Medication info
Esomeprazole Magnesium Trihydrate 40 mg Tablets

Esomeprazole Magnesium Trihydrate 40 mg Tablets

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›44.5mg / 1 tablet
Manufacturer / importer
한국프라임제약(주)
Appearance
Pink round film-coated tablets
Packaging
28 Tablets/Box[(7 Tablets/PTP x 4)]
Approval status
Active

MFDS item code 201508461 · Approved 2015.12.28 · Insurance code 663606910

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of relapse of Helicobacter pylori positive gastric ulcers, relief of gastrointestinal symptoms related to the use of non-steroidal anti-inflammatory drugs, treatment and prevention of gastric and duodenal ulcers, treatment of Zollinger-Ellison syndrome, effectiveness of maintenance therapy for preventing rebleeding of gastric ulcers.
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 esophagitis: 1 dose of 40 mg once daily for 4 weeks. If symptoms persist or do not improve, an additional 4 weeks of treatment may be needed. - Long-term maintenance therapy for esophagitis relapse prevention: 1 dose of 20 mg once daily. - Treatment of symptoms in gastroesophageal reflux disease without esophagitis: · 1 dose of 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention may be needed. · Once symptoms are relieved, for any ongoing symptoms, administer 1 dose of 20 mg once daily. · In adults, 1 dose of 20 mg may be given as needed. For patients at high risk of gastric and duodenal ulcers due to NSAID use, it is not recommended to give doses as needed for continuous symptom control. 2) Antibiotic combination therapy for eradication of Helicobacter pylori Administer 20 mg of this medication 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 (pain, discomfort, burning sensation) related to NSAID (COX-2 non-selective, selective) administration - 1 dose of 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention may be necessary; clinical trials exceeding 4 weeks have not been conducted. 4) Patients requiring continued NSAID administration - Treatment of gastric ulcers associated with NSAID use: 1 dose of 20 mg once daily for 4 to 8 weeks. - Prevention of gastric and duodenal ulcers associated with NSAID use: 1 dose of 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg twice a day. Subsequent dosages should be adjusted based on individual patient needs, continuing treatment while clinical symptoms are present. Most patients can be managed on a dosage between 80 mg and 160 mg per day. Dosages over 80 mg per day should be divided into two doses. 6) Maintenance therapy following IV induction for prevention of rebleeding from gastric or duodenal ulcers Administer 40 mg once daily for 4 weeks after IV induction for prevention of rebleeding from gastric or duodenal ulcers.
Children's dosage
For adolescents over 12 years old, the dosage is the same as that for adults: 1 dose of 40 mg once a day for 4 weeks. If there is no esophagitis, 1 dose of 20 mg once a day for 4 weeks, and dosage adjustments may be required based on symptom relief.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of relapse of Helicobacter pylori positive gastric ulcers, relief of gastrointestinal symptoms related to the use of non-steroidal anti-inflammatory drugs, treatment and prevention of gastric and duodenal ulcers, treatment of Zollinger-Ellison syndrome, effectiveness of maintenance therapy for preventing rebleeding of gastric ulcers.

  • Gastroesophageal reflux disease
  • erosive esophagitis
  • esophagitis
  • symptoms of gastroesophageal reflux disease without esophagitis
  • duodenal ulcers with Helicobacter pylori positivity
  • peptic ulcers
  • upper gastrointestinal symptoms
  • pain
  • discomfort
  • burning sensation
  • gastric ulcers
  • duodenal ulcers
View approved original text

This medication is used not only for the treatment of gastroesophageal reflux disease and erosive esophagitis but also for long-term maintenance therapy to prevent recurrence in patients with esophagitis. It is also effective for treating duodenal and gastric ulcers associated with Helicobacter pylori infection and helps eradicate Helicobacter pylori in combination with antibiotics. It is used for symptoms of the upper gastrointestinal tract caused by the use of non-steroidal anti-inflammatory drugs, as well as for the treatment and prevention of gastric ulcers. Furthermore, it helps treat patients with Zollinger-Ellison syndrome and prevent rebleeding from gastric ulcers or duodenal ulcers, broadly used for treating and preventing various gastrointestinal and esophageal diseases and ulcers.

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 esophagitis: 1 dose of 40 mg once daily for 4 weeks. If symptoms persist or do not improve, an additional 4 weeks of treatment may be needed. - Long-term maintenance therapy for esophagitis relapse prevention: 1 dose of 20 mg once daily. - Treatment of symptoms in gastroesophageal reflux disease without esophagitis: · 1 dose of 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention may be needed. · Once symptoms are relieved, for any ongoing symptoms, administer 1 dose of 20 mg once daily. · In adults, 1 dose of 20 mg may be given as needed. For patients at high risk of gastric and duodenal ulcers due to NSAID use, it is not recommended to give doses as needed for continuous symptom control. 2) Antibiotic combination therapy for eradication of Helicobacter pylori Administer 20 mg of this medication 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 (pain, discomfort, burning sensation) related to NSAID (COX-2 non-selective, selective) administration - 1 dose of 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention may be necessary; clinical trials exceeding 4 weeks have not been conducted. 4) Patients requiring continued NSAID administration - Treatment of gastric ulcers associated with NSAID use: 1 dose of 20 mg once daily for 4 to 8 weeks. - Prevention of gastric and duodenal ulcers associated with NSAID use: 1 dose of 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg twice a day. Subsequent dosages should be adjusted based on individual patient needs, continuing treatment while clinical symptoms are present. Most patients can be managed on a dosage between 80 mg and 160 mg per day. Dosages over 80 mg per day should be divided into two doses. 6) Maintenance therapy following IV induction for prevention of rebleeding from gastric or duodenal ulcers Administer 40 mg once daily for 4 weeks after IV induction for prevention of rebleeding from gastric or duodenal ulcers.

Children's dosage

For adolescents over 12 years old, the dosage is the same as that for adults: 1 dose of 40 mg once a day for 4 weeks. If there is no esophagitis, 1 dose of 20 mg once a day for 4 weeks, and dosage adjustments may be required based on symptom relief.

Precautions

This medication should not be administered to certain patients. For example, patients with allergies to this drug or its constituents, those who have experienced allergic reactions in the past, those allergic to certain antibiotics, and those currently taking specific heart medications should not use this drug. Additionally, this drug should not be administered to breastfeeding women and patients with a history of myocardial infarction. Caution is needed when taking this medication as various adverse reactions may occur. Gastrointestinal symptoms such as headaches, abdominal pain, diarrhea, nausea, and vomiting have been reported, as well as skin rashes, itching, and, rarely, severe allergic reactions or blood abnormalities. Long-term use may lead to decreased magnesium levels, potentially causing muscle cramps or cardiac issues, necessitating regular blood tests. Especially in cases of extended use beyond one year, there may be an increased risk of fractures; hence patients at risk of osteoporosis should consult their physician. This drug interacts with many other medications, so it is essential to inform the doctor or pharmacist about any other medications being taken. Caution is needed when used with anticoagulants, anticonvulsants, certain antibiotics, and antiviral agents. The safety of this medication during pregnancy has not been sufficiently established, so pregnant women should use it cautiously according to a doctor's guidance, and it is recommended that nursing mothers do not take this medication. In case of overdose, since there is no specific antidote, it is important to receive appropriate treatment based on symptoms. Lastly, this medication should be kept out of reach of children, and it is best not to transfer it into other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, shock, severe allergic reactions, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, severe skin reaction, difficulty breathing or shortness of breath, asthma attack, respiratory issues accompanied by coughing and fever, yellowing of skin or eyes (jaundice), overall lethargy, liver dysfunction (jaundice), sudden and severe headache, thunderclap headache, seizures, confusion.

Mild side effects

Itching, rash, insomnia, anxiety, mental confusion, depression, aggression, hallucinations, dizziness, perceptual abnormalities, drowsiness, taste disturbances, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, elevated liver enzymes, hepatitis, fractures, joint pain, muscle pain, weakness, hyperhidrosis, blood abnormalities (leukopenia, thrombocytopenia, etc.), fever, angioedema, peripheral edema.

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is room temperature between 1°C and 30°C. This helps to maintain the drug's effectiveness and safety for a long time.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

28 Tablets/Box[(7 Tablets/PTP x 4)]

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.