Esomeprazole Tablet 20 mg (Esomeprazole Magnesium Trihydrate)

Adult dosage

This medicine should be swallowed with a liquid such as water and should not be chewed or crushed. 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 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 medical evaluation is required. · Once symptoms have resolved, subsequent symptoms are controlled by administering 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. Use as needed to control subsequent 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 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 sensation) associated with administration of nonsteroidal anti-inflammatory drugs (nonselective or selective COX-2 inhibitors) - 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical evaluation is required. Clinical trials extending beyond 4 weeks have not been conducted. 4) Patients requiring continuous treatment with nonsteroidal anti-inflammatory drugs - Treatment of gastric ulcers associated with administration of nonsteroidal anti-inflammatory drugs: 20 mg once daily. The treatment period is 4∼8 weeks. - Prevention of gastric and duodenal ulcers associated with administration of nonsteroidal anti-inflammatory drugs: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg twice daily. Thereafter, the dose 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 daily. Doses above 80 mg daily should be divided into two doses. 6) Maintenance therapy following initiation of prevention of rebleeding from gastric or duodenal ulcers by intravenous injection Administer 40 mg once daily for 4 weeks following initiation of prevention of rebleeding from gastric or duodenal ulcers by intravenous injection. 4. Renal impairment No dose adjustment is necessary. Use with caution because there is limited experience in patients with severe renal impairment. 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

Adolescents aged 12 years and older: 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. Adolescents aged 12 years and older: 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. Adolescents aged 12 years and older: Symptomatic treatment of gastroesophageal reflux disease without esophagitis: Once symptoms have resolved, subsequent symptoms are controlled by administering 20 mg once daily. 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 patients who have specific allergic reactions or have had allergies to this medication or similar components in the past. Additionally, care should be taken as side effects or interactions may occur if taken with certain antibiotics or antivirals. Patients with heart disease or who have experienced myocardial infarction in the past, as well as lactating women, are advised against taking this medication. While taking this medication, various adverse reactions such as headache, dizziness, abdominal pain, diarrhea, skin rash may occur, and if symptoms are severe or persistent, consultation with a physician should be sought. Long-term use requires regular check-ups, particularly monitoring magnesium levels and overall health status for those taking it for more than one year. This medication reduces gastric acid, which may lead to bacterial growth in the stomach, slightly increasing the risk of infections such as diarrhea, hence prolonged diarrhea symptoms should be reported to healthcare personnel. Also, patients with osteoporosis or at risk of fractures should be cautious as prolonged or high-dose usage may increase fracture risk. There are many interactions with other drugs, so if taking other medications, be sure to inform your doctor or pharmacist, especially if combining with anticoagulants, antibiotics, antivirals, or anticonvulsants. Women who are pregnant or may become pregnant should consult with a healthcare professional before taking this medication, and it is safer for lactating women not to take this medication. In case of overdose, there is no specific antidote, so appropriate treatment should be given based on symptoms; it should be stored in a safe place out of reach of children.

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, allergic 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 distension, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis, increased liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, dermatitis, itching, rash, urticaria, hair loss, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction associated with eosinophilia and systemic symptoms, fracture, arthralgia, myalgia, muscle weakness, nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal distension, allergic reaction, back pain, chest pain, substernal pain, facial edema, facial flushing, fatigue, fever, influenza-like illness, generalized edema, leg edema, malaise, pain, stiffness, peripheral edema, flushing, hypertension, tachycardia, goiter, irritable bowel syndrome, exacerbation of constipation, dyspepsia, dysphagia, gastrointestinal developmental disorder, epigastric 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, earache, tinnitus, anemia, hypopigmented anemia, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia, hyperbilirubinemia, liver function abnormalities, increased ALT, increased AST, diabetes, hyperuricemia, increased ALP, polydipsia, vitamin B12 deficiency, weight gain, weight loss, exacerbation of arthritis, arthropathy, seizures, fibromyalgia syndrome, hernia, polymyalgia rheumatica, anorexia, apathy, increased appetite, confusion, exacerbation of depression, hypertonia, sensory loss, erectile dysfunction, insomnia, migraine, exacerbation of migraine, sleep disorder, tremor, visual field defects, dysmenorrhea, menstrual disorders, vaginitis, exacerbation of asthma, cough, dyspnea, laryngeal edema, pharyngitis, rhinitis, sinusitis, acne, anal itching, erythematous rash, papular rash, otitis media, dysosmia, ageusia, dysgeusia, 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, pyloric gland polyp, hypocalcemia, hypokalemia, rhabdomyolysis

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This helps to maintain the medication's effectiveness for a longer period.

Appearance

Pale pink round film-coated tablet

Package unit

28 tablets (14 tablets/ Alu-Alu X 2)