Osiome Capsule 40 mg (Esomeprazole Magnesium Trihydrate)

Adult dosage

Adults 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 for an additional 4 weeks. Long-term maintenance treatment 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 episodes may be controlled with 20 mg once daily. In adults, 20 mg may be administered once daily as needed. As-needed administration is not recommended for ongoing symptom control in patients at high risk of developing gastric and duodenal ulcers due to treatment with nonsteroidal anti-inflammatory drugs. Antibiotic combination therapy for Helicobacter pylori eradication Administer this medicine 20 mg in combination with amoxicillin 1 g and clarithromycin 500 mg twice daily for 7 days. Short-term treatment of upper gastrointestinal symptoms (pain, discomfort, heartburn) associated with nonsteroidal anti-inflammatory drug use (nonselective or selective COX-2 inhibitors) 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is required. Clinical trials lasting more than 4 weeks have not been conducted. Patients requiring ongoing 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. 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 be continued while clinical symptoms are present. Clinical data indicate that most patients can be controlled with a dose of 80 ∼ 160 mg per day. Doses greater than 80 mg per day should be divided into 2 doses. 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. In adults, 20 mg may be administered once daily as needed. As-needed administration is not recommended for ongoing symptom control in patients at high risk of developing gastric and duodenal ulcers due to treatment with nonsteroidal anti-inflammatory drugs. Renal impairment No dosage adjustment is required. Use with caution in patients with severe renal impairment because experience in these patients is limited. Hepatic impairment No dosage adjustment is required in patients with mild to moderate hepatic impairment. The dose of this medicine should not exceed 20 mg in patients with severe hepatic impairment. Older adults No dosage adjustment is required.

Children's dosage

Adolescents aged 12 years and older 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. 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. It should not be used in patients who are allergic to this medication, any of its components, or to benzimidazole derivatives. Additionally, patients allergic to amoxicillin or clarithromycin should not be treated when this medication is combined for the eradication of Helicobacter pylori. Patients taking specific heart-related medications or antiviral medications such as atazanavir, nelfinavir, or rilpivirine, and nursing women should not use this medication. Various adverse reactions may occur while taking this medication, with common symptoms including headache, abdominal pain, diarrhea, constipation, and nausea. Rarely, serious side effects such as blood disorders, allergic reactions, hypomagnesemia, mental confusion, skin rashes, and liver function abnormalities may occur; thus, if any unusual symptoms arise, medical consultation should be sought immediately. Regular examinations are required for long-term use, and if symptoms such as muscle pain or weakness appear, the possibility of rhabdomyolysis should be suspected and treated promptly. This medication suppresses gastric acid secretion, which may slightly increase the risk of bacterial infections in the gastrointestinal tract, and long-term high-dose use can increase the risk of fractures. Additionally, prolonged use beyond 3 months may lead to hypomagnesemia; thus, periodic monitoring of magnesium levels is necessary. This medication can interact with multiple other drugs; therefore, patients taking other medications must inform their healthcare provider or pharmacist, particularly those taking warfarin, methotrexate, antiviral medications, or antibiotics. Data regarding the safety of this medication during pregnancy is limited, so pregnant women should use it cautiously after consulting their doctor, and nursing women are advised not to take this medication. In the event of overdose, there is no specific antidote, and appropriate treatment according to the symptoms should be administered, as this medication is not removed by dialysis. Finally, this medication should be kept out of reach of children and not be transferred to another container, which is beneficial for maintaining quality.

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, agitation, mental confusion, depression, aggression, hallucinations, headache, dizziness, paresthesia, drowsiness, taste disturbances, 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, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, eosinophilia with systemic symptoms drug reaction, fracture, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal distension, allergic reaction, back pain, chest pain, sternal pain, facial swelling, facial flushing, fatigue, fever, influenza-like illness, generalized edema, leg edema, malaise, pain, stiffness, peripheral edema, flushing, hypertension, tachycardia, thyroid neoplasm, irritable bowel syndrome, worsening constipation, dyspepsia, dysphagia, gastrointestinal dysmotility, epigastric pain, belching, esophageal disorders, frequent bowel movements, gastroenteritis, gastrointestinal bleeding, hiccups, melena, oral disorders, pharyngeal disorders, rectal disorders, gastrointestinal symptoms, increased serum gastrin, tongue disorders, tongue swelling, ulcerative stomatitis, earache, tinnitus, anemia, hypopigmented anemia, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia, hyperbilirubinemia, abnormal liver function, increased ALT, increased AST, diabetes, hyperuricemia, increased ALP, polydipsia, vitamin B12 deficiency, weight gain, weight loss, exacerbation of arthritis, arthropathy, seizures, fibromyalgia syndrome, hernia, rheumatoid polymyalgia, anorexia, apathy, increased appetite, confusion, exacerbation of depression, hypertonia, sensory loss, erectile dysfunction, insomnia, migraine, exacerbation of migraine, sleep disorders, tremor, visual field defects, dysmenorrhea, menstrual disorders, vaginitis, exacerbation of asthma, cough, dyspnea, laryngeal edema, pharyngitis, rhinitis, sinusitis, acne, anorectal itching, erythematous rash, papular rash, otitis media, abnormal sense of smell, loss of taste, taste distortion, 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 may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the medication's efficacy.

Appearance

Hard capsules in green color containing white or gray spherical fine granules

Package unit

30 capsules/bottle, 100 capsules/bottle