Exepium Tablet 40 mg (Esomeprazole Magnesium Trihydrate)

Adult dosage

This medication should be swallowed with liquids such as water and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD). - Treatment of erosive esophagitis: Administer 40 mg once daily for 4 weeks. If the esophagitis is not resolved or symptoms continue, extend treatment for an additional 4 weeks. - Long-term maintenance therapy for prevention of recurrence in patients with esophagitis: 20 mg once daily. - Treatment of symptoms of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptom control is not achieved after 4 weeks, further medical evaluation is required. · Once symptoms are alleviated, continue to administer 20 mg once daily to control recurring symptoms as needed. · In adults, 20 mg may be administered once daily as needed. It is not recommended to administer on an as-needed basis for symptom control in patients at high risk for developing gastric or duodenal ulcers related to non-steroidal anti-inflammatory drug use. 2) Combination therapy with antibiotics for the eradication of Helicobacter pylori: Administer 20 mg of this medication with 1 g of amoxicillin and 500 mg of clarithromycin twice daily for 7 days. 3) Short-term treatment for upper gastrointestinal symptoms (pain, discomfort, burning sensation) associated with non-steroidal anti-inflammatory drug (COX-2 non-selective and selective) administration: - 20 mg once daily. If symptom control is not achieved after 4 weeks, further medical evaluation is required. Clinical trials exceeding 4 weeks have not been conducted. 4) For patients requiring continuous non-steroidal anti-inflammatory drug administration: - Treatment of gastric ulcers associated with non-steroidal anti-inflammatory drugs: 20 mg once daily. The treatment duration is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drugs: 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, with treatment continued during the presence of clinical symptoms. According to clinical data, most patients can be managed on doses of 80 to 160 mg daily. Doses above 80 mg daily should be divided into two doses. 6) Maintenance therapy following intravenous induction for prevention of rebleeding due to gastric or duodenal ulcers: Administer 40 mg once daily for 4 weeks after intravenous induction for the prevention of rebleeding due to gastric or duodenal ulcers. 2. For adolescents aged 12 years and older: 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis is not resolved or symptoms persist, treat for an additional 4 weeks. - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptom control is not achieved after 4 weeks, further medical evaluation is required. · Once symptoms are alleviated, continue to administer 20 mg once daily to control recurring symptoms as needed. · In adults, 20 mg may be administered once daily as needed. It is not recommended to administer on an as-needed basis for symptom control in patients at high risk for developing gastric or duodenal ulcers related to non-steroidal anti-inflammatory drug use. 3. For children under 12 years: There is no experience administering this medication to children under 12. 4. Renal impairment: No dose adjustment is necessary. There is limited experience administering this medication to patients with severe renal failure, so it should be administered with caution. 5. Hepatic impairment: No dose adjustment is necessary for patients with mild to moderate liver impairment. For patients with severe liver impairment, this medication should not exceed a dose of 20 mg. 6. Elderly: No dose adjustment is necessary.

Children's dosage

For children aged 12 years and older: 1) Treatment of gastroesophageal reflux disease (GERD) erosive esophagitis: 40 mg once daily for 4 weeks. If esophagitis is not resolved or symptoms persist, treat for an additional 4 weeks.

This medication should not be administered to certain patients. For example, patients who are allergic to this medication or its components, or have had hypersensitivity reactions to benzimidazole derivatives should not use it. Also, patients with hypersensitivity to penicillins or macrolides should not be treated with this medication when combined with amoxicillin and clarithromycin for the eradication of Helicobacter pylori. Pregnant women or patients with a history of myocardial infarction, and those taking certain antiviral drugs (atazanavir, nelfinavir, rilpivirine) should avoid using this medication. Various adverse reactions may occur with this medication, with common effects including headache, abdominal pain, diarrhea, constipation, and nausea; rare effects include blood abnormalities, hypersensitivity reactions, hypomagnesemia, liver dysfunction, skin rash, and myalgia. Regular blood tests may be necessary due to the risk of hypomagnesemia, especially with long-term use, and any symptoms of myalgia or weakness should prompt immediate consultation with a physician. This medication suppresses gastric acid secretion, which can induce bacterial proliferation in the gastrointestinal tract; therefore, in cases of persistent or worsening diarrhea, the possibility of Clostridium difficile infection should be considered. Additionally, prolonged or high-dose use may increase the risk of bone fractures, so caution is advised in patients with osteoporosis. This medication may interact with other drugs, therefore it is essential to consult a doctor or pharmacist when combined with warfarin, digoxin, methotrexate, clopidogrel, and certain antiviral drugs. Data on use during pregnancy is limited, and caution is required when administering to pregnant women; it is safest to avoid use in breastfeeding women. In cases of overdose, no specific antidote exists, so treatment should be symptomatic, and it should be stored out of reach of children.

Serious side effects

Urticaria, angioedema, anaphylaxis/shock, angioedema, urticaria, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), jaundice, liver failure, encephalopathy, interstitial nephritis, rhabdomyolysis, severe edema, severe allergic reactions, severe skin adverse reactions, respiratory distress, asthma attacks.

Mild side effects

• Fever
• peripheral edema
• insomnia
• anxiety
• confusion
• depression
• aggression
• hallucinations
• headache
• dizziness

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to maintain the storage temperature between 1 and 30 degrees Celsius to preserve the medication's efficacy.

Appearance

Pink round film-coated tablet

Package unit

28 tablets (14 tablets/PTP × 2)