Medication info
Esomel 20 mg Tablet (Esomeprazole Magnesium Trihydrate)

Esomel 20 mg Tablet (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Esomeprazole Magnesium Trihydrate›21.69mg / 1 tablet
Manufacturer / importer
(주)씨엠지제약
Appearance
Pale pink round film-coated tablet
Packaging
28 tablets (14 tablets/PTP x 2)
Approval status
Active

MFDS item code 201404651 · Approved 2014.10.10 · Insurance code 648602780

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive reflux esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcer, relief of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory medications, treatment and prevention of gastric ulcer and duodenal ulcer, treatment of Zollinger-Ellison syndrome, preventive maintenance effects against rebleeding from gastric ulcers.
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 reflux esophagitis: 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 - As needed
Children's dosage
Adolescents aged 12 and above - Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks - Treatment of symptoms of gastroesophageal reflux disease without esophagitis: 1

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive reflux esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcer, relief of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory medications, treatment and prevention of gastric ulcer and duodenal ulcer, treatment of Zollinger-Ellison syndrome, preventive maintenance effects against rebleeding from gastric ulcers.

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

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

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 reflux esophagitis: 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 - As needed

Children's dosage

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

Precautions

This medication should not be administered to certain patients. Patients with hypersensitivity to this drug or its components, or who have experienced such reactions in the past, should not use it. Additionally, when used in combination with amoxicillin or clarithromycin for Helicobacter pylori eradication, patients allergic to penicillin or macrolide antibiotics should also not be given this medication. It is also safer to avoid using this medication in patients on certain cardiac drugs, antiviral agents, and in nursing women. When taking this medication, attention is needed as various side effects may occur. Digestive symptoms like headache, abdominal pain, diarrhea, nausea, and vomiting are commonly reported, while rare cases may include hematological abnormalities, allergic reactions, mental symptoms, skin rashes, and liver function abnormalities. Especially, if muscle pain or weakness occurs, serious conditions like rhabdomyolysis should be suspected and immediate medical consultation is required. Regular check-ups are necessary when taken for extended periods. This medication decreases stomach acid secretion which may increase the risk of bacterial overgrowth in the stomach, thus if diarrhea persists, you should consult a doctor. Additionally, long-term use may increase the risk of fractures, so patients at risk of osteoporosis should be cautious. There may be a decrease in magnesium levels, requiring periodic checks of serum magnesium levels especially when taken long-term or in combination with certain medications. This medication may interact with other medications, so if there are concurrent medications, it is essential to inform healthcare providers. Caution is particularly needed when used with drugs affecting blood coagulation, antiviral agents, some antibiotics, and anticonvulsants. During pregnancy, safety data for this medication is limited, thus pregnant women should be cautious and consult a physician prior to use. Nursing mothers are advised not to take this medication. In case of overdose, there is no specific antidote, so appropriate treatment according to symptoms and general management is necessary. Finally, this medication should be kept out of reach of children, and transferring it to another container is not advisable for maintaining quality.

Side effects and when to seek care immediately

Serious side effects

Angioedema, anaphylaxis, shock, urticaria, severe rashes with fever, blistering, skin peeling, pain in oral/ocular mucosa, bronchospasm, difficulty breathing, jaundice, hepatitis, liver failure, encephalopathy in patients with pre-existing liver disease, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), severe swelling, elevated blood pressure

Mild side effects

Headache, dizziness, sensory disturbances, drowsiness, 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, fractures, arthralgia, myalgia, renal interstitial nephritis, gynecomastia, weakness, increased sweating, Clostridium difficile-associated diarrhea, allergic reactions, back pain, chest pain, facial swelling

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

Storage

This medication may be weak against air or moisture, so it should be stored in a tightly sealed container. Additionally, it is important to store it at room temperature between 1°C and 30°C to maintain its effectiveness.

Appearance and packaging

Appearance

Pale pink round film-coated tablet

Package unit

28 tablets (14 tablets/PTP 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.