Esomeprazole Magnesium Trihydrate 40mg (Eprasol Tablet)

Adult dosage

This medication must be swallowed with liquids such as water and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. - If esophagitis fails to respond or symptoms continue, continue for an additional 4 weeks. - Long-term maintenance therapy for the prevention of recurrence in esophagitis patients: 20 mg once daily. - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, additional evaluation is necessary. · Once symptoms are relieved, continuous symptoms should be controlled by administering 20 mg once daily. · In adults, 20 mg can be administered as needed once daily. It is not recommended to administer on an as-needed basis for the continuous control of symptoms in patients at high risk of developing gastric ulcers and duodenal ulcers due to non-steroidal anti-inflammatory drug use. 2) Antibiotic combination therapy for the eradication of Helicobacter pylori Administer 20 mg of this drug in combination with 1 g of Amoxicillin and 500 mg of Clarithromycin, two times a day for 7 days. 3) Short-term treatment for upper gastrointestinal symptoms (pain, discomfort, burning sensation) associated with non-steroidal anti-inflammatory drug administration (non-selective, selective COX-2) - 20 mg once daily. If symptoms are not controlled after 4 weeks, additional evaluation is necessary. Clinical trials exceeding 4 weeks have not been conducted. 4) Patients requiring long-term non-steroidal anti-inflammatory drug administration - Treatment of gastric ulcers associated with non-steroidal anti-inflammatory drug use: 20 mg once daily. Treatment duration is 4-8 weeks. - Prevention of gastric ulcers and duodenal ulcers associated with non-steroidal anti-inflammatory drug administration: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome Recommended starting dose is 40 mg twice daily. Subsequent doses should be adjusted according to the patient, and the treatment should continue as long as clinical symptoms persist. According to clinical data, the majority of patients can be managed at a dose of 80 to 160 mg daily. Doses exceeding 80 mg per day should be divided into two daily administrations. 6) Maintenance therapy following intravenous induction of prevention for rebleeding due to gastric or duodenal ulcers Administer 40 mg once daily for 4 weeks following induction for prevention of rebleeding due to gastric or duodenal ulcers. 2. Adolescents aged 12 and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis is not resolved or symptoms persist, continue 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, additional evaluation is necessary. · Once symptoms are relieved, continuous symptoms should be controlled by administering 20 mg once daily. · In adults, 20 mg can be administered as needed once daily. It is not recommended to administer on an as-needed basis for continuous control of symptoms in patients at high risk of developing gastric ulcers and duodenal ulcers due to non-steroidal anti-inflammatory drug use. 3. Children under 12 years There is no experience administering this medication to children under 12 years old. 4. Renal impairment There is no need to adjust the dosage. Caution should be exercised as there are not many cases of those who have been administered in severe renal impairment. 5. Hepatic impairment No dosage adjustment is necessary in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the dose should not exceed 20 mg. 6. Elderly No dosage adjustment is necessary.

Children's dosage

Adolescents aged 12 and older - Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. - If esophagitis is not resolved or symptoms persist, continue for an additional 4 weeks.

This medication should not be used by certain patients. For example, it should not be administered to those with an allergy to this drug or its components, or to those with hypersensitivity to certain antibiotics. Also, individuals with specific heart conditions or nursing women should not use this medication. Caution is required when using this medication as various side effects may occur. Common side effects include headaches, abdominal pain, diarrhea, nausea, and vomiting, while rare but serious symptoms may include blood disorders, allergic reactions, liver dysfunction, and skin rashes. When used for an extended period, regular health checks are necessary, particularly monitoring magnesium levels as there could be a risk of low magnesium levels, so blood tests for monitoring are crucial. Additionally, this medication has many drug interactions, and its effects may vary or side effects may increase based on the drugs taken together, so it is essential to inform a physician or pharmacist about any other medications being taken. Use during pregnancy or breastfeeding should be approached cautiously, and use should generally be avoided unless under special circumstances. In cases of overdose, as there are no specific antidotes, immediate hospital visit is necessary for proper treatment, and this medication is not eliminated by dialysis, so symptomatic treatment is required. This medication should be kept out of reach of children, and transferring it to another container could lead to degradation of quality or accidents, so care must be taken.

Serious side effects

Urticaria, angioedema, anaphylactic reaction/shock, hypomagnesemia, mental confusion, jaundice, hepatitis, liver failure, encephalopathy, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), rhabdomyolysis.

Mild side effects

Headaches, dizziness, sensory disturbances, drowsiness, taste disturbances, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, increased liver enzymes, dermatitis, itching, rash, hair loss, photosensitivity, fractures, arthralgia, myalgia, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, allergic reactions, facial swelling, facial flushing, fatigue, fever, hypertension,

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The proper storage temperature is room temperature between 1 to 30 degrees Celsius, and it should be avoided in extremely hot or cold places.

Appearance

Pink rectangular film-coated tablet

Package unit

28 tablets/PTP [(7 tablets/PTP × 4)]