USMEZOL 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 required. · Once symptoms have resolved, subsequent recurring 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 recurring symptoms is not recommended for patients at high risk of developing gastric and duodenal ulcers due to NSAID use. 2) Combination therapy with antibiotics for the eradication of Helicobacter pylori Administer this medicine 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 required. Clinical trials exceeding 4 weeks have not been conducted. 4) Patients requiring continued NSAID treatment - 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. Subsequent doses should 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 per day. Doses exceeding 80 mg per day 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. Since there is limited experience with administration to patients with severe renal impairment, use with caution. 5. Hepatic impairment No dose adjustment is necessary in patients with mild to moderate hepatic impairment. Patients with severe hepatic impairment should not exceed a dose of 20 mg of this medicine. 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 required. · Once symptoms have resolved, subsequent recurring 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 recurring symptoms is not recommended for patients at high risk of developing gastric and duodenal ulcers due to NSAID use. 3. Children under 12 years of age There is no experience with the use of this medicine in children under 12 years of age.

This medication should not be administered to patients with an allergy or hypersensitivity to certain components. Additionally, it is prohibited for patients taking certain antibiotics or medications, as well as nursing women. Rarely, its use may lead to a decrease in blood cell counts or various side effects such as allergic reactions or hypomagnesemia, so caution is needed. Regular check-ups are required for long-term use, and any changes in symptoms should be discussed with a doctor. This medication can inhibit gastric acid secretion, which could promote bacterial growth in the stomach, slightly increasing the risk of gastrointestinal infections. Patients with osteoporosis or those taking high doses for an extended period should exercise caution as the risk of fractures may be heightened. Furthermore, this medication may interact with several drugs, and patients should inform their doctor or pharmacist of any other medications they are taking. The safety of this medication during pregnancy has not been fully established, so it should be used cautiously, and it is recommended to avoid its use during breastfeeding. In cases of overdose, there is no specific antidote, and treatment and observation should be based on symptoms. Lastly, this medication should be kept out of reach of children, and it is safer not to transfer it to other containers.

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, anxiety, mental confusion, depression, aggression, hallucination, headache, dizziness, paresthesia, drowsiness, taste disturbance, blurred vision, bronchospasm, pancreatitis, abdominal pain, constipation, diarrhea, abdominal distention, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis, elevated liver enzymes, hepatitis, liver failure, encephalopathy, dermatitis, itching, rash, urticaria, alopecia, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reactions with eosinophilia and systemic symptoms, fracture, arthralgia, myalgia, muscle weakness, nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile associated diarrhea, abdominal distention, allergic reaction, back pain, chest pain, substernal chest 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 motility disorder, upper abdominal pain, belching, esophageal disorder, 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, hypochromic anemia, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia, hyperbilirubinemia, liver dysfunction, increased ALT, increased AST, diabetes, hyperuricemia, increased ALP, thirst, vitamin B12 deficiency, weight gain, weight loss, worsened 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, worsened migraine, sleep disorders, tremors, dizziness, visual field loss, paresthesia, drowsiness, dysmenorrhea, menstrual disorders, vaginitis, worsened asthma, cough, dyspnea, laryngeal edema, pharyngitis, rhinitis, sinusitis, acne, anal itching, rash, erythematous rash, papular rash, angioedema, dermatitis, itching, urticaria, increased sweating, otitis media, abnormal olfaction, taste loss, dysgeusia, urinary abnormalities, albuminuria, cystitis, dysuria, fungal infection, hematuria, urinary frequency, candidiasis, genital candidiasis, polyuria, conjunctivitis, visual disturbances, duodenitis, esophagitis, esophageal stenosis, esophageal ulcer, esophageal varices, gastric ulcer, gastritis, benign polyps or nodules, Barrett's esophagus, mucosal discoloration, hernia, systemic lupus erythematosus, cutaneous lupus erythematosus, hypocalcemia, hypokalemia, rhabdomyolysis, myalgia, elevated creatine kinase, increased serum and urine myoglobin, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's efficacy and safety.

Appearance

A hard capsule with a bluish-green upper part and a yellowish-brown lower part containing white or gray spherical fine granules.

Package unit

28 capsules/bottle