Nexzol Tablet 20 mg (Esomeprazole Magnesium Trihydrate)

Adult dosage

This medicine should be swallowed with a liquid such as water and must not be chewed or crushed. 1. Adults 1) Gastroesophageal reflux disease (GERD). - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis is 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 needed. · Once symptoms have resolved, subsequent recurrent symptoms are controlled by administering 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. As-needed administration to control recurrent symptoms is not recommended for patients at high risk of developing gastric and duodenal ulcers due to nonsteroidal anti-inflammatory drug 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, burning) 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 needed. Clinical trials of more than 4 weeks have not been conducted. 4) Patients requiring continuous nonsteroidal anti-inflammatory drug therapy - Treatment of gastric ulcers associated with nonsteroidal anti-inflammatory drug use: 20 mg once daily. The treatment period 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 above 80 mg per day should be divided and taken twice daily. 6) Maintenance therapy following induction of prevention of rebleeding due to gastric or duodenal ulcers with intravenous administration Administer 40 mg once daily for 4 weeks following induction of prevention of rebleeding due to gastric or duodenal ulcers with intravenous administration. 4. Renal impairment: No dose adjustment is necessary. Use with caution because there is limited experience with administration to patients with severe renal failure. 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 medicine should not exceed 20 mg. 6. Older adults: 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 is 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 needed. · Once symptoms have resolved, subsequent recurrent symptoms are controlled by administering 20 mg once daily. 3. Children under 12 years: There is no experience with administration of this medicine to children under 12 years.

This medication should not be used by patients with specific allergic reactions or a history of allergy to this drug or similar ingredients. Caution is required when used in combination with certain antibiotics or antiviral agents as side effects or drug interactions may occur. Patients with heart disease or a history of myocardial infarction, as well as breastfeeding women, should preferably avoid taking this medication. Various side effects may occur during the use of this medication, including headache, abdominal pain, diarrhea, skin rash, muscle pain, and hypomagnesemia. Especially with long-term use, regular blood tests and magnesium level checks are necessary. If serious muscle problems or systemic reactions occur, consult a healthcare professional immediately. This drug reduces stomach acid secretion, which can lead to bacterial overgrowth in the stomach, so if diarrhea persists, inform a healthcare professional. Furthermore, long-term use may increase the risk of fractures, so patients at risk of osteoporosis should exercise caution. This medication has significant potential for drug interactions; therefore, any concomitant medications must be disclosed to a doctor or pharmacist. Pregnant women should use this drug cautiously, and its use is not recommended during breastfeeding. There is no specific antidote for overdose, so appropriate treatment should be provided according to the symptoms, and it should be kept out of reach of children.

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, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, fracture, arthralgia, myalgia, muscle weakness, 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, generalized edema, leg edema, malaise, pain, stiffness, peripheral edema, flushing, hypertension, tachycardia, goiter, irritable bowel syndrome, worsening constipation, dyspepsia, dysphagia, gastrointestinal malformation, upper abdominal pain, belching, esophageal disorders, frequent bowel movements, gastroenteritis, gastrointestinal bleeding, hiccups, black stools, 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, thirst, vitamin B12 deficiency, weight gain, weight loss, exacerbation of arthritis, arthropathy, spasms, fibromyalgia syndrome, hernia, rheumatoid polymyalgia, arthralgia, anorexia, apathy, increased appetite, confusion, worsening depression, hypertonicity, anxiety, sensory impairment, erectile dysfunction, insomnia, migraine, exacerbation of migraine, sleep disorder, trembling, dizziness, visual field defect, 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, loss of taste, dysgeusia, urine 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, asthenia

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is also recommended to store it at a temperature between 1°C and 30°C at room temperature.

Appearance

Pale pink round film-coated tablet

Package unit

28 tablets (14 tablets/PTP packaging x 2)