Medication info
Nexium Tablets 40 mg (Esomeprazole Magnesium Trihydrate)

Nexium Tablets 40 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›44.5mg / 1 tablet
Manufacturer / importer
엔비케이제약(주)
Appearance
Pink round film-coated tablet
Packaging
28 tablets/PTP [(14 tablets/Alu-Alu×2)]
Approval status
Active

MFDS item code 201907881 · Approved 2019.11.12 · Insurance code 054800570

Summary

Main use
Treatment of gastroesophageal reflux disease and gastrointestinal diseases related to Helicobacter pylori infection, as well as prevention of gastric ulcer recurrence.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquid such as water and should not be chewed or crushed. 1. Gastroesophageal Reflux Disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If symptoms persist or are not resolved, continue for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in esophagitis patients: 20 mg once daily. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: 20 mg once daily. If symptoms do not control after 4 weeks, additional medical care is needed. Once symptoms improve, subsequent symptoms can be managed with 20 mg once daily. In adults, 20 mg may be taken once daily as needed. Continuous management of symptoms in patients at high risk for gastric ulcer and duodenal ulcer development due to non-steroidal anti-inflammatory drug use is not recommended. 2) Combination antibiotic therapy for eradication of Helicobacter pylori Administer this drug at 20 mg along with amoxicillin 1 g and clarithromycin 500 mg, twice daily for 7 days. 3) Short-term therapy for upper gastrointestinal symptoms (pain, discomfort, burning sensation) associated with non-steroidal anti-inflammatory drug (COX-2 non-selective, selective) administration - 20 mg once daily. If symptoms are not controlled after 4 weeks, additional medical care is needed. Clinical trials have not been conducted beyond 4 weeks. 4) Patients requiring continuous administration of non-steroidal anti-inflammatory drugs - Treatment of gastric ulcers associated with non-steroidal anti-inflammatory drugs: 20 mg once daily. Duration of treatment is 4 to 8 weeks. - Prevention of gastric ulcers 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 a day. Further dosing should be adjusted per patient, and treatment should continue as long as clinical symptoms are present. According to clinical data, most patients can be managed with a dose of 80 to 160 mg daily. Doses above 80 mg daily should be divided into two doses. 6) Maintenance therapy following intravenous prevention of rebleeding due to gastric ulcers or duodenal ulcers After intravenous prevention of rebleeding due to gastric ulcers or duodenal ulcers, administer 40 mg once daily for 4 weeks. 2. Adolescents aged 12 and older 1) Gastroesophageal Reflux Disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If symptoms persist or are not resolved, patients should continue for an additional 4 weeks. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: 20 mg once daily. If symptoms are not controlled after 4 weeks, additional medical care is needed. Once symptoms improve, subsequent symptoms can be managed with 20 mg once daily. In adults, 20 mg can be taken once daily as needed. Continuous management of symptoms in patients at high risk for gastric ulcer and duodenal ulcer development due to non-steroidal anti-inflammatory drug use is not recommended. 3. Children under 12 years of age There is no experience in administering this drug to children under 12 years. 4. Renal impairment Adjustment of the dose is not required. There are not many cases in patients with severe renal failure, so it should be administered cautiously. 5. Liver dysfunction In patients with mild to moderate liver impairment, adjustment of the dose is not required. In patients with severe liver impairment, the dose should not exceed 20 mg. 6. Elderly patients Adjustment of the dose is not required.
Children's dosage
Adolescents aged 12 and older - For the treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If symptoms persist or are not resolved, continue for an additional 4 weeks. - For gastroesophageal reflux disease without esophagitis symptoms.

Ingredients

Manufacturer
엔비케이제약(주)

Efficacy & effects

Treatment of gastroesophageal reflux disease and gastrointestinal diseases related to Helicobacter pylori infection, as well as prevention of gastric ulcer recurrence.

  • Gastroesophageal reflux disease
  • erosive esophagitis
  • esophagitis
  • duodenal ulcers
  • peptic ulcers
  • upper gastrointestinal pain
  • upper gastrointestinal discomfort
  • upper gastrointestinal burning
  • gastric ulcers
  • duodenal ulcers
  • Zollinger-Ellison syndrome
  • rebleeding.
View approved original text

This medication is used for the treatment of gastroesophageal reflux disease, especially erosive esophagitis, and for long-term maintenance therapy to prevent recurrence in esophagitis patients. It is also effective in treating and preventing recurrence of duodenal ulcers and peptic ulcers as part of a combination antibiotic therapy for eradication of Helicobacter pylori. Additionally, it helps in treating and preventing upper gastrointestinal symptoms and gastric ulcers caused by the use of non-steroidal anti-inflammatory drugs. It is used in the treatment of Zollinger-Ellison syndrome and for maintenance therapy to prevent rebleeding after intravenous administration of gastric ulcers and duodenal ulcers. Overall, it is an effective drug for the treatment and prevention of various gastrointestinal-related diseases.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquid such as water and should not be chewed or crushed. 1. Gastroesophageal Reflux Disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If symptoms persist or are not resolved, continue for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in esophagitis patients: 20 mg once daily. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: 20 mg once daily. If symptoms do not control after 4 weeks, additional medical care is needed. Once symptoms improve, subsequent symptoms can be managed with 20 mg once daily. In adults, 20 mg may be taken once daily as needed. Continuous management of symptoms in patients at high risk for gastric ulcer and duodenal ulcer development due to non-steroidal anti-inflammatory drug use is not recommended. 2) Combination antibiotic therapy for eradication of Helicobacter pylori Administer this drug at 20 mg along with amoxicillin 1 g and clarithromycin 500 mg, twice daily for 7 days. 3) Short-term therapy for upper gastrointestinal symptoms (pain, discomfort, burning sensation) associated with non-steroidal anti-inflammatory drug (COX-2 non-selective, selective) administration - 20 mg once daily. If symptoms are not controlled after 4 weeks, additional medical care is needed. Clinical trials have not been conducted beyond 4 weeks. 4) Patients requiring continuous administration of non-steroidal anti-inflammatory drugs - Treatment of gastric ulcers associated with non-steroidal anti-inflammatory drugs: 20 mg once daily. Duration of treatment is 4 to 8 weeks. - Prevention of gastric ulcers 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 a day. Further dosing should be adjusted per patient, and treatment should continue as long as clinical symptoms are present. According to clinical data, most patients can be managed with a dose of 80 to 160 mg daily. Doses above 80 mg daily should be divided into two doses. 6) Maintenance therapy following intravenous prevention of rebleeding due to gastric ulcers or duodenal ulcers After intravenous prevention of rebleeding due to gastric ulcers or duodenal ulcers, administer 40 mg once daily for 4 weeks. 2. Adolescents aged 12 and older 1) Gastroesophageal Reflux Disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If symptoms persist or are not resolved, patients should continue for an additional 4 weeks. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: 20 mg once daily. If symptoms are not controlled after 4 weeks, additional medical care is needed. Once symptoms improve, subsequent symptoms can be managed with 20 mg once daily. In adults, 20 mg can be taken once daily as needed. Continuous management of symptoms in patients at high risk for gastric ulcer and duodenal ulcer development due to non-steroidal anti-inflammatory drug use is not recommended. 3. Children under 12 years of age There is no experience in administering this drug to children under 12 years. 4. Renal impairment Adjustment of the dose is not required. There are not many cases in patients with severe renal failure, so it should be administered cautiously. 5. Liver dysfunction In patients with mild to moderate liver impairment, adjustment of the dose is not required. In patients with severe liver impairment, the dose should not exceed 20 mg. 6. Elderly patients Adjustment of the dose is not required.

Children's dosage

Adolescents aged 12 and older - For the treatment of erosive esophagitis: 40 mg once daily for 4 weeks. If symptoms persist or are not resolved, continue for an additional 4 weeks. - For gastroesophageal reflux disease without esophagitis symptoms.

Precautions

This drug should not be administered to certain patients. Patients who have had allergies or hypersensitivity reactions to this drug, its components, or similar classes of drugs should not take it. Also, patients taking certain antibiotics or antiviral agents, as well as some heart-related medications, should not use this drug. Nursing women should also refrain from taking this drug. Since this medication contains lactose, it should not be used by patients with lactose intolerance or related genetic disorders. Various adverse reactions may occur while taking this medication, so caution is advised. Reports of side effects include blood abnormalities, allergic reactions, electrolyte imbalances, psychiatric disorders, neurological symptoms, gastrointestinal disturbances, liver function abnormalities, skin rashes, etc. In particular, if muscle pain or weakness occurs, the possibility of rhabdomyolysis should be considered, and immediate consultation with a healthcare professional is advised. Regular check-ups are necessary for long-term use, and if there are symptoms suggestive of malignant tumors, they should be confirmed before taking the medication. Furthermore, as the acidity in the stomach may decrease due to this drug, increasing the risk of certain bacterial infections, if symptoms such as diarrhea persist, consultation with a physician is necessary. There may also be an increased risk of fractures, so patients with osteoporosis need regular monitoring. This drug can interact with other medications, so if you are taking other medications, make sure to inform your doctor or pharmacist. Caution is particularly needed when used in combination with anticoagulants, anticonvulsants, antidepressants, antiviral agents, and certain antibiotics. During pregnancy, the data regarding the safety of this drug is limited, so it should be used cautiously, and it is advisable not to take it while breastfeeding. In case of overdose, there is no specific antidote, so appropriate treatment should be sought immediately at a hospital. When storing this drug, it should be kept out of reach of children, and it is safest not to transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylactic reaction, shock, jaundice, hepatitis, liver failure, encephalopathy, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), interstitial nephritis, venous arrhythmias, QT prolongation, ventricular tachycardia, ventricular fibrillation, Torsades de pointes, acute seizures, consciousness disturbance.

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • insomnia
  • anxiety
  • mental confusion
  • depression
  • aggressiveness
  • hallucinations
  • taste disorders
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  • blurred vision
  • bronchospasm
  • abdominal pain
  • constipation
  • diarrhea
  • abdominal distension
  • nausea
  • vomiting
  • dry mouth
  • stomatitis
  • increased liver enzymes
  • dermatitis
  • itching
  • rash
  • hair loss
  • photosensitivity
  • fractures
  • arthralgia
  • myalgia
  • muscle weakness
  • asthenia
  • increased sweating
  • anemia
  • hypopigmented anemia
  • nosebleed
  • leukocytosis
  • leukopenia
  • thrombocytopenia

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature. This helps preserve the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

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

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.