Exlorazole Tablet 40 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 relapse 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 needed. · Once symptoms have resolved, subsequent episodes can be controlled with 20 mg once daily. · In adults, 20 mg may be taken once daily as needed. As-needed use to control recurrent symptoms is not recommended for patients at high risk of developing gastric and duodenal ulcers due to treatment with nonsteroidal anti-inflammatory drugs. 2) Combination antibiotic therapy for eradication of Helicobacter pylori Administer this drug 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 sensation) 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 needed. Clinical trials exceeding 4 weeks have not been conducted. 4) Patients requiring continued treatment with nonsteroidal anti-inflammatory drugs - 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 while clinical symptoms are present. Clinical data indicate that most patients can be controlled with a dose of 80 ∼ 160 mg per day. Doses greater than 80 mg per day should be divided into two doses. 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, as experience in 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. 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. For patients whose esophagitis has not healed or whose 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 required. · 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. For patients at high risk of developing gastric and duodenal ulcers due to treatment with nonsteroidal anti-inflammatory drugs, as-needed administration is not recommended to control recurring symptoms. 3. Children under 12 years of age: There is no experience with administration of this drug to children under 12 years of age.

This drug should not be used in patients with specific allergic reactions or those who are hypersensitive to certain antibiotics. Additionally, women with a history of heart disease or those who are breastfeeding should not take this medication. Various side effects such as headache, abdominal pain, diarrhea, nausea, skin rash may occur during the use of this drug, so if any abnormal symptoms occur, it is essential to consult a doctor immediately. Regular monitoring such as blood tests is necessary during long-term use, particularly when taken for more than one year, magnesium levels should be carefully monitored. This medication may interact with other drugs, so inform your doctor or pharmacist about any other medications you are taking. Care should be taken when used in combination with certain antivirals, antibiotics, anticoagulants, etc. During pregnancy, since the safety of this drug has not been fully established, it should only be taken after consulting a doctor. While breastfeeding, this medication may pass into breast milk, so it should be avoided. In case of overdose, as there are no specific antidotes, seek medical attention immediately for appropriate treatment. This medication should be kept out of reach of children, and transferring it to a different container may cause quality deterioration or accidents, so caution is advised.

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, anxiety, mental confusion, depression, aggressiveness, hallucinations, headache, dizziness, distorting perception, drowsiness, taste disturbances, blurred vision, bronchospasm, pancreatitis, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis, increased liver enzymes, hepatitis, liver failure, encephalopathy, dermatitis, itching, rash, urticaria, hair loss, photosensitivity, erythema multiforme, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, acute generalized exanthematous pustulosis, drug reactions with eosinophilia and systemic symptoms, fractures, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile associated diarrhea, abdominal distension, allergic reactions, back pain, chest pain, sternum pain, facial swelling, facial flushing, fatigue, fever, influenza-like symptoms, generalized edema, leg edema, lethargy, pain, stiffness, peripheral edema, flushing, hypertension, tachycardia, thyroid enlargement, irritable bowel syndrome, aggravated 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 swelling, ulcerative stomatitis, vomiting, earache, tinnitus, anemia, hypochromic anemia, cervical lymphadenopathy, nosebleeds, leukocytosis, leukopenia, thrombocytopenia, hyperbilirubinemia, impaired liver function, increased ALT, increased AST, diabetes, hyperuricemia, increased ALP, thirst, vitamin B12 deficiency, weight gain, weight loss, exacerbation of arthritis, arthropathy, cramps, fibromyalgia syndrome, hernia, rheumatoid polymyalgia, arthralgia, loss of appetite, apathy, increased appetite, confusion, worsening of depression, hypertonia, anxiety, sensory impairment, erectile dysfunction, insomnia, migraine, worsening of migraine, sleep disorders, tremors, dizziness, visual field loss, distorting perception, drowsiness, dysmenorrhea, menstrual disorders, vaginitis, exacerbation of 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, taste distortion, urinary abnormalities, albuminuria, cystitis, dysuria, fungal infections, hematuria, urination frequency, candidiasis, genital candidiasis, polyuria, conjunctivitis, visual disturbances, duodenitis, esophagitis, esophageal stricture, esophageal ulcers, esophageal varices, gastric ulcers, gastritis, benign polyps or nodules, Barrett's esophagus, mucosal discoloration, hernia, systemic lupus erythematosus, cutaneous lupus erythematosus, gastric fundic polyps, hypocalcemia, hypokalemia, rhabdomyolysis, myalgia, asthenia

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance

Pink circular film-coated tablet

Package unit

28 tablets / PTP (Alu-Alu)