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. For patients whose esophagitis has not healed or whose 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 required. · Once symptoms have resolved, subsequent recurring symptoms may be controlled with 20 mg once daily. · In adults, 20 mg may be taken once daily as needed. As-needed use to control recurring symptoms is not recommended for patients at high risk of gastric and duodenal ulcers due to nonsteroidal anti-inflammatory drug use. 2) Combination antibiotic therapy for Helicobacter pylori eradication 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, burning) associated with nonsteroidal anti-inflammatory drug (nonselective or selective COX-2 inhibitor) use - 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is required. Clinical studies lasting longer than 4 weeks have not been conducted. 4) Patients requiring continuous nonsteroidal anti-inflammatory drug therapy - Treatment of gastric ulcers associated with nonsteroidal anti-inflammatory drug use: 20 mg once daily. The treatment period 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 be continued while clinical symptoms are present. Clinical data indicate that most patients can be controlled with doses of 80 ∼ 160 mg per day. Doses above 80 mg per day should be divided into 2 doses. 6) Maintenance therapy following induction of prevention of rebleeding due to gastric or duodenal ulcers by intravenous administration Administer 40 mg once daily for 4 weeks following induction of prevention of rebleeding due to gastric or duodenal ulcers by intravenous administration. 4. Renal impairment No dose adjustment is necessary. Use with caution because there is limited experience in patients with severe renal impairment. 5. Hepatic impairment No dose adjustment is necessary in patients with mild to moderate hepatic impairment. The dose of this drug should not exceed 20 mg in patients with severe hepatic impairment. 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 medical evaluation is necessary. · Once symptoms have resolved, subsequent recurring symptoms may be controlled with 20 mg once daily. · In adults, 20 mg may be taken once daily as needed. As-needed use to control recurring symptoms is not recommended for patients at high risk of developing gastric and duodenal ulcers due to treatment with nonsteroidal anti-inflammatory drugs. 3. Children under 12 years of age There is no experience with administration of this medicine to children under 12 years of age.

This drug should not be used in patients with specific allergic reactions or those taking certain antibiotics and antivirals. While taking this drug, various side effects such as blood abnormalities, mental changes, neurological symptoms, and gastrointestinal issues may occur rarely; therefore, if any abnormal symptoms appear, immediate consultation with healthcare professionals is necessary. During prolonged use, regular checks of health status through periodic examinations are important. This drug suppresses gastric acid secretion, which lowers acidity in the stomach, potentially increasing the risk of gastrointestinal infections. Particularly, caution is needed as the risk of fractures may increase with long-term use lasting more than one year. This drug may interact with other medications, so patients must inform healthcare professionals about any medications they are taking. If pregnant or breastfeeding, it is essential to consult healthcare professionals before using this drug. In case of overdose, there is no specific antidote; thus, appropriate treatment should be administered based on symptoms. This medication should be kept out of reach of children and should not be transferred to other containers for safety.

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, anxiety, mental confusion, depression, aggression, hallucinations, headache, dizziness, paresthesia, drowsiness, taste disturbance, blurred vision, bronchospasm, pancreatitis, abdominal pain, constipation, diarrhea, abdominal distension, nausea, vomiting, xerostomia, stomatitis, gastrointestinal candidiasis, microscopic colitis, elevated liver enzymes, jaundice, 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 associated with eosinophilia and systemic symptoms, fracture, arthralgia, myalgia, muscle weakness, nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal bloating, allergic reaction, back pain, chest pain, sternal pain, facial edema, facial flushing, fatigue, fever, influenza-like illness, generalized edema, leg edema, malaise, pain, stiffness, peripheral edema, flushing, hypertension, tachycardia, goiter, irritable bowel syndrome, worsening of constipation, dyspepsia, dysphagia, gastrointestinal developmental disorder, epigastric pain, belching, esophageal disorder, frequent bowel movement, gastroenteritis, gastrointestinal bleeding, hiccups, melena, oral disorder, pharyngeal disorder, rectal disorder, gastrointestinal symptoms, increased serum gastrin, tongue disorder, glossitis, ulcerative stomatitis, earache, tinnitus, anemia, hypopigmented anemia, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia, hyperbilirubinemia, abnormal liver function, increased ALT, increased AST, diabetes, hyperuricemia, increased ALP, dry mouth, vitamin B12 deficiency, weight gain, weight loss, worsening of arthritis, arthropathy, convulsions, fibromyalgia syndrome, hernia, rheumatoid polymyalgia, anorexia, apathy, increased appetite, confusion, worsening of depression, hypertonicity, sensory loss, erectile dysfunction, insomnia, migraine, worsening of migraine, sleep disorder, tremors, visual field defect, dysmenorrhea, menstrual disorders, vaginitis, worsening of asthma, cough, dyspnea, laryngeal edema, pharyngitis, rhinitis, sinusitis, acne, anal itching, erythematous rash, papular rash, otitis media, dysosmia, ageusia, dysgeusia, urinary abnormalities, albuminuria, cystitis, dysuria, fungal infection, hematuria, frequency of urination, candidiasis, genital candidiasis, polyuria, conjunctivitis, visual disturbances, duodenitis, esophagitis, esophageal stricture, esophageal ulcer, esophageal varices, gastric ulcer, gastritis, benign polyps or nodules, Barrett's esophagus, mucosal pigmentation, hernia, systemic lupus erythematosus, cutaneous lupus erythematosus, gastric foveolar polyps, hypocalcemia, hypokalemia, rhabdomyolysis

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

Appearance

A hard capsule with upper and lower light pink color containing white or gray spherical fine granules

Package unit

28C/bottle