Esomeprazole Magnesium Capsules 40mg (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 necessary. · Once symptoms have resolved, subsequent recurrent symptoms may be controlled with 20 mg once daily. · In adults, 20 mg once daily may be taken as needed. As-needed treatment 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 eradication of Helicobacter pylori Administer this drug 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 necessary. Clinical studies extending beyond 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 duration 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 for as long as 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 of prevention of rebleeding from gastric or duodenal ulcers After intravenous induction of prevention of rebleeding from gastric or duodenal ulcers, administer 40 mg once daily for 4 weeks. 4. Renal impairment No dose adjustment is necessary. Use with caution because experience with administration to 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. Elderly patients No dose adjustment is necessary.

Children's dosage

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. Adolescents aged 12 years and older: 1) Gastroesophageal reflux disease (GERD) - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is necessary. · Once symptoms have resolved, subsequent recurrent symptoms may be controlled with 20 mg once daily. Children under 12 years of age: There is no experience with administration of this drug to children under 12 years of age.

This medication should not be used in patients with specific allergic reactions or those who have had allergic reactions to similar medications in the past. Particularly, patients taking certain antibiotics or some heart-related medications, as well as nursing mothers, should not take this medication. Rarely, during the use of this drug, decreased blood cell counts or allergic reactions, electrolyte imbalances, and neurological symptoms may occur; if any abnormal symptoms arise, immediate consultation with a physician is advised. Regular examinations to check for side effects during prolonged use are important. This drug may reduce stomach acid, which can lead to increased bacterial growth in the stomach, raising the risk of intestinal infections; thus, if symptoms like diarrhea persist, the physician should be informed. Prolonged high-dose use may increase the risk of fractures, so patients at risk of osteoporosis need regular bone density checks. Magnesium levels may decrease, so patients using this drug over a long duration or taking certain medications should regularly check their serum magnesium levels. This medication has many interactions with other drugs, particularly anticoagulants, antidepressants, and anticonvulsants, so caution is needed when used together, and consultations with a physician should occur when starting or discontinuing medications. There is insufficient information regarding the safety of this drug during pregnancy, so pregnant women should discuss with their doctor before use and should avoid use while nursing.

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, anxiety, mental confusion, depression, aggression, hallucinations, headache, dizziness, dysesthesia, drowsiness, taste disorder, blurred vision, bronchospasm, pancreatitis, abdominal pain, constipation, diarrhea, abdominal distension, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis, elevated liver enzymes, hepatitis, liver failure, encephalopathy, dermatitis, itching, rash, urticaria, hair loss, photosensitivity, erythema multiforme, epidermal necrolysis, Stevens-Johnson syndrome, toxic epidermal necrolysis, 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 distension, allergic reaction, back pain, chest pain, retrosternal pain, facial edema, facial flushing, fatigue, influenza-like illness, generalized edema, leg edema, lethargy, pain, stiffness, peripheral edema, flushing, hypertension, tachycardia, thyroid gland enlargement, irritable bowel syndrome, exacerbation of constipation, dyspepsia, dysphagia, gastrointestinal malformation, epigastric pain, belching, esophageal disorder, frequent bowel movements, gastroenteritis, gastrointestinal hemorrhage, hiccups, melena, oral disorder, pharyngeal disorder, rectal disorder, gastrointestinal symptoms, increased serum gastrin, tongue disorder, tongue swelling, ulcerative stomatitis, vomiting, earache, tinnitus, anemia, hypopigmented anemia, cervical lymphadenopathy, nosebleed, 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, arthralgia, anorexia, apathy, increased appetite, confusion, exacerbation of depression, hypertonia, anxiety, sensory loss, erectile dysfunction, insomnia, migraine, exacerbation of migraine, sleep disorder, tremor, dizziness, visual field defect, dysesthesia, drowsiness, dysmenorrhea, menstrual disorder, 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, phantom smell, loss of taste, taste alteration, urinary abnormality, 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 polyp or nodule, Barrett's esophagus, mucosal discoloration, hernia, systemic lupus erythematosus, cutaneous lupus erythematosus, hypocalcemia, hypokalemia, rhabdomyolysis, myalgia, asthenia

This medication should be stored in a tightly sealed container that prevents air or moisture from entering. It is also advisable to keep the medication at room temperature between 1 to 30 degrees Celsius, away from extremes of hot or cold. This will help maintain the effectiveness of the medication and ensure its safe use.

Appearance

A hard capsule with a green body and cap containing white or gray spherical fine granules

Package unit

28 capsules per bottle