Medication info
Isome Tablet 40 mg (Esomeprazole Magnesium Hydrate)

Isome Tablet 40 mg (Esomeprazole Magnesium Hydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Dihydrate›43.38mg / 1 tablet
Manufacturer / importer
(주)킴스제약
Appearance
Pink round film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu×2)
Approval status
Active

MFDS item code 201803827 · Approved 2018.09.27

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 ulcers 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, and should not be chewed or crushed. 1. Adults 1) Gastroesophageal Reflux Disease (GERD). - Treatment of erosive reflux esophagitis: administer 40 mg once daily for 4 weeks. If symptoms persist, continue for another 4 weeks. - Long-term maintenance therapy for recurrence prevention: 20 mg once daily. - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: 1 day 1 time, 20 mg once daily.
Children's dosage
Adolescents aged 12 years and older: - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. - Symptomatic treatment without esophagitis: 20 mg once daily. - Symptom relief.

Ingredients

Manufacturer
(주)킴스제약

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 ulcers and duodenal ulcers, treatment of Zollinger-Ellison syndrome, prevention of rebleeding from gastric and duodenal ulcers, and maintenance therapy.

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

This medication is used for the treatment of esophagitis caused by gastroesophageal reflux disease and for preventing its recurrence, for the treatment and prevention of recurrence of duodenal and peptic ulcers caused by Helicobacter pylori infection, for the treatment and prevention of upper gastrointestinal symptoms and ulcers that occur during NSAID use, for Zollinger-Ellison syndrome, and for maintenance therapy after preventing rebleeding of gastric or duodenal ulcers.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquid, and should not be chewed or crushed. 1. Adults 1) Gastroesophageal Reflux Disease (GERD). - Treatment of erosive reflux esophagitis: administer 40 mg once daily for 4 weeks. If symptoms persist, continue for another 4 weeks. - Long-term maintenance therapy for recurrence prevention: 20 mg once daily. - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: 1 day 1 time, 20 mg once daily.

Children's dosage

Adolescents aged 12 years and older: - Treatment of erosive reflux esophagitis: 40 mg once daily for 4 weeks. - Symptomatic treatment without esophagitis: 20 mg once daily. - Symptom relief.

Precautions

This medication should not be administered to certain patients. Patients who are allergic to this drug or its ingredients or have had hypersensitivity reactions should not take it. Additionally, caution is needed for patients allergic to penicillin antibiotics or macrolide antibiotics when used in combination. Specifically, patients taking certain medications or nursing mothers should not take this medication. Various adverse reactions have been reported for this drug, with common symptoms including headache, abdominal pain, diarrhea, and constipation. Rarely, blood-related abnormalities, hypersensitivity reactions, hypomagnesemia, psychiatric symptoms, liver function abnormalities, and skin rashes may occur, and if symptoms appear, immediate consultation with healthcare providers is necessary. Prolonged use may mask symptoms of malignancy; therefore, if symptoms such as weight loss, vomiting, or hematemesis occur, medical consultation is required. Regular examinations are necessary for those taking the drug for more than one year. This drug suppresses gastric acid secretion, which may increase the risk of bacterial overgrowth in the gastrointestinal tract, so if diarrhea persists, inform your healthcare provider. The risk of fractures may increase, so patients at risk for osteoporosis should have periodic monitoring. This drug is not suitable for patients with certain genetic diseases, particularly those with fructose intolerance, should avoid it. There are many drug interactions; therefore, while taking this medication, it is essential to discuss any concomitant medications with a physician or pharmacist. Caution is especially required when interacting with antiviral drugs, antibiotics, anticoagulants, and anticonvulsants. The safety of this medication during pregnancy has not been fully established; thus, pregnant women should consult their physician before taking it. Breastfeeding women are advised not to take this medication. In case of overdose, there is no specific antidote, so seek immediate medical attention for appropriate treatment, and keep it out of reach of children. To maintain quality, it is advised not to transfer this drug to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylactic reactions, shock, hypomagnesemia, hepatitis with or without jaundice, liver failure, encephalopathy, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), interstitial nephritis, seizures, severe skin reactions (SJS, TEN, DRESS, AG

Mild side effects

Headache, dizziness, sensory disturbances, drowsiness, taste disorders, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal distention, nausea, vomiting, dry mouth, stomatitis, Candida infection in the gastrointestinal tract, increased liver enzymes, dermatitis, itching, rash, hair loss, photosensitivity, fracture, arthralgia, myalgia, gynecomastia, weakness, increased sweating, abdominal distension, allergic reactions, back pain, chest pain, sternal pain, facial swelling, facial flushing, fatigue, fever,

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

Storage

This drug should be stored in a tightly closed container, protected from air and moisture. The storage temperature should be kept between 1 to 30 degrees Celsius, avoiding extremely hot or cold places.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alu×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.