Medication info
Esomeprazole Magnesium Trihydrate 40 mg (Xmezol)

Esomeprazole Magnesium Trihydrate 40 mg (Xmezol)

Prescription medicationTablet
Ingredient · strength
Esomeprazole Magnesium Trihydrate›44.5mg / 1 tablet
Manufacturer / importer
영진약품(주)
Appearance
Pink round film-coated tablet
Packaging
28 tablets ((14 tablets/Alu-Alu PTP*2)
Approval status
Active

MFDS item code 201404633 · Approved 2014.10.08 · Insurance code 642403910

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and relapse prevention of Helicobacter pylori-positive peptic ulcers, relief of upper gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, treatment and prevention of gastric ulcers and duodenal ulcers, treatment of Zollinger-Ellison syndrome, and maintenance therapy for prevention of gastric ulcer rebleeding.
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: 40 mg administered once daily for 4 weeks. If esophagitis is not resolved or symptoms persist, treatment may continue for an additional 4 weeks. - Long-term maintenance therapy to prevent relapse in patients with esophagitis: 20 mg administered once daily. - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: · Once daily, 20 mg. If symptoms remain uncontrolled after 4 weeks, further consultation is necessary. · Once symptoms improve, the continuing symptoms can be controlled by administering 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. It is not recommended to administer as needed for continuous symptom control in patients at high risk for gastric or duodenal ulcer development due to non-steroidal anti-inflammatory drug treatment. 2. Combination therapy with antibiotics for eradicating Helicobacter pylori Administer 20 mg of this medication combined 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) associated with non-steroidal anti-inflammatory drug (COX-2 non-selective, selective) administration - 20 mg once daily. If symptoms remain uncontrolled after 4 weeks, further consultation is necessary. Clinical trials exceeding 4 weeks have not been conducted. 4. For patients requiring continuous treatment with non-steroidal anti-inflammatory drugs - Treatment of gastric ulcers associated with non-steroidal anti-inflammatory drug use: 20 mg once daily. Duration of treatment is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug use: 20 mg once daily. 5. Treatment of Zollinger-Ellison syndrome Initial recommended dosage is 40 mg twice daily. Further adjustments should be made based on individual responses, and treatment should continue while clinical symptoms are present. According to clinical data, most patients can be controlled at doses ranging from 80 to 160 mg per day. Any dose exceeding 80 mg should be split into two doses daily. 6. Maintenance therapy after prevention of rebleeding associated with gastric or duodenal ulcers through intravenous administration Following intravenous administration for the prevention of rebleeding, administer 40 mg once daily for 4 weeks.
Children's dosage
Adolescents aged 12 and older - Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg administered once daily for 4 weeks - Symptomatic treatment without esophagitis: once daily, 40 mg.

Ingredients

Manufacturer
영진약품(주)

Efficacy & effects

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

  • Gastroesophageal reflux disease
  • erosive esophagitis
  • 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 primarily used for the treatment and prevention of relapse in gastroesophageal reflux disease and erosive esophagitis. It is also effective in the treatment and prevention of duodenal ulcers and peptic ulcers caused by Helicobacter pylori. It helps prevent gastric and duodenal ulcers associated with gastrointestinal symptoms that may occur when using non-steroidal anti-inflammatory drugs. It is also used for the treatment of Zollinger-Ellison syndrome and for maintenance therapy to prevent rebleeding of gastric or duodenal ulcers. In summary, this medication is broadly used for the treatment and prevention of gastric and esophageal-related ulcers and inflammatory diseases.

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: 40 mg administered once daily for 4 weeks. If esophagitis is not resolved or symptoms persist, treatment may continue for an additional 4 weeks. - Long-term maintenance therapy to prevent relapse in patients with esophagitis: 20 mg administered once daily. - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: · Once daily, 20 mg. If symptoms remain uncontrolled after 4 weeks, further consultation is necessary. · Once symptoms improve, the continuing symptoms can be controlled by administering 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. It is not recommended to administer as needed for continuous symptom control in patients at high risk for gastric or duodenal ulcer development due to non-steroidal anti-inflammatory drug treatment. 2. Combination therapy with antibiotics for eradicating Helicobacter pylori Administer 20 mg of this medication combined 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) associated with non-steroidal anti-inflammatory drug (COX-2 non-selective, selective) administration - 20 mg once daily. If symptoms remain uncontrolled after 4 weeks, further consultation is necessary. Clinical trials exceeding 4 weeks have not been conducted. 4. For patients requiring continuous treatment with non-steroidal anti-inflammatory drugs - Treatment of gastric ulcers associated with non-steroidal anti-inflammatory drug use: 20 mg once daily. Duration of treatment is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug use: 20 mg once daily. 5. Treatment of Zollinger-Ellison syndrome Initial recommended dosage is 40 mg twice daily. Further adjustments should be made based on individual responses, and treatment should continue while clinical symptoms are present. According to clinical data, most patients can be controlled at doses ranging from 80 to 160 mg per day. Any dose exceeding 80 mg should be split into two doses daily. 6. Maintenance therapy after prevention of rebleeding associated with gastric or duodenal ulcers through intravenous administration Following intravenous administration for the prevention of rebleeding, administer 40 mg once daily for 4 weeks.

Children's dosage

Adolescents aged 12 and older - Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg administered once daily for 4 weeks - Symptomatic treatment without esophagitis: once daily, 40 mg.

Precautions

This medication should not be administered to certain patients. For example, patients with hypersensitivity to this medication, its components, or benzimidazole derivatives, or those with a history of such reactions, should not use it. Additionally, when used in combination with amoxicillin or clarithromycin for the eradication of Helicobacter pylori, patients with hypersensitivity to penicillin or macrolide antibiotics should not be treated. It is also safe to avoid this medication for patients on specific heart-related drugs, antiviral medications, and lactating women. Various adverse reactions may occur during the use of this medication. Common symptoms include headache, abdominal pain, diarrhea, constipation, and nausea; rare occurrences may include blood abnormalities, liver function abnormalities, skin rashes, and myalgia. Particularly with long-term use, electrolyte abnormalities such as hypomagnesemia may occur, necessitating regular monitoring. This medication suppresses gastric acid secretion and lowers the acidity in the stomach, which may increase the risk of bacterial infections in the gastrointestinal tract, so if diarrhea persists, consult a physician. Moreover, there may be an increased risk of fractures with long-term use, so caution is advised for patients at risk for osteoporosis. This medication is prone to interactions with other drugs that can alter blood concentrations or cause side effects depending on the types of drugs taken concurrently; thus, consultation with a healthcare professional is essential. Due to limited safety data for this medication during pregnancy, it should be administered carefully when necessary, and it is recommended not to take it while breastfeeding. In case of overdose, special antidotes are not available, so treatment must be symptomatic and general care needed, and it should be stored out of reach of children. Transferring this medication to another container may adversely affect its quality, so caution should be exercised.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylactic reaction/shock, severe rash with fever, blisters, skin peeling, pain of mucous membranes in the mouth/eyes, jaundice, hepatitis, liver failure, encephalopathy, severe headache, seizures, consciousness disturbances, visual abnormalities, paralysis, severe edema, elevated blood pressure, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).

Mild side effects

Headache, dizziness, paresthesia, drowsiness, taste disturbances, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal distention, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, elevated liver enzymes, dermatitis, itching, rash, alopecia, photosensitivity, fractures, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, allergic reactions, back pain, chest pain, chest discomfort.

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 air and moisture. The storage temperature should be maintained between 1 and 30 degrees Celsius room temperature. This will help to maintain the efficacy of the medication for a longer time.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets ((14 tablets/Alu-Alu PTP*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.