Medication info
Esoton Tablets 40 mg (Esomeprazole Magnesium Trihydrate)

Esoton Tablets 40 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Dihydrate›43.38mg / 1 tablet
Manufacturer / importer
제일약품(주)
Appearance
Pink round film-coated tablet
Packaging
28 tablets (14 tablets/AluAlu * 2)
Approval status
Active

MFDS item code 201900627 · Approved 2019.01.24 · Insurance code 645406040

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori-positive peptic ulcers, relief of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, treatment and prevention of gastric and duodenal ulcers, treatment of Zollinger-Ellison syndrome, and maintenance therapy to prevent rebleeding from gastric ulcers.
Who uses it
Adults · Children
Adult dosage
This medication should be taken with liquids such as water and not chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive gastroesophagitis: 40 mg once daily for 4 weeks. - In patients where esophagitis is not improving or symptoms persist, another 4 weeks of treatment is required. - Long-term maintenance therapy for preventing recurrence in patients with esophagitis: 20 mg once daily. - For symptom treatment of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If control is not achieved after 4 weeks, further medical consultation is needed. · Once symptoms are alleviated, subsequent continuous symptoms should be treated with 20 mg once daily. · For adults, 20 mg may be given as needed once daily. It is not recommended to use this on an as-needed basis for continuous symptom control in patients at high risk of gastric and duodenal ulcers due to the use of non-steroidal anti-inflammatory drugs. 2) Antibiotic combination therapy for eradication of Helicobacter pylori 20 mg of this medication should be given with 1 g of amoxicillin and 500 mg of clarithromycin, administered twice daily for 7 days. 3) Short-term therapy for upper gastrointestinal symptoms (pain, discomfort, burning sensation) related to non-steroidal anti-inflammatory drugs (non-selective and selective COX-2) - 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical consultation is needed. Clinical trials beyond 4 weeks have not been conducted. 4) For patients requiring continuous use of non-steroidal anti-inflammatory drugs - Treatment of gastric ulcers associated with non-steroidal anti-inflammatory drugs: 20 mg once daily. The duration of treatment is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers associated with 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. The subsequent dose should be adjusted for each patient, and treatment should continue as long as clinical symptoms are present. According to clinical data, most patients can be controlled at doses of 80 to 160 mg per day. Doses above 80 mg per day should be divided into two doses. 6) Maintenance therapy after prevention of rebleeding due to gastric or duodenal ulcers induced by intravenous injection After intravenous injection to prevent rebleeding due to gastric or duodenal ulcers, 40 mg should be administered once daily for 4 weeks. 2. Adolescents aged 12 years and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive gastroesophagitis: 40 mg once daily for 4 weeks. If esophagitis is not improving or symptoms persist, another 4 weeks of treatment is required. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical consultation is needed. · Once symptoms are alleviated, subsequent continuous symptoms should be treated with 20 mg once daily. · For adults, 20 mg may be given as needed once daily. It is not recommended to use this on an as-needed basis for continuous symptom control in patients at high risk of gastric and duodenal ulcers due to the use of non-steroidal anti-inflammatory drugs. 3. Children under 12 years There is no experience with dosing in children under 12 years. 4. Renal impairment Dosage adjustment is not necessary. Given the limited cases in severe renal failure, it should be administered with caution. 5. Hepatic impairment Dosage adjustment is not necessary in patients with mild to moderate liver impairment. In patients with severe liver impairment, doses should not exceed 20 mg of this medication. 6. Elderly patients Dosage adjustment is not necessary.
Children's dosage
Adolescents aged 12 years and older should be administered the same as adults. There is no experience with dosing in children under 12 years, so it is not recommended.

Ingredients

Manufacturer
제일약품(주)

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori-positive peptic ulcers, relief of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, treatment and prevention of gastric and duodenal ulcers, treatment of Zollinger-Ellison syndrome, and maintenance therapy to prevent rebleeding from gastric ulcers.

  • Gastroesophageal reflux disease
  • erosive gastroesophagitis
  • esophagitis
  • 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 in the treatment of gastroesophageal reflux disease and erosive gastroesophagitis. It is also effective in maintaining therapy to prevent recurrence in patients with esophagitis. It assists in antibiotic combination therapy for treating duodenal ulcers and peptic ulcers caused by Helicobacter pylori infection. It is also used to relieve upper gastrointestinal symptoms associated with the use of non-steroidal anti-inflammatory drugs, and for the treatment and prevention of gastric ulcers. It is effective in the treatment of Zollinger-Ellison syndrome and applicable for maintenance therapy to prevent rebleeding from gastric or duodenal ulcers. Overall, it is used for the treatment and prevention of various conditions related to gastrointestinal diseases.

Dosage and Administration

Adult dosage

This medication should be taken with liquids such as water and not chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive gastroesophagitis: 40 mg once daily for 4 weeks. - In patients where esophagitis is not improving or symptoms persist, another 4 weeks of treatment is required. - Long-term maintenance therapy for preventing recurrence in patients with esophagitis: 20 mg once daily. - For symptom treatment of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If control is not achieved after 4 weeks, further medical consultation is needed. · Once symptoms are alleviated, subsequent continuous symptoms should be treated with 20 mg once daily. · For adults, 20 mg may be given as needed once daily. It is not recommended to use this on an as-needed basis for continuous symptom control in patients at high risk of gastric and duodenal ulcers due to the use of non-steroidal anti-inflammatory drugs. 2) Antibiotic combination therapy for eradication of Helicobacter pylori 20 mg of this medication should be given with 1 g of amoxicillin and 500 mg of clarithromycin, administered twice daily for 7 days. 3) Short-term therapy for upper gastrointestinal symptoms (pain, discomfort, burning sensation) related to non-steroidal anti-inflammatory drugs (non-selective and selective COX-2) - 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical consultation is needed. Clinical trials beyond 4 weeks have not been conducted. 4) For patients requiring continuous use of non-steroidal anti-inflammatory drugs - Treatment of gastric ulcers associated with non-steroidal anti-inflammatory drugs: 20 mg once daily. The duration of treatment is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers associated with 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. The subsequent dose should be adjusted for each patient, and treatment should continue as long as clinical symptoms are present. According to clinical data, most patients can be controlled at doses of 80 to 160 mg per day. Doses above 80 mg per day should be divided into two doses. 6) Maintenance therapy after prevention of rebleeding due to gastric or duodenal ulcers induced by intravenous injection After intravenous injection to prevent rebleeding due to gastric or duodenal ulcers, 40 mg should be administered once daily for 4 weeks. 2. Adolescents aged 12 years and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive gastroesophagitis: 40 mg once daily for 4 weeks. If esophagitis is not improving or symptoms persist, another 4 weeks of treatment is required. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical consultation is needed. · Once symptoms are alleviated, subsequent continuous symptoms should be treated with 20 mg once daily. · For adults, 20 mg may be given as needed once daily. It is not recommended to use this on an as-needed basis for continuous symptom control in patients at high risk of gastric and duodenal ulcers due to the use of non-steroidal anti-inflammatory drugs. 3. Children under 12 years There is no experience with dosing in children under 12 years. 4. Renal impairment Dosage adjustment is not necessary. Given the limited cases in severe renal failure, it should be administered with caution. 5. Hepatic impairment Dosage adjustment is not necessary in patients with mild to moderate liver impairment. In patients with severe liver impairment, doses should not exceed 20 mg of this medication. 6. Elderly patients Dosage adjustment is not necessary.

Children's dosage

Adolescents aged 12 years and older should be administered the same as adults. There is no experience with dosing in children under 12 years, so it is not recommended.

Precautions

This medication should not be used in patients who have an allergy to benzimidazole compounds or any other components of this medication. When using this medication, it should not be combined with penicillin-based antibiotics or macrolide antibiotics if there is an allergy to them. There may be risks when combined with specific cardiac-related medications or antiviral agents, so patients taking these medications must consult their doctor. Women who are breastfeeding are advised not to take this medication. This medication can cause various adverse reactions, including headaches, abdominal pain, diarrhea, and skin rashes. Although rare, serious blood disorders, liver dysfunction, and severe skin reactions may occur; thus, patients should immediately inform healthcare professionals if any unusual symptoms appear. It is important to regularly check health status through examinations when used long-term. This medication suppresses gastric acid secretion, which can change the gastric environment, increasing the risk of gastrointestinal infections. Moreover, long-term use may increase the risk of fractures, making caution necessary in patients at risk of osteoporosis. This medication is likely to interact with other drugs, so any concurrent medications should be reported to healthcare professionals. Particular caution is advised when combined with anticoagulants, antibiotics, antiviral agents, and antiepileptics. Safety data regarding this medication is limited during pregnancy, so pregnant women should take it under medical guidance. In case of overdose, there is no specific antidote, so immediate medical attention should be sought for appropriate treatment. This medication should be stored out of reach of children and not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylactic reaction, shock, angioedema, hypomagnesemia, severe hypomagnesemia-related hypocalcemia, hypokalemia, mental confusion, aggression, hallucinations, pancreatitis, microscopic colitis, jaundice, liver failure, encephalopathy, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, eosinophilia with systemic symptoms associated drug reaction.

Mild side effects

Headache, dizziness, sensory disturbances, drowsiness, taste disorder, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, increased liver enzymes, hepatitis, dermatitis, itching, rash, hair loss, photosensitivity, fractures, arthralgia, myalgia, weakness, increased sweating, Clostridium difficile-associated diarrhea, allergic reactions, back pain, chest pain, facial swelling, facial flushing, fatigue, fever, malaise, pain, redness.

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. Doing so ensures the medication's efficacy and safety for a long time.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets (14 tablets/AluAlu * 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.