Usmezol Capsule 40mg (Esomeprazole Magnesium Trihydrate)

Adult dosage

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. 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 in patients with mild to moderate hepatic impairment. Patients with severe hepatic impairment should not exceed a dose of 20 mg of this medicine. 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 medication should not be administered to certain patients. For example, patients with known allergies or a history of hypersensitivity to this drug or its components, or to benzimidazole group drugs, should not take this medication. Additionally, patients with hypersensitivity to penicillin antibiotics or macrolide antibiotics used in combination during Helicobacter pylori eradication therapy should also avoid this medication. There is a risk of interaction when combined with certain specific drugs, so patients taking terfenadine, cisapride, pimodipine, astemizole, atazanavir, nelfinavir, and rilpivirine containing products should also avoid this medication. Breastfeeding women should not take this medication. This medication can cause various adverse reactions. Common reactions may include headache, abdominal pain, diarrhea, constipation, nausea, vomiting, etc., while serious side effects such as blood disorders, hypersensitivity reactions, hypomagnesemia, neurological symptoms, liver function abnormalities, and skin rashes may occur infrequently. Long-term use requires regular health checks, especially for those taking it for over a year, as the risk of fractures and the possibility of hypomagnesemia should be closely monitored. Furthermore, since this medication inhibits gastric acid secretion and lowers the acidity in the stomach, there may be a slightly increased risk of gastrointestinal bacterial infections. If diarrhea persists, consult healthcare practitioners. This medication can interact with various drugs, so if other medications are being taken, it is crucial to inform a doctor or pharmacist. Caution is particularly needed when used in conjunction with warfarin, digoxin, methotrexate, and clopidogrel. Data on the safety of this medication during pregnancy is limited, so pregnant women should consult a physician before taking it. In case of overdose, there is no specific antidote; treatment should be symptomatic, and this medication is not removed by dialysis. Finally, it is essential to keep this medication out of the reach of children and not transfer it to other containers to maintain safety and quality.

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, anxiety, confusion, depression, aggression, hallucination, headache, dizziness, paresthesia, drowsiness, taste disorder, blurred vision, bronchospasm, pancreatitis, abdominal pain, constipation, diarrhea, abdominal distension, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis, elevated liver enzymes, hepatitis, jaundice, liver failure, encephalopathy, dermatitis, itching, rash, urticaria, hair loss, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, Ryu's syndrome, acute generalized exanthematous pustulosis, eosinophilia, drug reaction with systemic symptoms, fracture, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal distension, allergic reaction, back pain, chest pain, retrosternal pain, facial edema, facial flushing, fatigue, influenza-like illness, generalized edema, leg edema, malaise, pain, rigidity, anemia, hypopigmented anemia, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia, hyperbilirubinemia, liver dysfunction, elevated ALT, elevated AST, diabetes, hyperuricemia, elevated ALP, polydipsia, vitamin B12 deficiency, weight gain, weight loss, exacerbation of arthritis, arthropathy, convulsions, fibromyalgia syndrome, hernia, rheumatoid polymyalgia, loss of appetite, apathy, increased appetite, confusion, exacerbation of depression, muscle hypertonia, sensory impairment, erectile dysfunction, insomnia, migraine, exacerbation of migraines, sleep disorders, tremors, visual field defects, dysmenorrhea, menstrual disorders, vaginitis, exacerbation of asthma, cough, shortness of breath, laryngeal edema, pharyngitis, rhinitis, sinusitis, acne, anal itching, erythematous rash, papular rash, otitis media, altered sense of smell, loss of taste, taste distortion, abnormal urination, 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, mucosal discoloration, fracture, hypocalcemia, hypokalemia, rhabdomyolysis, myalgia, asthenia

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

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

Package unit

28 capsules/bottle