Esomeprazole Capsule 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. 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. 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. 4. Renal impairment No dose adjustment is necessary. Since there is limited experience with administration to patients with severe renal impairment, use with caution. 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 drug should not be used by patients with allergies or hypersensitivity to certain components. Additionally, caution is required when co-administered with penicillin and macrolide antibiotics in hypersensitive patients. Pregnant or breastfeeding women are advised not to take this medication. It is important to carefully monitor for various side effects, such as blood disorders, hypersensitivity reactions, neurological abnormalities, and gastrointestinal disorders, which may rarely appear during treatment. Regular check-ups are essential during long-term use. As this drug may interact with other medications, particularly antiviral drugs, anticoagulants, and antibiotics, consulting a doctor is necessary when taking these in combination. There may be a slight increase in gastrointestinal infection risk, so if symptoms such as diarrhea persist, consult a healthcare professional. Long-term use may lead to increased fracture risk, hypomagnesemia, and appropriate monitoring is required if necessary. If serious allergic reactions occur during medication, such as skin rash or breathing difficulties, the drug should be discontinued immediately, and medical attention should be sought. There is no specific antidote for overdose, so symptomatic treatment should be administered, and it should be stored out of reach of children.

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, anxiety, mental confusion, depression, aggression, hallucination, headache, dizziness, paresthesia, drowsiness, dysgeusia, blurred vision, bronchospasm, pancreatitis, abdominal pain, constipation, diarrhea, abdominal distension, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis, elevated liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, dermatitis, itching, rash, urticaria, hair loss, photosensitivity, erythema multiforme, mucosal decontamination syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized pustular psoriasis, eosinophilia and systemic symptoms associated drug reaction, fractures, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal distention, allergic reaction, back pain, chest pain, sternal pain, facial edema, facial flushing, fatigue, flu-like symptoms, generalized edema, leg swelling, malaise, pain, stiffness, anemia, hypopigmented anemia, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia, hyperbilirubinemia, liver dysfunction, elevated ALT, elevated AST, diabetes, hyperuricemia, elevated ALP, polydipsia, vitamin B12 deficiency, weight gain, weight loss, exacerbation of arthritis, arthropathy, convulsions, fibromyalgia syndrome, hernia, rheumatoid polymyalgia, anorexia, apathy, increased appetite, confusion, worsening depression, muscular hypertonicity, sensory decrease, erectile dysfunction, insomnia, migraine, worsening migraine, sleep disorder, tremors, visual field defect, dysmenorrhea, menstrual disorders, vaginitis, exacerbation of asthma, cough, dyspnea, laryngeal edema, pharyngitis, rhinitis, sinusitis, acne, anal itching, erythematous rash, papular rash, otitis media, altered olfaction, loss of taste, taste distortion, urinary abnormalities, albuminuria, cystitis, dysuria, fungal infection, hematuria, frequency of urination, 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

This medication should be stored in a closed container to protect it from air and moisture. It is recommended to maintain storage temperature between 1 and 30 degrees Celsius.

Appearance

A hard capsule with a green upper and lower part containing white or gray spherical fine granules

Package unit

28 capsules/bottle, 100 capsules/bottle