Nextra Capsule 20 mg (Esomeprazole Magnesium Trihydrate)

Adult dosage

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

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. 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 medication should not be used in patients with specific allergic reactions. For example, it should not be administered to patients who have had hypersensitivity reactions to this drug or its components, or to benzimidazole derivatives. Additionally, caution should be taken when used in conjunction with amoxicillin or clarithromycin for the eradication of Helicobacter pylori in patients allergic to those antibiotics. Particularly, it is not safe for patients taking specific heart-related medications or for nursing mothers. While taking this medication, various side effects such as hematological abnormalities, allergic reactions, electrolyte imbalances, neurological symptoms, gastrointestinal issues, liver function abnormalities, skin rashes, muscle weakness, and others may occur rarely. During long-term use, it is important to regularly monitor blood tests and electrolyte levels. This drug suppresses gastric acid secretion and lowers gastric acidity, which can slightly increase the risk of bacterial infections in the gastrointestinal tract. Additionally, long-term use may increase the risk of fractures, so patients at risk for osteoporosis should undergo bone density tests. There may be drug interactions while taking this medication, so patients taking anticoagulants, antibiotics, antivirals, anticonvulsants, should definitely consult with a physician or pharmacist. The safety of this drug has not been fully established during pregnancy, so pregnant women should consult healthcare professionals before use. Nursing mothers are advised against using this medication due to the potential for it to be passed into breast milk. In case of overdose, there is no specific antidote, and if symptoms occur, immediate treatment in a medical institution is required. Finally, this medication should be kept out of reach of children and should not be transferred to another container.

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, anxiety, confusion, depression, aggression, hallucinations, 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, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reactions with eosinophilia and systemic symptoms, fractures, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal distension, allergic reaction, back pain, chest pain, sternal pain, facial edema, facial flushing, fatigue, fever, influenza-like illness, generalized edema, leg edema, lethargy, pain, stiffness, peripheral edema, flushing, hypertension, tachycardia, goiter, irritable bowel syndrome, worsening constipation, dyspepsia, dysphagia, gastrointestinal malformation, 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 swelling, ulcerative stomatitis, vomiting, earache, tinnitus, anemia, hypopigmented anemia, cervical lymphadenopathy, nosebleed, leukocytosis, leukopenia, thrombocytopenia, hyperbilirubinemia, liver dysfunction, increased ALT, increased AST, diabetes, hyperuricemia, increased ALP, polydipsia, vitamin B12 deficiency, weight gain, weight loss, worsening of arthritis, arthropathy, seizures, fibromyalgia syndrome, hernia, polymyalgia rheumatica, arthralgia, anorexia, apathy, increased appetite, confusion, worsening depression, muscle hypertonicity, anxiety, sensory impairment, erectile dysfunction, insomnia, migraine, worsening migraine, sleep disorder, tremors, dizziness, visual field defects, paresthesia, 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, abnormal olfaction, taste loss, taste dysesthesia, 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 polyps or nodules, Barrett's esophagus, mucosal discoloration, hernia, systemic lupus erythematosus, cutaneous lupus erythematosus, hypocalcemia, hypokalemia, rhabdomyolysis, myalgia, elevated creatine kinase, increased serum and urinary myoglobin, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis

This medication may be sensitive to air or moisture, so it must be kept in a tightly closed container. It is advisable to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature to preserve the drug's efficacy and safety for a long time.

Appearance

A hard capsule with the upper part being turquoise and the lower part light yellow, containing spherical fine granules that are white or gray.

Package unit

28 capsules/bottle, 100 capsules/bottle