Isosol 40mg (Esomeprazole Magnesium Trihydrate)

Adult dosage

This medication should be swallowed with a liquid such as water and should 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 has not healed or symptoms persist, continue treatment for an additional 4 weeks. - Long-term maintenance therapy to prevent relapse 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 may be controlled with 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. On-demand use to control recurrent symptoms is not recommended for patients at high risk of developing gastric and duodenal ulcers due to nonsteroidal anti-inflammatory drug treatment. 2) Combination therapy with antibiotics for eradication of Helicobacter pylori Administer this medication 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 needed. Clinical trials lasting more than 4 weeks have not been conducted. 4) Patients requiring continuous treatment with nonsteroidal anti-inflammatory drugs - Treatment of gastric ulcers associated with nonsteroidal anti-inflammatory drug treatment: 20 mg once daily. The treatment period is 4∼8 weeks. - Prevention of gastric and duodenal ulcers associated with nonsteroidal anti-inflammatory drug treatment: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg twice daily. The dose should then 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 daily. Doses above 80 mg daily should be divided and taken twice daily. 6) Maintenance therapy following induction of prevention of rebleeding from gastric or duodenal ulcers by intravenous injection Administer 40 mg once daily for 4 weeks following induction of prevention of rebleeding from gastric or duodenal ulcers by intravenous injection. 4. Renal impairment No dosage adjustment is necessary. Use with caution because there is limited experience in patients with severe renal impairment. 5. Hepatic impairment No dosage 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 medication. 6. Elderly patients No dosage 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 needed. · Once symptoms have resolved, subsequent recurrent symptoms may be controlled with 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. On-demand use to control recurrent symptoms is not recommended for patients at high risk of developing gastric and duodenal ulcers due to nonsteroidal anti-inflammatory drug treatment. 3. Children under 12 years There is no experience with administration of this medication to children under 12 years.

This medication should not be used in specific patients. It should not be administered to patients who are allergic to this drug or its components, or have a history of hypersensitivity to benzimidazole derivatives. Additionally, patients allergic to antibiotics such as amoxicillin or clarithromycin should avoid combined use when attempting to eradicate Helicobacter pylori. It is also advisable for patients taking certain cardiac-related medications or antiviral drugs and for breastfeeding women to avoid using this medication. This drug can rarely cause various adverse reactions such as blood abnormalities, allergic reactions, electrolyte imbalances, central nervous system symptoms, and gastrointestinal disorders. In particular, hypomagnesemia may occur, so regular blood tests and monitoring of condition are necessary for long-term use. If severe skin reactions or muscular symptoms appear, immediate consultation with a healthcare provider is recommended. This drug can increase the risk of bacterial overgrowth in the gastrointestinal tract by inhibiting gastric acid secretion and may particularly increase the risk of Clostridium difficile infection in hospitalized patients. Furthermore, long-term use may raise the risk of osteoporotic fractures, so caution is needed in patients at risk of fractures. This drug can interact with other medications, especially anticoagulants, antibiotics, antivirals, and anticonvulsants, so consultation with a specialist is advised when taken with these. If other medications are being taken, they must be disclosed, and dosage adjustments or monitoring may be necessary. Safety data on its use during pregnancy is limited, so women who are pregnant or planning to become pregnant should use it with caution, and it is recommended that breastfeeding women avoid this medication. In cases of overdose, there is no specific antidote, so treatment should be symptom-based with general supportive measures, and it should be stored safely out of reach of children. Also, transferring the medication to another container is discouraged due to the potential for quality degradation and accident risk.

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, anxiety, mental confusion, depression, aggression, hallucinations, headache, dizziness, altered perception, drowsiness, taste disorder, blurred vision, bronchospasm, pancreatitis, abdominal pain, constipation, diarrhea, abdominal distension, 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, mucous membrane syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, fractures, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, hyperhidrosis, Clostridium difficile-associated diarrhea, abdominal distension, allergic reaction, back pain, chest pain, substernal pain, facial edema, facial flushing, fatigue, influenza-like symptoms, generalized edema, leg edema, malaise, pain, stiffness, peripheral edema, flushing, hypertension, tachycardia, thyroid enlargement, irritable bowel syndrome, aggravated constipation, dyspepsia, dysphagia, gastrointestinal malformation, epigastric pain, belching, esophageal disorder, 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, nosebleed, leukocytosis, leukopenia, thrombocytopenia, hyperbilirubinemia, impaired liver function, increased ALT, increased AST, diabetes, hyperuricemia, increased ALP, polydipsia, vitamin B12 deficiency, weight gain, weight loss, aggravated arthritis, arthropathy, seizures, fibromyalgia, hernia, rheumatoid polymyalgia, anorexia, apathy, increased appetite, confusion, aggravated depression, muscle rigidity, sensory loss, erectile dysfunction, insomnia, migraine, aggravated migraine, sleep disorder, tremors, visual field defects, dysmenorrhea, menstrual disorders, vaginitis, aggravated asthma, cough, dyspnea, laryngeal edema, pharyngitis, rhinitis, sinusitis, acne, anal itching, erythematous rash, papular rash, otitis media, altered sense of smell, taste loss, taste distortion, 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 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 closed container to prevent exposure to air or moisture and should be kept at room temperature, between 1 and 30 degrees Celsius. By storing it this way, the effectiveness of the medication can be maintained for a longer period.

Appearance

Pink round film-coated tablets

Package unit

28 tablets/box [14 tablets/Alu-Alu × 2]