Medication info
New Esomeprazole Tablet 20 mg (Esomeprazole Magnesium Trihydrate)

New Esomeprazole Tablet 20 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›22.25mg / 1 tablet
Manufacturer / importer
안국뉴팜(주)
Appearance
Pale pink, round film-coated tablet
Packaging
28 tablets (14 tablets/PTP) x 2, 30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201604270 · Approved 2016.07.11 · Insurance code 053600410

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, relief of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, treatment and prevention of gastric and duodenal ulcers, treatment of Zollinger-Ellison syndrome, prevention of rebleeding from gastric and duodenal ulcers and maintenance therapy
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquid such as water and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg taken once daily for 4 weeks. - If symptoms are not treated or persist, an additional 4 weeks of administration. - Maintenance therapy for prevention of recurrence of esophagitis: 20 mg taken once daily. - Symptom treatment for gastroesophageal reflux disease without esophagitis: 2 mg taken once daily.
Children's dosage
Adolescents aged 12 and above 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg administered once daily for 4 weeks. - If symptoms persist or are not treated, an additional 4 weeks of administration.

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, relief of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, treatment and prevention of gastric and duodenal ulcers, treatment of Zollinger-Ellison syndrome, prevention of rebleeding from gastric and duodenal ulcers and maintenance therapy

  • Gastroesophageal reflux disease
  • erosive esophagitis
  • esophagitis
  • Helicobacter pylori positive duodenal ulcer
  • peptic ulcer
  • upper gastrointestinal symptoms
  • pain
  • discomfort
  • burning sensation
  • gastric ulcers and duodenal ulcers related to non-steroidal anti-inflammatory drug administration
  • Zollinger-Ellison syndrome
  • rebleeding caused by gastric or duodenal ulcers
View approved original text

This medication is used to treat gastroesophageal reflux disease and erosive esophagitis and prevent recurrence. It is also effective for the treatment and prevention of recurrence of duodenal ulcers and peptic ulcers caused by Helicobacter pylori infection. It helps in treating and preventing upper gastrointestinal symptoms or gastric ulcers caused by non-steroidal anti-inflammatory drugs. It is also used to treat Zollinger-Ellison syndrome, and it is effective in preventing rebleeding from gastric or duodenal ulcers and for maintenance therapy. It is broadly used for various gastrointestinal diseases to improve symptoms and prevent recurrence.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquid such as water and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg taken once daily for 4 weeks. - If symptoms are not treated or persist, an additional 4 weeks of administration. - Maintenance therapy for prevention of recurrence of esophagitis: 20 mg taken once daily. - Symptom treatment for gastroesophageal reflux disease without esophagitis: 2 mg taken once daily.

Children's dosage

Adolescents aged 12 and above 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg administered once daily for 4 weeks. - If symptoms persist or are not treated, an additional 4 weeks of administration.

Precautions

This medication should not be administered to certain patients. Patients who are allergic to this drug or its components, have experienced hypersensitivity reactions, are allergic to certain antibiotics, and those taking specific heart-related medications may be at risk when using this drug. Women who are breastfeeding, as well as patients with a history of heart disease, should avoid using this drug. This medication contains a pigment called Yellow No. 5, and patients allergic or hypersensitive to this component should use it cautiously. When using this drug, various side effects may appear. For example, decreased blood cell count, allergic reactions, electrolyte imbalances, headache, dizziness, gastrointestinal problems, liver function abnormalities, skin rashes, muscle weakness have been reported. In addition, severe side effects such as serious skin reactions or muscle damage may occur, so it is crucial to consult medical professionals immediately if symptoms appear. Regular check-ups to monitor for abnormalities are essential if this medication is used long-term. This drug can inhibit gastric acid secretion and may promote bacterial growth in the stomach, so it is necessary to inform medical personnel if symptoms of diarrhea or infection persist. Moreover, the risk of fractures may increase with long-term use, so patients at risk of osteoporosis should be cautious. This medication may interact with other drugs, so it is essential to inform your doctor or pharmacist about any other medications being taken. Particularly, caution is advised when used with antiviral agents, antibiotics, anticoagulants, antidepressants, etc. Safety data for this drug during pregnancy is limited, so women who are pregnant or planning to become pregnant should consult a physician before use. If breastfeeding, it is advisable to avoid this medication as it may be transmitted through breast milk. There is no specific antidote for overdose; appropriate treatment should be received according to symptoms. Lastly, this medication should be kept out of reach of children and stored in the original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylactic reaction, shock, severe allergic reactions, severe rash accompanied by high fever, blisters, skin peeling, pain in oral/ocular mucosa, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), severe skin abnormal reactions, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough and fever

Mild side effects

  • Headache
  • insomnia
  • anxiety
  • confusion
  • depression
  • aggression
  • hallucinations
  • dizziness
  • altered perception
  • drowsiness
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  • taste disorders
  • blurred vision
  • bronchospasm
  • abdominal pain
  • constipation
  • diarrhea
  • abdominal distension
  • nausea
  • vomiting
  • dry mouth
  • stomatitis
  • gastrointestinal candidiasis
  • increased liver enzymes
  • hepatitis
  • dermatitis
  • itching
  • rash
  • hair loss
  • photosensitivity
  • erythema multiforme
  • myalgia
  • muscle weakness
  • arthralgia
  • fracture
  • interstitial nephritis
  • gynecomastia
  • asthenia
  • increased sweating

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

Storage

This drug may be sensitive to air or moisture, so it should be stored in a sealed container. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature, which will help maintain the efficacy and safety of the medication for a long time.

Appearance and packaging

Appearance

Pale pink, round film-coated tablet

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

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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.