Eszole Tablets 20 mg (Esomeprazole Magnesium Trihydrate)

Adult dosage

Swallow this medicine with a liquid such as water; do not chew or crush it. 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 it 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 symptoms may be controlled by administering 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. As-needed administration to control subsequent symptoms is not recommended for patients at high risk of developing gastric and duodenal ulcers due to use of nonsteroidal anti-inflammatory drugs. 2) Combination therapy with antibiotics for eradication of Helicobacter pylori Administer this medicine 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 (nonselective or selective COX-2 inhibitors) - 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is required. Clinical trials lasting longer than 4 weeks have not been conducted. 4) Patients requiring ongoing 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 continue for as long as 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 into two doses. 6) Maintenance therapy following intravenous treatment to prevent rebleeding from gastric or duodenal ulcers Administer 40 mg once daily for 4 weeks following intravenous treatment to prevent rebleeding from gastric or duodenal ulcers. 4. Renal impairment: No dose adjustment is necessary. Use with caution because there is limited experience in patients with severe renal failure. 5. Hepatic impairment: No dose adjustment is necessary in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, do not exceed a dose of 20 mg of this medicine. 6. Older adults: 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 it 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 required. · Once symptoms have resolved, subsequent symptoms may be controlled by administering 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. As-needed administration to control subsequent symptoms is not recommended for patients at high risk of developing gastric and duodenal ulcers due to use of nonsteroidal anti-inflammatory drugs. 3. Children under 12 years: There is no experience with administration of this medicine to children under 12 years of age.

This medication should not be administered to patients who have allergies to specific components or who have experienced hypersensitivity reactions. This medication should be avoided in patients with hypersensitivity to penicillin and macrolide antibiotics, especially when combined with Helicobacter pylori eradication therapy. It is also contraindicated in patients with a history of heart disease or myocardial infarction, and in those on specific antiviral medications or breastfeeding women. Various side effects may occur during the administration of this medication, including headache, abdominal pain, diarrhea, nausea, skin rash, myalgia, and rarely, serious blood disorders or allergic reactions. Long-term use may lead to electrolyte imbalances such as hypomagnesemia, requiring regular testing. This medication reduces gastric acid, which may increase the risk of certain bacterial infections in the gastrointestinal tract; if diarrhea persists, consultation with a doctor is necessary. Additionally, patients with osteoporosis or high fracture risk should be cautious as long-term use may increase the risk of fractures. This medication has a high potential for drug interactions, especially when combined with anticoagulants, anticonvulsants, antidepressants, and antiviral medications, so strict adherence to the doctor's instructions is required. During pregnancy, the safety of this medication has not been fully established, so it should be used with caution under the doctor's guidance, and it is advisable to avoid use during breastfeeding. In the case of overdose, there is no specific antidote; therefore, it is necessary to visit a medical institution immediately for appropriate treatment. This medication should be kept out of reach of children and should not be transferred to another container.

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, anxiety, confusion, depression, aggression, hallucination, headache, dizziness, paresthesia, drowsiness, taste disturbance, blurred vision, bronchospasm, pancreatitis, abdominal pain, constipation, diarrhea, abdominal distension, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis, elevated liver enzymes, hepatitis, liver failure, encephalopathy, dermatosis, itching, rash, urticaria, hair loss, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reactions associated with eosinophilia and systemic symptoms, fracture, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile associated diarrhea, abdominal bloating, allergic reaction, back pain, chest pain, retrosternal pain, facial edema, facial flushing, fatigue, fever, influenza-like illness, generalized edema, leg edema, lethargy, pain, stiffness, peripheral edema, flushing, hypertension, tachycardia, goiter, irritable bowel syndrome, worsening constipation, dyspepsia, dysphagia, gastrointestinal malformation, epigastric pain, belching, esophageal disorders, frequent bowel movements, gastroenteritis, gastrointestinal bleeding, hiccups, melena, oral disorders, pharyngeal disorders, rectal disorders, gastrointestinal symptoms, increased serum gastrin, tongue disorders, tongue edema, ulcerative stomatitis, vomiting, earache, tinnitus, anemia, hypopigmented anemia, cervical lymphadenopathy, nosebleed, leukocytosis, leukopenia, thrombocytopenia, hyperbilirubinemia, liver dysfunction, increased ALT, increased AST, diabetes, hyperuricemia, increased ALP, thirst, vitamin B12 deficiency, weight gain, weight loss, worsening arthritis, arthropathy, convulsions, fibromyalgia syndrome, hernia, polymyalgia rheumatica, arthralgia, loss of appetite, apathy, increased appetite, confusion, worsening depression, hypertonia, anxiety, sensory loss, erectile dysfunction, insomnia, migraine, worsening migraine, sleep disorders, tremors, dizziness, visual field defects, paresthesia, drowsiness, dysmenorrhea, menstrual disorders, vaginitis, worsening asthma, cough, dyspnea, laryngeal edema, pharyngitis, rhinitis, sinusitis, acne, anal itching, rash, erythematous rash, papular rash, angioedema, dermatitis, itching, urticaria, increased sweating, otitis media, dysosmia, taste loss, taste disorder, urinary abnormalities, albuminuria, cystitis, dysuria, fungal infection, hematuria, urinary frequency, 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 discoloration, hernia, systemic lupus erythematosus, discoid lupus erythematosus, hypocalcemia, hypokalemia, rhabdomyolysis

This medication should be stored in a tightly closed container to prevent air or moisture infiltration, and it is advisable to store it at room temperature between 1 and 30 degrees Celsius. This will help maintain the medication's effectiveness and prevent deterioration.

Appearance

Light pink, round film-coated tablet

Package unit

28 tablets (14 tablets x 2 PTP)