Esomeprazole Magnesium 40 mg Capsule

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 another 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 recurrent symptoms are controlled by administering 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. As-needed administration to control recurrent symptoms is not recommended for patients at high risk of developing gastric or duodenal ulcers due to nonsteroidal anti-inflammatory drug use. 2) Combination therapy with antibiotics for Helicobacter pylori eradication 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 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 trials lasting longer than 4 weeks have not been conducted. 4) Patients requiring continued nonsteroidal anti-inflammatory drug treatment - 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. According to clinical data, most patients can be controlled with doses of 80 ∼ 160 mg per day. Doses greater than 80 mg per day should be divided into two doses. 6) Maintenance therapy following initiation of prevention of recurrent bleeding due to gastric or duodenal ulcers by intravenous injection Administer 40 mg once daily for 4 weeks following initiation of prevention of recurrent bleeding due to gastric or duodenal ulcers by intravenous injection. 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. In patients with severe hepatic impairment, the dose of this medicine should not exceed 20 mg. 6. Elderly patients No dose adjustment is necessary.

Children's dosage

2. Adolescents 12 years of age 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 another 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 recurrent symptoms are controlled by administering 20 mg once daily. 3. Children under 12 years of age There is no experience with administration of this medicine to children under 12 years of age.

This medication should not be used in certain patients. For example, it should not be administered to individuals with an allergy to this drug, its components, or benzimidazole derivatives. Patients allergic to certain antibiotics used in conjunction with Helicobacter pylori eradication therapy should also avoid this medication. Caution is needed for those with hypersensitivity reactions to macrolide antibiotics or penicillin antibiotics. This drug should also not be given to patients taking certain medications, such as terfenadine, cisapride, pimodivir, or astemizole, nor to those taking atazanavir, nelfinavir, or rilpivirine formulations. Women who are breastfeeding should not take this medication as there is a possibility it could be passed into breast milk. Various side effects may occur while using this medication, and patients should be cautious. Commonly reported side effects include headache, abdominal pain, diarrhea, nausea, and vomiting, while rare occurrences include blood abnormalities, liver dysfunction, severe allergic reactions, and skin rashes. Regular check-ups are important during long-term use of this medication to monitor for any adverse reactions, especially if taken for more than one year, as low magnesium levels and increased fracture risk may arise. This medication reduces stomach acid, which may slightly increase the risk of gastrointestinal infections. If diarrhea persists or worsens, consult a doctor. This medication may interact with various drugs, so inform healthcare providers if you are taking other medications. Particular caution is advised when combining with antiplatelet agents, antibiotics, antiviral agents, or anticonvulsants. Safety data for this medication during pregnancy is limited, so pregnant women should use it cautiously after consulting with a doctor. There is no specific antidote for overdose; appropriate treatment should be given based on symptoms, and it should be stored out of reach of children. Finally, it is advisable to keep this medication in its original container to maintain quality and not to transfer it to another container.

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, agitation, mental confusion, depression, aggression, hallucinations, headache, dizziness, paresthesia, drowsiness, taste disorder, blurred vision, bronchospasm, pancreatitis, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis, increased liver enzymes, hepatitis, jaundice, liver failure, encephalopathy, dermatitis, itching, rash, urticaria, hair loss, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, acute generalized exanthematous pustulosis, drug reaction 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, substernal pain, facial edema, facial flushing, fatigue, fever, influenza-like illness, generalized edema, leg edema, lethargy, pain, stiffness, anemia, hypochromic anemia, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, 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, rheumatoid polymyalgia, anorexia, apathy, increased appetite, confusion, worsening depression, hypertonia, sensory impairment, erectile dysfunction, insomnia, migraine, exacerbation of migraine, sleep disorder, tremor, visual field defect, dysmenorrhea, menstrual disorder, vaginitis, exacerbation of asthma, cough, dyspnea, laryngeal edema, pharyngitis, rhinitis, sinusitis, acne, anal itching, erythematous rash, papulovesicular rash, otitis media, dysosmia, loss of taste, taste distortion, 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, cutaneous lupus erythematosus, hypocalcemia, hypokalemia, rhabdomyolysis

This medication should be kept in a tightly closed container to prevent air and moisture exposure, with a storage temperature maintained between 1 to 30 degrees Celsius at room temperature for optimal effectiveness.

Appearance

A hard capsule with a pale pink upper and lower part containing spherical fine granules that are white or gray.

Package unit

28C/bottle