Medication info
Epramin Tablet 20mg (Esomeprazole Magnesium Trihydrate)

Epramin Tablet 20mg (Esomeprazole Magnesium Trihydrate)

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

MFDS item code 202002942 · Approved 2020.04.23 · Insurance code 644604110

Summary

Main use
Treatment and prevention of gastroesophageal reflux disease (erosive esophagitis), eradication of Helicobacter pylori positive peptic ulcer, and treatment and prevention of NSAID-related gastric ulcers.
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: 40 mg administered once daily for 4 weeks. For patients whose esophagitis is unresolved or continues to have symptoms, continue for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg administered once daily. - Gastroesophageal reflux disease symptom treatment regimen without esophagitis: · 20 mg administered once daily. If symptoms are not controlled after 4 weeks, further medical consultation is required. · Once symptoms are relieved, ongoing symptoms should be controlled with 20 mg administered once daily. · In adults, 20 mg can be administered as needed once daily. It is not recommended to administer as needed for continuous symptom control in patients at high risk for gastric and duodenal ulcers due to NSAID use. 2) Combination therapy with antibiotics for Helicobacter pylori eradication Administer 20 mg of this medication with 1 g of amoxicillin and 500 mg of clarithromycin, two times a day for 7 days. 3) Short-term therapy for upper gastrointestinal symptoms (pain, discomfort, burning sensation) related to NSAID (non-selective and selective COX-2) administration - 20 mg administered once daily. If symptoms are not controlled after 4 weeks, further medical consultation is required. Clinical trials extending beyond 4 weeks have not been conducted. 4) Patients requiring continuous NSAID administration - Treatment of gastric ulcers related to NSAID administration: 20 mg once daily. Treatment duration is 4 to 8 weeks. - Preventing gastric and duodenal ulcers related to NSAID administration: 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 depending on the patient, and treatment should continue as long as clinical symptoms are present. According to clinical data, most patients can be managed with a dose of 80 to 160 mg daily. For doses exceeding 80 mg daily, split doses into two daily administrations. 6) Maintenance therapy after inducing prevention of rebleeding from gastric or duodenal ulcers via intravenous infusion Administer 40 mg once daily for 4 weeks after inducing prevention of rebleeding from gastric or duodenal ulcers through intravenous administration. 2. Adolescents aged 12 and above 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg administered once daily for 4 weeks. For patients whose esophagitis is unresolved or continues to have symptoms, continue for an additional 4 weeks. - Treatment regimen for gastroesophageal reflux disease symptoms without esophagitis: · 20 mg administered once daily. If symptoms are not controlled after 4 weeks, further medical consultation is required. · Once symptoms are relieved, ongoing symptoms should be controlled with 20 mg administered once daily. · In adults, 20 mg can be administered as needed once daily. It is not recommended to administer as needed for continuous symptom control in patients at high risk for gastric and duodenal ulcers due to NSAID use. 3. Children under 12 years of age There is no experience administering this medication to children under 12. 4. Renal impairment Dosage adjustment is not necessary. Since there are not many cases administered to severely renally impaired patients, it should be administered with caution. 5. Hepatic impairment No dosage adjustment is necessary for mild to moderate hepatic impairment. In severely impaired patients, doses should not exceed 20 mg. 6. Elderly No dosage adjustment is necessary.
Children's dosage
Adolescents aged 12 and above - Treatment of erosive esophagitis: 40 mg administered once daily for 4 weeks. - Treatment regimen for gastroesophageal reflux disease symptoms without esophagitis: · 20 mg administered once daily.

Ingredients

Manufacturer
조아제약(주)

Efficacy & effects

Treatment and prevention of gastroesophageal reflux disease (erosive esophagitis), eradication of Helicobacter pylori positive peptic ulcer, and treatment and prevention of NSAID-related gastric ulcers.

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

This medicine is used for the treatment of gastroesophageal reflux disease, especially erosive esophagitis, and for long-term maintenance therapy to prevent recurrence in patients with esophagitis. It is also effective in treating and preventing duodenal ulcers as part of a combination therapy with antibiotics for the eradication of Helicobacter pylori. Additionally, it is used for the treatment and prevention of gastric and duodenal ulcers associated with short-term treatment of upper gastrointestinal symptoms due to the use of NSAIDs. It is indicated as a maintenance therapy after inducing prevention of rebleeding from gastric or duodenal ulcers and for the treatment of Zollinger-Ellison syndrome. This is a medication effective for various gastric diseases and ulcer treatment and prevention.

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: 40 mg administered once daily for 4 weeks. For patients whose esophagitis is unresolved or continues to have symptoms, continue for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg administered once daily. - Gastroesophageal reflux disease symptom treatment regimen without esophagitis: · 20 mg administered once daily. If symptoms are not controlled after 4 weeks, further medical consultation is required. · Once symptoms are relieved, ongoing symptoms should be controlled with 20 mg administered once daily. · In adults, 20 mg can be administered as needed once daily. It is not recommended to administer as needed for continuous symptom control in patients at high risk for gastric and duodenal ulcers due to NSAID use. 2) Combination therapy with antibiotics for Helicobacter pylori eradication Administer 20 mg of this medication with 1 g of amoxicillin and 500 mg of clarithromycin, two times a day for 7 days. 3) Short-term therapy for upper gastrointestinal symptoms (pain, discomfort, burning sensation) related to NSAID (non-selective and selective COX-2) administration - 20 mg administered once daily. If symptoms are not controlled after 4 weeks, further medical consultation is required. Clinical trials extending beyond 4 weeks have not been conducted. 4) Patients requiring continuous NSAID administration - Treatment of gastric ulcers related to NSAID administration: 20 mg once daily. Treatment duration is 4 to 8 weeks. - Preventing gastric and duodenal ulcers related to NSAID administration: 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 depending on the patient, and treatment should continue as long as clinical symptoms are present. According to clinical data, most patients can be managed with a dose of 80 to 160 mg daily. For doses exceeding 80 mg daily, split doses into two daily administrations. 6) Maintenance therapy after inducing prevention of rebleeding from gastric or duodenal ulcers via intravenous infusion Administer 40 mg once daily for 4 weeks after inducing prevention of rebleeding from gastric or duodenal ulcers through intravenous administration. 2. Adolescents aged 12 and above 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg administered once daily for 4 weeks. For patients whose esophagitis is unresolved or continues to have symptoms, continue for an additional 4 weeks. - Treatment regimen for gastroesophageal reflux disease symptoms without esophagitis: · 20 mg administered once daily. If symptoms are not controlled after 4 weeks, further medical consultation is required. · Once symptoms are relieved, ongoing symptoms should be controlled with 20 mg administered once daily. · In adults, 20 mg can be administered as needed once daily. It is not recommended to administer as needed for continuous symptom control in patients at high risk for gastric and duodenal ulcers due to NSAID use. 3. Children under 12 years of age There is no experience administering this medication to children under 12. 4. Renal impairment Dosage adjustment is not necessary. Since there are not many cases administered to severely renally impaired patients, it should be administered with caution. 5. Hepatic impairment No dosage adjustment is necessary for mild to moderate hepatic impairment. In severely impaired patients, doses should not exceed 20 mg. 6. Elderly No dosage adjustment is necessary.

Children's dosage

Adolescents aged 12 and above - Treatment of erosive esophagitis: 40 mg administered once daily for 4 weeks. - Treatment regimen for gastroesophageal reflux disease symptoms without esophagitis: · 20 mg administered once daily.

Precautions

This medication should be used with caution in individuals with specific allergic reactions or when taken in conjunction with certain antibiotics. During the use of this medication, various adverse reactions may occur, albeit rarely, with symptoms such as headache, abdominal pain, diarrhea, and rash reported. Regular check-ups are necessary during long-term use, and the risk of gastrointestinal infections may increase, thus if diarrhea persists, consultation with a physician is advisable. Additionally, there is an increased risk of fractures, so patients with osteoporosis require caution. This medication may interact with several other medications, so anyone taking other medications should consult their physician or pharmacist. It is advisable to avoid using this medication during pregnancy or breastfeeding. In case of overdose, there is no specific antidote, so treatment should be administered according to symptoms and it should be kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylaxis, shock, hypomagnesemia, severe edema, severe allergic reactions, jaundice, hepatitis, hepatic failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis, eosinophilia with systemic symptoms induced by the drug reaction (DRESS syndrome), interstitial nephritis, rhabdomyolysis, severe skin reactions, and serious skin adverse reactions.

Mild side effects

Headache, dizziness, drowsiness, insomnia, anxiety, mental confusion, depression, aggression, hallucination, taste disturbance, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, candidiasis, increased liver enzymes, dermatitis, itching, rash, hair loss, photosensitivity, fractures, arthralgia, myalgia, gynecomastia, weakness, increased sweating, Clostridium difficile-associated diarrhea, allergic reactions, back pain, and chest pain.

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 air and moisture from entering. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets/Alu-Alu[(14 tablets/Alu-Alu X 2)]

Same-ingredient medicines

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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.