Medication info
Nexiten Tablets 40mg (Esomeprazole Magnesium Trihydrate)

Nexiten Tablets 40mg (Esomeprazole Magnesium Trihydrate)

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

MFDS item code 201906673 · Approved 2019.09.24

Summary

Main use
Improvement of gastrointestinal diseases such as gastroesophageal reflux disease (erosive reflux esophagitis) treatment and Helicobacter pylori-positive peptic ulcer treatment.
Who uses it
Adults · Children
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 reflux esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis is untreated or symptoms persist, continue for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention is necessary. · Once symptoms improve, subsequent symptoms can be managed with 20 mg once daily. · In adults, 20 mg can be administered once daily as needed. For patients at high risk of developing gastric or duodenal ulcers due to nonsteroidal anti-inflammatory drug use, continuous symptom management is not recommended as needed.
Children's dosage
Adolescents aged 12 years and older 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis is untreated or symptoms persist, continue for an additional 4 weeks.

Ingredients

Manufacturer
(주)라이트팜텍

Efficacy & effects

Improvement of gastrointestinal diseases such as gastroesophageal reflux disease (erosive reflux esophagitis) treatment and Helicobacter pylori-positive peptic ulcer treatment.

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

This medication is used for the treatment of gastroesophageal reflux disease, particularly erosive reflux esophagitis, and for maintenance therapy to prevent relapse in patients with esophagitis. Additionally, it helps treat and prevent recurrence of duodenal ulcers and peptic ulcers caused by Helicobacter pylori infection. It is also effective for the treatment of upper gastrointestinal symptoms and gastric ulcers caused by the use of non-steroidal anti-inflammatory drugs, as well as for the prevention of gastric ulcers and duodenal ulcers. It is used in the treatment of Zollinger-Ellison syndrome and for maintenance therapy to prevent bleeding due to gastric ulcers or duodenal ulcers. In summary, this medication is widely used for the treatment and prevention of various gastrointestinal diseases.

Dosage and Administration

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 reflux esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis is untreated or symptoms persist, continue for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention is necessary. · Once symptoms improve, subsequent symptoms can be managed with 20 mg once daily. · In adults, 20 mg can be administered once daily as needed. For patients at high risk of developing gastric or duodenal ulcers due to nonsteroidal anti-inflammatory drug use, continuous symptom management is not recommended as needed.

Children's dosage

Adolescents aged 12 years and older 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis is untreated or symptoms persist, continue for an additional 4 weeks.

Precautions

This medication should not be used in certain patients. Patients who are allergic to this medication or any of its components, or who have experienced hypersensitivity reactions to benzimidazole derivatives should not take this medication. Additionally, patients who are allergic to penicillin-based or macrolide antibiotics should not use this medication when combined with amoxicillin or clarithromycin for the eradication of Helicobacter pylori. Patients taking certain heart-related medications or antivirals, as well as nursing women, should also avoid taking this medication. Adverse effects may occur with this medication, so caution is needed. Common gastrointestinal symptoms such as headache, abdominal pain, diarrhea, nausea, and vomiting may occur. Rarely, serious symptoms such as blood disorders, hypersensitivity, and hypomagnesemia have been reported. If symptoms such as myalgia, weakness, or arrhythmia occur, consult a doctor immediately. Regular examinations are necessary with long-term use of this medication. When taking for more than a year, magnesium levels in the blood should be monitored regularly, and since there may be an increased risk of fractures, bone density tests are also recommended. Additionally, if symptoms suggestive of malignancy occur, malignancy must be ruled out before taking this medication. This medication may interact with other drugs, so patients should inform their doctor or pharmacist of any medications they are currently taking. Care should be taken, especially when used with anticoagulants like warfarin, antivirals, anticonvulsants, antidepressants, etc., and dosage adjustments or monitoring may be required. Data on the safety of this medication in pregnancy is limited, so women who are pregnant or planning to become pregnant should consult a healthcare professional before taking this medication. It is recommended that nursing women do not take this medication. In case of overdose, there is no specific antidote, so treatment according to symptoms and general maintenance therapy is required. It should be kept out of reach of children and should not be stored in other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, shock, severe allergic reactions, jaundice, hepatitis, liver failure, encephalopathy, mucocutaneous skin syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), acute generalized exanthematous pustulosis, eosinophilia and systemic symptoms drug reaction (DRESS syndrome), rhabdomyolysis, severe edema, hypocalcemia, hypokalemia, severe hypomagnesemia, severe neurological symptoms (seizures).

Mild side effects

Headache, dizziness, paresthesia, drowsiness, taste disturbance, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, increased liver enzymes, hepatitis, dermatitis, itching, rash, hair loss, photosensitivity, fractures, arthralgia, myalgia, renal interstitial nephritis, gynecomastia, weakness, increased sweating, Clostridium difficile-associated diarrhea, allergic reactions, chest pain, facial swelling.

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

Storage

This medication should be stored in a sealed container to prevent exposure to air or moisture. It is important to maintain the storage temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets/box [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.