Medication info

Esoditi Oral Disintegrating Tablet 40 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥Approval withdrawn
Ingredient · strength
Esomeprazole Magnesium Trihydrate›43.38mg / 1 tablet
Manufacturer / importer
(주)태준제약
Appearance
Round white tablet with gray speckles
Packaging
28 tablets/box [7 tablets/PTP X 4]
Approval status
Approval withdrawn

MFDS item code 201902349 · Approved 2019.04.16

This product's status changed to Approval withdrawn on 2024.01.09. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of gastroesophageal reflux disease (such as erosive reflux esophagitis), treatment and prevention of recurrence of Helicobacter pylori-positive peptic ulcers, and relief of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs.
Who uses it
Adults · Children
Adult dosage
This medication should be placed on the tongue and allowed to dissolve with saliva; it should not be chewed or crushed. 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. - If untreated or symptoms persist, extend for an additional 4 weeks. - Maintenance therapy for prevention of recurrence: 20 mg once daily. - For the treatment of gastroesophageal reflux disease symptoms without esophagitis: 20 mg once daily.
Children's dosage
Adolescents aged 12 and older - For the treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. - If not treated or symptoms persist, extend for an additional 4 weeks. - Symptoms of gastroesophageal reflux disease without esophagitis.

Ingredients

Manufacturer
(주)태준제약

Efficacy & effects

Treatment of gastroesophageal reflux disease (such as erosive reflux esophagitis), treatment and prevention of recurrence of Helicobacter pylori-positive peptic ulcers, and relief of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs.

  • Gastroesophageal reflux disease
  • erosive reflux esophagitis
  • esophagitis
  • symptoms of gastroesophageal reflux disease without esophagitis
  • Helicobacter pylori-positive duodenal ulcers
  • peptic ulcers
  • upper gastrointestinal symptoms
  • pain
  • discomfort
  • burning sensation
  • gastric ulcers and duodenal ulcers related to non-steroidal anti-inflammatory drug use
  • Zollinger-Ellison syndrome
View approved original text

This medication is effective for the long-term maintenance therapy of gastroesophageal reflux disease, particularly erosive reflux esophagitis, and for the prevention of recurrence. It is also used for the relief of symptoms in gastroesophageal reflux disease without esophagitis. It can be used in combination with antibiotics for the treatment and prevention of recurrence of duodenal ulcers and peptic ulcers due to Helicobacter pylori infection. It is also effective for the relief of gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug use and for the treatment and prevention of gastric ulcers and duodenal ulcers. It is used in the treatment of Zollinger-Ellison syndrome and for the prevention of rebleeding of gastric or duodenal ulcers. This medication helps in the treatment and prevention of various gastrointestinal diseases.

Dosage and Administration

Adult dosage

This medication should be placed on the tongue and allowed to dissolve with saliva; it should not be chewed or crushed. 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. - If untreated or symptoms persist, extend for an additional 4 weeks. - Maintenance therapy for prevention of recurrence: 20 mg once daily. - For the treatment of gastroesophageal reflux disease symptoms without esophagitis: 20 mg once daily.

Children's dosage

Adolescents aged 12 and older - For the treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. - If not treated or symptoms persist, extend for an additional 4 weeks. - Symptoms of gastroesophageal reflux disease without esophagitis.

Precautions

This medication should not be used in patients who are allergic to this drug or any of its components, or who have had hypersensitivity reactions to benzimidazole derivatives. Patients allergic to certain antibiotics such as penicillins and macrolides should also be cautious when using this medication together. During treatment with this medication, it is important not to take certain drugs, such as terfenadine, cisapride, pimodivir, and astemizole. Patients taking atazanavir, nelpinavir, or rilpivirine should avoid using this medication. Women who are nursing should not take this medication. This medication can cause a variety of side effects, including a decrease in blood cell count or allergic reactions, insomnia, headache, abdominal pain, liver dysfunction, skin rashes, and other symptoms. Particularly, long-term use can lead to electrolyte imbalances such as hypomagnesemia, thus regular monitoring is necessary. Long-term use of this medication may increase the risk of gastrointestinal bacterial infections; therefore, if diarrhea persists, it is important to consult with a healthcare professional. Additionally, patients with osteoporosis or those at risk of fractures should be cautious as prolonged high-dose use may increase the risk of fractures. This medication may interact with other drugs, so it is essential to inform your healthcare provider of any other medications currently being taken. In particular, when used in combination with warfarin, digoxin, methotrexate, clopidogrel, etc., blood concentration changes need to be monitored. Safety data regarding the use during pregnancy is limited; therefore, if pregnant, consulting a healthcare provider before taking this medication is crucial. If a breastfeeding woman takes this medication, the safety of the baby has not been established, and nursing should be discontinued or an alternative medication should be chosen. In case of overdose, there are no specific antidotes; treatment should be symptomatic, following the guidance of healthcare professionals. This medication should be kept out of reach of children, and transferring it to other containers may lead to accidental ingestion or quality deterioration.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylactic reactions, shock, hypomagnesemia, mental confusion, severe rash with fever, blisters, exfoliative dermatitis, oral/ocular mucosal pain, bronchospasm, jaundice, hepatitis, liver failure, encephalopathy, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, DRESS syndrome, rhabdomyolysis, severe edema, hypertension, severe allergic reactions, severe skin adverse reactions.

Mild side effects

Headache, dizziness, paresthesia, drowsiness, taste disturbances, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal distension, nausea, vomiting, dry mouth, stomatitis, elevated liver enzymes, dermatitis, itching, rash, hair loss, photosensitivity, fractures, arthralgia, myalgia, nephritis, gynecomastia, weakness, increased sweating, Clostridium difficile-associated diarrhea, allergic reactions, back pain, chest pain, facial swelling, flushing, fatigue, rash.

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. This storage method helps to maintain the medication's efficacy and prevent degradation.

Appearance and packaging

Appearance

Round white tablet with gray speckles

Package unit

28 tablets/box [7 tablets/PTP X 4]

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.