Medication info

CG-Pra 20 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥Approval withdrawn
Ingredient · strength
Esomeprazole Magnesium Trihydrate›22.25mg / 1 tablet
Manufacturer / importer
(주)휴온스생명과학
Appearance
Pink round film-coated tablet
Packaging
28 tablets / PTP [14 tablets / Alu-Alu x 2]
Approval status
Approval withdrawn

MFDS item code 202002255 · Approved 2020.03.31

This product's status changed to Approval withdrawn on 2024.04.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

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 (NSAIDs), treatment and prevention of gastric and duodenal ulcers, treatment of Zollinger-Ellison syndrome, and maintenance therapy for the prevention of rebleeding of gastric ulcers.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with water or other liquids and not chewed or crushed. 1. Gastroesophageal reflux disease (GERD) - Treatment for erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks; if treatment is incomplete, take an additional 4 weeks. - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: 20 mg once daily; if symptoms are not controlled, further consultation is needed.
Children's dosage
Adolescents aged 12 years and older - Gastroesophageal reflux disease (GERD) - Treatment for erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks; if treatment is incomplete, take an additional 4 weeks. - Gastroesophageal reflux disease symptoms without esophagitis.

Ingredients

Manufacturer
(주)휴온스생명과학

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 (NSAIDs), treatment and prevention of gastric and duodenal ulcers, treatment of Zollinger-Ellison syndrome, and maintenance therapy for the prevention of rebleeding of gastric ulcers.

  • Gastroesophageal reflux disease
  • erosive reflux esophagitis
  • esophagitis
  • symptoms of gastroesophageal reflux disease without esophagitis
  • Helicobacter pylori-positive duodenal ulcers
  • peptic ulcers
  • upper gastrointestinal pain
  • upper gastrointestinal discomfort
  • upper gastrointestinal burning sensation
  • NSAID-related gastric ulcers
  • NSAID-related duodenal ulcers
  • Zollinger-Ellison syndrome
View approved original text

This medication is effective for the treatment and symptom relief of gastroesophageal reflux disease and erosive reflux esophagitis. It is also used in combination with antibiotics for the eradication of Helicobacter pylori and for the treatment and prevention of recurrence in patients with duodenal ulcers and peptic ulcers. It assists in the treatment of gastrointestinal symptoms associated with NSAIDs and in the treatment and prevention of gastric ulcers and duodenal ulcers. It contributes to patient health improvement by treating Zollinger-Ellison syndrome and providing maintenance therapy to prevent rebleeding. Therefore, it is widely used for the treatment of various gastrointestinal diseases and symptoms.

Dosage and Administration

Adult dosage

This medication should be swallowed with water or other liquids and not chewed or crushed. 1. Gastroesophageal reflux disease (GERD) - Treatment for erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks; if treatment is incomplete, take an additional 4 weeks. - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: 20 mg once daily; if symptoms are not controlled, further consultation is needed.

Children's dosage

Adolescents aged 12 years and older - Gastroesophageal reflux disease (GERD) - Treatment for erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks; if treatment is incomplete, take an additional 4 weeks. - Gastroesophageal reflux disease symptoms without esophagitis.

Precautions

This medication should not be administered to certain patients. For example, patients allergic to this medication or its ingredients or those who have experienced hypersensitivity should not take it. In addition, patients allergic to penicillin or macrolide antibiotics should exercise caution if taking this medication in combination. Concurrent use with certain heart-related medications or antiviral agents is prohibited. This medication is not recommended for nursing mothers. During treatment, although rare, blood disorders such as leukopenia, thrombocytopenia, hypomagnesemia, hypersensitivity reactions, gastrointestinal symptoms, skin rashes, and various side effects may occur; if any abnormal symptoms arise, consult a doctor immediately. Regular check-ups are needed with long-term use, especially after over a year of continuous use, magnesium levels should be checked periodically. As this medication inhibits gastric acid secretion, there is a slight increased risk of bacterial infections in the gastrointestinal tract, and the risk of fractures may also increase, thus caution is needed for patients at risk of osteoporosis. This medication has many drug interactions, so it is essential to consult healthcare personnel regarding the concurrent use of other medications during treatment with this drug. Although no significant issues were found in animal studies during pregnancy, it should be prescribed cautiously to pregnant women, and breastfeeding mothers should avoid taking it. There is no specific antidote for overdose, so appropriate treatment according to symptoms should be administered, and it should be kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylactic reactions, shock, angioedema, fever, jaundice, hepatitis, liver failure, Stevens-Johnson syndrome (skin and mucous membrane syndrome), toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), interstitial nephritis, Clostridium difficile-associated diarrhea, myocardial infarction, deep vein thrombosis, QT prolongation, ventricular tachycardia, ventricular fibrillation, Torsades de Pointes.

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, elevated liver enzymes, hepatitis, dermatitis, itching, rash, hair loss, photosensitivity, fractures, joint pain, muscle pain, muscular weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal bloating, allergic reactions.

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

Storage

This medication should be stored in a tightly closed container to prevent air or humidity from entering. Additionally, it should be kept at room temperature between 1°C to 30°C, avoiding very cold or hot places.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets / PTP [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.