Nextracapsule 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. For patients whose esophagitis has not healed or whose symptoms persist, continue treatment for an additional 4 weeks. - Long-term maintenance treatment 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, control subsequent symptoms by administering 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. As-needed administration to control recurring symptoms is not recommended for patients at high risk of developing gastric or duodenal ulcers due to treatment with nonsteroidal anti-inflammatory drugs. 2) Combination therapy with antibiotics for eradication of Helicobacter pylori Administer 20 mg of this drug together with 1 g of amoxicillin and 500 mg of clarithromycin, 2 times 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 evaluation is required. Clinical trials exceeding 4 weeks have not been conducted. 4) Patients requiring continued administration of 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 2 times daily. The dose should thereafter 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 into 2 doses per day. 6) Maintenance therapy after intravenous initiation of prevention of rebleeding due to gastric or duodenal ulcers Administer 40 mg once daily for 4 weeks after intravenous initiation of prevention of rebleeding due to gastric or duodenal ulcers. 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 for 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. For patients whose esophagitis has not healed or whose 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 required. · Once symptoms have resolved, control subsequent symptoms by administering 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. As-needed administration to control recurring symptoms is not recommended for patients at high risk of developing gastric or duodenal ulcers due to treatment with nonsteroidal anti-inflammatory drugs. 3. Pediatric patients under 12 years of age There is no experience with the administration of this drug to pediatric patients under 12 years of age.

This drug should not be administered to certain patients. For example, it should not be used in cases of allergy to this drug or its components, or in case of hypersensitivity to certain antibiotics. In addition, while receiving this drug, there may be various adverse reactions, so caution is required. Commonly, symptoms such as headache, abdominal pain, and diarrhea may occur, and rarely, blood abnormalities, liver dysfunction, and severe skin reactions have been reported. Regular check-ups are necessary for long-term use of this drug, and it is especially important to periodically check magnesium levels when used for more than one year. There may be a slight increase in the risk of gastrointestinal infections, so if diarrhea persists or worsens, immediate consultation with a healthcare provider is required. This drug can interact with other medications, so it is essential to inform the doctor or pharmacist if you are taking other medications. Caution is particularly required when used in combination with anticoagulants, antiviral agents, or certain antibiotics. If pregnant or nursing, the safety of this drug has not been adequately confirmed, so it should be used after consulting a doctor. In case of overdose, there are no specific antidotes, so appropriate treatment should be sought based on symptoms, and it should be kept out of reach of children. Finally, if severe symptoms such as skin rash, shortness of breath, or severe headache occur during the use of this drug, immediate medical attention should be sought.

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, agitation, confusion, depression, aggression, hallucination, headache, dizziness, altered perception, drowsiness, taste disorder, 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, eosinophilia with systemic symptoms associated drug reaction, fracture, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal bloating, allergic reaction, back pain, chest pain, sternal pain, facial edema, facial flushing, fatigue, influenza-like illness, generalized edema, leg edema, malaise, pain, stiffness, peripheral edema, flushing, hypertension, tachycardia, thyroid enlargement, irritable bowel syndrome, worsening constipation, dyspepsia, dysphagia, gastrointestinal malformation, epigastric pain, belching, esophageal disorders, frequent bowel movements, gastroenteritis, gastrointestinal bleeding, hiccups, black stool, oral disorders, pharyngeal disorders, rectal disorders, gastrointestinal symptoms, increased serum gastrin, tongue disorders, tongue swelling, ulcerative stomatitis, vomiting, earache, tinnitus, anemia, hypochromic anemia, cervical lymphadenopathy, nosebleed, 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, rheumatic polymyalgia, arthralgia, loss of appetite, apathy, increased appetite, disorientation, worsening depression, hypertonia, agitation, sensory loss, erectile dysfunction, insomnia, migraine, exacerbation of migraine, sleep disorders, tremor, dizziness, visual field loss, altered perception, drowsiness, dysmenorrhea, menstrual disorders, 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, olfactory alteration, taste loss, 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 polyp or nodule, Barrett's esophagus, mucosal discoloration, hernia, systemic lupus erythematosus, cutaneous lupus erythematosus, hypocalcemia, hypokalemia, rhabdomyolysis

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. The recommended storage temperature is room temperature between 1 and 30 degrees Celsius.

Appearance

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

Package unit

28 capsules/bottle, 100 capsules/bottle