Esomeprazole Capsule 20mg (Esomeprazole Magnesium Hydrate)

Adult dosage

1. Adults 1) Gastroesophageal reflux disease (GERD). - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. Patients whose esophagitis has not healed or whose symptoms persist should take the product 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 recurring symptoms may be controlled with 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. As-needed use is not recommended for controlling recurring symptoms in patients at high risk of gastric and duodenal ulcers due to NSAID use. 2) Combination therapy with antibiotics for eradication of Helicobacter pylori Administer this product 20 mg 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 use of nonsteroidal anti-inflammatory drugs (COX-2 nonselective or selective) - 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is necessary. Clinical studies of treatment longer than 4 weeks have not been conducted. 4) Patients requiring continuous NSAID therapy - Treatment of gastric ulcers associated with NSAID use: 20 mg once daily. The treatment period is 4∼8 weeks. - Prevention of gastric and duodenal ulcers associated with NSAID use: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg twice daily. The dose should then be adjusted for each patient, and treatment should continue while clinical symptoms are present. Clinical data indicate that most patients can be controlled with doses of 80 ∼ 160 mg daily. Doses above 80 mg daily should be divided and taken twice daily. 6) Maintenance therapy following intravenous induction to prevent rebleeding from gastric or duodenal ulcers Administer 40 mg once daily for 4 weeks following intravenous induction to prevent rebleeding from gastric or duodenal ulcers. 4. Renal impairment No dose adjustment is necessary. Use with caution because experience in patients with severe renal failure 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 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. Patients whose esophagitis has not healed or whose symptoms persist should take the product 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. - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: Once symptoms have resolved, subsequent recurring symptoms may be controlled with 20 mg once daily. 3. Children under 12 years of age There is no experience with administration of this product to children under 12 years of age.

This medication should not be used in patients with known allergies to this medication or its components, or a history of hypersensitivity to benzimidazoles. Additionally, it should not be administered to patients with allergies to certain antibiotics or those taking specific heart-related medications, nor to nursing women. Various side effects may occur while taking this medication, so if unusual symptoms such as headache, dizziness, abdominal pain, diarrhea, skin rash arise, immediate consultation with a doctor is necessary. Regular monitoring is required for prolonged use, especially for those taking it for more than one year, paying close attention to magnesium levels and fracture risk. This medication may interact with other drugs, so any other medications being taken must be reported to healthcare providers, particularly when taken alongside anticoagulants, antiviral agents, or antibiotics. During pregnancy or breastfeeding, the safety of this medication has not been sufficiently established, so it is crucial to consult a doctor before taking it. In the case of overdose, there is no specific antidote, so one should visit a medical facility for proper treatment immediately, and since this drug cannot be removed through dialysis, symptomatic treatment is essential. Keep this medication out of reach of children, and avoid transferring it to other containers as it may negatively affect quality.

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, anxiety, confusion, depression, aggression, hallucinations, headache, dizziness, paresthesia, drowsiness, taste disturbances, blurred vision, bronchospasm, pancreatitis, abdominal pain, constipation, diarrhea, abdominal distension, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis, increased liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, dermatitis, itching, rash, urticaria, hair loss, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, acute generalized exanthematous pustulosis, eosinophilia and systemic symptoms associated drug reaction, fractures, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile associated diarrhea, abdominal bloating, allergic reaction, back pain, chest pain, sternal pain, facial edema, facial flushing, fatigue, influenza-like illness, generalized edema, leg edema, lethargy, pain, stiffness, anemia, hypopigmented anemia, cervical lymphadenopathy, epistaxis, leukocytosis, thrombocytopenia, hyperbilirubinemia, liver dysfunction, increased ALT, increased AST, diabetes, hyperuricemia, increased ALP, dry mouth, vitamin B12 deficiency, weight gain, weight loss, exacerbation of arthritis, arthropathy, convulsions, fibromyalgia syndrome, hernia, rheumatic polymyalgia, appetite loss, apathy, increased appetite, confusion, worsening depression, hypertonicity, sensory loss, erectile dysfunction, insomnia, migraine, worsening migraine, sleep disturbances, 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 modification, urinary abnormalities, albuminuria, cystitis, dysuria, fungal infections, hematuria, urinary 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 discoloration, hernia, systemic lupus erythematosus, cutaneous lupus erythematosus, gastric pyloric polyp, hypocalcemia, hypokalemia, rhabdomyolysis, myalgia, elevated creatine kinase, elevated serum and urinary myoglobin

This medication is sensitive to air and moisture, so it should be stored in a sealed container. Additionally, it should be kept away from extremely hot or cold places, ideally stored at room temperature between 1°C and 30°C.

Appearance

An opaque capsule with a turquoise upper part and a yellowish-brown lower part containing white or gray spherical fine granules.

Package unit

28 capsules/bottle, 100 capsules/bottle