication should be stored in a tightly sealed container to protect it from exposure to air and moisture. It is advisable to maintain storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Pale 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.

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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.