Osium 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. 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 used in patients with specific allergic reactions or those who have previously had allergies to this drug or similar ingredients. Patients taking certain antibiotics or medications, particularly in combination with penicillin-type or macrolide antibiotics, should be cautious. Women who are pregnant or breastfeeding must consult a specialist before using this medication. If this drug is used long-term, regular check-ups must be conducted to confirm that there are no adverse reactions or side effects. Various side effects may occur during treatment, such as headache, dizziness, abdominal pain, skin rash, muscle pain, etc.; if symptoms are severe or persistent, one should consult a doctor immediately. Especially, this drug can lower gastric acidity, which may increase the risk of certain bacterial infections; thus, if gastrointestinal symptoms like diarrhea persist, inform healthcare professionals. Be aware that this drug may interact with many other medications, so if there are other medications being taken, it is vital to inform healthcare professionals, as the effects of some medications may change. During the treatment, the dose and duration directed by the doctor must be strictly followed, and one must not arbitrarily stop or increase the dose. If severe rashes or difficulty breathing, indicative of serious allergic reactions, appear, stop taking the medication immediately and seek emergency treatment. In case of overdose, there is no specific antidote, so visit a medical institution immediately for appropriate treatment. This medication must be stored out of the reach of children and it is advisable to avoid transferring it to other containers.

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, elevated liver enzymes, jaundice, hepatitis, liver failure, encephalopathy, dermatitis, itching, rash, urticaria, hair loss, photosensitivity, erythema multiforme, mucosal membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reactions with eosinophilia and systemic symptoms, fractures, arthralgia, myalgia, muscle weakness, nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal distension, allergic reaction, back pain, chest pain, sternal pain, facial edema, facial flushing, fatigue, flu-like symptoms, generalized edema, leg edema, lethargy, pain, stiffness, anemia, hypopigmented anemia, cervical lymphadenopathy, nasal bleeding, leukocytosis, leukopenia, thrombocytopenia, hyperbilirubinemia, liver dysfunction, increased ALT, increased AST, diabetes, hyperuricemia, increased ALP, polydipsia, vitamin B12 deficiency, weight gain, weight loss, exacerbation of arthritis, arthropathy, convulsions, fibromyalgia syndrome, hernia, rheumatic polymyalgia, decreased appetite, apathy, increased appetite, confusion, worsening depression, hypertonicity, sensory loss, erectile dysfunction, insomnia, migraine, worsening migraine, sleep disorder, tremors, visual field defect, dysmenorrhea, menstrual disorders, vaginitis, worsening asthma, cough, shortness of breath, laryngeal edema, pharyngitis, rhinitis, sinusitis, acne, anal itching, erythematous rash, papular rash, otitis media, dysosmia, taste loss, ageusia, abnormal urination, albuminuria, cystitis, dysuria, fungal infection, hematuria, urination 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, fundic gland polyp, hypocalcemia, hypokalemia, rhabdomyolysis

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature at room temperature between 1 degree and 30 degrees.

Appearance

A hard capsule with an upper turquoise blue part and a lower pale yellow part containing white or gray spherical fine granules.

Package unit

30 capsules/bottle, 100 capsules/bottle