Neximazole Capsule 20 mg (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 required. · Once symptoms have resolved, subsequent recurring symptoms may be controlled 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 and duodenal ulcers due to NSAID use. 2) Combination therapy with antibiotics for the eradication of Helicobacter pylori Administer this medicine 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 required. Clinical trials exceeding 4 weeks have not been conducted. 4) Patients requiring continued NSAID treatment - Treatment of gastric ulcers associated with NSAID use: 20 mg once daily. The treatment period is 4∼8 weeks. - Prevention of gastric and duodenal ulcers associated with NSAID use: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg twice daily. Subsequent doses 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 per day. Doses exceeding 80 mg per day should be divided and taken twice daily. 6) Maintenance therapy following intravenous induction to prevent rebleeding from gastric or duodenal ulcers Administer 40 mg once daily for 4 weeks following intravenous induction to prevent rebleeding from gastric or duodenal ulcers. 5. Hepatic impairment: No dose adjustment is necessary in patients with mild to moderate hepatic impairment. Patients with severe hepatic impairment should not exceed a dose of 20 mg of this medicine. 4. Renal impairment: No dose adjustment is necessary. Since there is limited experience with administration to patients with severe renal impairment, use with caution. 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 required. · Once symptoms have resolved, subsequent recurring symptoms may be controlled by administering 20 mg once daily. 3. Children under 12 years of age: There is no experience with the use of this medicine in children under 12 years of age.

This drug should not be used in patients who are allergic or have had hypersensitivity reactions to this drug, its components, or benzimidazole derivatives. Additionally, when used in conjunction with amoxicillin or clarithromycin for the eradication of Helicobacter pylori, patients who are allergic to those antibiotics should not take this drug. Patients taking specific cardiovascular drugs or antiviral agents, as well as nursing women, should also avoid using this drug. While taking this drug, various adverse reactions may occur, so patients should immediately consult a doctor if they experience unusual symptoms such as headaches, dizziness, abdominal pain, nausea, skin rash, muscle pain, and so on. Long-term use may increase the risk of hypomagnesemia, fractures, skin and systemic lupus erythematosus, gastric gland polyps, so regular check-ups are needed. This drug has many drug interactions, especially when taken with anticoagulants, antibiotics, antiviral agents, anticonvulsants, and caution is required. Patients should inform their doctor or pharmacist of any other medications they are taking. There is limited safety data during pregnancy; therefore, pregnant women should consult their physician before taking this drug. If breastfeeding, it is safer not to use this drug, as there is a possibility it could be transmitted through breast milk. In case of overdose, there is no specific antidote, and this drug is not well eliminated from the body, so patients should go to the hospital immediately for appropriate treatment in case of overdose. Finally, this drug should be kept out of reach of children, and it is safe not to transfer it to another container, and the prescribed dosage and administration must be strictly followed.

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, anxiety, confusion, depression, aggression, hallucination, headache, dizziness, paresthesia, drowsiness, taste disturbance, blurred vision, bronchospasm, pancreatitis, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis, increased liver enzymes, hepatitis, liver failure, encephalopathy, dermatitis, itching, rash, urticaria, hair loss, photosensitivity, erythema multiforme, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, Riel syndrome, acute generalized pustular eruption, eosinophilia with systemic symptoms 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, fever, influenza-like illness, general edema, leg edema, malaise, pain, rigidity, anemia, hypochromic anemia, cervical lymphadenopathy, nosebleed, leukocytosis, leukopenia, thrombocytopenia, hyperbilirubinemia, abnormal liver function, increased ALT, increased AST, diabetes, hyperuricemia, increased ALP, thirst, vitamin B12 deficiency, weight gain, weight loss, exacerbation of arthritis, arthropathy, convulsion, fibromyalgia syndrome, hernia, rheumatoid polymyalgia, anorexia, apathy, increased appetite, confusion, worsening depression, hypertonia, sensory loss, erectile dysfunction, insomnia, migraine, worsening migraine, sleep disorder, tremor, visual field defect, dysmenorrhea, menstrual disorder, vaginitis, exacerbation of asthma, cough, shortness of breath, laryngeal edema, pharyngitis, rhinitis, sinusitis, acne, anal itching, erythema rash, papular rash, otitis media, abnormal olfaction, taste loss, taste dysgeusia, 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, rigidity, arrhythmia, seizure, systemic lupus erythematosus, cutaneous lupus erythematosus, gastric fundic polyps, hypocalcemia, hypokalemia, rhabdomyolysis

This drug should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. Storing it this way helps preserve the drug's effectiveness for a long time.

Appearance

A hard capsule with a greenish-blue upper part and a yellowish-brown lower part containing white or gray spherical fine granules.

Package unit

28 capsules/bottle, 100 capsules/bottle