Esomark Capsule 40 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. For patients whose esophagitis has not healed or whose 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 necessary. · Once symptoms have resolved, subsequent recurring symptoms are controlled with 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 treatment with nonsteroidal anti-inflammatory drugs. 2) Combination therapy with antibiotics for Helicobacter pylori eradication 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 sensation) 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 necessary. Clinical studies extending beyond 4 weeks have not been conducted. 4) Patients requiring continuous treatment with nonsteroidal anti-inflammatory drugs - Treatment of gastric ulcers associated with the use of nonsteroidal anti-inflammatory drugs: 20 mg once daily. The treatment period is 4∼8 weeks. - Prevention of gastric and duodenal ulcers associated with the use of nonsteroidal anti-inflammatory drugs: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg twice daily. The dose should thereafter 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 above 80 mg per day should be divided into two doses. 6) Maintenance therapy following intravenous induction of prevention of rebleeding due to gastric or duodenal ulcers Administer 40 mg once daily for 4 weeks following intravenous induction of prevention of rebleeding due to gastric or duodenal ulcers. 4. Renal impairment No dose adjustment is necessary. Use with caution because there is limited experience in 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. 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 necessary. · Once symptoms have resolved, subsequent recurring symptoms are controlled with 20 mg once daily. 3. Children under 12 years of age There is no experience with administering this medicine to children under 12 years of age.

This medicine should not be administered to patients who are hypersensitive to benzimidazole compounds or have experienced such reactions in the past. Furthermore, caution should be exercised when combined with this medication in patients with allergies to penicillin-class or macrolide-class antibiotics. Serious side effects may occur when combined with certain heart-related medications or antiviral agents, so it is essential to consult a physician if any other medications are currently being taken. This drug should not be administered to breastfeeding women. It is crucial to regularly check for adverse reactions, such as through blood tests, during long-term use. This medication suppresses gastric acid secretion and may increase the risk of bacterial overgrowth in the stomach. Thus, if gastrointestinal symptoms such as diarrhea persist, immediate consultation with healthcare professionals is necessary. The risk of fractures may increase with long-term use, so attention must be paid to bone health, and bone density testing is recommended if necessary. Hypomagnesemia may occur, so regular blood tests are needed when taking this medicine for an extended period or concurrently with medications that lower magnesium levels. If any hypersensitivity reactions such as skin rash, difficulty breathing, or facial swelling occur while taking this medication, it should be discontinued immediately, and medical attention should be sought. There is a high possibility of interactions with other medications, so all current medications should be disclosed to healthcare professionals and taken according to their guidance. The safety of this drug has not been fully established during pregnancy, so it is essential to consult a physician thoroughly before taking it during pregnancy. There are no specific antidotes in case of overdose; therefore, appropriate treatment should be sought immediately at a hospital when symptoms appear. This medication should be kept out of the reach of children, and transferring it to another container should be avoided as it may cause quality degradation or accidents.

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, anxiety, mental confusion, depression, aggression, hallucinations, headache, dizziness, perceptual disturbances, drowsiness, taste disorders, blurred vision, bronchospasm, pancreatitis, abdominal pain, constipation, diarrhea, abdominal distension, nausea, vomiting, xerostomia, 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, Reiter's syndrome, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, fractures, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal bloating, allergic reaction, back pain, chest pain, substernal chest pain, facial edema, facial flushing, fatigue, flu-like symptoms, generalized edema, leg edema, lethargy, pain, stiffness, anemia, hypopigmented anemia, cervical lymphadenopathy, epistaxis, 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, anorexia, apathy, increased appetite, confusion, worsening of depression, hypertonia, sensory loss, erectile dysfunction, insomnia, migraine, exacerbation of migraine, sleep disorders, tremors, visual field defects, dysmenorrhea, menstrual disorders, vaginitis, exacerbation of asthma, cough, dyspnea, laryngeal edema, pharyngitis, rhinitis, sinusitis, acne, anal itching, erythematous rash, papular rash, otitis media, abnormal olfaction, taste loss, taste disorder, 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

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. Proper storage will help sustain the medication's effectiveness and ensure safe use.

Appearance

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

Package unit

28 capsules/bottle