Esomeprazole 40 mg Tablets (Esomeprazole Magnesium Trihydrate)

Adult dosage

This medicine should be swallowed with a liquid such as water. Do not chew or crush it. 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 required. · Once symptoms have resolved, control subsequent symptoms by administering 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. For patients at high risk of developing gastric and duodenal ulcers due to NSAID use, as-needed administration is not recommended to control subsequent symptoms. 2) Combination therapy with antibiotics for eradication of Helicobacter pylori Administer this medicine 20 mg 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 required. Clinical trials exceeding 4 weeks have not been conducted. 4) Patients requiring continuous NSAID therapy - Treatment of gastric ulcers associated with NSAID use: 20 mg once daily. The treatment duration 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. The dose should subsequently 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 greater than 80 mg per day should be divided and taken twice daily. 6) Maintenance therapy following induction with intravenous treatment to prevent rebleeding from gastric or duodenal ulcers Administer 40 mg once daily for 4 weeks following induction with intravenous treatment to prevent rebleeding from 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 impairment. 5. Hepatic impairment No dose adjustment is necessary in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, do 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. 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 medical evaluation is required. · Once symptoms have resolved, subsequent symptoms are controlled by administering 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. Use as needed to control subsequent symptoms is not recommended for patients at high risk of developing gastric and duodenal ulcers due to treatment with nonsteroidal anti-inflammatory drugs. 3. Children under 12 years of age There is no experience with administration of this medicine to children under 12 years of age.

This medicine should not be used in patients who have specific allergic reactions or a history of allergy to this drug or similar components. Additionally, it is important to consult a doctor when taken together with certain antibiotics or other medications, as side effects or interactions may occur. Women who are breastfeeding or patients with a history of myocardial infarction should also avoid this medication. While taking this drug, various side effects such as headache, dizziness, abdominal pain, diarrhea, skin rash may appear, and if symptoms are severe or persistent, a doctor should be notified immediately. Regular health check-ups are necessary during long-term use, particularly monitoring should be done for the side effect of decreased magnesium levels. This drug can reduce stomach acid secretion, which may increase the risk of bacterial growth in the stomach, heightening the risk of infections such as diarrhea. Additionally, long-term use may increase the risk of bone fractures, so patients with osteoporosis should be careful. When taking this drug with other medications, it is crucial to inform healthcare professionals about all medications being taken due to the potential for drug interactions. During pregnancy, the safety of this medication has not been fully established, so it should only be used cautiously when necessary. There is no specific antidote for overdose, and proper treatment should be given according to symptoms; it is also important to keep this medication out of the reach of children.

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, anxiety, mental confusion, depression, aggressiveness, hallucinations, headache, dizziness, paresthesia, 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, jaundice, hepatitis, liver failure, encephalopathy, dermatitis, itching, rash, urticaria, hair loss, photosensitivity, erythema multiforme, skin-mucosa syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized pustular psoriasis, eosinophilia and systemic symptoms with drug reactions, fractures, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal bloating, allergic reactions, back pain, chest pain, sternal pain, facial edema, facial flushing, fatigue, fever, influenza-like illness, generalized edema, leg edema, lethargy, pain, stiffness, peripheral edema, flushing, hypertension, tachycardia, goiter, irritable bowel syndrome, constipation worsening, dyspepsia, dysphagia, gastrointestinal malformation, epigastric pain, belching, esophageal disorders, frequent bowel movements, gastroenteritis, gastrointestinal bleeding, hiccups, black stools, oral disorders, pharyngeal disorders, rectal disorders, gastrointestinal symptoms, increased plasma gastrin, tongue disorders, tongue edema, ulcerative stomatitis, vomiting, otitis, tinnitus, anemia, hypochromic anemia, cervical lymphadenopathy, nosebleeds, leukocytosis, leukopenia, thrombocytopenia, hyperbilirubinemia, liver dysfunction, increased ALT, increased AST, diabetes, hyperuricemia, increased ALP, thirst, 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, worsening depression, hypertonia, anxiety, sensory decrease, erectile dysfunction, insomnia, migraine, exacerbation of migraine, sleep disorders, tremors, dizziness, visual field defects, paresthesia, drowsiness, dysmenorrhea, menstrual disorders, vaginitis, exacerbation of asthma, cough, dyspnea, laryngeal edema, pharyngitis, rhinitis, sinusitis, acne, anal itching, rash, erythematous rash, papular rash, angioedema, dermatitis, itching, urticaria, increased sweating, otitis media, altered olfaction, loss of taste, taste alteration, urinary abnormalities, albuminuria, cystitis, dysuria, fungal infections, hematuria, micturition frequency, candidiasis, genital candidiasis, polyuria, conjunctivitis, visual disturbances, duodenitis, esophagitis, esophageal stricture, esophageal ulcers, esophageal varices, gastric ulcers, gastritis, benign polyps or nodules, Barrett's esophagus, mucosal discoloration, hernia, systemic lupus erythematosus, cutaneous lupus erythematosus, hypocalcemia, hypokalemia, rhabdomyolysis, myalgia, asthenia

This medication may be sensitive to air or moisture, therefore it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1°C and 30°C.

Appearance

Pink round film-coated tablets

Package unit

28 tablets (14 tablets/ Alu-Alu X 2)