Medication info
Unisium Tablet 40 mg (Esomeprazole Magnesium Trihydrate)

Unisium Tablet 40 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›43.38mg / 1 tablet
Manufacturer / importer
한국유니온제약(주)
Appearance
Pink round film-coated tablet
Packaging
28T (14T/PTP X 2)
Approval status
Active

MFDS item code 201507785 · Approved 2015.11.20 · Insurance code 665506790

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment 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, and maintenance of rebleeding prevention.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquid such as water and must not be chewed or crushed. 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. - If esophagitis is untreated or symptoms persist, continue for an additional 4 weeks. - Maintenance therapy for prevention of recurrence: 20 mg once daily. - Treatment of symptoms of gastroesophageal reflux disease without esophagitis: 20 mg once daily.
Children's dosage
For adolescents aged 12 and older 1. Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 4 weeks. - If symptoms persist or are not treated, continue for an additional 4 weeks.

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment 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, and maintenance of rebleeding prevention.

  • Gastroesophageal reflux disease
  • erosive esophagitis
  • esophagitis
  • duodenal ulcer
  • 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 treatment of gastroesophageal reflux disease, especially erosive esophagitis, and for long-term maintenance therapy to prevent recurrence in esophagitis patients. It is also effective in relieving symptoms of gastroesophageal reflux disease without esophagitis. It is used in combination with antibiotics for the treatment and prevention of recurrence of duodenal ulcers and peptic ulcers in patients with Helicobacter pylori infection. Additionally, it helps in the treatment and prevention of gastric and duodenal ulcers associated with upper gastrointestinal symptoms due to non-steroidal anti-inflammatory drug use. The medication is also used to treat Zollinger-Ellison syndrome and as a maintenance therapy to prevent rebleeding due to gastric or duodenal ulcers. Overall, it is an effective medication for the treatment and prevention of various diseases of the stomach and esophagus.

Dosage and Administration

Adult dosage

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

Children's dosage

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

Precautions

This medication should not be administered to patients who are hypersensitive to certain ingredients or benzimidazole derivatives. Patients with hypersensitivity to penicillin or macrolide antibiotics should also be cautious. Special caution should be taken during combination therapy for eradication of Helicobacter pylori. Additionally, this medication is not to be administered to patients taking certain heart-related medications or antivirals, nursing women, or those with a history of myocardial infarction. Uncommon adverse reactions may occur in various systems including blood, immune, metabolic, psychiatric, neurological, gastrointestinal, liver, skin, etc., so patients should consult a physician if any abnormal symptoms arise. Prolonged use may lead to electrolyte imbalances such as hypomagnesemia, necessitating regular testing. This medication can suppress gastric acid secretion, increasing the risk of bacterial overgrowth in the stomach, so if diarrhea persists, it should be reported to healthcare professionals. Due to numerous drug interactions, patients must consult a physician or pharmacist when taking with other medications, especially antivirals, anticoagulants, and certain antibiotics. Its safety during pregnancy has not been fully established, so it should only be used cautiously when necessary, and it should not be used during breastfeeding. In case of overdose, as there is no specific antidote, patients should seek immediate treatment from medical institutions. It is safe to store out of reach of children and not transfer into other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylaxis, shock, severe hypomagnesemia, mental confusion, pancreatitis, jaundice, hepatitis, liver failure, encephalopathy, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), interstitial nephritis, rhabdomyolysis, Clostridium difficile-associated diarrhea, severe.

Mild side effects

  • Headache
  • dizziness
  • paresthesia
  • drowsiness
  • taste disturbance
  • blurred vision
  • bronchospasm
  • abdominal pain
  • constipation
  • diarrhea
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  • abdominal distension
  • nausea
  • vomiting
  • dry mouth
  • stomatitis
  • gastrointestinal candidiasis
  • increased liver enzymes
  • dermatitis
  • itching
  • rash
  • hair loss
  • photosensitivity
  • fractures
  • arthralgia
  • myalgia
  • muscle weakness
  • asthenia
  • increased sweating
  • allergic reaction
  • back pain
  • chest pain
  • substernal chest pain
  • facial edema
  • facial flushing
  • fatigue
  • fever
  • influenza-like symptoms.

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 recommended to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28T (14T/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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.