Medication info
Nelfra 20 mg (Esomeprazole Magnesium Trihydrate)

Nelfra 20 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Dihydrate›21.69mg / 1 tablet
Manufacturer / importer
한국넬슨제약(주)
Appearance
Pale pink rectangular film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alux2)
Approval status
Active

MFDS item code 201700947 · Approved 2017.02.22 · Insurance code 656701990

Summary

Main use
Treatment and prevention of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of Helicobacter pylori positive peptic ulcer, alleviation of upper gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed whole 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 treatment fails or symptoms persist, an additional 4 weeks of dosing - Maintenance therapy to prevent recurrence in esophagitis: 20 mg once daily - Treatment for symptoms of gastroesophageal reflux disease without esophagitis:
Children's dosage
Adolescents aged 12 years and older - Gastroesophageal reflux disease (GERD) - Erosive esophagitis treatment: 40 mg once daily for 4 weeks - Additional 4 weeks in case of treatment failure - For gastroesophageal reflux disease without esophagitis:

Ingredients

Manufacturer
한국넬슨제약(주)

Efficacy & effects

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

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

This medication can be used long-term for the treatment and prevention of gastroesophageal reflux disease, especially erosive esophagitis. It is also effective in alleviating symptoms of gastroesophageal reflux disease without esophagitis. It is used as part of combination therapy with antibiotics for treating duodenal ulcers or peptic ulcers due to Helicobacter pylori infection, helping to prevent recurrence. It is also suitable for short-term therapy related to upper gastrointestinal symptoms that may occur from using non-steroidal anti-inflammatory drugs. For patients requiring continuous use of non-steroidal anti-inflammatory drugs, it helps treat and prevent gastric ulcers and duodenal ulcers. Additionally, it is used for the treatment of Zollinger-Ellison syndrome and as maintenance therapy to prevent rebleeding from gastric or duodenal ulcers. Overall, it is used in the treatment and prevention of various gastrointestinal disorders.

Dosage and Administration

Adult dosage

This medication should be swallowed whole 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 treatment fails or symptoms persist, an additional 4 weeks of dosing - Maintenance therapy to prevent recurrence in esophagitis: 20 mg once daily - Treatment for symptoms of gastroesophageal reflux disease without esophagitis:

Children's dosage

Adolescents aged 12 years and older - Gastroesophageal reflux disease (GERD) - Erosive esophagitis treatment: 40 mg once daily for 4 weeks - Additional 4 weeks in case of treatment failure - For gastroesophageal reflux disease without esophagitis:

Precautions

This medication should not be administered to patients who have allergic reactions or hypersensitivity to specific ingredients. In particular, patients who are allergic to penicillins, macrolide antibiotics, those taking specific heart-related medications, and nursing women should avoid using this medication. This medication contains Yellow No. 5 (Tartrazine), and patients with allergies to this component should be cautious. During use, various side effects such as headache, dizziness, abdominal pain, diarrhea, and skin rash may occur, so if any abnormal symptoms appear, immediate consultation with a doctor is necessary. Especially, if symptoms such as muscle pain, weakness, or arrhythmias occur, stop taking the medication immediately and seek medical evaluation. This medication can lower gastric acidity, increasing the risk of bacterial infections, so if diarrhea persists or worsens, inform healthcare providers. Long-term use may increase the risk of bone fractures, so patients at risk for osteoporosis should undergo regular examinations. Additionally, this medication can lower serum magnesium levels, so patients using it long-term or in combination with certain diuretics should periodically check their magnesium levels. The safety of this medication during pregnancy has not been sufficiently confirmed, so pregnant women should consult a doctor before use. Nursing women are advised not to take this medication. In case of overdose, there is no specific antidote, so appropriate treatment should be provided based on symptoms, and it should be stored out of reach of children. Furthermore, this medication may interact with various drugs, so it is essential to inform medical professionals if other medications are being taken. Regular monitoring of symptoms and test results is important while taking this medication, and immediate consultation with professionals is necessary if any unusual symptoms occur.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylactic reaction/shock, severe rash with high fever, blisters, skin peeling, pain on mucous membranes of mouth/eyes, bronchospasm, difficulty breathing or shortness of breath, jaundice, hepatitis, hepatic failure, encephalopathy, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), severe edema.

Mild side effects

  • Leukopenia
  • thrombocytopenia
  • fever
  • angioedema
  • peripheral edema
  • hyponatremia
  • hypomagnesemia
  • insomnia
  • anxiety
  • mental confusion
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  • depression
  • aggression
  • hallucinations
  • headache
  • dizziness
  • sensory disturbances
  • drowsiness
  • taste disorders
  • blurred vision
  • vertigo
  • bronchospasm
  • pancreatitis
  • abdominal pain
  • constipation
  • diarrhea
  • abdominal distension
  • nausea
  • vomiting
  • dry mouth
  • stomatitis
  • gastrointestinal candidiasis
  • microscopic colitis
  • liver enzyme elevation.

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

Storage

This medication must be stored in a tightly sealed container to prevent exposure to air or moisture. Additionally, it is important to maintain storage temperature between 1 degree and 30 degrees Celsius to ensure the medication's effectiveness.

Appearance and packaging

Appearance

Pale pink rectangular film-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alux2)

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

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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.