Esomeprazole Magnesium Capsule 20 mg (Esomeprazole Magnesium Trihydrate)

Adult dosage

1. Adults 1) Gastroesophageal reflux disease (GERD). - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis has not healed or symptoms persist, continue treatment for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence 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 evaluation is necessary. · Once symptoms have resolved, subsequent recurrent symptoms may be controlled with 20 mg once daily. · In adults, 20 mg once daily may be taken as needed. As-needed treatment to control recurrent symptoms is not recommended for patients at high risk of developing gastric or duodenal ulcers due to nonsteroidal anti-inflammatory drug use. 2) Combination therapy with antibiotics for eradication of Helicobacter pylori Administer this drug 20 mg in combination with amoxicillin 1 g and clarithromycin 500 mg twice daily for 7 days. 3) Short-term treatment of upper gastrointestinal symptoms (pain, discomfort, heartburn) associated with the use of nonsteroidal anti-inflammatory drugs (nonselective or selective COX-2 inhibitors) - 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is necessary. Clinical studies extending beyond 4 weeks have not been conducted. 4) Patients requiring continued nonsteroidal anti-inflammatory drug treatment - Treatment of gastric ulcers associated with nonsteroidal anti-inflammatory drug use: 20 mg once daily. The treatment duration is 4∼8 weeks. - Prevention of gastric and duodenal ulcers associated with nonsteroidal anti-inflammatory drug use: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg twice daily. The dose should subsequently be adjusted for each patient, and treatment should continue for as long as clinical symptoms are present. Clinical data indicate that most patients can be controlled with doses of 80 ∼ 160 mg per day. Doses exceeding 80 mg per day should be divided and taken twice daily. 6) Maintenance therapy following intravenous induction of prevention of rebleeding from gastric or duodenal ulcers After intravenous induction of prevention of rebleeding from gastric or duodenal ulcers, administer 40 mg once daily for 4 weeks. 4. Renal impairment No dose adjustment is necessary. Use with caution because experience with administration to patients with severe renal impairment is limited. 5. Hepatic impairment No dose adjustment is necessary in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the dose of this drug should not exceed 20 mg. 6. Elderly patients No dose adjustment is necessary.

Children's dosage

2. Adolescents aged 12 years and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis has not healed or symptoms persist, continue treatment 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 evaluation is necessary. · Once symptoms have resolved, subsequent recurrent symptoms may be controlled with 20 mg once daily. 3. Children under 12 years of age There is no experience with administration of this drug to children under 12 years of age.

This medication should not be used by patients with allergies or hypersensitivity to specific ingredients. Additionally, patients currently on certain antibiotics or antiviral medications, as well as lactating women, should not take this medicine. While taking this medication, various side effects may occur, so it is important to consult a healthcare professional immediately if any unusual symptoms arise. Headaches, abdominal pain, diarrhea, dizziness, skin rashes, and myalgia have all been reported as possible effects in various parts of the body. If this medication is taken for an extended period, regular check-ups to monitor health status are important. Especially when taken for more than one year, there may be risks of decreased magnesium levels or increased fracture risk, so caution is necessary. This medication suppresses stomach acid secretion, which may increase the risk of bacterial growth in the stomach, so if diarrhea persists, it must be reported to healthcare professionals. Additionally, caution is needed as symptoms of malignant tumors such as gastric cancer or gastric ulcers may be masked. This drug interacts with many other medications, so it is essential to consult a doctor or pharmacist about other drugs being taken while on this medication. Special care should be taken when used in conjunction with anticoagulants, antibiotics, antivirals, and anticonvulsants. Women who are pregnant or breastfeeding need to be especially careful about the use of this medication and must consult healthcare professionals thoroughly before making a decision. In the case of an overdose, there is no specific antidote, so it is crucial to seek appropriate treatment at a hospital immediately; this medication is not removed by dialysis, and general symptomatic treatment is required. Finally, this medication should be kept out of reach of children, and it is important to avoid transferring it to other containers to maintain quality.

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, anxiety, mental confusion, depression, aggression, hallucinations, headache, dizziness, altered perception, drowsiness, taste disturbance, blurred vision, bronchospasm, pancreatitis, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis, elevated liver enzymes, hepatitis, liver failure, encephalopathy, dermatitis, itching, rash, urticaria, hair loss, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized pustular psoriasis, drug reaction with eosinophilia and systemic symptoms, fracture, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal distension, allergic reaction, back pain, chest pain, substernal pain, facial edema, facial flushing, fatigue, influenza-like illness, generalized edema, leg edema, malaise, pain, stiffness, anemia, hypochromic anemia, cervical lymphadenopathy, epistaxis, leukocytosis, thrombocytopenia, hyperbilirubinemia, hepatic dysfunction, increased ALT, increased AST, diabetes, hyperuricemia, increased ALP, xerostomia, vitamin B12 deficiency, weight gain, weight loss, exacerbation of arthritis, arthropathy, seizures, fibromyalgia syndrome, hernia, rheumatoid polymyalgia, anorexia, apathy, increased appetite, confusion, worsening depression, generalized muscle tension, sensory impairment, erectile dysfunction, insomnia, migraine, exacerbation of migraine, sleep disorders, tremors, visual field defects, dysmenorrhea, menstrual disorders, vaginitis, exacerbation of asthma, cough, dyspnea, laryngeal edema, pharyngitis, rhinitis, sinusitis, acne, anal itching, erythematous rash, papular rash, otitis media, abnormal olfaction, loss of taste, taste disorders, abnormal urination, albuminuria, cystitis, dysuria, fungal infection, hematuria, urination frequency, candidiasis, genital candidiasis, polyuria, conjunctivitis, visual disturbances, duodenitis, esophagitis, esophageal stricture, esophageal ulcer, esophageal varices, gastric ulcer, gastritis, benign polyp or nodule, Barrett's esophagus, mucosal pigmentation, hernia, systemic lupus erythematosus, discoid lupus erythematosus, gastric fundic polyps, hypocalcemia, hypokalemia, rhabdomyolysis

This drug can be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is recommended to keep the storage temperature between 1°C and 30°C at room temperature. This helps to maintain the medicine's effectiveness and safety over time.

Appearance

Hard capsule with spherical microgranules in white or gray color, with an upper greenish blue and lower pale yellow color.

Package unit

28 capsules/bottle