Medication info
Omethon S Tablet 20 mg (Esomeprazole Magnesium Trihydrate)

Omethon S Tablet 20 mg (Esomeprazole Magnesium Trihydrate)

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

MFDS item code 201603678 · Approved 2016.06.21 · Insurance code 657306890

Summary

Main use
Treatment of gastroesophageal reflux disease (reflux esophagitis, symptoms) and eradication of Helicobacter pylori (duodenal ulcer), treatment and prevention of gastric ulcers related to non-steroidal anti-inflammatory drugs.
Who uses it
Adults · Children
Adult dosage
This medication 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: Administer 40 mg once a day for 4 weeks. - If esophagitis is not treated or symptoms persist, take an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once a day. - Symptoms treatment of gastroesophageal reflux disease without esophagitis: · 20 mg once a day. If symptoms are not controlled after 4 weeks, further medical consultation is needed. · Once symptoms are alleviated, continuous symptoms are treated with 20 mg once a day. · In adults, 20 mg once a day may be taken as needed. It is not recommended to take continuously as needed for patients at high risk for gastric and duodenal ulcers due to non-steroidal anti-inflammatory drug administration. 2) Antibiotic combination therapy for the eradication of Helicobacter pylori Administer this drug 20 mg in combination with 1 g of amoxicillin and 500 mg of clarithromycin twice daily for 7 days. 3) Short-term therapy for upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drugs (non-selective, selective COX-2) (pain, discomfort, burning sensation) - 20 mg once a day. If symptoms are not controlled after 4 weeks, further medical consultation is needed. Clinical trials have not been conducted beyond 4 weeks. 4) Patients requiring continued administration of non-steroidal anti-inflammatory drugs - Treatment of gastric ulcers associated with non-steroidal anti-inflammatory drug administration: 20 mg once a day. Treatment duration is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug administration: 20 mg once a day. 5) Treatment of Zollinger-Ellison syndrome Recommended initial dose is 40 mg twice daily. Subsequent doses should be adjusted for each patient, and treatment should continue while clinical symptoms persist. According to clinical data, most patients can be controlled at doses of 80 to 160 mg daily. If doses exceed 80 mg daily, it should be divided into two doses. 6) Maintenance therapy after intravenous induction for the prevention of re-bleeding from gastric or duodenal ulcers After intravenous induction for the prevention of re-bleeding from gastric or duodenal ulcers, administer 40 mg once daily for 4 weeks. 2. For adolescents over 12 years 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: Administer 40 mg once a day for 4 weeks. If esophagitis is not treated or symptoms persist, take an additional 4 weeks. - Symptoms treatment of gastroesophageal reflux disease without esophagitis: · 20 mg once a day. If symptoms are not controlled after 4 weeks, further medical consultation is needed. · Once symptoms are alleviated, continuous symptoms are treated with 20 mg once a day. · In adults, 20 mg once a day may be taken as needed. It is not recommended to take continuously as needed for patients at high risk for gastric and duodenal ulcers due to non-steroidal anti-inflammatory drug administration. 3. For children under 12 years Experience with administering this drug to children under 12 years is lacking. 4. In cases of renal impairment There is no need to adjust the dose. Caution is advised as there is limited experience in administering to patients with severe renal failure. 5. In cases of hepatic impairment There is no need to adjust the dose for patients with mild to moderate hepatic impairment. In patients with severe liver impairment, doses exceeding 20 mg should not be given. 6. In the elderly There is no need to adjust the dose.
Children's dosage
For adolescents over 12 years - Treatment of gastroesophageal reflux disease - Erosive reflux esophagitis: Administer 40 mg once a day for 4 weeks. - If esophagitis is not treated or symptoms persist, take an additional 4 weeks

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

Treatment of gastroesophageal reflux disease (reflux esophagitis, symptoms) and eradication of Helicobacter pylori (duodenal ulcer), treatment and prevention of gastric ulcers related to non-steroidal anti-inflammatory drugs.

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

This medication is used to treat gastroesophageal reflux disease and erosive reflux esophagitis, as well as to provide long-term maintenance therapy to prevent recurrence in esophagitis patients. It also helps relieve symptoms of gastroesophageal reflux disease without esophagitis. It is used in combination with antibiotics for the treatment of duodenal ulcers and peptic ulcers caused by Helicobacter pylori infection and to prevent recurrence. Additionally, it is effective as a short-term therapy to treat upper gastrointestinal symptoms such as pain, discomfort, and burning sensation caused by the consumption of non-steroidal anti-inflammatory drugs. It is used to treat gastric ulcers in patients requiring continuous administration of non-steroidal anti-inflammatory drugs and to prevent gastric and duodenal ulcers. Finally, it is used in the treatment of Zollinger-Ellison syndrome and for maintaining prevention of re-bleeding from gastric or duodenal ulcers. Thus, it is widely used for the treatment and prevention of various gastrointestinal disorders.

Dosage and Administration

Adult dosage

This medication 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: Administer 40 mg once a day for 4 weeks. - If esophagitis is not treated or symptoms persist, take an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once a day. - Symptoms treatment of gastroesophageal reflux disease without esophagitis: · 20 mg once a day. If symptoms are not controlled after 4 weeks, further medical consultation is needed. · Once symptoms are alleviated, continuous symptoms are treated with 20 mg once a day. · In adults, 20 mg once a day may be taken as needed. It is not recommended to take continuously as needed for patients at high risk for gastric and duodenal ulcers due to non-steroidal anti-inflammatory drug administration. 2) Antibiotic combination therapy for the eradication of Helicobacter pylori Administer this drug 20 mg in combination with 1 g of amoxicillin and 500 mg of clarithromycin twice daily for 7 days. 3) Short-term therapy for upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drugs (non-selective, selective COX-2) (pain, discomfort, burning sensation) - 20 mg once a day. If symptoms are not controlled after 4 weeks, further medical consultation is needed. Clinical trials have not been conducted beyond 4 weeks. 4) Patients requiring continued administration of non-steroidal anti-inflammatory drugs - Treatment of gastric ulcers associated with non-steroidal anti-inflammatory drug administration: 20 mg once a day. Treatment duration is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug administration: 20 mg once a day. 5) Treatment of Zollinger-Ellison syndrome Recommended initial dose is 40 mg twice daily. Subsequent doses should be adjusted for each patient, and treatment should continue while clinical symptoms persist. According to clinical data, most patients can be controlled at doses of 80 to 160 mg daily. If doses exceed 80 mg daily, it should be divided into two doses. 6) Maintenance therapy after intravenous induction for the prevention of re-bleeding from gastric or duodenal ulcers After intravenous induction for the prevention of re-bleeding from gastric or duodenal ulcers, administer 40 mg once daily for 4 weeks. 2. For adolescents over 12 years 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: Administer 40 mg once a day for 4 weeks. If esophagitis is not treated or symptoms persist, take an additional 4 weeks. - Symptoms treatment of gastroesophageal reflux disease without esophagitis: · 20 mg once a day. If symptoms are not controlled after 4 weeks, further medical consultation is needed. · Once symptoms are alleviated, continuous symptoms are treated with 20 mg once a day. · In adults, 20 mg once a day may be taken as needed. It is not recommended to take continuously as needed for patients at high risk for gastric and duodenal ulcers due to non-steroidal anti-inflammatory drug administration. 3. For children under 12 years Experience with administering this drug to children under 12 years is lacking. 4. In cases of renal impairment There is no need to adjust the dose. Caution is advised as there is limited experience in administering to patients with severe renal failure. 5. In cases of hepatic impairment There is no need to adjust the dose for patients with mild to moderate hepatic impairment. In patients with severe liver impairment, doses exceeding 20 mg should not be given. 6. In the elderly There is no need to adjust the dose.

Children's dosage

For adolescents over 12 years - Treatment of gastroesophageal reflux disease - Erosive reflux esophagitis: Administer 40 mg once a day for 4 weeks. - If esophagitis is not treated or symptoms persist, take an additional 4 weeks

Precautions

This drug should not be used in patients who have had allergic reactions to certain components or benzimidazole derivatives. It is also necessary to exercise caution when using this drug in combination for patients with allergies to penicillin-based antibiotics or macrolide antibiotics. Consultation with a doctor is needed because taking this drug with certain heart-related medications or antiviral agents may result in side effects or drug interactions. It is safest for nursing mothers to refrain from taking this drug. Patients with a history of heart disease or myocardial infarction are also advised not to use this drug. Regular checking for adverse reactions or health status is important when using this drug for long periods. Various side effects may occur, including insomnia, headache, dizziness, gastrointestinal disturbances, skin rashes, muscle pain, so if symptoms are severe, tell your doctor. Particularly, if muscle pain or weakness worsens, serious conditions such as rhabdomyolysis may occur, requiring careful monitoring. This drug can increase the risk of infections such as diarrhea by suppressing gastric acid secretion, which may promote bacterial growth in the stomach. Long-term use may lead to hypomagnesemia, so periodic checks of magnesium levels are necessary. Due to potential drug interactions, especially when used in combination with anticoagulants, antidepressants, anticonvulsants, antiviral agents, etc., consultation with medical staff is essential. There is limited safety data regarding usage during pregnancy, so caution is advised when administering during pregnancy, and it is recommended not to take while nursing. In case of overdose, as there is no specific antidote, immediate medical treatment is required, and it should be kept out of the reach of children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylactic reactions, shock, hypomagnesemia, jaundice, hepatitis, liver failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), interstitial nephritis, rhabdomyolysis, severe allergic reactions, severe skin reactions, severe edema or urination abnormalities

Mild side effects

Headache, dizziness, abnormal sensation, drowsiness, taste disturbance, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal distention, nausea, vomiting, dry mouth, stomatitis, increased liver enzymes, dermatitis, itching, rash, hair loss, photosensitivity, fractures, joint pain, myalgia, interstitial nephritis, gynecomastia, weakness, increased sweating, Clostridium difficile-associated diarrhea, allergic reactions, chest pain, facial swelling, facial flushing, fatigue, fever, leg

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

Storage

This drug should be stored in a tightly closed container to avoid exposure to air or moisture, and it is safe to store at room temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets/Alu-Alu packaging (14 tablets/Alu-Alu 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.