Esomark Tablet 40 mg (Esomeprazole Magnesium Trihydrate)

Adult dosage

This medicine should be swallowed with a liquid such as water and must 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. Patients whose esophagitis has not healed or whose symptoms persist should take the medicine 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 needed. · Once symptoms have resolved, subsequent recurrent symptoms may be controlled by administering 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. As-needed administration is not recommended for controlling recurrent symptoms in patients at high risk of developing gastric or duodenal ulcers due to treatment with nonsteroidal anti-inflammatory drugs. 2) Combination therapy with antibiotics for eradication of Helicobacter pylori Administer this medicine 20 mg with amoxicillin 1 g and clarithromycin 500 mg 2 times daily for 7 days. 3) Short-term treatment of upper gastrointestinal symptoms (pain, discomfort, burning sensation) associated with 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. No clinical trials exceeding 4 weeks have been conducted. 4) Patients requiring continuous treatment with nonsteroidal anti-inflammatory drugs - Treatment of gastric ulcers associated with 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 use of nonsteroidal anti-inflammatory drugs: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg 2 times daily. The dose should then be adjusted individually, and treatment should continue while clinical symptoms are present. According to clinical data, most patients can be controlled with doses of 80 ∼ 160 mg daily. Doses above 80 mg daily should be divided into 2 doses. 6) Maintenance therapy following intravenous induction to prevent rebleeding due to gastric or duodenal ulcers Administer 40 mg once daily for 4 weeks following intravenous induction to prevent rebleeding due to gastric or duodenal ulcers. 4. Renal impairment No dose adjustment is necessary. Use with caution because there is limited experience administering this medicine to patients with severe renal impairment. 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. Older adults No dose adjustment is necessary.

Children's dosage

Adolescents aged 12 years or older: Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. Patients whose esophagitis has not healed or whose symptoms persist should take the medicine for an additional 4 weeks. Adolescents aged 12 years or older: Symptomatic treatment of gastroesophageal reflux disease without esophagitis: 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is needed. Adolescents aged 12 years or older: Once symptoms have resolved, subsequent recurrent symptoms may be controlled by administering 20 mg once daily. Adolescents aged 12 years or older: In adults, 20 mg may be administered once daily as needed. As-needed administration is not recommended for controlling recurrent symptoms in patients at high risk of developing gastric and duodenal ulcers due to treatment with nonsteroidal anti-inflammatory drugs. Children under 12 years of age: There is no experience administering this medicine to children under 12 years of age.

This medication should not be used in patients who are allergic to specific components or have a history of hypersensitivity to benzimidazole derivatives. Moreover, caution is required when combining this medication with penicillin or macrolide antibiotics in patients with known allergies. Patients taking certain heart-related medications or antiviral agents, as well as women with a history of myocardial infarction or who are nursing, are advised not to use this medication. This drug may cause various side effects, with common occurrences being headache, abdominal pain, diarrhea, etc. Rarely, blood abnormalities, severe allergic reactions, liver function impairment, and skin rashes have been reported. Long-term use may result in issues such as hypomagnesemia, increased risk of fractures, and increased risk of gastrointestinal infections, so regular check-ups are necessary. This drug suppresses gastric acid secretion, lowering acidity in the stomach, which may affect the absorption of certain medications, leading to interactions; therefore, consultation with a healthcare provider is essential when taken alongside other medications. Particularly, caution should be exercised when combined with anticoagulants like warfarin, as well as certain antiviral agents, antibiotics, and antiepileptics. During pregnancy, data on the safety of this drug is limited, thus it should be used cautiously under the judgment of a physician. It is advisable not to take this drug while breastfeeding. In case of overdose, since there is no specific antidote, symptomatic treatment is necessary, and the medication should be kept out of reach of children.

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, anxiety, mental confusion, depression, aggression, hallucinations, headache, dizziness, abnormal perception, 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, hepatitis, liver failure, encephalopathy, dermatitis, itching, rash, urticaria, hair loss, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, Lyell syndrome, acute generalized exanthematous pustulosis, eosinophilia, drug reactions 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, sternum pain, facial edema, facial flushing, fatigue, fever, influenza-like illness, generalized edema, leg edema, malaise, pain, stiffness, peripheral edema, flushing, hypertension, tachycardia, goiter, irritable bowel syndrome, exacerbation of constipation, dyspepsia, dysphagia, gastrointestinal developmental disorders, epigastric pain, belching, esophageal disorders, frequent bowel movements, gastroenteritis, gastrointestinal bleeding, hiccups, melena, oral disorders, pharyngeal disorders, rectal disorders, gastrointestinal symptoms, elevated serum gastrin, tongue disorders, tongue edema, ulcerative stomatitis, vomiting, ear pain, tinnitus, anemia, hypochromic anemia, cervical lymphadenopathy, nosebleed, leukocytosis, leukopenia, thrombocytopenia, hyperbilirubinemia, abnormal liver function, elevated ALT, elevated AST, diabetes, hyperuricemia, elevated ALP, polydipsia, vitamin B12 deficiency, weight gain, weight loss, exacerbation of arthritis, arthropathy, seizures, fibromyalgia syndrome, hernia, rheumatoid polymyalgia, arthralgia, loss of appetite, apathy, increased appetite, confusion, exacerbation of depression, hypertonicity, anxiety, sensory impairment, erectile dysfunction, insomnia, migraine, exacerbation of migraine, sleep disorders, tremors, dizziness, visual field defects, abnormal perception, drowsiness, dysmenorrhea, menstrual disorders, vaginitis, exacerbation of asthma, cough, dyspnea, laryngeal edema, pharyngitis, rhinitis, sinusitis, acne, anal itching, rash, erythema rash, papular rash, angioedema, dermatitis, itching, urticaria, increased sweating, otitis media, abnormal olfaction, taste loss, taste disorientation, 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, gastric adenomatous polyp, hypocalcemia, hypokalemia, rhabdomyolysis

This medication should be stored in a tightly closed container to prevent the ingress of air or moisture. It is advisable to store it at room temperature, between 1°C and 30°C.

Appearance

Pink round film-coated tablet

Package unit

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