Medication info
Nexipra Tablet 20 mg (Esomeprazole Magnesium Trihydrate)

Nexipra Tablet 20 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Esomeprazole Magnesium Trihydrate›22.3mg / 1 tablet
Manufacturer / importer
국제약품(주)
Appearance
Pale pink round film-coated tablet
Packaging
28 tablets (14 tablets/PTP × 2)
Approval status
Active

MFDS item code 201403997 · Approved 2014.08.27 · Insurance code 643703840

Summary

Main use
Treatment and prevention of relapse for gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, relief of upper gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with fluids 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 is not resolved or symptoms persist, continue for another 4 weeks. - Long-term maintenance therapy for prevention of recurrence in patients with esophagitis: 20 mg once daily. - Symptomatic treatment regimen for gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical evaluation is required. · Once symptoms are alleviated, further symptoms should be controlled by administering 20 mg once daily. · In adults, 20 mg can be given as needed. It is not recommended to administer it as needed for ongoing symptom control in patients with a high risk of gastric or duodenal ulcers due to non-steroidal anti-inflammatory drug administration. 2. Antibiotic combination therapy for the eradication of Helicobacter pylori: Administer this medication 20 mg in conjunction with 1 g of amoxicillin and 500 mg of clarithromycin twice daily for 7 days. 3. Short-term treatment of upper gastrointestinal symptoms (pain, discomfort, burning sensation) related to the administration of non-steroidal anti-inflammatory drugs (COX-2 non-selective, selective): 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical evaluation is necessary. 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 drug administration: 20 mg once daily. Treatment duration is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug administration: 20 mg once daily. 5. Treatment of Zollinger-Ellison syndrome: The recommended initial dose is 40 mg twice daily. Subsequent dosing should be adjusted based on the individual patient, continuing the treatment for as long as clinical symptoms persist. According to clinical data, most patients can be managed at doses between 80 mg and 160 mg daily. Doses above 80 mg daily should be divided into 2 doses. 6. Maintenance therapy following intravenous induction for prevention of rebleeding from gastric or duodenal ulcers: Following intravenous induction for prevention of rebleeding, administer 40 mg once daily for 4 weeks.
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 treated or symptoms persist, continue for another 4 weeks.

Ingredients

Manufacturer
국제약품(주)

Efficacy & effects

Treatment and prevention of relapse for gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, relief of upper gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs.

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

This medication is used as maintenance therapy to treat gastroesophageal reflux disease and to prevent relapse of erosive reflux esophagitis. It is also effective for the treatment and prevention of recurrence of duodenal ulcers and gastric ulcers when used in combination with antibiotics for the eradication of Helicobacter pylori. It is used for alleviating upper gastrointestinal symptoms and treating gastric ulcers, as well as preventing gastric and duodenal ulcers. It may assist in the treatment of Zollinger-Ellison syndrome and is used as maintenance therapy after intravenous induction for the prevention of re-bleeding from gastric or duodenal ulcers. Overall, this drug is used for treating various gastrointestinal disorders and preventing recurrence.

Dosage and Administration

Adult dosage

This medication should be swallowed with fluids 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 is not resolved or symptoms persist, continue for another 4 weeks. - Long-term maintenance therapy for prevention of recurrence in patients with esophagitis: 20 mg once daily. - Symptomatic treatment regimen for gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical evaluation is required. · Once symptoms are alleviated, further symptoms should be controlled by administering 20 mg once daily. · In adults, 20 mg can be given as needed. It is not recommended to administer it as needed for ongoing symptom control in patients with a high risk of gastric or duodenal ulcers due to non-steroidal anti-inflammatory drug administration. 2. Antibiotic combination therapy for the eradication of Helicobacter pylori: Administer this medication 20 mg in conjunction with 1 g of amoxicillin and 500 mg of clarithromycin twice daily for 7 days. 3. Short-term treatment of upper gastrointestinal symptoms (pain, discomfort, burning sensation) related to the administration of non-steroidal anti-inflammatory drugs (COX-2 non-selective, selective): 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical evaluation is necessary. 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 drug administration: 20 mg once daily. Treatment duration is 4 to 8 weeks. - Prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug administration: 20 mg once daily. 5. Treatment of Zollinger-Ellison syndrome: The recommended initial dose is 40 mg twice daily. Subsequent dosing should be adjusted based on the individual patient, continuing the treatment for as long as clinical symptoms persist. According to clinical data, most patients can be managed at doses between 80 mg and 160 mg daily. Doses above 80 mg daily should be divided into 2 doses. 6. Maintenance therapy following intravenous induction for prevention of rebleeding from gastric or duodenal ulcers: Following intravenous induction for prevention of rebleeding, administer 40 mg once daily for 4 weeks.

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 treated or symptoms persist, continue for another 4 weeks.

Precautions

This medication should not be used in patients with a history of allergy or hypersensitivity to specific components. In particular, patients who are hypersensitive to penicillin or macrolide antibiotics, those who are on specific cardiovascular medications, nursing mothers, and patients with a history of myocardial infarction should avoid using this medication. Patients with an allergy to Yellow No. 4 (Tartrazine) should use it cautiously. Various adverse reactions may occur with this drug, including headache, abdominal pain, diarrhea, rash, myalgia, and liver function abnormalities among others. Although rare, serious skin reactions, blood abnormalities, and hypomagnesemia can occur, necessitating immediate consultation with a physician if symptoms appear. Regular monitoring is required during long-term use, and any changes in symptoms should be discussed with a doctor. This medication may interact with other drugs, so it’s important to inform healthcare providers of any other medications being taken. Caution is necessary when used in conjunction with antiviral agents, antibiotics, anticoagulants, and others. The safety of this drug during pregnancy has not been fully established, so caution is advised during use, and it is recommended not to be taken while breastfeeding. In case of overdose, there is no specific antidote, so treatment should be symptomatic, and it should be kept out of reach of children. It is also advisable not to transfer the medication to another container, and to maintain it in the original packaging.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylactic reaction, shock, angioedema, systemic lupus erythematosus, discoid lupus erythematosus, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, DRESS syndrome, jaundice, hepatitis, liver failure, encephalopathy, sudden and severe headache, seizures, altered consciousness, vision disturbances, severe generalized edema accompanied by elevated blood pressure, thrombocytopenia, agranulocytosis, pancytopenia, asthenia

Mild side effects

Headache, dizziness, sensory disturbances, drowsiness, taste disorders, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, pancreatitis, liver enzyme elevation, hepatitis, dermatitis, itching, rash, hair loss, photosensitivity, erythema multiforme, fractures, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal distension

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

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture from entering. The storage temperature should be maintained between 1°C and 30°C at room temperature. This will help keep the efficacy of the medication for a longer period.

Appearance and packaging

Appearance

Pale pink round film-coated tablet

Package unit

28 tablets (14 tablets/PTP × 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.