Medication info
New Esopra Tablet 40 mg (Esomeprazole Magnesium Trihydrate)

New Esopra Tablet 40 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›44.5mg / 1 tablet
Manufacturer / importer
안국뉴팜(주)
Appearance
Pink round film-coated tablets
Packaging
28 tablets (14 tablets/PTP) x 2, 30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201604269 · Approved 2016.07.11 · Insurance code 053600370

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), eradication of Helicobacter pylori positive peptic ulcers and prevention of recurrence, relief of gastrointestinal symptoms related to NSAIDs, treatment and prevention of gastric ulcers and duodenal ulcers, treatment of Zollinger-Ellison syndrome, maintenance therapy for prevention of rebleeding from gastric ulcers.
Who uses it
Adults · Children
Adult dosage
This drug should be swallowed with liquids like water and not chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: Administer 40 mg once daily for 4 weeks. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily. - Treatment of symptoms of gastroesophageal reflux disease without esophagitis: 20 mg once daily.
Children's dosage
Adolescents aged 12 years and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: Administer 40 mg once daily for 4 weeks. - Treatment of symptoms of gastroesophageal reflux disease without esophagitis.

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive esophagitis), eradication of Helicobacter pylori positive peptic ulcers and prevention of recurrence, relief of gastrointestinal symptoms related to NSAIDs, treatment and prevention of gastric ulcers and duodenal ulcers, treatment of Zollinger-Ellison syndrome, maintenance therapy for prevention of rebleeding from gastric ulcers.

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

This medication can be used for a long time to treat gastroesophageal reflux disease and erosive esophagitis and to prevent the recurrence of esophagitis. It is also effective in the treatment of duodenal ulcers and peptic ulcers caused by Helicobacter pylori, and helps prevent recurrence. It is effective in treating upper gastrointestinal symptoms or gastric ulcers and prevention associated with the use of NSAIDs. It is used to treat Zollinger-Ellison syndrome and is also applied as maintenance therapy to prevent rebleeding from gastric or duodenal ulcers after intravenous administration. Overall, this drug is used to improve and treat various gastrointestinal diseases.

Dosage and Administration

Adult dosage

This drug should be swallowed with liquids like water and not chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: Administer 40 mg once daily for 4 weeks. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily. - Treatment of symptoms of gastroesophageal reflux disease without esophagitis: 20 mg once daily.

Children's dosage

Adolescents aged 12 years and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: Administer 40 mg once daily for 4 weeks. - Treatment of symptoms of gastroesophageal reflux disease without esophagitis.

Precautions

This drug should not be used in patients with known allergies to this drug or its components. Particularly, caution is needed when co-administering this drug with penicillin-type antibiotics or macrolide antibiotics in patients with allergies to these medications. Additionally, it is advisable that patients taking certain heart-related medications or antiviral drugs, and nursing mothers or patients with a history of myocardial infarction do not use this drug. This drug may cause various side effects, with headache, abdominal pain, diarrhea, dizziness, and skin rash being commonly reported. Rarely, hematological abnormalities, liver dysfunction, severe allergic reactions, or muscular problems may occur, so if any unusual symptoms appear, immediate consultation with a healthcare professional is necessary. If taking this drug for an extended period, regular checks to confirm any abnormalities are important. As this drug suppresses gastric acid secretion, it may increase the risk of certain bacterial infections. There may be an increased risk of fractures; therefore, bone health should be regularly monitored in long-term use. Further, this drug is highly likely to interact with other medications, so if taking other drugs, it is essential to inform the healthcare professional. During pregnancy, safety data on this drug are limited, thus it should be used cautiously, and it is recommended to avoid administering this drug while breastfeeding. In case of overdose, since no specific antidote is available, treatment should be provided based on the symptoms, and it must be stored in a place out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylactic reactions, shock, skin peeling, severe rash, blisters, oral/ocular mucosal pain, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), severe hypomagnesemia, liver failure, encephalopathy, liver abnormalities (including jaundice), severe edema, rhabdomyolysis, severe allergic reactions, severe skin reactions.

Mild side effects

  • Headache
  • insomnia
  • anxiety
  • confusion
  • depression
  • aggression
  • hallucinations
  • dizziness
  • drowsiness
  • taste disturbance
Show 27 more
  • blurred vision
  • bronchospasm
  • abdominal pain
  • constipation
  • diarrhea
  • abdominal bloating
  • nausea
  • vomiting
  • dry mouth
  • stomatitis
  • increased liver enzymes
  • dermatitis
  • itching
  • rash
  • hair loss
  • photosensitivity
  • fractures
  • arthralgia
  • myalgia
  • gynecomastia
  • weakness
  • increased sweating
  • allergic reactions
  • urticaria
  • increased sweating
  • urinary abnormalities
  • increased blood gastrin levels.

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

Storage

This drug should be contained in a sealed container and stored at temperatures between 1°C and 30°C in a cool, dry place, avoiding direct sunlight.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

28 tablets (14 tablets/PTP) x 2, 30 tablets/bottle, 300 tablets/bottle

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.