Medication info
Omepros ES Tablets 20 mg (Esomeprazole Magnesium Trihydrate)

Omepros ES Tablets 20 mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥
Ingredient · strength
Esomeprazole Magnesium Trihydrate›22.3mg / 1 tablet
Manufacturer / importer
(주)새한제약
Appearance
Pale pink round film-coated tablet
Packaging
28 tablets (14 tablets/PTP X 2)
Approval status
Active

MFDS item code 201905243 · Approved 2019.07.23 · Insurance code 651300740

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), eradication of Helicobacter pylori, prevention of recurrence of peptic ulcers, alleviation of gastrointestinal symptoms related to nonsteroidal anti-inflammatory drugs, and prevention of gastric ulcer.
Who uses it
Adults · Children
Adult dosage
This medication should be taken with liquids such as water, and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: administer 40 mg once daily for 4 weeks - If symptoms persist or are not treated, an additional 4 weeks of administration - Maintenance therapy to prevent recurrence: 20 mg once daily - Symptomatic therapy (in the absence of esophagitis): 20 mg once daily
Children's dosage
Adolescents aged 12 years and older - Treatment of erosive esophagitis: administer 40 mg once daily for 4 weeks - If symptoms persist or are not treated, an additional 4 weeks of administration - Symptomatic therapy (in the absence of esophagitis).

Ingredients

Manufacturer
(주)새한제약

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive esophagitis), eradication of Helicobacter pylori, prevention of recurrence of peptic ulcers, alleviation of gastrointestinal symptoms related to nonsteroidal anti-inflammatory drugs, and prevention of gastric ulcer.

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

This medication is used for the treatment of gastroesophageal reflux disease and erosive esophagitis, and it is also helpful for long-term maintenance therapy to prevent recurrence in patients with esophagitis. Additionally, it is effective in alleviating symptoms in patients with gastroesophageal reflux disease who do not have esophagitis. It is utilized in conjunction with antibiotics for eradication of Helicobacter pylori and for the treatment and prevention of recurrence of duodenal ulcers and peptic ulcers. It is also used for alleviating upper gastrointestinal symptoms associated with nonsteroidal anti-inflammatory drug usage and for treating and preventing gastric and duodenal ulcers. The medication has excellent efficacy in the treatment of Zollinger-Ellison syndrome and in the prevention and maintenance therapy of rebleeding from gastric ulcers or duodenal ulcers. It is used for the treatment and prevention of various gastrointestinal diseases.

Dosage and Administration

Adult dosage

This medication should be taken with liquids such as water, and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: administer 40 mg once daily for 4 weeks - If symptoms persist or are not treated, an additional 4 weeks of administration - Maintenance therapy to prevent recurrence: 20 mg once daily - Symptomatic therapy (in the absence of esophagitis): 20 mg once daily

Children's dosage

Adolescents aged 12 years and older - Treatment of erosive esophagitis: administer 40 mg once daily for 4 weeks - If symptoms persist or are not treated, an additional 4 weeks of administration - Symptomatic therapy (in the absence of esophagitis).

Precautions

This medication should not be used in certain patients. Patients who are allergic to this medication, its components, or have experienced hypersensitivity to benzimidazole drugs should not take this medication. Furthermore, caution is advised for patients allergic to penicillin or macrolide antibiotics used in treatment for the eradication of Helicobacter pylori. Patients currently taking specific medications, such as terfenadine, cisapride, pimodizone, astemizole, atazanavir, nelfinavir, or rilpivirine should also avoid using this medication. Nursing mothers and patients with a history of myocardial infarction should not use this medication. This medication contains a coloring agent called Yellow No. 5 (Tartrazine), so patients with hypersensitivity or a history of allergy to this ingredient should use it cautiously. Various adverse reactions may occur during the use of this medication. For example, blood-related issues, hypersensitivity reactions, electrolyte imbalances, psychiatric symptoms, neurological symptoms, gastrointestinal disorders, liver function abnormalities, skin rashes, muscle pain, and kidney problems have been reported. Rarely, serious skin reactions or severe adverse effects such as rhabdomyolysis may occur, so patients should consult healthcare professionals immediately if symptoms appear. This medication inhibits gastric acid secretion, which may slightly increase the risk of gastrointestinal infections. Long-term use may increase the risk of fractures, so patients at risk for osteoporosis should have their condition monitored regularly. Additionally, long-term use may lead to hypomagnesemia, and magnesium levels may need to be periodically tested and supplemented as necessary. This medication has a high potential for drug interactions, so special caution is required when taken alongside anticoagulants, anticonvulsants, certain antibiotics, antiviral agents, antidepressants, etc. If patients are taking other medications, they must inform their physician or pharmacist, and should seek consultation immediately if new symptoms arise. Data on the safety of this medication during pregnancy is limited, so it should only be used after adequate consultation with a physician during pregnancy. Nursing mothers are also advised not to take this medication. In case of overdose, there are no specific antidotes, so symptomatic treatment should be administered instead, along with general supportive care. Lastly, this medication should be stored out of the reach of children, and transferring it to other containers is not recommended as it may adversely affect the quality of the medication.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, anaphylactic reactions, shock, severe allergic reactions, angioedema, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, DRESS syndrome, mucocutaneous blistering syndrome, severe skin adverse reactions, jaundice, hepatic failure, encephalopathy, sudden and severe headache, seizures, confusion, visual disturbances, paralysis, agranulocytosis, pancytopenia, interstitial nephritis, severe adverse reactions.

Mild side effects

  • Leukopenia
  • thrombocytopenia
  • agranulocytosis
  • pancytopenia
  • fever
  • peripheral edema
  • hyponatremia
  • hypomagnesemia
  • insomnia
  • anxiety
Show 23 more
  • confusion
  • depression
  • aggression
  • hallucinations
  • headache
  • dizziness
  • sensory disturbances
  • drowsiness
  • taste disturbances
  • blurred vision
  • vertigo
  • bronchospasm
  • pancreatitis
  • abdominal pain
  • constipation
  • diarrhea
  • abdominal distension
  • nausea
  • vomiting
  • dry mouth
  • stomatitis
  • gastrointestinal candidiasis
  • microscopic colitis.

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. The recommended storage temperature is room temperature between 1 and 30 degrees Celsius to maintain the medication's 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.