Esomeprazole Magnesium Hydrate 40 mg Tablets

Adult dosage

This medication should be swallowed with liquids such as water and should not be chewed or crushed. Patients who have difficulty swallowing tablets may dissolve this medication in half a glass of non-carbonated water for administration. Other drinks should not be used as they may dissolve the enteric coating. The dissolved medication should be swallowed immediately or within 30 minutes without chewing, and the cup used for administration should be rinsed with half a glass of non-carbonated water to consume the remnants. Tablets floating in water should not be chewed or crushed during administration. Patients who cannot swallow tablets may administer this medication via a gastrointestinal tube after dissolving it in non-carbonated water. It is crucial to carefully check the compatibility of the selected syringe and tube for administration. The method for administering using a gastrointestinal tube is as follows: 1. Place the tablet in a suitable syringe and fill it with about 25 mL of water and about 5 mL of air. In some cases, 50 mL of water may be required to avoid clogging the tube with dissolved granules. 2. Shake the syringe to dissolve the tablet for about 2 minutes. 3. Raise the end of the syringe to check for any obstructions. 4. While holding the end up, connect the syringe to the tube. 5. After shaking the syringe, position the end downward and immediately inject 5 to 10 mL into the tube. After injection, raise the end of the syringe again and shake it (to avoid clogging, ensure the end remains pointed upwards). 6. Lower the end again and immediately inject another 5 to 10 mL into the tube. Repeat this process until all medication in the syringe has been administered. 7. If any sediment remains in the syringe, add 25 mL of water and 5 mL of air, and repeat step 5. In some cases, 50 mL of water may be needed. 1. Adults 1) Gastroesophageal reflux disease (GERD). - Treatment of erosive gastroesophageal reflux disease: Administer 40 mg once daily for 4 weeks. If symptoms persist or esophagitis is untreated, continue for an additional 4 weeks. - Long-term maintenance therapy to prevent relapse in patients with esophagitis: 20 mg once daily. - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: 20 mg once daily. If symptoms are not controlled after 4 weeks, further consultation is required. - Once symptoms are alleviated, ongoing symptoms can be controlled with 20 mg once daily. In adults, 20 mg once daily may be administered as needed. Continuous administration is not recommended for patients at high risk of gastric and duodenal ulcers due to non-steroidal anti-inflammatory drugs. 2) Combination antibiotic therapy for Helicobacter pylori eradication: Administer this medication 20 mg in conjunction with 1 g amoxicillin and 500 mg clarithromycin twice daily for 7 days. 3) Short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug (non-selective and selective COX-2) administration (pain, discomfort, burning): 20 mg once daily. If symptoms are not controlled after 4 weeks, further consultation is needed. Clinical trials exceeding 4 weeks have not been conducted. 4) Patients requiring continuous non-steroidal anti-inflammatory drug administration - Treatment of gastric ulcers associated with non-steroidal anti-inflammatory drug administration: 20 mg once daily. Treatment duration is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug administration: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg twice daily. Subsequent doses should be adjusted for each patient, and therapy should continue as long as clinical symptoms are present. According to clinical data, most patients can be managed at doses ranging from 80 to 160 mg daily. Doses exceeding 80 mg per day should be taken in divided doses twice daily. 6) Maintenance therapy following intravenous induction for the prevention of rebleeding from gastric or duodenal ulcers After intravenous induction for the prevention of rebleeding from gastric or duodenal ulcers, administer 40 mg once daily for 4 weeks. 2. Adolescents aged 12 and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive gastroesophageal reflux disease: Administer 40 mg once daily for 4 weeks. If symptoms persist or esophagitis is untreated, continue for an additional 4 weeks. - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further consultation is required. · Once symptoms are alleviated, ongoing symptoms can be controlled with 20 mg once daily. In adults, 20 mg once daily may be administered as needed. Continuous administration is not recommended for patients at high risk of gastric and duodenal ulcers 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 dysfunction: No dose adjustment is needed. Caution is warranted due to limited experience administering to severe renal failure patients. 5. Hepatic dysfunction: No dose adjustment is needed for mild to moderate hepatic impairment. Patients with severe hepatic impairment should not exceed a dose of 20 mg. 6. Elderly: No dose adjustment is needed.

Children's dosage

Adolescents aged 12 and older - Treatment of erosive gastroesophageal reflux disease: 40 mg once daily for 4 weeks - Treatment of symptoms of gastroesophageal reflux disease without esophagitis: 20 mg once daily Children under 12 years

This medication should not be used in certain patients. For example, patients who are allergic to this drug, its components, or have experienced hypersensitivity reactions should not take it. Additionally, patients with allergies to penicillin or macrolide antibiotics should be cautious when taking this medication in combination. Patients who are taking certain drugs, such as terfenadine, cisapride, pimodivir, astemizole, atazanavir, nelpivirine, or rilpivirine should also avoid taking this medication due to potential issues. Women who are breastfeeding and patients with a history of myocardial infarction should not take this medication. This drug can cause various adverse reactions such as headaches, abdominal pain, diarrhea, nausea, vomiting, skin rashes, muscle pain, and low magnesium levels. In severe cases, rare occurrences of anaphylactic shock, liver failure, and serious skin reactions may occur, so it is important to consult a doctor immediately if symptoms worsen or if adverse reactions are suspected. Regular examinations are crucial to check for adverse reactions during long-term use. Special caution is needed for long-term use exceeding one year due to the risk of fractures and the possibility of low magnesium levels. This drug suppresses gastric acid secretion, which can promote bacterial growth in the stomach, potentially increasing the risk of infections such as diarrhea. This medication has a high potential for drug interactions, especially when taken with anticoagulants, antiviral medications, antibiotics, or anticonvulsants, and adjustments should be made in consultation with a doctor or pharmacist. Safety data regarding use during pregnancy is limited, therefore pregnant women should consult healthcare professionals before taking this medication, and it is advisable for breastfeeding women not to take it. In the event of an overdose, there are no specific antidotes, so appropriate treatment should be received based on symptoms. Safe storage is necessary, keeping it out of the reach of children.

Serious side effects

Hives, severe swelling, angioedema, anaphylaxis, shock, severe allergic reactions, severe rashes with fever, blisters, peeling skin, pain of oral/ocular mucosa, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Clostridium difficile-associated diarrhea, hepatitis, liver failure, jaundice, encephalopathy, liver abnormalities (jaundice).

Mild side effects

Headache, dizziness, sensory disturbances, drowsiness, taste disorders, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal distension, nausea, vomiting, dry mouth, stomatitis, increased liver enzymes, dermatitis, itching, rashes, hair loss, photosensitivity, fractures, arthralgia, myalgias, interstitial nephritis, gynecomastia, weakness, increased sweating, Clostridium difficile-associated diarrhea, allergic reactions, chest pain, facial swelling, flushing, fatigue, fever, leg pain.

This medication should be stored in a tightly closed container to protect it from air or moisture. It is best to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

Pink, round, film-coated tablet

Package unit

28 tablets/box [14 tablets/Alu-Alu×2]