Medication info
Nexprazole 20mg (Esomeprazole Magnesium Trihydrate)

Nexprazole 20mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Dihydrate›21.69mg / 1 tablet
Manufacturer / importer
한화제약(주)
Appearance
Pink round film-coated tablets
Packaging
28 tablets (14 tablets / Alu-Alu X 2)
Approval status
Active

MFDS item code 201600986 · Approved 2016.02.22 · Insurance code 651601970

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis) and treatment of Helicobacter pylori-positive peptic ulcer, relief of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs.
Who uses it
Adults · Children
Adult dosage
The medication should be swallowed whole with liquids like 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 continue or there is no improvement, continue for an additional 4 weeks. - Maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily. - Treatment of symptoms associated with gastroesophageal reflux disease in the absence of esophagitis.
Children's dosage
For adolescents aged 12 years and older: 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. - If not improved or symptoms persist, an additional 4 weeks of treatment.

Ingredients

Manufacturer
한화제약(주)

Efficacy & effects

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

  • Gastroesophageal reflux disease
  • erosive esophagitis
  • esophagitis
  • symptoms of gastroesophageal reflux disease without esophagitis
  • Helicobacter pylori-positive duodenal ulcers
  • peptic ulcers
  • upper gastrointestinal symptoms
  • pain
  • discomfort
  • burning sensation
  • gastric ulcer related to non-steroidal anti-inflammatory drug administration
  • duodenal ulcers
View approved original text

This medication is used for the treatment of gastroesophageal reflux disease and erosive esophagitis, and it is effective as a long-term maintenance therapy to prevent recurrence in patients with esophagitis. It also helps alleviate symptoms of gastroesophageal reflux disease in absence of esophagitis. This drug is utilized for the treatment and prevention of recurrence of duodenal ulcers and peptic ulcers caused by Helicobacter pylori infection. It is effective for the treatment, prevention of gastric ulcers and duodenal ulcers related to the use of non-steroidal anti-inflammatory drugs, and is also used for the treatment of Zollinger-Ellison syndrome. It assists in the maintenance therapy to prevent rebleeding from gastric or duodenal ulcers post intravenous injection. This medication is beneficial for the treatment and prevention of various gastrointestinal diseases.

Dosage and Administration

Adult dosage

The medication should be swallowed whole with liquids like 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 continue or there is no improvement, continue for an additional 4 weeks. - Maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily. - Treatment of symptoms associated with gastroesophageal reflux disease in the absence of esophagitis.

Children's dosage

For adolescents aged 12 years and older: 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. - If not improved or symptoms persist, an additional 4 weeks of treatment.

Precautions

This medication should not be administered to certain patients. Patients who have allergy or hypersensitivity to this drug or its components, or to benzimidazole derivatives, should not use it. Moreover, patients with hypersensitivity to antibiotics amoxicillin or clarithromycin should not be administered when used in combination for the eradication of Helicobacter pylori. Patients taking specific heart medications or with a history of myocardial infarction, as well as nursing women, should not use this medication. This medication may cause various side effects. Gastrointestinal symptoms such as headache, abdominal pain, diarrhea, nausea, and vomiting may occur frequently, and sometimes neurological symptoms like dizziness and insomnia are also reported. Rarely, serious side effects such as decreased blood cell count, hypersensitivity reactions, liver function anomalies, skin rashes, and myalgia may occur, requiring immediate consultation with a physician if symptoms are severe or persistent. With long-term use, electrolyte disturbances such as hypomagnesemia may arise, necessitating regular testing. This medication inhibits gastric acid secretion, thereby lowering gastric acidity, which can alter the normal bacterial balance in the gastrointestinal tract, potentially increasing the risk of certain infections. Additionally, long-term or high-dose usage may elevate the risk of fractures, so caution is advised in patients with a risk of osteoporosis. This medication has a high potential for interaction with other drugs. Particularly, when used in combination with antibiotics, antivirals, anticoagulants, antidepressants, etc., the effects of the drugs may change, making it imperative to inform your doctor or pharmacist about medications currently being taken. Moreover, co-administration with certain drugs may alter the plasma concentration of this medication or other medications, necessitating caution. Due to limited data on safety during pregnancy, pregnant women should use this medication cautiously and after consulting a physician. Nursing women should avoid this medication since it may be excreted in breast milk. There are no specific antidotes for overdose, so symptomatic treatment and general management are necessary; it should be stored out of reach of children to ensure safety. Additionally, transferring to another container is advised against due to the risk of quality degradation or misuse.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, shock, severe edema, hypomagnesemia, hypocalcemia, hypokalemia, hepatitis, liver failure, jaundice, Stevens-Johnson syndrome, toxic epidermal necrolysis, mucosal membrane syndrome, acute generalized exanthematous pustulosis, eosinophilia, and systemic symptoms associated with drug reaction (DRESS syndrome), interstitial nephritis, severe allergic reactions, severe skin adverse reactions, respiratory distress, difficulty in breathing.

Mild side effects

Headache, insomnia, anxiety, mental confusion, depression, aggression, hallucinations, dizziness, altered perception, drowsiness, taste disturbances, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal distension, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, pancreatitis, elevated liver enzymes, dermatitis, itching, rashes, hair loss, photosensitivity, fractures, arthralgia, myalgia, muscle weakness, asthenia, increased sweating, Clostridium difficile-associated diarrhea.

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage will safeguard the medication's efficacy.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

28 tablets (14 tablets / Alu-Alu X 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.