Esomeprazole Magnesium Hydrate Capsule 40 mg

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

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. If esophagitis has not healed or 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 evaluation is necessary. · Once symptoms have resolved, subsequent recurrent symptoms may be controlled with 20 mg once daily. 3. 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 certain patients. Patients who are allergic to this drug or any of its ingredients, or who have experienced hypersensitivity reactions to benzimidazole derivatives should avoid its use. Avoid using this medication in combination with amoxicillin or clarithromycin for the eradication of Helicobacter pylori if there is a hypersensitivity to these antibiotics. Additionally, it is safer not to use this medication for patients taking certain heart-related medications or antiviral drugs, and women who are breastfeeding. Various side effects may occur when using this medicine. Gastrointestinal symptoms such as headaches, abdominal pain, diarrhea, nausea, and vomiting can frequently occur. Rarely, multiple abnormal reactions, including decreased blood cell counts, allergic reactions, hypomagnesemia, psychological changes, liver function abnormalities, and skin rashes have been reported. Especially if muscle pain or weakness occurs, the possibility of severe muscle diseases such as rhabdomyolysis should be suspected, and immediate consultation with a physician is advised. Long-term use of this medication may mask the symptoms of malignant tumors, so if there are warning signs such as unintentional weight loss, recurrent vomiting, or black stools, it is essential to consult a specialist. Regular examinations to check health status are important for long-term users. Furthermore, because this medication suppresses gastric acid secretion, it may slightly increase the risk of bacterial overgrowth in the gastrointestinal tract, leading to an increased risk of diarrhea or infections. Patients with osteoporosis or a high risk of fractures should be cautious as long-term use can increase the risk of fractures. Since there are many drug interactions, especially when taken with anticoagulants, antibiotics, antiviral medications, or anticonvulsants, it is essential to inform doctors or pharmacists. The concentrations of other drugs may change when used concurrently with this medication, potentially altering their effects or side effects. The safety of this medication has not been sufficiently established in pregnant women, so it should only be used if necessary and under the judgment of a physician, and breastfeeding women should avoid using this medication. In case of overdose, there is no specific antidote, and appropriate treatment should be given based on the symptoms. It should be stored out of reach of children. Transferring the medication to another container is discouraged for quality and safety reasons.

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, anxiety, mental confusion, depression, aggression, hallucinations, headache, dizziness, sensory disturbances, 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, 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 distention, allergic reaction, back pain, chest pain, retrosternal pain, facial edema, facial flushing, fatigue, fever, influenza-like illness, generalized edema, leg edema, malaise, pain, stiffness, tachycardia, flushing, hypertension, thyroid gland enlargement, irritable bowel syndrome, exacerbation of constipation, dyspepsia, dysphagia, gastrointestinal malformation, epigastric pain, belching, esophageal disorders, frequent bowel movements, gastritis, gastrointestinal bleeding, hiccups, melena, oral disorders, pharyngeal disorders, rectal disorders, gastrointestinal symptoms, increased serum gastrin, tongue disorders, tongue edema, ulcerative stomatitis, earache, tinnitus, anemia, hypochromic anemia, cervical lymphadenopathy, epistaxis, leukocytosis, thrombocytopenia, hyperbilirubinemia, liver dysfunction, elevated ALT, elevated AST, diabetes, hyperuricemia, elevated ALP, thirst, vitamin B12 deficiency, weight gain, weight loss, exacerbation of arthritis, arthropathy, convulsions, fibromyalgia syndrome, hernia, polymyalgia rheumatica, anorexia, apathy, increased appetite, confusion, exacerbation of depression, hypertonia, sensory loss, erectile dysfunction, insomnia, migraine, exacerbation of migraine, sleep disorders, tremors, 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, abnormal olfaction, loss of taste, taste disorder, 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 polyp or nodule, Barrett's esophagus, mucosal discoloration, hernia, systemic lupus erythematosus, cutaneous lupus erythematosus, hypocalcemia, hypokalemia, rhabdomyolysis, myalgia

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture, preferably at room temperature between 1 and 30 degrees Celsius. This will help maintain the effectiveness of the medication for a longer period.

Appearance

A hard capsule of upper and lower green color containing spherical pellets that are pale yellow to light gray.

Package unit

28 capsules/bottle