Esomeprazole Magnesium Trihydrate 40 mg Tablet

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: administer 40 mg once daily for 4 weeks. - If esophagitis is not treated or symptoms continue, take for another 4 weeks. - Long-term maintenance therapy for prevention of relapse in esophagitis patients: 20 mg once daily. - Treatment of symptoms of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical evaluation is necessary. · Once symptoms are alleviated, continuing symptoms should be controlled by administering 20 mg once daily. · In adults, 20 mg once daily may be administered as needed. It is not recommended to administer this treatment on an as-needed basis for patients with a high risk of gastric and duodenal ulceration due to non-steroidal anti-inflammatory drugs. 2) Antibiotic combination therapy for eradicating Helicobacter pylori Administer this medication 20 mg with 1 g of amoxicillin and 500 mg of clarithromycin twice a day for 7 days. 3) Short-term therapy for treatment of upper gastrointestinal symptoms (pain, discomfort, burning sensation) related to non-steroidal anti-inflammatory drug (COX-2 non-selective, selective) therapy - 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is necessary. Clinical trials have not been conducted beyond 4 weeks. 4) For patients requiring continuous non-steroidal anti-inflammatory drug therapy - Treatment of gastric ulcers associated with non-steroidal anti-inflammatory drug use: 20 mg once daily. Treatment duration is 4 to 8 weeks. - Prevention of gastric ulcers and duodenal ulcers related to non-steroidal anti-inflammatory drug therapy: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg twice daily. Subsequent doses should be adjusted according to the patient, and treatment should be continued as long as clinical symptoms are present. According to clinical data, the majority of patients can be adjusted at daily doses of 80 to 160 mg. For doses of 80 mg or more, it should be divided into two doses per day. 6) Maintenance therapy after intravenous induction to prevent rebleeding from gastric ulcers or duodenal ulcers After intravenous induction to prevent rebleeding from gastric or duodenal ulcers, administer 40 mg once daily for 4 weeks. 2. Adolescents aged 12 years and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: administer 40 mg once daily for 4 weeks. If esophagitis is not treated or symptoms persist, take for another 4 weeks. - Treatment therapy for symptoms of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical evaluation is necessary. · Once symptoms are alleviated, continuing symptoms should be controlled by administering 20 mg once daily. · In adults, 20 mg once daily may be administered as needed. It is not recommended to administer this treatment on an as-needed basis for patients with a high risk of gastric and duodenal ulceration due to non-steroidal anti-inflammatory drugs. 3. Children under 12 years There is no experience administering this medication to children under 12 years. 4. Renal impairment There is no need to adjust the dose. However, due to limited data in patients with severe renal impairment, caution should be exercised. 5. Hepatic impairment In patients with mild to moderate liver dysfunction, there is no need to adjust the dose. In patients with severe liver dysfunction, the dose should not exceed 20 mg. 6. Elderly There is no need to adjust the dose.

Children's dosage

Adolescents aged 12 years and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: administer 40 mg once daily for 4 weeks - If esophagitis is not treated or symptoms persist, continue for another 4 weeks.

This medication should not be administered to certain patients. Patients with allergies or a history of hypersensitivity to this medication, its ingredients, or benzimidazole derivatives should not use it. Furthermore, patients allergic to penicillin antibiotics or macrolide antibiotics should not be treated with amoxicillin or clarithromycin when used in conjunction with this medication for the eradication of Helicobacter pylori. Additionally, patients taking specific cardiac medications or antivirals, nursing mothers, and those with a history of myocardial infarction should ideally not use this medication. This medication may cause a variety of adverse reactions. The most common symptoms include headache, abdominal pain, diarrhea, constipation, nausea, and vomiting, and sometimes dizziness or insomnia as neurological symptoms may appear. Rarely, blood disorders, liver dysfunction, severe allergic reactions, skin rashes, hair loss, muscle weakness, and nephritis have been reported. Additionally, hypomagnesemia may develop, so magnesium levels should be monitored regularly during long-term use. This medication can obscure symptoms of malignant tumors or delay diagnosis; therefore, in gastric ulcer patients with warning signs such as weight loss, recurrent vomiting, hematemesis, or melena, malignancy must be ruled out. Regular examinations are necessary during long-term use, especially if taken for more than 1 year; any changes in symptoms should prompt immediate consultation with a physician. This medication suppresses gastric acid secretion and may increase bacterial growth in the gastrointestinal tract, so if diarrhea persists, the possibility of Clostridium difficile infection should be considered. Also, long-term use may increase the risk of fractures, so patients at risk for osteoporosis should be carefully monitored. Due to potential drug interactions, especially with antibiotics, antivirals, anticoagulants, anticonvulsants, immunosuppressants, and some antidepressants, consultation with a physician or pharmacist is necessary when combined with this medication. Changing blood concentrations of some drugs may occur with this medication, so monitoring the status of medications being taken is important. Data on the safety of this medication during pregnancy are limited, so caution is advised when taken by pregnant women, and nursing mothers are generally advised not to take this medication. In case of overdose, there is no specific antidote, and symptomatic treatment should be initiated, keeping the medication out of reach of children. It is also crucial to preserve the medication in its original packaging and not transfer it to other containers to maintain its quality.

Serious side effects

• Angioedema, anaphylaxis reaction/shock → severe allergic reaction
• Urticaria → severe allergic reaction
• Angioedema → severe allergic reaction
• Severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain → severe skin reaction
• Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis, eosinophilia with systemic symptoms drug reaction (DRESS syndrome) → serious

Mild side effects

• Hematologic and lymphatic system: leukopenia, thrombocytopenia, agranulocytosis, pancytopenia
• Immune system: fever, angioedema, hypersensitivity
• Metabolism/nutrition: peripheral edema, hyponatremia, hypomagnesemia
• Psychiatric: insomnia, anxiety, confusion, depression, aggression, hallucinations
• Nervous system: headache, dizziness, paresthesia, drowsiness, taste disturbance
• Vision: blurred vision
• Auditory and vestibular: dizziness
• Respiratory system: bronchospasm
• Gastrointestinal: pancreatitis, abdominal pain,

This medication may be sensitive to air or moisture, so it must be stored in a sealed container. It is recommended to maintain a storage temperature between 1°C and 30°C (room temperature). This helps to preserve the effectiveness of the medication for a longer time.

Appearance

Pink oblong film-coated tablet

Package unit

28 tablets/box [(7 tablets/Alu-Alu x 4)]